Benzenesulfonic acid, mono-C11-13-branched alkyl derivs., calcium salts

Endpoint summary

Description of key information

A series of skin and eye irritation studies were conducted on Ninate 401A (Branched CaDDBS), Ninate 60E (Linear CaDDBS) and Ninate 70I (Linear CaDDBS). Results show that these materials are primary dermal irritants and cause mild to severe irritation of the eyes.

Key value for chemical safety assessment

Skin irritation / corrosion

Endpoint conclusion

Endpoint conclusion:

adverse effect observed (irritating)

Eye irritation

Endpoint conclusion

Endpoint conclusion:

adverse effect observed (irritating)

Additional information

Two dermal irritation studies were conducted in accordance with FHSA/CPSC Guidelines. In the first, Ninate 401A was applied at a dose of 0.5 mL per site to unabraded and abraded skin sites in a clipped area of each of three albino rabbits. The test sites were occluded and the test material remained on the skin for a 4 hour contact period. Application sites were graded using the Draize scoring system at 4.5, 24, 72, 168 and 336 hours after application. The primary dermal irritation score was 6.0, indicating that the substance is a primary dermal irritant. In the second, Ninate 60E was applied at a dose of 0.5 mL per site to unabraded and abraded skin sites in a clipped area of each of three albino rabbits. The test sites were occluded and the test material remained on the skin for a 4 hour contact period. Again the application sites were graded using the Draize scoring system at 4.5, 24, 72, 168 and 336 hours after application. The primary dermal irritation score was 7.0, indicating that the substance is a primary dermal irritant.

Three eye irritation studies were conducted, two in accordance with FHSA/CPSC guidelines and one using the in vitro BCOP method. In the first study, Ninate 401A was applied at a dose of 0.1 mL undiluted to one eye in each of three albino rabbits. Eyes were graded at 1, 24, 48, 72, 168 and 336 hours. There were positive eye irritation reactions in all of the three test animals. The maximum group mean score was 89.4/110.0 at the 336 hour observation. Ninate 401A is classified as extremely irritating. In the second, Ninate 60E was applied at a dose of 0.1 mL undiluted to one eye in each of three albino rabbits. Eyes were graded at 1, 24, 48, 72, 168 and 336 hours. There were positive eye irritation reactions in all of the three test animals. The maximum group mean score was 62.6/110.0 at the 336 hour observation. Ninate 60E is classified as extremely irritating. In addition, a Bovine Corneal Opacity and Permeability Assay (BCOP) was used to assess the potential ocular irritancy of three test articles to isolated bovine corneas. Corneas, obtained as a by-product from freshly slaughtered animals, are mounted in special holders and exposed to the test articles. An in vitro score is determined based on the induction and permeability (to fluorescein). Based on the results of the BCOP test, the three test materials would be classified as: mild irritant (Ninate 401A), moderate irritant (Ninate 60E), and severe irritant (Ninate 70 I).

Justification for selection of skin irritation / corrosion endpoint:

A series of skin and eye irritation studies were conducted on Ninate 401A (Branched CaDDBS), Ninate 60E (Linear CaDDBS) and Ninate 70I (Linear CaDDBS). Results show that these materials are primary dermal irritants.

Justification for selection of eye irritation endpoint:

A series of skin and eye irritation studies were conducted on Ninate 401A (Branched CaDDBS), Ninate 60E (Linear CaDDBS) and Ninate 70I (Linear CaDDBS). Results show that these materials cause mild to severe irritation of the eyes.

Effects on skin irritation/corrosion: irritating

Effects on eye irritation: highly irritating

Justification for classification or non-classification

Based on the results of the in vivo skin irritation studies, Branched CaDDBS is classified as R38 according to the DSD and as Category 2 irritant under the CLP. Based on the in vivo and in vitro eye irritation studies, Branched CaDDBS is classified as R41 according to the DSD and as Category 1 irritant under the CLP.