Registration Dossier
Registration Dossier
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EC number: 201-857-5 | CAS number: 88-75-5
Endpoint summary
Administrative data
Description of key information
The test substance did not show skin and eye irritating potential under the test conditions chosen in the study performed similar to OECD guidelines 404 and 405 by BASF (XIX/429, 1970).
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 / corrosion
In the BASF study (XIX/429, 1970) the acute skin irritation / corrosion property of the test substance was determined after a single dermal administration to rabbits. The study was conducted similar to the OECD-Guideline 404. The test substance was diluted in water and occlusively applied to the shaved backs of 2 Vienna White rabbits for 1, 5, 15 min, and 20 hours, respectively. Following exposure, the test material was washed off with Lutrol and the skin reaction was appraised after 24 hours and 8 days on the basis of the Draize scoring system. Mean 24 hour edema score was 0 after 15 min of exposure, and 1 after 20 hours of exposure, respectively. Mean 24 hour erythema score was 0 after 5 min of exposure, and 1 after 15 min and 20 hours of exposure. Only the latter effect was not fully reversible within 8 days following exposure. Concluding, the test substance revealed no skin irritating potential.
Eye irritation
In the BASF study (XIX/429, 1970), the acute eye irritation property of the test substance was determined after a single administration to 1 White rabbit each sex (weight at study initiation: Male: 2.88 kg; female: 2.11 kg). The study was conducted similar to the OECD-Guideline 405. 50 mm³ of the test substance were placed into one eye of each animal; the other eye was treated with talcum and served as control. The eye irritation was evaluated according to Draize as recommended by the actual guideline. The cornea and chemosis scores were grade 0.3 in the mean over 24, 48 and 72 hours in one animal, and 0.67 in the other, respectively. The latter was fully reversible within 72 hours, whereas the cornea score of the first animal was fully reversible within 24 hours, and the chemosis score within 48 hours. The conjunctivae scores for both animals were 1 in the mean over 24, 48 and 72 hours and were fully reversible within 72 hours and 8 days, respectively. The eyes treated with talcum showed redness (score 1) after 1 and 24 hours, which was fully reversible after 8 days. Concluding, the test substance revealed no eye irritating properties.
Respiratory irritation
No data available.
Justification for classification or non-classification
Dangerous Substance Directive (67/548/EEC)
The available experimental test data is reliable and suitable for the purpose of classification under Directive 67/548/EEC.
Based on the data, classification for skin and eye irritation is not warranted.
Classification, Labeling, and Packaging Regulation (EC) No. 1272/2008
The available experimental test data is reliable and suitable for the purpose of classification under Regulation (EC) No.1272/2008.
Based on the data, classification for skin and eye irritation / corrosion is not warranted.
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