Reaction product of Propanoic acid, 3-[[bis(2-methylpropoxy)phosphinothioyl]thio]-2-methyl- and tridecanamine, N-tridecyl-, branched and linear

Endpoint summary

Description of key information

In a primary skin irritation study (OECD 404), skin irritation was observed in all test animals (BASF SE, 2015). No eye irritating potential was detected in a primary eye irritation study (OECD 405) (BASF SE, 2015).

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)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

Skin irritation

In a primary dermal irritation study according to OECD guideline 404 and EU method B.4, young adult New Zealand White rabbits (3 females) were dermally exposed to 0.5 mL of the test substance for 4 hours under a semiocclusive dressing. After removal of the patch the application area was washed. Animals were then observed for 14 days.

The following test item-related clinical observations were recorded during the course of the study:

- Very slight to severe erythema (grade 1-4)

- Very slight to severe edema (grade 1-4)

- Scaling or severe scaling

- Erythema and edema beyond the application area

- Plaque-like incrustations

- Yellowish or yellowish to brownish discoloration of the application area

The cutaneous reactions were not reversible in all three animals within 14 days after removal of the patch. Mean scores over 24, 48 and 72 hours for each animal were 3.0, 3.3 and 3.3 for erythema and 2.7, 2.3 and 2.3 for edema. Thus, the test substance is regarded as dermal irritant.

Eye irritation

key study

In a primary eye irritation study according to OECD guideline 405 and EU method B.5, 0.1 mL of the undiluted test substance was instilled into the conjunctival sac of three young adult New Zealand white rabbits (females) for 24 hours. About, and not less than 24 hours after application the eye was rinsed with tap water. Animals then were observed for 7 days. Irritation was scored by the method of Draize et al. (1961). The ocular reactions were assessed approximately 1, 24, 48, 72 hours and 7 days after application. Additional eye examinations were performed at 24 and 48 h after application with the instillation of a fluorescein solution. Due to a negative finding at the 24 and 48 hour reading (no corneal lesions detectable with fluorescein) no further readings were performed with the aid of fluorescein.

The following test item-related clinical observations were recorded during the course of the study:

- Slight conjunctival redness (grade 1)

- Slight conjunctival chemosis (grade 1)

- Slight to obvious discharge (grade 1 to 2)

- Additional findings like injected scleral vessels in a circumscribed or circular area were noted in the animals from hour 1 until hour 48.

The ocular reactions were reversible in all animals within 7 days after application. Mean scores calculated for each animal over 24, 48 and 72 hours were 0.0, 0.0 and 0.0 for corneal opacity, 0.0, 0.0 and 0.0 for iris lesions, 0.3, 0.3 and 1.0 for redness of the conjunctiva and 0.0, 0.0 and 0.3 for chemosis. Thus, the test substance is not regarded as eye irritant.

 

supporting study

The potential of the test substance to cause ocular irritation or serious damage to the eyes was assessed by a single topical application of 750 μL of a 10 % test substance preparation to the epithelial surface of isolated bovine corneas. Three corneas were treated with the test substance preparation for 10 minutes followed by a 2-hours post-incubation period. In addition to the test substance a negative control (NC; de-ionized water) and a positive control (PC; 100 % dimethylformamide) were applied to three corneas each. Corneal opacity was measured quantitatively as the amount of light transmitted through the cornea. Permeability was measured quantitatively as the amount of sodium fluorescein dye that passes across the full thickness of the cornea. Both measurements were used to calculate an In Vitro Irritancy Score of the test substance. In addition H&E-stained cross sections of the corneas were evaluated for the irritation potential of the test substance. The following results were obtained in the BCOP Test:

	Mean Opacity Value	Mean Permeability Value	Mean In Vitro Irritancy Score
Test substance	2.7	0.001	2.7
negative control	0.2	0.003	0.2
positive control	105	0.663	114.9

Histological evaluation revealed no changes indicating severe eye damage in all corneas of the test substance. Based on the observed results and applying the evaluation criteria cited in chapter 3.10 it was concluded, that the test substance does not cause ocular corrosion or severe irritation in the Bovine Corneal Opacity and Permeability Test (BCOP Test) under the test conditions chosen.

Justification for classification or non-classification

The available experimental test data are reliable and suitable for classification purposes under Regulation 1272/2008. As a result the substance needs to be classified and labelled as skin irritating cat. 2, H315 "Causes skin irritation" under Regulation (EC) No 1272/2008. Histological evaluation revealed no changes indicating severe eye damage in all corneas of the test substance. The test substance was not irritating to the eyes.