Registration Dossier

Administrative data

Description of key information

An in vivo eye irritation and in vivo skin irritation study were conducted on FBSEE diol. The results of the studies were:

 

- Eye Irritation: Mildly irritating (not classified) when tested according to OECD 405 (2002).

 

- Skin Irritation: Non-irritating when tested according to OECD 404 (2002).

Key value for chemical safety assessment

Additional information

Eye Irritation:

The primary eye irritation/corrosion potential of the test article was evaluated in New Zealand White Rabbits. The study was conducted in compliance with OECD GLP (1997). The test method was based on OECD No. 405 (2002), EC No. 440/2008, EPA OPPTS 870.2400 (1998) and JMAFF guidelines (2011). Single samples of approximately 64 mg of test article (a volume of approximately 0.1 mL) were instilled in the conjunctival sac of one of the eyes of each animal. The lids were held together for about one second to prevent loss of the test substance. The remaining untreated eye served as the control. The eyes were observed at 1, 24, 48, and 72 hours and 7 days after instillation. Immediately after the 24-hour observation, a solution of 2% fluorescein in water was instilled in both eyes of each animal to quantitatively determine corneal epithelial damage. Corneal opacity (maximum grade 1) and epithelial damage (maximum 35% of the corneal area) that had resolved within 72 hours was observed in one animal. Slight dulling of the normal luster of the cornea was noted in the other two animals on Day 1. Iridial irritation (grade 1) was observed in all animals and resolved within 24 hours. Conjunctivae redness, chemosis, and discharge (maximum grade 2) was seen in all animals but had resolved within 7 days. Individual animal average corneal opacity scores (24-72 hours) were 0.7, 0.0, and 0.0. Individual animal average iritis scores (24-72 hours) were 0.0 in all animals. Individual animal average conjunctival redness scores (24-72 hours) were 2.0, 1.7, and 1.3. Individual animal average conjunctival chemosis scores (24-72 hours) were 1.3, 0.3, and 0.7. Based on the results of the study, the test article is a mild ocular irritant and has no obligatory labeling requirements for eye irritation according to GHS.

 

Skin Irritation:

 

The skin irritation potential of the test article was evaluated in albino rabbits. The test was conducted under OECD GLP (1997) conditions. The test method was based on OECD No. 404 (2002), EC No. 440 (2008), US EPA, OPPTS 870.2500 (1998), and JMAFF Guidelines (2011). Three male rabbits were exposed to 0.5 grams of the test article moistened with water by application onto clipped skin for 4 hours using a semi-occlusive dressing. Sites were cleaned of residual test substance using tap water after 4 hours of exposure. Animals were observed twice daily for mortality/viability, at least once daily for toxicity, and body weight was taken on the day of treatment (prior to application) and after the final observation. The exposed sites were examined at 1, 24, 48, and 72 hours and scored for erythema and edema. Erythema and edema scores of zero were reported at all time points for all animals (PII=0.0/8.0). Based on the results of the study (all scores 0, PII=0.0/8.0), the test article is not a skin irritant.

Justification for classification or non-classification

Based on the results of the studies, FBSEE diol is not classified for ocular or dermal irritation according to CLP.