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EC number: 906-170-0 | CAS number: -
- 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
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Endpoint summary
Administrative data
Description of key information
Neither classified as a skin or eye irritant
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:
- January 09 to March 02, 1987
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study according to OECD Guideline 404 under GLP
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- 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: L'Abbaye de Bellefontaine, F-49122 Begrolles en Mauges, France
- Weight at study initiation: 2.5 ± 0.1 kg
- Housing: Individually in polystyrene cages
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 6 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ±3 °C
- Humidity (%): 50 ± 20
- Photoperiod (hrs dark / hrs light): 12/12 - Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit):0.5 ml - Duration of treatment / exposure:
- 4 hours
- Observation period:
- 1h, 24h, 48 h, and 72 h after exposure termination;
- Number of animals:
- 3 animals
- Details on study design:
- TEST SITE
- Area of exposure: right flank
- coverage: 6 cm²
- Type of wrap if used: gauze patch held in place with semi-occlusive dressing
SCORING SYSTEM:
Erythema score: 0-4
Edema score: 0-4 - Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: OECD GHS
- Conclusions:
- Under the conditions of this assay, the test article has no skin irritating potential.
- Executive summary:
DBE has been tested for skin irritation on 3 New Zealand White rabbits according to OECD guideline n° 404 and EU guideline n° B.4 (Draize Method) in compliance with Good Laboratory Practice. The rabbits received a dermal dose of 0.5 ml of DBE on a gauze on intact and abraded skin sites under an semiocclusive dressing for a period of 24 hours. Scores for erythema and oedema were measured 1, 24, 48 and 72 hours after patch removal and primary cutaneous index was calculated (maximum possible index =12)
No sign of dermal irritation (score = 0 for erythema and oedema) was observed for intact skin site of the 3 rabbits at any reading time. Primary Irritation Index was = 0.0. No other signs of intoxication were observed.
Based on these results DBE is not classified irritating to skin according to the criteria of the Directive 67/548/CEE and according to EU Regulation 1272/2008 (CLP).
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not 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:
- January 09 to March 26, 1987
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study according OECD Guideline 405; Study under GLP Regulations;
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- GLP compliance:
- yes (incl. QA statement)
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Abbaye de Bellefontaine, F49122 Begrolles en Mauges, France;
- Weight at study initiation: 2.5 ± 0.1 kg
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum):ad libitum
- Acclimation period:5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 3
- Humidity (%): 50 ± 20
- Photoperiod (hrs dark / hrs light): 12/12 - Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 ml; - Duration of treatment / exposure:
- one time application of test article to eye
- Observation period (in vivo):
- 1h after application, followed by daily observation for 3 days (minimum) to 21 days (maximum);
- Number of animals or in vitro replicates:
- 3 animals
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): not specified
SCORING SYSTEM: Scoring according to Kay and Calandra (1962) J. Soc. Cosmet. Chem 13, 281-289. - Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48h
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48h
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48h
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: OECD GHS
- Conclusions:
- Under the conditions of this study, the test article RP/DE is considered not irritating.
- Executive summary:
The eye irritating potential of the test article RP/DE has been investigated in the rabbit under the OECD Guideline 405 and under GLP Regulations. Moderate effects on the conjunctiva and on chemosis were observed in two animals 1 hour after application of the test article while the same effects were marked in one animal. Two days after application of the test article, the effects had disappeared. Under the conditions of this study, the test article RD/DE was considered not irritating to the eye.
Reference
The observed effects on the conjuctivae and on chemosis 1 hour after application were moderate in two animals and marked in one animal.Two days after the applicaton of the test article, all ocular effects have disappeared.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Skin irritation:
Two in vivo studies using rabbits are available for skin irritation. One study (Clouzeau, 1987) was of reliability 1 according to Klimisch cotation criteria and was therefore selected as the key study. The other study (Sarver, 1989) was of reliability 2 according to Klimisch cotation criteria and was used as a supporting study. In the key study, no signs of skin irritation (erythema or edema) was observed following a 4-hour semi-occlusive application of the test substance to the shaved skin of 3 rabbits and observation up to 72 hours after the end of application. In the supporting study, the skin reactions were very variable from one rabbit to another. At the 72-hour observation timepoint, one rabbit exhibited severe erythema with fissuring of the skin and slight edema, whereas no to mild erythema was observed in the 5 other animals. One rabbit exhibited no dermal irritation at all throughout the observation period. Considering the mean values for erythema :
Rabbit Nr. |
Erythema mean score |
1 |
2.3 |
2 |
2.0 |
3 |
0.0 |
4 |
1.7 |
5 |
1.0 |
6 |
3.3 |
Global mean value |
1.7 |
the incidence of scores of 2 or more was below 2/3 animals, and the global mean value over all the animals tested was lower than 2. Therefore the results of the supporting study are consistent with those of the key study and support the absence of classification for skin irritation.
Eye irritation:
Three in vivo studies using rabbits are available for eye irritation:
- In the study selected as a key study based on its reliability 1 according to Klimisch cotation criteria (Clouzeau, 1987), moderate conjunctival and chemosis effects were observed in 2 animals one hour after instillation, and only slight conjunctival redness was noted 24 hours after instillation. All effects were fully reversible within 2 days after application. The intensity and duration of the signs of irritation therefore did not warrant any classification.
- In another study considered of reliability 2 according to Klimisch cotation criteria (Valentine, 1993), signs of ocular irritation were observed in 1 out of the 4 rabbits tested. However, a low volume of instillation (10 µL) was used and the observation period was limited to 48 hours after instillation. No reliable conclusion could be made from this study. However, consistently with the key study, no major sign of eye irritation was observed.
- In the third study, considered of reliability 3 according to Klimisch cotation criteria due to the low number of animals used and the low level of details provided regarding the ocular observations (Silber, 1980), signs of irritation were observed in the unwashed eye of a single rabbit, which may have been susceptible. Such data are therefore inappropriate for classification purpose.
Overall, the results of in vivo testing indicate the absence of a need for classification for eye irritation.
Justification for selection of skin irritation / corrosion endpoint:
GLP and OECD guideline 404 compliant study, with the highest Klimish score (1 vs. 2 for the other one)
Justification for selection of eye irritation endpoint:
GLP and OECD guideline 405 compliant study, with the highest Klimish score (1 vs. 2 or 3 for the other ones)
Justification for classification or non-classification
The incidence and severity of the signs of irritation observed among those different studies were below the criteria of Annex VI Directive 67/548/EEC or EU Regulation 1272/2008 (CLP), therefore warranting no classification for skin or eye irritation.
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