Registration Dossier

Administrative data

Description of key information

Terphenyl, hydrogenated was very well tolerated in rats after both dermal and ocular testing for irritation and corrosion according to the Draize method. Scores were 0.1 on a scale of 8 for skin irritation and 0.3 on a scale of 110 for eye irritation.

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

A key study for skin irritation was performed in rats with Terphenyl, hydrogenated (Branch et al., 1980); the study was conducted according to Draize method, and was considered to be reliable, adequate and relevant. A primary irritation score (mean of 24 and 72h) of 0.1 on a scale of 8.0 was calculated following a 24-hour dermal occlusive exposure of Terphenyl, hydrogenated to the intact and abraded skin of six rabbits. No apparent signs of systemic toxicity were observed. A supporting study was available in rabbits, however the reliability was low (Klimisch score 4) as there were no data on the test material composition. The primary irritation score following a 24-hour dermal exposure to the skin was 2 on a scale of 8.0 (Clarks et al., 1979). Another study was not further considered for safety assessment (Monsanto, IBT study, 1970). IBT studies are considered to be unreliable unless otherwise stated (as documented in the OECD HPV manual). A key study for eye irritation was performed in rats with terphenyl, hydrogenated (Branch et al., 1980); the study was conducted according to Draize method, and was considered to be reliable, adequate and relevant. When 0.1 mL of undiluted Terphenyl, hydrogenated was instilled into the conjunctival sac of the rabbit eye, the average of the Draize irritation scores for 24, 48 and 72 hours was 0.3 on a scale of 110 for six rabbit eyes. Minor corneal involvement was observed in one eye during the study. All treated eyes had regained a normal appearance by the second day of observation. Another study was available (Monsanto, IBT study, 1970), however it was not taken into account for safety assessment for the same reason as above. 

Justification for classification or non-classification

The endpoint does not meet classification criteria according to EU and/or CLP criteria.