Registration Dossier

Administrative data

Description of key information

skin irritation
in vivo, rabbit: not irritant (internal standard method, BASF test, BASF AG 1975)
in vitro, EpiDerm Skin Corrosion / Irritation Test: not irritant (GLP, OECD 431, BASF SE, 2010d)
eye irritation
in vivo, rabbit: not irritant (GLP, OECD 405, BASF SE 2010e)
in vivo, rabbit: not irritant (internal standard method, BASF test, BASF AG 1975)
respiratory irritation
no data available

Key value for chemical safety assessment

Additional information

There are reliable studies available to assess the potential of the substance for skin and eye irritation.

 

skin irritation

In a new guideline conform in vitro study according to GLP requirements using the human EpiDerm Skin Corrosion / Irritation Test the test substance Golpanol ALS wasserfrei showed neither a potential of corrosivity nor of irritation (BASF SE, 2010d).The test substance did not induce the cell viability relative to the negative control after 3 min and 1 h, respectively, while the positive control substance produced valid reactions.

The test substance is not able to reduce MTT directly. The mean viability of the test-substance treated tissues determined after an exposure period of 3 minutes was 114%, and it was 89% after an exposure period of 1 hour (corrosion test).

The mean viability of the test-substance treated tissues determined after an exposure period of 1 hour with about 42 hours post-incubation was 95% (irritation test).

Based on the observed results and applying the evaluation criteria it was concluded, that Golpanol ALS wasserfrei does not show a skin irritation potential in the EpiDerm™ skin corrosion/irritation test under the test conditions chosen.

The available in vivo study meets scientific standards with acceptable restrictions (limited documentation). Skin irritation was tested in White Vienna rabbits using an internal standard method (BASF test) (BASF AG, 1975). Two animals were treated with 1 ml of the test substance Golpanol ALS for 1, 5, 15 minutes and 2 other animals for 20 hours using occlusive conditions. An application site of 2.5 x 2.5 cm was covered with the test substance. After an exposure time of 1, 5, and 15 minutes the mean scores for erythema and edema were 0.0 for both sexes in the 24 - 72 h reading. The exposure for 20 h caused questionable to light spotted redness in both rabbits which was revesible after 8 days. Mean scores for erythema of the 20 h exposure were 0.67 and 1.67 in the 24 -72 h readings, respectively.

No further effects were noticed.

 

eye irritation

A new GLP conform in vivo study was performed to assess the acute eye irritation or corrosion potential of the test substance Golpanol ALS wasserfrei in White New Zealand rabbits according to the OECD guideline 405 (BASF SE 2010e). An amount of 0.1 ml bulk volume of the test substance was single ocular applied to three 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 on day 7. Slight or moderate conjunctival redness, slight to marked conjunctival chemosis and slight to severe discharge were observed in the animals during the course of the study. In addition injected scleral vessels in a circumscribed area or circular were noted in the animals during the observation period. 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 for corneal opacity and for iris lesions, 1.7, 1.3 and 1.3 for redness of the conjunctiva and 1.0, 0.3 and 0.0 for chemosis.

Considering the described ocular reactions as well as the average score for irritation, Golpanol ALS wasserfrei does not show an eye irritation potential which is relevant for classification under the test conditions chosen.

An older available study meets scientific standards with acceptable restrictions (limited documentation; 50 µl instead of 100 µl test substance instilled). The study is however sufficient for evaluation of this endpoint. Eye irritation in White Vienna rabbits was tested using an internal standard method (BASF test) (BASF AG, 1975). Two animals were treated with 50 µl of the test substance Golpanol ALS and observed for 8 days. Slight redness was monitored for 48 h in the female and 24 h in the male rabbit. The findings were reversible in within 72 hours after application. Mean scores for erythema were 0.67 for the female and 0.33 for the male animal in the 24 - 72 h reading, respectively.

No further effects were noticed. Considering the described ocular reactions, Golpanol ALS does not show an eye irritation potential which is relevant for classification under the test conditions chosen.

 

respiratory irritation

no data available

 

Justification for classification or non-classification

skin and eye irritation

Based on the available in vivo and in vitro studies, there is no indication of an irritant property of the test substance to the eyes and skin which is relevant for classification.

Thus, no classification is warranted according to the criteria of DSD (67/548/EEC) and CLP (1272/2008/EC), respectively.

 

respiratory irritation

No data available