Registration Dossier
Registration Dossier
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EC number: 206-017-1 | CAS number: 288-13-1
Endpoint summary
Administrative data
Description of key information
skin
rabbit, 24 h, occlusive: irritant (standardized test protocol, Draize Test; BASF 1980)
eye
rabbit, eyes not rinsed: seriously eye damaging (standardized test protocol, according to Fed. Reg.; BASF 1980)
Key value for chemical safety assessment
Additional information
There are reliable data from animal studies available to assess the skin and eye irritation potential of the substance.
skin
A set of standardized tests was performed by BASF (1980) where rabbits were exposed to the test substance under occlusive conditions for different time periods.
In a Draize test following a standard test protocol, shaved skin areas of three New Zealand White rabbits received 500 mg of the test substance (purity unknown) in water for 24 h. During the relevant reading period of 24 -72 h, the mean erythema score was 2.8 and the mean edema score was 2.3 (scoring system according to the OECD/Draize scheme). The observation period was finished after the 72 h reading since all animals are were dead because of hematuria, splenic congestion, bloody intestine lymph nodes, petechia at the thymus, soaked liver - alltogether a strong substance-related toxicity. Under the conditions of the test, the test substance was considered as irritant to the skin.
Additionally, four, two and six Vienna White rabbits were exposed for 5 min, 1h and 2 h, respectively, to 500 mg of the test substance (purity unknown, 80% in water). Here, readings after 48 and 72 hours were not performed with all animals.
After treatment for 2 hours, leather-like necrosis (considered as full-thickness necrosis) was observed in 1/6 animals, superficial or parchmenty necrosis (considered as not full-thickness necrosis) in 3/6 animals and partly strong scaling in the two other animals. Irreversible skin damage was observed in these four animals by pathological observation. Slight to severe erythema and slight to moderate edema were observed in all animals and not completely reversible in all animals within the observation period of 8 days. Overall mean scores were 2.8 for erythema (ranging from 1.5 to 4.0 in the single animals) and 1.7 for edema (1.0 to 2.0) in the relevant reading period from 24 to 72 hours. According to the conditions of the test, the test substance fullfilled the criteria to be classified as corrosive.
After treatment for 1 hour, superficial necrosis (considered as not full-thickness necrosis) was observed in 1/2 animals and scaling in the other animal. Reversible slight to moderate erythema but no edema were observed in the animals. Overall mean score was 1.5 for erythema in the relevant reading period from 24 to 72 hours. According to the conditions of the test, the test substance fullfilled the criteria to be classified as skin irritant.
After treatment for 5 minutes, slight to moderate erythema (overall mean score 0.5) and slight edema (overall mean score 0.3) was not fully reversible within 8 days. Severe scaling was observed in 2/4 animals. According to the conditions of the test, the test substance fullfilled the criteria to be classified as skin irritant.
eye
In a following Fed. Reg. protocol, 100 mg of the unchanged test substance (purity unknown) was administered to the eyes of three New Zealand White rabbits; the eyes were not rinsed. During the relevant reading period 24 -72 h, the overall scores for corneal opacity, iritis, conjunctivae redness and chemosis were 1.0, 1.0, 3.0 and 4.0, respectively (according to the OECD/Draize scheme). Discharge was also observed (mean score 3.0). Effects were only partly reversible during the observation period, therefore the test substance was considered as causing serious damage to the eyes (BASF, 1980).
Effect level: empty Endpoint conclusion: Adverse effect observed
Effect level: empty Endpoint conclusion: Adverse effect observed
Justification for classification or non-classification
According to the conditions of the available test results, the test substance Pyrazole has to be considered as skin irritant (R38 and skin irritation Cat. 2 following 67/548/EEC and GHS requirements, respectively). In 4/6 animals treated for 2 hours under occlusive conditions, full-thickness necrosis was observed. Occlusive conditions are considered as harsh in comparison with the actual OECD guideline working with semiocclusive conditions. Additionally, in another occlusive test for 24 hours, no full thickness necrosis was observed. Following a weight of evidence approach it is considered that the substance comprised a strong irritant, but not a corrosive potential.
According to the conditions of the available test results, the test substance Pyrazole has to be considered as causing severe damage to the eyes (R41 and eye irritation Cat. 1 following 67/548/EEC and GHS requirements, respectively).
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