Registration Dossier

Administrative data

Description of key information

The key study for skin irritation in rabbits was not conducted according to contemporary guideline/s and GLP , however, the report contains sufficient data to permit a meaningful evaluation of study results. Based on the average irritation score of 5.7, the susbtance meets the criteria for a skin irritant.
The results of the acute eye irritation study showed evidence of eye irritation. Based on the irritation scores and the absence of long-term reversibility observations, the substance is considered as potentially causing eye damage.
There was no evidence of respiratory inhalation following acute inhalation exposure to the substance.

Key value for chemical safety assessment

Skin irritation / corrosion

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Eye irritation

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Respiratory irritation

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

Additional information

Eye and skin irritation studies have been performed in the rabbit (Parekh, C. 1980).

Eyes exposed to CS-1246 showed signs of irritation to the cornea, iris, and conjunctiva of both washed and unwashed eyes the effects persisting up to 72 hours in majority of animals (i.e. 5/6 unwashed and 3/3 washed eyes). On day 7 post-treatment, the irritation was still present in 3/6 unwashed and 2/3 washed eyes. While there were signs of recovery by day 7, no further observations were conducted. Based on the eye irritation scores seen on day 7 and the absence of any subsequent assessment of eye irritation, it seems prudent to consider the material as potentially causing eye damage.

Dermal exposure to CS-1246 produced erythema and edema on the intact and abraded sites. The average irritation score was 5.7, and therefore the material considered be an irritant to skin.

Respiratory Irritation: while deaths occurred following acute inhalation exposure, histopathological examination of the lungs of all rats failed to show treatment-related pulmonary injury (Terrill, J.B. and Hogan, G.K., 1982).

 

References:

Parekh, C. (1980) Acute Toxicity Profile of P-1601 (Oxazolidine E). 

International Minerals and Chemicals Corp. The Dow Chemical Company Report No: DR-0365-7725-001. Not GLP, Unpublished

Terrill, J.B. and Hogan, G.K. (1982) An Acute Inhalation Toxicity Study of ZOLDINE ZE (P-1601) in the Rat. BIODYNAMICS Inc. The Dow Chemical Company Report No: DR-0365-7725-002 Not GLP, Unpublished

 


Effects on skin irritation/corrosion: highly irritating

Effects on eye irritation: highly irritating

Justification for classification or non-classification

Based on the eye irritation scores and the absence of observation of eye irritation post 7 days, the substance is precautionary classified as Xi R41 (Risk of serious damage to eyes ) and under CLP, serious eye damage Cat 1 H318 (causes serious damage to eyes).

Based on the skin irritation scores, the substance is classified as Xi R38 (irritating to skin) and under CLP, skin corrosion/irritation Cat.2; H315.

Based on the absence of any histopathological changes in the lungs following acute inhalation exposure, the substance is not considered to be a respiratory irritant. Therefore, no classification is proposed for respiratory irritation.