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EC number: 617-219-8 | CAS number: 81334-34-1
- 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
Endpoint summary
Administrative data
Description of key information
In two primary skin irritation tests, no skin effects were observed (BASF SE, 2013; American Cyanamid Company 1990)
Two primary eye irritation studies are available. In one study no irritation potential was observed (BASF SE, 2013). In the other study, cornea opacities were still observed until the end of the 21 day observation period (American Cyanamid Company, 1990).
Key value for chemical safety assessment
Skin irritation / corrosion
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Eye irritation
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irreversible damage)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Skin irritation
key study
A primary dermal irritation study has been performed according to OECD guideline 404 (BASF SE, 18H0141/04X051, 2013). The potential of the test substance to cause acute dermal irritation or corrosion was assessed by a single topical application of an amount of 0.5 g of the test item for 4 hours to the intact skin of three White New Zealand rabbits (stepwise procedure starting with one animal and supplementing two additional animals), using a patch of 2.5 cm x 2.5 cm, covered with semi-occlusive dressing. After removal of the patch the application area was washed off. The cutaneous reactions were assessed immediately after removal of the patch, approximately 1, 24, 48 and 72 hours after removal of the patch. No signs of systemic toxicity or skin effects were observed in all three animals. Mean scores over 24, 48 and 72 hours for each animal were 0.0, 0.0 and 0.0 for erythema and 0.0, 0.0 and 0.0 for edema. Considering the absence of cutaneous reactions as well as the average score for irritation, the test substance does not show a skin irritating potential under the test conditions chosen.
supporting study
A primary dermal irritation study has been performed according to 43 FR 37336, Part 163, guideline no. 81-5 (American Cyanamid Company, T-0229, 1990). Six male albino rabbits (New Zealand White strain) were used for the study. The rabbits were dosed with 0.5 g of the test substance as received, applied to a 1 inch-square gauze pad, moistened with tap water, and applied to the intact skin. The application sites were examined at the following intervals after removal of the test material for irritation: 1 hour, 24 hours, 48 hours, and 72 hours. The application sites were scored using the Draize scale for the evaluation of skin irritation. A barely perceptible erythema was present in 1/6 animals at the 1 hour observation. All signs of irritation had resolved by the 24-hour observation. No overt signs of toxicity were observed during the study period and all animals survived the experimental period. It was concluded that the test substance was not irritating to the rabbit skin.
Eye irritation (WoE)
BASF SE, 11H0141/04X052, 2013
The potential of the test substance to cause damage to the conjunctiva, iris or cornea was assessed according to OECD guideline 405. A single ocular application of 0.1 mL bulk volume (about 29 mg) of the test item 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 and 72 hours after application in two out of three animals and in a weekly interval until day 7 in a third animal. The following test item-related clinical observations were recorded during the course of the study:
· Slight conjunctival redness (grade 1)
· Slight to moderate conjunctival chemosis (grade 1-2)
· Slight to obvious discharge (grade 1-2)
· Additional findings like injected scleral vessels in a circumscribed or circular area were noted in all three animals from hour 1 until hour 48 after application. In two animals the ocular reactions were reversible within 72 hours and in one additional animal within 7 days after application. Mean scores calculated for each animal over 24, 48 and 72 hours were 0.0, 0.0 and 0.0 for corneal opacity, 0.0, 0.0 and 0.0 for iris lesions, 1.0, 0.7 and 0.7 for redness of the conjunctiva and 0.7, 0.3 and 0.3 for chemosis. Considering the described ocular reactions as well as the average score for irritation, the test substance does not show an eye irritating potential under the test conditions chosen.
American Cyanamid Company, IZ-415 -001, 1990
The eye irritating potential was assessed in a primary eye irritation test according to EPA guideline OPP 81-4. Six male albino rabbits (New Zealand White strain) were used for the study. The rabbits were dosed with 0.1 g of the test substance instilled into the conjunctival sac of the left eye.The eyes were examined at the following intervals: pretreatment (-4 hours), 1 hour, 24 hours, 48 hours, 72 hours, 4 days, 7 days, 10 days, 14 days, 17 days, and 21 days.The eyes were scored using the Draize scale for the evaluation of eye irritation. Eye irritation at one hour after dosing was characterized by slight redness of the conjunctivae (6/6), moderate chemosis (6/6), and a slight ocular discharge (6/6). Diffuse areas of corneal opacity were observed in 6/6 animals with mild-moderate conjunctival irritation (6/6), moderate chemosis (6/6), and a slight-moderate ocular discharge (6/6) at 24 hours postdosing. At 48 hours postdosing, diffuse corneal opacities were still present in 6/6 animals. Conjunctival irritation at 48 hours consisted of slight-to-moderate redness, moderate chemosis, and a mild ocular discharge. At 72 hours postdosing, corneal opacities were still present in 5/6 animals. Conjunctival irritation at 72 hours consisted of mild-to-moderate redness, mild to moderate chemosis, and a slight ocular discharge (4/6). Irritation observed at 4 days postdosing was similar to the 72-hour observation with the exception that 1/6 animals now exhibited translucent areas of corneal irritation. At the 7-day observation, corneal opacities persisted in 3/6 animals with 1/6 animals exhibiting slight vascularization of the cornea. Conjunctival irritation at 7 days consisted of slight redness in 5/6 animals and moderate chemosis in 1/6 animals. One of six animals had completely recovered at the 7-day observation. Corneal opacities were still present in 3/6 animals with all 3 animals exhibiting slight-moderate vascularization of the cornea. A slight redness of the conjunctivae (4/6) and mild chemosis (2/6) was still present at 10 days. At the 14-day observation only 2 animals still exhibited corneal opacities and vascularization. Conjunctival irritation had completely resolved in the remaining animals. Corneal opacities persisted in the remaining 2 animals for the remainder of the 21-day observation period. It was concluded that the test substance was irreversibly irritating to the rabbit eye.
Conclusions
Both eye irritation tests show an equal validity with regards to GLP and guideline compliance. The purity of the tested substance in both studies is also similar (97.7 % vs. 99.5 %) as well as the study performance. Only the number of test animals differs in both tests (3 vs. 6 animals). Therefore the worst case was regarded for local effects considering the test substance to be eye irritating with irreversible effects.
Justification for classification or non-classification
The available experimental test data are reliable and suitable for classification purposes under Regulation 1272/2008. As a result the substance does not need to be classified and labelled as skin irritating. The test substance needs to be classified as eye damaging cat. 1 (H318) under Regulation (EC) No 1272/2008, as amended for the ninth time in Regulation EC No 2016/1179.
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