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EC number: 256-032-2 | CAS number: 42978-66-5
- 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
In-vitro:
- EpiDerm Corrosivity test: not corrosive
(2004, OECD 431, reliability 2)
In vivo:
- Rabbit, 4 h, semiocclusive: not irritating to skin (2004, acc. OECD
404, GLP, reliability 1)
- Rabbit, 4 h, semiocclusive: mildly irritating to skin Cat. 3 (2002,
acc. OECD 404, GLP, reliability 1)
- Rabbit, 4 h, occlusive: not irritating to skin (1982, comp. OECD 404,
reliability 2)
Eye
In-vitro:
- HET-CAM corrosion test: non corrosive
(2004, reliability 2)
In vivo:
- Rabbit, 24 h, substance was not washed out: irritating Cat. 2B (2004,
acc. OECD 405, GLP, reliability 1)
- Rabbit, 24 h, substance was not washed out: severely irritating Cat. 1
(1982, comp. OECD 405, reliability 2)
Respiratory system
No data available
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:
- 24 Nov. - 18. Dec. 2003
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Remarks:
- GLP compliant
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- 2002
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2500 (Acute Dermal Irritation)
- Version / remarks:
- 1998
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Version / remarks:
- 1992
- GLP compliance:
- yes
- Remarks:
- Landesanstalt für Pflanzenbau und Pflanzenschutz Rheinland Pfalz, Sep 2001
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Centre Lago S.A., Vonnas, France
- Weight at study initiation: 3.80 - 4.63 kg
- Housing: individually in stainless steel wire mesh cages with grating, floor area: 3000 cm2
- Diet: Kliba-Labordiaet, about 130 g/animal per day
- Water: ad libitum, tap water
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-24 °C
- Humidity (%): 30-70 %
- Photoperiod (hrs dark / hrs light): 12/12 - Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: untreated skin sites of the same animals
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied: 0.5 ml, undiluted - Duration of treatment / exposure:
- 4 hours
- Observation period:
- 72 hours
- Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: 2.5 cm x 2.5 cm
- Type of wrap if used: The test substance was covered with a test patch (Idealbinde, Pfälzische Verbandstoff-Fabrik, Kaiserslautern) and Fixomull
stretch (adhesive fleece), Beiersdorf AG, semiocclusive
REMOVAL OF TEST SUBSTANCE
- Washing: The test substance was removed at the end of the exposure period with Lutrol and Lutrol / water (1:1).
- Time after start of exposure: after the 4 hours of exposure
SCORING SYSTEM: accodring to OECD guideline 404 - Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible within: the first 24 hours before the reading
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Other effects:
- Slight eryrthema (grade 1) was observed in two animals immediately and 1 hour after removal of the patch and persisted in one animal up to 24 hours. Moderate erythema (grade 2), noted in one animal immediately and 1 hour after removal of the patch, decreased to slight erythema after 24 hours.
No other cutaneous reactions were observed during the study.
The cutaneous reactions were reversible in one animal within 24 hours and in two animals within 48 hours after removal of the patch. - Interpretation of results:
- GHS criteria not met
- Conclusions:
- under the conditions of the present in vivo study with rabbits the test item was considered to be non-irritating to the skin.
- Executive summary:
In-vivo, a skin irritation test was performed with three New Zealand White rabbits, according to OECD guideline 404 and in compliance with GLP (reliability 1). At least 24 hours before substance administration the dorsolateral part of the trunk of the animals was clipped. The untreated skin sites of the animals served as control. A 4-hour semiocclusive exposure to ca. 0.5 ml of the undiluted test substance produced the following effects: slight eryrthema (grade 1) was observed in two animals immediately and 1 hour after removal of the patch and persisted in one animal up to 24 hours. Moderate erythema (grade 2), noted in one animal immediately and 1 hour after removal of the patch, decreased to slight erythema after 24 hours. No other cutaneous reactions were observed during the study. The cutaneous reactions were reversible in one animal within 24 hours and in two animals within 48 hours after removal of the patch.
Based on this study findings the test item was considered to be non iriitating to the skin of rabbits.
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:
- 24. Nov - 18. Dec. 2003
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Remarks:
- GLP compliant
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- 2002
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Version / remarks:
- 1992
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2400 (Acute Eye Irritation)
- Version / remarks:
- 1998
- Guideline:
- other: MAFF Testing Guideline of 12 Nousan No. 8147
- Version / remarks:
- 2000
- GLP compliance:
- yes
- Remarks:
- Landesanstalt für Pflanzenbau und Pflanzenschutz Rheinland Pfalz, Sep 2001
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Centre Lago S.A., Vonnas, France
- Weight at study initiation: 3.12 - 3.22 kg
- Housing: individually in stainless steel wire mesh cages with grating, floor acrea: 3000 cm2
- Diet: Kliba-Labordiaet, about 130 g/animal per day
- Water: ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-24 °C
- Humidity (%): 30-70 %
- Photoperiod (hrs dark / hrs light): 12/12 - Vehicle:
- unchanged (no vehicle)
- Controls:
- other: untreated eye of the same animals
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied: 0.1 ml - Duration of treatment / exposure:
- 24 hours
- Observation period (in vivo):
- 7 days
- Number of animals or in vitro replicates:
- 3 (2 females, 1 male)
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing: with 3 to 6 ml of hand warm tap water for 1 to 2 minutes using a syringe with a blunt probe.
- Time after start of exposure: 24 hours after application
SCORING SYSTEM: according to OECD guideline 405
TOOL USED TO ASSESS SCORE: daylight tubes "Lumilux" (L 58/860 Plus Eco 25x1, Osram, Germany) - Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 2
- Reversibility:
- fully reversible within: 72 hours
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 3
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1.67
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0.67
- Max. score:
- 2
- Reversibility:
- fully reversible within: 72 hours
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 2.33
- Max. score:
- 3
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 2
- Reversibility:
- fully reversible within: 72 hours
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 2.67
- Max. score:
- 3
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 1.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 hours
- Irritant / corrosive response data:
- Suppuration, contracted pupil, discharge of blood and injected scleral vessels in a circumscribed area or circular were noted during the observation period within the first 72 hours. All findings were fully reversible within 7 days at the latest.
- Interpretation of results:
- Category 2B (mildly irritating to eyes) based on GHS criteria
- Conclusions:
- The substance has to be classified as mildly irritating to eyes (Category 2B) according to GHS-criteria.
- Executive summary:
An eye irritation test in rabbits was performed according to the method described in OECD guideline 405 (GLP, reliability 1). An amount of 0.1 ml of the test substance was applied to one eye of three White New Zealand rabbits (stepwise procedure starting with one animal and supplementing two additional animals). About 24 hours after application the eye was rinsed with tap water. The ocular reactions were assessed approximately 1, 24, 48, 72 hours and 7 days after application. Slight corneal opacity, moderate iritis, moderate or severe conjunctival redness, slight to marked conjunctival chemosis and slight to severe discharge were observed during the course of the study. In addition suppuration, contracted pupil, discharge of blood and injected scleral vessels in a circumscribed area or circular were noted during the observation period.
The ocular reactions were reversible in all animals within 7 days after application. The average score (24 to 72 hours) for irritation was calculated to be 1.0 for corneal opacity, 0.4 for iris, 2.3 for conjunctival redness and 1.7 for chemosis. There was one animal with a mean score of 2.67 for redness, the other two animals were at 2 and 2.33.
Considering the described ocular reactions as well as the average score for irritation, the test substance shows a slight eye irritation potential under the test conditions chosen.
Reference
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
There are valid in-vitro and in-vivo data available for the assessment of the skin and eye irritation potential of the test item.
Skin
In an in-vitro EpiDerm test, the test substance was investigated for possible corrosive properties (2004, no GLP, reliability 2). The undiluted test material was exposed to the EpiDerm model for 3 minutes and for 1 hour. The evaluation of the results led to the conclusion, that the substance is non corrosive.
In-vivo, a reliable Key-study is available which was performed with three New Zealand White rabbits, according to OECD guideline 404 and in compliance with GLP (reliability 1). At least 24 hours before substance administration the dorsolateral part of the trunk of the animals was clipped. The untreated skin sites of the animals served as control. A 4-hour semiocclusive exposure to ca. 0.5 ml of the undiluted test substance produced the following effects: slight eryrthema (grade 1) was observed in two animals immediately and 1 hour after removal of the patch and persisted in one animal up to 24 hours. Moderate erythema (grade 2), noted in one animal immediately and 1 hour after removal of the patch, decreased to slight erythema after 24 hours. No other cutaneous reactions were observed during the study. The cutaneous reactions were reversible in one animal within 24 hours and in two animals within 48 hours after removal of the patch.
Also, in a further in-vivo study, in accordance with the OECD guideline 404 and in compliance with GLP (reliability 1). The rabbits received a single four hour, semi-ocdusive, dermal administration of 0.5 ml of the test substance as supplied and were observed for 15 days. Very-slight or well-defined erythema with or without very-slight or slight oedema was apparent throughout the first 72 hours after bandage removal. On Day 8 exfoliation was apparent in two animals one of which showed very-slight erythema; the animals were overtly normal a week later. The means of scores for the skin reactions at approximately 24, 48 and 72 hours after administration were calculated and revealed a mean score of 2.0, 1.7 and 1,7 for erythema and 1.0, 0.7, and 1.0 for oedema for animals 1 to 3, respectively.
Mild skin effects were also seen in another study, with animals treated for 4 h with the undiluted test substance under occlusive conditions. Skin reactions were observed for a period of 8 days. The value for edema formation was 1 over all animals tested and 1 for individual animals. The value for erythema formation was 1.5 over all animals tested and 2 in the first animal and 1 in the second animal. In one animal, erythema formation was not fully reversible at the end of the observation period on day 8.
Eye
In an in-vitro HET-CAM test, the test substance was investigated for possible corrosive properties (2004, reliability 2). The test substance was applied to 3 eggs undiluted and to another 3 eggs as a 10 % solution in olive oil. The time (seconds) until appearance of haemorrhagia and coagulation was noted for each. No effects within the observation period of 300 seconds were noted. Neither haemorrhagia nor coagulation occured in any of the eggs tested. The test substance did not produce changes indicative for severe eye irritation.
An eye irritation test in rabbits was performed according to the method described in OECD guideline 405 (GLP, reliability 1, 2004). An amount of 0 .1 ml of the test substance was applied to one eye of three White New Zealand rabbits (stepwise procedure starting with one animal and supplementing two additional animals). About 24 hours after application the eye was rinsed with tap water. The ocular reactions were assessed approximately 1, 24, 48, 72 hours and 7 days after application. Slight corneal opacity, moderate iritis, moderate or severe conjunctival redness, slight to marked conjunctival chemosis and slight to severe discharge were observed during the course of the study. In addition suppuration, contracted pupil, discharge of blood and injected scleral vessels in a circumscribed area or circular were noted during the observation period . The ocular reactions were reversible in all animals within 7 days after application. The average score (24 to 72 hours) for irritation was calculated to be 1.0 for corneal
opacity, 0.4 for iris, 2.3 for conjunctival redness and 1.7 for chemosis. There was one animal with a mean score of 2.67 for redness, the other two animals were at 2 and 2.33.
In another study, a Draize test was conducted with 6 New Zealand White rabbits, the eyes were also left unwashed after application of 0.1 ml tripropylene glycol diacrylate and the animals were observed for 8 days (BASF AG 1982, Val. 2). Symptoms included ulceration, loss of hair at the border of the eye lids, scars on the eyelid and narrowed pupils. The mean scores were 1.17 for corneal opacity (1.0 for 3/6 rabbits and 1.33 for the other 3/6 animals), 1 for iris lesions (1 for 6/6 animals), 1.94 for redness of the conjunctivae (2.0 for 5/6 and 1.67 for the 6th animal) and 1.39 for edema formation (0.67, 1, 1, 1.67, 2 and 2 for the individual rabbits). The lesions were still present at the end of the observation period in most of the animals. This result, however, should be considered as overpredictive due to the harsh test conditions if compared to actual guideline recommendations (substance was not washed out after 24 hours, observation period was completed after 8 days). Additionally, no information was available in terms of the amount and definition of impurities within the test material.
Respiratory system: No data available
Justification for classification or non-classification
Skin
The available experimental test data are reliable and suitable for classification purposes under Regulation 1272/2008. A GLP-compliant OECD 404 study is available for skin irritation. In this study, the scores for the test item treated tissues were below the thresholds for classification as a skin irritant. Thus, the substance is not considered to be classified for skin or eye irritation under Regulation (EC) No. 1272/2008, as amended for the thirteenth time in Regulation (EC) No. 2018/1480.
Nevertheless, the test substance is legally classified as a skin irritant category 2 (Annex VI, 1272/2008).
Eye
The available experimental test data are reliable and suitable for classification purposes under Regulation 1272/2008. A GLP-compliant OECD 405 study is available for the assessment of the eye irritation potential. indicating that the substance is not considered to be classified for eye irritation Cat. 2B under Regulation (EC) No. 1272/2008, as amended for the thirteenth time in Regulation (EC) No. 2018/1480.
Additionally, the test item is legally classified as an eye irritant category 2 (Annex VI, 1272/2008).
Respiratory system
Actually, there are no data available for a classification according to this endpoint, but the test substance is classified to cause irritation of the respiratory tract (STOT SE 3) (Annex VI, 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.
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