Registration Dossier

Administrative data

Description of key information

Not a skin or eye irritant when tested in rabbits.

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

EYE IRRITATION

To assess the irritant and/or corrosive effects on the eyes of rabbits, TBPA Diol was instilled into the right eye of each of six rabbits. Observations were recorded at 1, 24, 48 and 72 hours after treatment. No positive ocular scores were recorded. The test article was not irritating to the eyes. This study was conducted according to Good Laboratory Practices. (Mallory et al. 1986. Primary Eye Irritation. PH 421-ET-009-86. Saytex RB-79 Diol. Lot # 19-1941-B. Pharmakon Research International, Inc. Waverly, PA. Sponsor: Ethyl Corporation, Baton Rouge, LA)

The right conjunctival sacs of the right eyes of three male and female New Zealand albino rabbits were instilled with 0.1 ml of TBPA Diol. Redness and chemosis of the conjunctiva were observed for 72 hours. Discharge was noted in one rabbit at 24 hours. TBPA Diol was not a primary eye irritant under the conditions of this test. (PHT 4-Diol Summaries of Toxicity Data. 1981. Great Lakes Chemical Corporation, West Lafayette, IN)

SKIN IRRITATION

The backs of three male and female New Zealand albino rabbits were clipped. The skin of three were abraded. A single application of TBPA Diol (0.5 ml) was made to the back of each rabbit under a gauze patch and wrapped with an airtight occlusive wrap. The skin was examined at 24, 48 and 72 hours post-dosing. No irritation was noted on the intact skin. Erythema and edema were observed on the abraded skin. The primary irritation index, according to the method of Draize, was 0.7. TBPA Diol was not a primary skin irritant under the conditions of this test. (PHT 4-Diol Summaries of Toxicity Data. 1981. Great Lakes Chemical Corporation, West Lafayette, IN)

Justification for classification or non-classification

The study results indicate the test article does not meet the criteria for classification and labeling under REACH.