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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Description of key information

Skin irritation/corrosion in rabbits: irritating (BASF AG, 1970)
Eye irritation in rabbits: not irritating (BASF AG, 1970)
Respiratory irritation: no data available

Key value for chemical safety assessment

Skin irritation / corrosion

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Eye irritation

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Additional information

Skin irritation/corrosion:

In the key study, the test substance was applied to a 2.5 x 2.5 cm application site of white Vienna rabbits for 20 h under occlusive conditions (BASF AG, 1970). The skin was intact. After the application time, the skin was washed with water which may have contained a mild detergent. Animals were observed for 8 days and skin changes were observed on working days. Findings were recorded after 24 and 48 hours and at the end of the observation period. Findings were graded as described in OECD guideline 404 (according to Draize). According to the results of this study the test substance is considered to be irritating to the rabbit skin.

There is supporting evidence for a skin irritation potential from another skin irritation study in rabbits that was performed according to the Guidelines of the United States Environmental Protection Agency (EPA) Paragraph 163.81-5 "Primary Dermal Irritation Study" (Federal Register, Vol. 43, No. 163, August 22, 1978). Under the conditions of this skin irratation study in the rabbit the substance was determined to be mildly irritating to the skin (Evonik, 1981).

This assessment is further supported by the results from another skin irritation study (Smyth et al., 1951). In this study, primary skin irritation on rabbits was recorded in a 10-grade ordinal series and was based upon the severest reaction that develops on the clipped skin of each of five albino rabbits within 24 hours of the uncovered application of 0.01 ml of undiluted sample. Slight erythema were described as irritant/corrosive response data.

Eye irritation:

In the key study, eye irritation was tested using a BASF-internal method (BASF AG, 1970). White Vienna rabbits were used. Approx. 50 µl of the undiluted test substance were applied to the conjunctival sac of one eye of 2 animals. The other, saline-treated eye served as control. The animals were observed several times on the treatment day and up to 8 days afterwards, and findings were recorded on working days. The eyes were not washed out after 24 h as specified in OECD Guideline 405. Both animals showed slight eye irritation during the first 3 hours that was fully reversible within 24 hours. According to the results of this study the test substance is considered to be not irritating to the rabbit eye.

This assessment is supported by the results from another eye irritation study in rabbits (Evonik, 1981). This study was performed according to the guideline "Acute eye irritation testing" of the Interagency Regulatory Liaison Group, CPSC, EPA, FDA, OSHA, from January 1981. Under the conditions of this study the test material was found to cause no irritation when applied to the rabbit eye mucosa.

Supportingly, in another study by Smyth et al. (1951) 0.5 ml undiluted material gave an injury of 0 to 1.0 points within 18 - 24 hours. The lowest injury grade (Grade 1) in a 10-grade series was assigned to the substance by the authors.

Respiratory irritation:

There are no data available concerning respiratory irritation.


Effects on skin irritation/corrosion: irritating

Justification for classification or non-classification

Dangerous Substance Directive (67/548/EEC):

The available experimental test data concerning skin irritation/corrosion and eye irritation are reliable and suitable for the purpose of classification under Directive 67/548/EEC. According to these data the substance is classified as irritating to the skin (Xi; R38). The data concerning eye irritation are conclusive but not sufficient for classification. No classification is warranted concerning respiratory irritation due to lacking data.

 

Classification, Labeling, and Packaging Regulation (EC) No. 1272/2008:

The available experimental test data concerning skin irritation/corrosion and eye irritation are reliable and suitable for the purpose of classification under Regulation (EC) No. 1272/2008. As a result the substance is classified to be irritating to the skin (Skin irrit. Cat. 2; H315). No classification is warranted concerning eye irritation (data conclusive but not sufficient for classification). No classification is warranted concerning respiratory irritation due to lacking data.