Di-sec-butylphenol, mixed isomers

Endpoint summary

Description of key information

Skin irritation: PDII = 4.0, irritant (OECD 404), Xi, R 38
Eye irritation: maximum group mean score of 12.0. No positive criteria according to EEC. No symbol and risk phrase required

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:

Phenol, 2,6-bis(1-methylpropyl) was evaluated for its irritancy potential to the skin of the New Zealand White rabbit.

The test material produced a primary irritation index of 4.0 and was classified as moderate irritant to rabbit skin according to Draize classification scheme. No corrosive effects were noted.

The test material was also classified as irritant according to EEC labelling regulations. The symbol "Xi" and risk phrase R 38 "IRRITATING TO SKIN" are therefore required.

Test method:

The test method used followed that described in the OECD Guidelines for Testing of Chemicals (1981) No. 404 "Acute Dermal Irritation/Corrosion" referenced as Method B4 in Commission Directive 84/449/EEC (which constitutes Annex V of Council Directive 67/548/EEC. The results may be used as a basis for classification and labelling under Annex VI of Council Directive 67/548/EEC (as adapted to technical progress by Commission Directive 91/325/EEC).

A single 4 -hour, semi-ocludded application of the test material to the intact skin of three rabbits produced well-defined erythema and slight oedema. Adverse dermal reactions noted seven days after treatment were desquamation or crust formation.

Eye irritation:

Phenol, 2,6 -bis(1 -methylpropyl) was evaluated for its irritancy potential to the eye of the New Zealand White rabbit.

The test material produced a maximum group mean score of 12.0 and was classified as a mild irritant (class 4 on a 1 to 8 scale) to the rabbit eye according to a modified Kay and Calandra classification system.

The test material was also classified as non-irritant according to the EEC labelling regulations. No symbol and risk phrase are required.

Test method: The method used followed that described in the OECD Guidelines for testing of Chemicals (1987) No. 405 "Acute Eye Irritation/Corrosion" referenced as Method B5 in Commission Directive 84/449/EEC (which constitutes Annex V of Council Directive 67/548/EEC).

The results may be used as a basis for classification and labelling under Annex VI of Council Directive 67/548/EEC (as adapted to technical progress by Commission Directive 91/325/EEC).

A single instillation of the test material to the non-irrigated eye of three rabbits produced iridial inflammation and/or minimal to moderate conjunctival irritation. Haemorrhage of the nictitating membrane was noted in one treated eye one and 24 hours after treatment. Treated eyes appeared normal 24, 48 or 72 hours after treatment.

Effects on skin irritation/corrosion: irritating

Justification for classification or non-classification

Skin irritation:

The test material produced positive criteria in 3/3 rabbits according to the EEC labelling regulations and was classified as irritant to rabbit skin. The symbol "Xi" and risk phrase R 38 "IRRITATING TO SKIN" are therefore required.

Eye irritation:

The test material did not produce positive criteria in any rabbit according to the EEC labelling regulations and was classified as non-irritant to the rabbit eye. No symbol and risk phrase are therefore required.