Reaction mass of N-butylphosphorothioic triamide and N-propylphosphorothioic triamide

Endpoint summary

Description of key information

Skin: not irritating (BASF, 2009)
Eye: irritating (BASF, 2009)

Additional information

Skin irritation:

The potential of LIMUS-Sambaydestillation to cause acute dermal irritation or corrosion was assessed in a study according to OECD guideline 404 and GLP. A single topical application of an amount of 0.5 g of the undiluted pasty test substance was made for 4 hours to the intact skin of three White New Zealand rabbits using a patch of 2.5 cm x 2.5 cm, covered with semiocclusive dressing. After removal of the patch the application area was washed off. The cutaneous reactions were assessed immediately after removal of the patch, approximately 1, 24, 48 and 72 hours after removal of the patch. Slight or moderate erythema was observed in the animals within 24 hours after removal of the patch. The cutaneous reactions were reversible in all animals within 48 hours after removal of the patch at latest. Mean scores over 24, 48 and 72 hours for each animal were 0.0, 0.3 and 0.0 for erythema and 0.0 for edema. Considering the described cutaneous reactions as well as the average score for irritation, LIMUS-Sambaydestillation does not show a skin irritation potential under the test conditions chosen.

Eye irritation:

The potential of LIMUS-Sambaydestillation to cause damage to the conjunctiva, iris or cornea was assessed in a study according to OECD 405 guideline and GLP by a single ocular application of 0.1 mL bulk volume (about 74 mg) of the test substance to one eye of three White New Zealand rabbits (stepwise procedure starting with one animal and supplementing two additional animals). About 24 hours after application the eye was rinsed with tap water.

The ocular reactions were assessed approximately 1, 24, 48 and 72 hours after application and then in weekly intervals until day 21.

Slight to marked corneal opacity, moderate iritis, slight to moderate conjunctival redness, slight to marked conjunctival chemosis and slight to severe discharge were observed in the animals during the course of the study.

Additional findings like suppuration, discharge of blood, contracted pupil, vascularization into the central part of the cornea in a circumscribed area and injected scleral vessels in a circumscribed area or circular were noted in the animals during the observation period. The ocular reactions relevant for evaluation were reversible in one animal within 14 days and in two animals within 21 days after application. One animal showed injected scleral vessels in a circumscribed area up to study termination on day 21.

Mean scores calculated for each animal over 24, 48 and 72 hours were 1.0, 0.7 and 1.7 for corneal opacity, 0.3, 0.3 and 1.0 for iris lesions, 2.0 for redness of the conjunctiva and 2.0, 1.7 and 2.3 for chemosis.

Considering the described ocular reactions as well as the average score for irritation, LIMUS-Sambaydestillation shows an eye irritation potential under the test conditions chosen.

Justification for classification or non-classification

Based on the available skin and eye irritation studies, the substance has to be classified R 36 (Directive 67/548/EEC) and Eye corrosion/irritation Cat 2 (CLP).