Registration Dossier

Administrative data

Description of key information

In the skin irritation study, conducted according to an appropriate OECD 404 Test Guideline and in compliance with GLP, the test material Reaction Mass of trimethoxy(aminoalkyl)silanes and modified alkylether oligomers was reported to be not irritating to skin (Dow Corning Corporation, 1990c).

In the eye irritation study, conducted according to OECD 405 Test Guideline and in compliance with GLP, the test material, Reaction Mass of trimethoxy(aminoalkyl)silanes and modified alkylether oligomers, was reported to be mildly irritating to eyes (Dow Corning Corporation, 1990d).

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:
adverse effect observed (irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

In the skin irritation study, conducted according to OECD 404 Test Guideline and in compliance with GLP, the test material Reaction Mass of trimethoxy(aminoalkyl)silanes and modified alkylether oligomers was reported to be not irritating to skin (Dow Corning Corporation, 1990c).

Following a single 4-hour application of 0.5 ml of undiluted test item onto the previously clipped dorsal area of 4 rabbits, no signs of erythema or oedema were noted in any of the test animals. No effects were observed on body weight gain, food consumption or behaviour in any of the test animals.

In the eye irritation study, conducted according to OECD 405 Test Guideline and in compliance with GLP, the test material, Reaction Mass of trimethoxy(aminoalkyl)silanes and modified alkylether oligomers, was reported to be mildly irritating to eyes (Dow Corning Corporation, 1990d).

Following a single instillation of 0.1 ml undiluted test item into the right eye of two groups of three rabbits, no effects were observed in body weight gain or food consumption of the rabbits. Eye irritation was noted in group one animals with unwashed eyes after instillation. No eye irritation was noted in group two animals with washed eyes following treatment. Slight to moderate swelling and iritis and slight damage to cornea were noted at 24, 48 and 72 hours in group one animals. All eyes appeared normal by day 14 of the observation period. Group two animals experienced slight to severe pain after instillation of the test material. At 1 and 24 hours, slight to moderate conjunctival redness with swelling in all rabbits and slight corneal injury was observed in one animal at 24 hours. At 48 hours observation, slight redness with swelling was seen in 2/3 rabbits and one animal still showed slight corneal injury and slight iritis. All treated eyes appeared normal by day 7 of the observation period.

Justification for classification or non-classification

Based on the available data for Reaction Mass of trimethoxy(aminoalkyl)silanes and modified alkylether oligomers, no classification is required for skin irritation, and Category 2, "H319: Causes serious eye irritation" is required for eye irritation according to Regulation (EC) No. 1272/2008.