Lanolin, hydrogenated

Endpoint summary

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)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

The skin and eye irritation potential of the substance was based on data on the substance itself and on Similar Substance 02. Justification for Read Across is given in Section 13 of IUCLID.

Skin irritation

The substance was evaluated for its skin irritation potential according to a test method described by Draize et al. (1944). The substance was applied in the trunk of 6 New Zealand albino rabbits, to clipped areas of intact and abraded skin. Following application, the trunk of each animal was covered with an impermeable occlusive wrapping. 24 hours following application the wrapping and test substance were removed and the test sited were individually examined and scored for erythema and edema at 24 and 72 hours. The mean score for erythema (24 /72 hours) was 0.66 for 5 rabbits (reversible within 48 hrs) and 1 for all rabbits whereas edema was 0 for all animals.

Similar substance was evaluated for its skin irritation potential according to a test method patterned after the Draize procedure as described in 16 CFR 1500.41. The substance was applied on the back of 6 albino rabbits, to shaved areas of intact and abraded skin. 24 hours following application the test substance was removed and the test sites were individually examined and scored for erythema and edema at 24 and 72 hours. The mean score for erythema (24/48/72 hours) was 0.66 for 2 rabbits (not reversible within 72 hrs), 1 for 3 rabbits (not reversible within 72 hours) and 0 for one rabbit. Edema score was 1 for 3 rabbits (not reversible within 72 hours) and 0.66 for 3 animals (reversible only for 2 animals within 48 hrs).

It seems that Similar substance has a higher skin irritation potential than the substance since it produced a higher edema and erythema score.

Based on the scoring obtained in the two studies, for erythema and edema, the substance is not considered to be a skin irritant.

Eye irritation

The substance was evaluated for its eye irritation potential to rabbits by a procedure followed modification of that used by Draize et. al. 1944. The substance was applied in the right eye of the 6 albino rabbits, while the left eye was left untreated and served as control. The eyes of the animals remained unwashed. Changes in cornea (opacity), iris, conjuctivae (redness, chemosis, discharge) were evaluated and scored at 24, 48, 72 hours and 4 and 7 days following application. The mean scores following grading at 24, 48 and 72 for cornea opacity, iris and conjuctivae chemosis was 0 for all animals. The mean scores for conjuctivae redness was 0.33 for 5 out of 6 animals. One animal died after 3 days following application while one animal dies after 2 days following application. The deaths were not treatment related.

The eye irritation potential of Similar substance to rabbits was evaluated by the procedure described in 16 CFR 1500.42. The substance was applied in the eye of the 6 albino rabbits. The eyes of the animals remained unwashed. Changes in cornea (opacity), iris, conjuctivae (redness, chemosis, discharge) were evaluated and scored at 24, 48, 72 hours and 7 days following application. The mean scores following grading at 24, 48 and 72 for cornea opacity and iris was 0 for all animals. The mean scores for conjuctivae redness was 1 for 3 animals, 1.33, 0.66 and 0.33 for 1 animal. Mean score for conjuctivae chemosis was 1 for 4 animals, and 0.66 and 0.33 for 1 animal. All reactions were reversible within 7 days observation period.

Based on the scores obtained for the target and similar substance, it seems that the eye irritation potential of the similar substace is higher in comparison to the one of the target substance.

Based on the scores obtained, the substance is considered as a non-eye irritant.

Justification for classification or non-classification

Skin Irritation / Corossion

A corrosive substance is a substance that produces destruction of skin tissue, namely, visible necrosis through the epidermis and into the dermis, in at least 1 tested animal after exposure up to 4 hour duration. To classify a substance as irritant, the major criterion is that at least 2 of 3 tested animals have a mean score of ≥ 2.3 - ≤ 4.0.

The mean score for erythema (24 /72 hours) was 0.66 for 5 rabbits (reversible within 48 hrs) and 1 for all rabbits whereas edema was 0 for all animals.

The substance is not classified as skin irritant because in the performed tests it doesn't meet the classification criteria of the CLP regulation (EC) No. 1272/2008.

Eye Irritation

Serious eye damage means the production of tissue damage in the eye, or serious physical decay of vision, following application of a test substance to the anterior surface of the eye, which is not fully reversible within 21 days of application.

Eye irritation means the production of changes in the eye following the application of test substance to the anterior surface of the eye, which are fully reversible within 21 days of application.

The mean scores of observed values of irritation/corrosion were calculated for each rabbit, after 24, 48, 72 hours after installation of test material. The mean scores following grading for cornea opacity, iris and conjuctivae chemosis was 0 for all animals. The mean scores for conjuctivae redness was 0.33 for 5 out of 6 animals.

The test substance does not meet the criteria indicated in Annex I: 3.3.2.1.1 of the CLP regulation (EC) No. 1272/2008 for eye irritation or serious eye damage, therefore it is not classified for eye irritation.