Registration Dossier

Administrative data

Description of key information

Based on the results of a study according to OECD Test Guideline 404 under GLP, the test substance is considered to be skin irritating.
Based on the results of a study according to OECD Test Guideline 431 under GLP, the test substance is considered to be not skin corrosive.
Based on the results of a study according to OECD Test Guideline 405 under GLP, the test substance is considered to be eye irritating.

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)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Skin irritation/corrosion:

An in vitro study according to OECD test guideline 431 and GLP showed that the test substance is not skin corrosive. This complements the results of an in vivo study according to OECD Test Guideline 404 and GLP. Three female albino rabbits were exposed to the test article at two skin sites on the back. After 4 hours of exposure the test article was removed and the skin was examined 1, 24, 48 and 72 hours as well as 7, 14 and 21 days after termination of exposure.

The test article caused a moderate to severe erythema and a moderate oedema in all three rabbits.

Under the experimental conditions described in this report, the mean score for erythema was 2.9 and for oedema was 2.9.

The test substance is thus irritating to the skin.

Eye irritation:

The local effect of the registered substance was investigated according to the method recommended in the OECD Guideline 405 (2002) and the council regulation (EC) No 440/2008 part B.5. (2008). During an initial test, an amount of 0.1 ml of the undiluted test item was applied in one eye of a female albino rabbit. The eye was examined and the changes were graded according to a numerical scale after 1 hr, 24 hrs, 48 hrs and 72 hrs as well as on day 7, 14 and 21. Well defined changes were observed in the treated eye. Since the animal used during the initial test did not show corneal defects on day 7, two more female albino rabbits were treated with 0.1 ml of the undiluted test item each. Likewise ocular defects were graded after 1 hr, 24 hrs, 48 hrs and 72 hrs as well as on day 7, 14 and 21. The two test animals showed also well defined changes concerning the eyes.

The mean scores (24/48/72 hours) in the individual animals were:

- corneal opacity (without fluorescein): 1.00/0.67/0.33

- corneal opacity (with fluorescein): 1.33/1.00/0.67

- iris lesions: 0.67/0.67/0.33

- redness of the conjunctiva: 2.33/1.67/1.67

- Oedema of the conjunctiva: 2.00/1.33/1.67

All observed effects were fully reversible within 7 days.

Additionally, an in vitro study was performed to assess the corneal irritation and damage potential of the test substance by means of the BCOP assay using fresh bovine corneae. After a first opacity measurement of the fresh bovine corneae (k), the neat test item, the positive, and the negative controls were applied to corneae and incubated for 10 minutes at 32 ± 2 °C in complete medium. After the incubation phase the test item, the positive, and the negative controls were each rinsed from the corneae and opacity was measured again (t10). Further, the corneae were incubated for another 120 minutes at 32 ± 2 °C in complete medium, and opacity was measured a third time (t130). After the opacity measurements permeability of the corneae was determined while application of 1 mL of a fluorescein solution for 90 minutes at 32 ± 2 °C in a horizontal position. The coming out liquid was measured spectrophotometricaly.

With the negative control (0.9% NaCI solution) neither an increase of opacity nor permeability of the corneae could be observed. The mean in vitro score was calculated as 0.91.

The positive control (2-Ethoxyethanol) showed clear opacity and distinctive permeability of the comeae and therefore, is classified as severe eye irritant. The mean in vitro score was calculated as 76.33.

The test item did not cause any opacity or permeability of the corneae compared with the results of the negative control. The calculated mean in vitro score was 1.52 and therefore, the test item was classified as not corrosive to the eye.


Effects on skin irritation/corrosion: irritating

Effects on eye irritation: irritating

Justification for classification or non-classification

Skin irritation/corrosion:

Interpreting the results of both the in vitro and in vivo test by applying the evaluation system of the EU regulation 1272/2008 and EU directive 67/548/EEC, the test substance is considered irritating to the skin. Eye irritation: Based on the results of an in vivo study the registered substance • shall not be classified as irritating to eyes according to annex VI of the directive 67/548/EEC (2009) as well as the directive 2006/12 11EC (2006, 2007) • shall be classified as irritating to eyes according to category 2B of the GHS (2007), because of the data concerning the opacity of the cornea obtained after the use of Fluorescein. • shall be classified as irritating to eyes according to category 2 of the regulation (EC) No 1272/2008 (2008)7, because of the data concerning the opacity of the cornea obtained after the use of Fluorescein.