Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 918-668-5 | CAS number: 128601-23-0
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
![](https://poisoncentres.echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
Endpoint summary
Administrative data
Description of key information
Skin Irritation
Hydrocarbons, C9 Aromatics:
Hydrocarbons, C9, Aromatics are not corrosives and are mild to moderate dermal irritants for rabbit (OECD TG 404). A series of skin irritation studies were conducted using rabbits and standard test protocols.The mean erythema scores in the four independent key studies ranged from 1.9 to 4.0; mean edema scores in these same studies ranged from 0.0 to 2.2. Therefore, Hydrocarbons, C9 aromatics can be considered to be mildly to moderately irritating to the skin, with any effects generally reversible. In addition, a study was conducted in which 26 human volunteers were dermally exposed to C9 aromatics. Results showed no evidence of aromatics being a dermal irritant to humans. Using qualitative weight of evidence reasoning, the C9 Aromatics may cause mild skin irritation, but results are insufficient to classify.
Hydrocarbons, C10 Aromatics, >1% Naphthalene:
not corrosives or dermal irritants
Ocular Irritation
Hydrocarbons, C9 Aromatics:
C9 Aromatics are not ocular irritating for rabbits (OECD TG 405). All study results indicate that the C9 Aromatics are not ocular irritants to rabbits.
Hydrocarbons, C10 Aromatics, >1% Naphthalene:
not ocular irritants
Respiratory Irritation
Hydrocarbons, C9 Aromatics:
No studies were located to indicate that C9 Aromatics are respiratory irritants. However, a constituent of the C9 Aromatics, 1,3,5-trimethylbenzene, is classified as STOT Single Exp. 3 (H335: May cause respiratory irritation).
Hydrocarbons, C10 Aromatics, >1% Naphthalene:
Not respiratory irritants
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 29/09/1992-21/10/1992
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP study according to EEC Directive 84/449.
- Qualifier:
- according to guideline
- Guideline:
- other: Directive 67/548/EEC (OECD TG 404)
- GLP compliance:
- yes (incl. QA statement)
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Froxfield Farms U.K. Ltd
- Age at study initiation: 3 to 5 months
- Weight at study initiation: 3.02-3.54 kg
- Housing: singly in hanging stainless steel cages with perforated or wire-mesh flooring, animals identified by cage-labels and ear-tags
- Diet (e.g. ad libitum): Standard Rabbit Diet, S.Q.C., Special Diets Services Ltd.
- Water (e.g. ad libitum): tap water
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 15-20
- Humidity (%): 30-70
- Photoperiod (hrs dark / hrs light): 12/12 - Type of coverage:
- semiocclusive
- Preparation of test site:
- other: clipped
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 ml
- Concentration (if solution): neat
- Duration of treatment / exposure:
- 4 hours
- Observation period:
- 1, 24, 48, and 72 hrs
7, 14, 21 days - Number of animals:
- 6
- Details on study design:
- TEST SITE
- Area of exposure: dorsal skin
- Type of wrap if used: 6 cm² lint patch covered with a larger gauze patch
REMOVAL OF TEST SUBSTANCE
- Washing (if done): with water
- Time after start of exposure: 4 hrs
SCORING SYSTEM: Draize - Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 1.9
- Max. score:
- 2
- Reversibility:
- fully reversible within: 21 days
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritant / corrosive response data:
- Desquamation was noted in all animals on day 7. By day 21 all symptoms were fully reversed.
- Interpretation of results:
- other: not classified
- Remarks:
- Criteria used for interpretation of results: EU
- Conclusions:
- Hydrocarbons, C9, aromatics is a mild skin irritant.
- Executive summary:
This study examined the irritation/corrosion of Hydrocarbons, C9, aromatics to rabbit skin. 0.5 ml of test substance was applied to the clipped dorsal skin of 3 male and 3 female rabbits for 4 hrs. Animals were then examined at 1, 24, 48, and 72 hrs, and 7, 14, and 21 days after the end of exposure and scored using the Draize method for signs of erythema, edema, and corrosion. Mean erythema score (24, 48, and 72 hrs) was 1.9, and the mean edema score (24, 48, and 72 hrs) was 0.0. Desquamation was noted in all animals on day 7. By day 21 all symptoms were fully reversed. Hydrocarbons, C9, aromatics, is therefore not corrosive and only mildly irritating to skin. According to EU GHS guidelines, Hydrocarbons, C9, aromatics, would be not be classified as a skin irritant.
- Endpoint:
- skin irritation: in vivo
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- 1989/12/04 -1989/12/07
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: According to or similar to guideline study OECD 404: GLP
- Justification for type of information:
- A discussion and report on the read across strategy is given as an attachment in IUCLID Section 13.
- Reason / purpose for cross-reference:
- read-across: supporting information
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
Source: l'Abbaye de Bellefontaine
Sex: Male (6)
Age at study initiation: Approximately 12 weeks
Weight at study initiation: 2.5 +/- 0.1 kg
Housing: Individually
Diet (e.g. ad libitum): ad libitum
Water (e.g. ad libitum): Automatic watering system, ad libitum
Acclimation period: 5
ENVIRONMENTAL CONDITIONS
Temperature (°C): 20 +/- 3
Humidity (%): 30-70%
Photoperiod (hrs dark / hrs light): 12/12
Monitored at least once a day - Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- Amount(s) applied (volume or weight): 0.5 ml
Concentration (if solution): neat - Duration of treatment / exposure:
- Test material was administered to the clipped backs as a single dose introduced under a gauze patch and held in contact with the skin by means of a semi-occlusive dressing for 4 hours. Residual test material was then removed.
- Observation period:
- 1, 24, 48, and 72h post application and once per day on Day 7
- Number of animals:
- Male (6)
- Details on study design:
- SCORING SYSTEM: Draize scale for dermal irritation
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 1 hour
- Score:
- ca. 1.7
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24 h
- Score:
- ca. 1.8
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 48 h
- Score:
- ca. 1.2
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 72 h
- Score:
- ca. 1
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 1.3
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 1 hour
- Score:
- ca. 2.7
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24 h
- Score:
- ca. 1
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 48 h
- Score:
- ca. 0
- Max. score:
- 0
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 72 h
- Score:
- ca. 0
- Max. score:
- 0
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- ca. 0.33
- Irritant / corrosive response data:
- Topical application of Coupe Aromatique 180 -230 elicited mild dermal responses. The erythema was noted as slight at the 72 hour time point while the edema that was noted in the animals was completely reversed by the 48 hour observation.
- Interpretation of results:
- other: Not irritating
- Remarks:
- Criteria used for interpretation of results: EU
- Conclusions:
- The average erythema score (24,48, and 72 hours) was 1.3. The average edema score (24,48, and 72 hours) was 0.33. Classification as a dermal irritant is not warranted under the new Regulation (EC) 1272/2008 on classification, labeling and packaging of substances and mixtures (CLP) or under Directive 67/518/EEC for dangerous substances and Directive 1999/45/EC for preparations.
- Executive summary:
In this study, 6 rabbits were subjected to a 4h dermal (shaved) exposure of 0.5 ml of Coupe Aromatique 180 -230 via a semi-occluded patch. Dermal responses were evaluated at 1, 24, 48, and 72h post-dosing according to the Draize method of scoring. At the 1, 24, and 72 hour observations two animals were noted with a well defined erythema and edema. The average erythema score (24,48, and 72 hours) was 1.3. The average edema score (24,48, and 72 hours) was 0.33.
Classification as a dermal irritant is not warranted under the new Regulation (EC) 1272/2008 on classification, labeling and packaging of substances and mixtures (CLP) or under Directive 67/518/EEC for dangerous substances and Directive 1999/45/EC for preparations.
- Endpoint:
- skin irritation: in vitro / ex vivo
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- an in vitro skin irritation study does not need to be conducted because adequate data from an in vivo skin irritation study are available
Referenceopen allclose all
Dermal Scores for Each Animal
Dermal Response | 1 hr | 24 hr | 48 hr | 72 hr | 7 days | 10 days | 14 days | |
TT017 M | Erythema | 1 | 2 | 2 | 2 | 1 | 1 | 0 |
Edema | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
TT019 M | Erythema | 1 | 2 | 2 | 2 | 1 | 0 | 0 |
Edema | 0 | 0 | 0 | 0 | 0c | 0 | 0 | |
TT021 M | Erythema | 1 | 2 | 2 | 1 | 1 | 0 | 0 |
Edema | 0 | 0 | 0 | 0 | 0d | 0 | 0 | |
TT036 F | Erythema | 1 | 2 | 2 | 2 | 0 | 0 | 0 |
Edema | 0 | 0 | 0 | 0 | 0 | 0c | 0 | |
TT038 F | Erythema | 1 | 2 | 2 | 1 | 1 | 0 | 0 |
Edema | 0 | 0 | 0 | 0 | 0 | 0c | 0 | |
TT043 F | Erythema | 1 | 2 | 2 | 2 | 1 | 0 | 0 |
Edema | 0 | 0 | 0 | 0 | 0c | 0b | 0 |
b - slight desquamation
c - desquamation
d - reduced pliability
Summary of other skin irritation studies
End Point | Study Reference | ||||||||||||||||||||||||
REACH requirement | IUCLID Section | Study Name | Data Waiving | Waiving Justification | Species | Study Result Type | Test Guideline/Qualifier | Test Guideline/Guideline | Test Guideline/Deviations | Reliability | Rational For Reliability | GLP Compliance | Test Materials/Identity | Study Result | Reference Type | Reference Author | Reference Year | Reference Title | Bibliographic Source | Testing Laboratory | Reference Report No. | Owner Company | Company Study No. | Report Date | Data access |
8.1 Skin Irritation or Corrosion | 7.3.1 | Primary Dermal Irritation Study in the Rabbit | Rabbit | experimental result | equivalent or similar to | OECD Guideline 404 | Exposure for 24 hrs, rather than 4 hrs. | 2 | In general agreement with OECD test guideline 404. | No data | MRD-ECH-80-14 | not classifiable | study report | ANON | 1980 | Primary Dermal Irritation Study in the Rabbit | HSPA0139 | Bio/dynamics Inc. | 6301-80 | ExxonMobil Petroleum & Chemical BVBA | 80MRL23 | 31/12/1980 | yes | ||
8.1 Skin Irritation or Corrosion | 7.3.1 | Primary Skin Irritation - Rabbit | Rabbit | experimental result | equivalent or similar to | OECD Guideline 404 | Exposure for 24 hrs, rather than 4 hrs, no sex data available, 12 rabbits used, and no data reported for 48 hr time point. | 2 | Uses Draize Method which is in general agreement with OECD test guideline 404. | No data | MRD-61-14 | not classifiable | study report | ANON | 1963 | Primary Skin Irritation - Rabbit | HSPA0143 | Hazleton Laboratories, Inc. | 29890 | ExxonMobil Petroleum & Chemical BVBA | 63MRL2 | yes | |||
8.1 Skin Irritation or Corrosion | 7.3.1 | Primary Dermal Irritation Study in the Rabbit | Rabbit | experimental result | equivalent or similar to | OECD Guideline 404 | Study ended on day 7, when there was still unresolved delayed erythema. | 2 | In general agreement with OECD test guideline 404. | No data | MRD-83-208 | not irritating | study report | ANON | 1984 | Primary Dermal Irritation Study in the Rabbit | HSPA0144 | Exxon Biomedical Science, Inc. | 320804 | ExxonMobil Petroleum & Chemical BVBA | 84MRL88 | 13/04/1984 | yes | ||
8.1 Skin Irritation or Corrosion | 7.3.1 | Primary Dermal Irritation Study in the Rabbit | Rabbit | experimental result | equivalent or similar to | OECD Guideline 404 | No | 2 | In general agreement with OECD test guideline 404 - GLP. | Yes | MRD-85-734 | irritating | study report | ANON | 1986 | Primary Dermal Irritation Study in the Rabbit | HSPA0145 | Exxon Biomedical Science, Inc. | 273404 | ExxonMobil Petroleum & Chemical BVBA | 86MRL60 | 09/04/1986 | yes | ||
8.1 Skin Irritation or Corrosion | 7.3.1 | Primary Dermal Irritation Study in the Rabbit | Rabbit | experimental result | equivalent or similar to | OECD Guideline 404 | No | 1 | In agreement with OECD test guideline 404 - GLP. | Yes | MRD-89-522 | not irritating | study report | ANON | 1990 | Primary Dermal Irritation Study in the Rabbit | HSPA0146 | Exxon Biomedical Science, Inc. | 252204 | ExxonMobil Petroleum & Chemical BVBA | 90MRL97 | 02/02/1990 | yes | ||
8.1 Skin Irritation or Corrosion | 7.3.1 | Primary Dermal Irritation Study in the Rabbit | Rabbit | experimental result | equivalent or similar to | OECD Guideline 404 | Exposure for 24 hrs, rather than 4 hrs. | 2 | In general agreement with OECD test guideline 404. | No data | MRD-ECH-80-14 | not classifiable | study report | ANON | 1980 | Primary Dermal Irritation Study in the Rabbit | HSPA0138 | Bio/dynamics Inc. | 6301-80 | ExxonMobil Petroleum & Chemical BVBA | 80MRL20 | 11/07/1980 | yes | ||
8.1 Skin Irritation or Corrosion | 7.3.1 | Primary Irritation of the Skin | Rabbit | experimental result | equivalent or similar to | OECD Guideline 404 | Exposure for 24 hrs, rather than 4 hrs. | 2 | Uses Draize Method which is in general agreement with OECD test guideline 404. Summary of study only. | No data | Shellsol A | moderate irritant | study report | Coombs, AD, Blair, D, Doak, SM, Carter, BI | 1977 | The Acute Toxicity of Shellsol A | HSPA0685 | Sittingbourne Research Centre | M(T)-1-77 | Shell Chemicals Europe BV | June, 1977 | yes |
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irritating)
Eye irritation
Link to relevant study records
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1990/05/02-1990/05/15
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: According to OECD Guideline 405. GLP
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Hazelton Research Products, Inc.
- Sex: female (6)
- Age at study initiation: 14 weeks
- Weight at study initiation: 2.48-2.75 kg
- Housing: Individually
- Diet (e.g. ad libitum): Agway Certified Diet R.C.A. Rabbit (pellets), restricted with new food each day
- Water (e.g. ad libitum): Automatic watering system, ad libitum
- Acclimation period: 15 days
ENVIRONMENTAL CONDITIONS
- Temperature (°F): 65-70
- Humidity (%): 40-60
- Photoperiod (hrs dark / hrs light): 12/12 - Vehicle:
- unchanged (no vehicle)
- Controls:
- other: contralateral eye served as control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 ml
- Concentration (if solution): neat - Duration of treatment / exposure:
- Test material was introduced into the lower conjunctival sac of the right eye of each animal, the upper and lower lids were gently held together for one second prior to releasing to prevent loss of material.
- Observation period (in vivo):
- 1, 4, 24, 48, and 72 hrs post instillation and once per day on days 4 and 7.
- Number of animals or in vitro replicates:
- Female (6)
- Details on study design:
- SCORING SYSTEM: Draize scale for ocular irritation
- Irritation parameter:
- conjunctivae score
- Remarks:
- Redness
- Basis:
- mean
- Time point:
- other: 1 hr
- Score:
- 1.7
- Max. score:
- 2
- Reversibility:
- fully reversible within: 72 hrs
- Irritation parameter:
- conjunctivae score
- Remarks:
- Redness
- Basis:
- mean
- Time point:
- 24 h
- Score:
- 0.5
- Max. score:
- 1
- Reversibility:
- fully reversible within: 72 hrs
- Irritation parameter:
- conjunctivae score
- Remarks:
- Redness
- Basis:
- mean
- Time point:
- 48 h
- Score:
- 0.33
- Max. score:
- 1
- Reversibility:
- fully reversible within: 72 hrs
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: 1 hr
- Score:
- 1.33
- Reversibility:
- fully reversible within: 48 hrs
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24 h
- Score:
- 0.17
- Max. score:
- 1
- Reversibility:
- fully reversible within: 48 hrs
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 48 h
- Score:
- 0
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 72 h
- Score:
- 0
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 1-72 hrs
- Score:
- 0
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 1-72 hrs
- Score:
- 0
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Remarks on result:
- other: Mean 24, 48, and 72-hour scores not specified
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Remarks on result:
- other: Mean 24, 48, and 72-hour scores not specified
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Remarks on result:
- other: Mean 24, 48, and 72-hour scores not specified
- Irritant / corrosive response data:
- Redness was noted for all animals at the 1 hr observation point, for 3 animals at the 24 hr observation point, and for two animals at the 48 hr observation point. Chemosis was noted for all animals at the 1 hr observation and for 1 animal at the 24 hr observation point. Only one animal was noted in having discharge at the 1 hr time point. All animals were free of any occular irritation after the 48 hr observation. The maximum Draize score was 8 at the 1 hr time point.
- Interpretation of results:
- other: Not irritating
- Remarks:
- Criteria used for interpretation of results: EU
- Conclusions:
- Based on the individual and mean scores of ocular irritations, test substance would not be considered an ocular irritant under either EU GHS guidelines or under the EU requirements for dangerous substances and preparations guidelines.
- Executive summary:
This study was conducted to determine the potential of the substance to cause irritation to the eye in a rabbit model system. Six rabbits were instilled with 0.1 ml of MRD-89 -522, neat. Ocular examinations occurred at 1, 4, 24, 48, and 72 hrs, and days 4 and 7 post instillation. Ocular damage was assessed and scored according to the Draize eye test. All animals survived the exposure. Maximum observed Draize score was 8. Irritation subsided as the study progressed and all animals were clear of ocular irritation after the 48 hr observation. Based on the individual and mean scores, test substance should not be considered an ocular irritant under either EU GHS guidelines or under the EU requirements for dangerous substances and preparations guidelines.
- Endpoint:
- eye irritation: in vivo
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- From April 23, 1990 to May 24, 1990
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Acceptable, well-documented study report in agreement with OECD guideline 405-GLP
- Justification for type of information:
- A discussion and report on the read across strategy is given as an attachment in IUCLID Section 13.
- Reason / purpose for cross-reference:
- exposure-related information
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- increased number of animals
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Hazleton Research
- Age at study initiation: Approximately 14 weeks
- Weight at study initiation: 2.29-2.75 kg
- Housing: Individual
- Diet (e.g. ad libitum): restricted feeding regimen per manufacturers recommendation
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 15 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): maintained range of 18.3-21.1 °C
- Humidity (%): maintained range of 40-60%
- Photoperiod (hrs dark / hrs light): 12 hrs dark / 12 hrs light
IN-LIFE DATES: From: 1990-05-08 To: 1990-05-22 - Vehicle:
- unchanged (no vehicle)
- Controls:
- other: untreated eye served as control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit):0.1ml
- Concentration (if solution): undiluted - Duration of treatment / exposure:
- Test material was introduced into the lower conjunctival sac of the right eye of each animal. The upper and lower lids were gently held together for one second prior to releasing to prevent loss of material
- Observation period (in vivo):
- 1, 24, 48, 72 hours post-instillation and once per day on days 4, 7, 10, and 14
- Number of animals or in vitro replicates:
- Six animals (all females)
- Details on study design:
- SCORING SYSTEM: Draize Method
TOOL USED TO ASSESS SCORE: 2% sodium fluorescein dye under UV light - Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- ca. 1.46
- Max. score:
- 8
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- other: redness
- Basis:
- mean
- Time point:
- other: 1h
- Score:
- ca. 1.17
- Max. score:
- 2
- Irritation parameter:
- other: redness
- Basis:
- mean
- Time point:
- 24 h
- Score:
- ca. 0.5
- Max. score:
- 1
- Irritation parameter:
- other: redness
- Basis:
- mean
- Time point:
- 48 h
- Score:
- ca. 0.17
- Max. score:
- 1
- Irritation parameter:
- other: redness
- Basis:
- mean
- Time point:
- 72 h
- Score:
- ca. 0.6
- Max. score:
- 1
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: 1h
- Score:
- ca. 1.67
- Max. score:
- 2
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24 h
- Score:
- 0
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 48 h
- Score:
- 0
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 72 h
- Score:
- ca. 0.2
- Max. score:
- 1
- Reversibility:
- fully reversible within: 14 days
- Other effects:
- Alopecia around the treated eye was noted for one animal on days 10 and 14.
One animal died prior to study termination (day 3). This animal exhibited poor food consumption, distended abdomen, and small amount of stool on day 2. It was the opinion of the study director that this death was not test material related, but due to a gastro-intestinal problem. - Interpretation of results:
- other: Not irritating
- Remarks:
- Criteria used for interpretation of results: EU
- Conclusions:
- Classification as an ocular irritant is not warranted under the new Regulation (EC) 1272/2008 on classification, labeling and packaging of substances and mixtures (CLP) or under Directive 67/518/EEC for dangerous substances and Directive 1999/45/EC for preparations.
- Executive summary:
Application of 0.1ml of MRD-89-523 to the eye of six rabbits elicited slight, transient conjunctival redness, chemosis, and some discharge. Mean scores for redness at 24, 48, 72 hours were 0.50, 0.17, and 0.60 respectively. The scores for chemosis were 1.67, 0, and 0. There were no positive scores for corneal, or iridial irritation. Ocular irritation was most prominent at the 1 hour, 72 hour and day 4 observations where the total Draize score ranged from 4-12. Additional observations included alopecia in one animal on days 10 and 14. All other animals were free of signs of irritation within 14 days of dosing.
Classification as an ocular irritant is not warranted under the new Regulation (EC) 1272/2008 on classification, labeling and packaging of substances and mixtures (CLP) or under Directive 67/518/EEC for dangerous substances and Directive 1999/45/EC for preparations.
- Endpoint:
- eye irritation: in vitro / ex vivo
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- an in vitro eye irritation study does not need to be conducted because adequate data from an in vivo eye irritation study are available
Referenceopen allclose all
Summary of other eye irritation studies:
Chemical Name: | Hydrocarbons, C9, aromatics | ||||||||||||||||||||||||
Reference Substance: | |||||||||||||||||||||||||
CAS Number: | 64742-95-6 | ||||||||||||||||||||||||
EC Number: | 265-199-0 | ||||||||||||||||||||||||
SMILES: | |||||||||||||||||||||||||
End Point | Study Reference | ||||||||||||||||||||||||
REACH requirement | IUCLID Section | Study Name | Data Waiving | Waiving Justification | Species | Study Result Type | Test Guideline/Qualifier | Test Guideline/Guideline | Test Guideline/Deviations | Reliability | Rational For Reliability | GLP Compliance | Test Materials/Identity | Study Result | Reference Type | Reference Author | Reference Year | Reference Title | Bibliographic Source | Testing Laboratory | Reference Report No. | Owner Company | Company Study No. | Report Date | Data access |
8.2 Eye Irritation | 7.3.2 | Draize Eye Irritation Studies - Rabbits | Rabbit | Experimental result | Equivalent or similar to | OECD guideline 405 | Eyes of some animals were irrigated | 2 | Acceptable, well-documented study report in general agreement with OECD guideline 405. Not performed according to GLP. | No | MRD-61-14 | not irritating | Study report | ANON | 1961 | Draize Eye Irritation Studies - Rabbits | HSPA0147 | Hazleton Laboratories | ExxonMobil Petroleum & Chemical BVBA | 61MRL7 | yes | ||||
8.2 Eye Irritation | 7.3.2 | Ocular Irritation Study in the Rabbit | Rabbit | Experimental result | Equivalent or similar to | OECD guideline 405 | Failed to continue study to 21 days when symptoms were still present at 72 hrs. | 2 | Similar to OECD guideline 405. | yes | MRD-90-720 | not classifiable | Study report | ANON | 1990 | Ocular Irritation Study in the Rabbit | HSPA0150 | Exxon Biomedical Sciences, Inc. | 172013 | ExxonMobil Petroleum & Chemical BVBA | 90MRL166 | 12/06/1990 | yes | ||
8.2 Eye Irritation | 7.3.2 | Eye Irritation Study in Rabbits | Rabbit | Experimental result | Equivalent or similar to | OECD guideline 405 | No | 2 | Similar to OECD guideline 405. | No data | MRD-ECH-80-14 | not irritating | Study report | ANON | 1980 | Eye Irritation Study in Rabbits | HSPA0148 | Bio/dynamics Inc. | 29641 | ExxonMobil Petroleum & Chemical BVBA | 80MRL16 | 11/07/1980 | yes | ||
8.2 Eye Irritation | 7.3.2 | Eye Irritation | Rabbit | Experimental result | According to | Federal Register, 28, (110), 6.6.1963. para 191.12. Test for eye irritation. | No | 2 | Summary only of study. | No data | Shellsol A | not irritating | Study report | Coombs, AD, Blair, D, Doak, SM, Carter, BI | 1977 | The Acute Toxicity of Shellsol A | HSPA0686 | Sittingbourne Research Centre | M(T)-1-77 | Shell Chemicals Europe BV | June, 1977 | yes | |||
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Skin Irritation
Hydrocarbons,C9 aromatics are not corrosives and are mild to moderate dermal irritants for rabbits (OECD TG 404). Topical application of Hydrocarbons, C9 Aromatics to the clipped backs of rabbits under semi-occlusive dressing for 4 hours elicited dermal responses in all animals. The mean erythema scores in the four independent key studies ranged from 1.9 to 4.0; mean edema scores in these same studies ranged from 0.0 to 2.2. Therefore, Hydrocarbons, C9 aromatics can be considered to be mildly to moderately irritating to rabbit skin, with any effects generally reversible. In addition, a study was conducted in which 26 human volunteers were dermally exposed to Hydrocarbons, C9 aromatics. Results showed no evidence of aromatics being a dermal irritant to humans. Using qualitative weight of evidence reasoning, the C9 Aromatics may cause mild skin irritation to rabbits, but are not irritating to human skin.
Hydrocarbons, C10 aromatics, >1% Napthalene are not corrosives or dermal irritants for rabbit (OECD TG 404). Topical application of C10 aromatics to the clipped backs of rabbits under semi-occlusive dressing for 4 hours elicited dermal responses in all animals. The dermal responses consisted of erythema ranging from very slight to well defined erythema and very slight edema. A total of 14 animal studies were examined that covered all substance in the category. Five studies used occlusive dressing and did not report sufficient data for classification. Eight studies that were of superior quality and used GLP standards reported data which did not lead to classification. C10 aromatics are not irritating to human skin when evaluated in a repeated patch test as a 50% w/w preparation. Application of a 50% w/w preparation of C10 aromatics under semi-occlusive conditions did not result in signs of primary irritation. In another study at the same concentration, application of C10 aromatics to the skin without or in conjunction with UV irradiation did not elicit an irritation response in any of the study participants. Using qualitative weight of evidence reasoning, the hydrocarbons, C10 aromatics, >1% napthalene are not irritating to rabbit or human skin.
Ocular Irritation
Hydrocarbons, C9 aromatics are not ocular irritants (OECD TG 405) when evaluated in rabbits following a single 0.1 mL ocular instillation. Testing of Hydrocarbons,C9 Aromatics generally demonstrated reversible conjunctive redness, chemosis, and infrequent discharge in animals. Draize scores were generally low. All study results indicate that the Hydrocarbons,C9 Aromatics are not irritating for rabbits.
Hydrocarbons, C10 aromatics, >1% Napthalene are not ocular irritants (OECD TG 405) when evaluated in rabbits following a single 0.1 mL ocular instillation. Testing of C10 aromatics generally demonstrated reversible conjunctive redness, chemosis, and infrequent discharge in animals. Draize scores were generally low. A total of 7 studies were examined that covered all substance in the category. All study results indicate that hydrocarbons, C10 aromatics, >1% Napthalene are not irritating for rabbits.
Respiratory Irritation
No studies were located to indicate that Hydrocarbons, C9 Aromatics are respiratory irritants.
Justification for classification or non-classification
Based on available data, Hydrocarbons, C9, aromatics, do not warrant classification as skin, ocular, or respiratory irritants under the Regulation (EC) 1272/2008 on classification, labeling and packaging of substances and mixtures (CLP). However, a constituent of Hydrocarbons, C9 Aromatics, 1,3,5-trimethylbenzene, is classified as a respiratory irritant (STOT Single Exp. 3: H335) under EU CLP. Therefore, Hydrocarbons, C9, aromatics are also classified as respiratory irritants under EU Regulation (EC) 1272/2008.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
![ECHA](/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/echa_logo.png)