Registration Dossier
Registration Dossier
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EC number: 221-375-9 | CAS number: 3081-14-9
Endpoint summary
Administrative data
Description of key information
In conclusion, the test substance 77PD showed a practically non-irritating potential to rabbit skin (Bayer AG 1990). The even very low skin irritation potential is confirmed by another skin irritation study (Monsanto Co. 1973). No eye irritating effects were noted in a GLP and OECD guideline study (Bayer AG 1990). An earlier eye irritation study revealed slight and transient eye irritating effects of 77PD (Monsanto Co. 1973).
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:
- no adverse effect observed (not irritating)
Additional information
Skin irritation
The skin irritating potential of 77PD was evaluated in a GLP and OECD guideline study (TG 404) in New Zealand White rabbits (Bayer AG 1990). 500 mg of the test substance was applied under semi-occlusive conditions onto the clipped intact skin of 3 female rabbits for an exposure period of 4 hours. Evaluation of skin irritation was made 1 hour, 24 hours, 48 hours, 72 hours and seven days after termination of exposure. The degree of skin irritation was recorded as specified by DRAIZE and any additional serious lesions or toxic effects were also recorded. Evaluation of skin erythema was not possible during the first 48 hours (two animals) and 72 hours (one animal) due to the intense coloration by the test substance. Nevertheless, no other inflammatory signs (e.g. oedema, formation) became apparent within this period and no irritant effects were observed after 72 hours and 7 days respectively. The authors concluded that therefore a significant irritant effect of 77PD to the skin may be excluded.
This negative finding is supported by an earlier skin irritation study in New Zealand Albino rabbits (Monsanto Co. 1973). The undiluted test substance (0.5 ml) was applied under semi-occlusive dressings to clipped intact and abraded skin of 6 New Zealand albino rabbits for 24 hours. The test substance 77PD was practically non-irritating to rabbit skin (mean irritation score intact and abraded skin: 0.0/8.0). However, a slight defatting effect (skin flaked off in seven to ten days) were observed.
Eye irritation
The eye irritating potential of the test substance 77PD was evaluated in a GLP and OECD Guideline study (TG 405) in three female New Zealand White rabbits (Bayer AG 1990). A dose of 100 µl of the test substance was instilled into the conjunctival sac of one eye of each of the three rabbits; the other eye remained untreated and served as control. Twenty four hours after instillation of the test substance each treated eye was rinsed with saline. The eyes were examined and the grade of ocular reaction was recorded at one hour, 24 hours, 48 hours, 72 hours and seven days after termination of treatment. The signs of cornea, iris, conjunctivae and discharge were recorded as described by DRAIZE and the aqueous humour (opacity) as described by MCDONALD and SHADDUCK; in addition any other serious lesions or toxic effects were recorded. The test substance 77PD was not irritating to the eye (irritation index 0.0).
A very slight eye irritation potential of 77PD was noted in an earlier eye irritation study (Monsanto Co. 1973). The undiluted test substance (0.1 ml) was placed into eyes of six New Zealand Albino rabbits. A 7-day observation period followed the application of the test substance. Eye response were scored in accordance with the Federal Hazardous substances Act (F.H.S.A.), 21 CFR, § 191.12 (1964). The test substance was slightly irritating to the rabbit eye (irritation score 24, 48, and 72 hours: 8.5/110.0). Slight effects on the conjunctivae were noted in animals at 24, 48 and 72 hours (mean score 24 h: 10.0/110, 48 h: 9.3/110.0, 72 h: 6.3/110.0) but were reversible within 168 hours. The test substance was not classified as eye irritating.
Justification for classification or non-classification
No classification is required according to the classification criteria 67/548/EWG and regulation no. 1272/2008 (GHS).
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