Registration Dossier

Administrative data

Description of key information

Skin irritation/corrosion: The test item produced a primary irritation index of 0.3 and was classified as a mild irritant to rabbit skin according to the Draize classification scheme.  No corrosive effects were noted.
Eye irritation: The test substance was instilled into one eye of each of nine albino rabbits (6 not rinsed and 3 rinsed). No signs of systemic toxicity or mortality were observed and the primary irritation index of 0.33 classifies the test substance as non-irritating. Irrigation with water increased the score to 2.0 at 1 hour and the classification to practically non-irritating.

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:
no adverse effect observed (not irritating)

Additional information

Skin Irritation/Corrosion:

Introduction.

The study was performed to assess the irritancy potential of the test item to the skin of the New Zealand White rabbit. The method was designed to be compatible with the following:

- OECD Guidelines for the Testing of Chemicals No. 404 "Acute Dermal Irritation/Corrosion" (adopted 24 April 2002)

- Method B4 Acute Toxicity (Skin Irritation) of Commission Regulation (EC) No. 440/2008

Results.

3-minute and 1-hour semi-occluded applications of the test item to the intact skin of one rabbit produced no evidence of skin irritation.

A single 4-hour, semi-occluded application of the test item to the intact skin of three rabbits produced very slight erythema and very slight oedema. Two treated skin sites appeared normal at the 24-hour observation and the remaining treated skin site appeared normal at the 48-Hour observation. No corrosive effects were noted.

Conclusion.

The test item produced a primary irritation index of 0.3 and was classified as a mild irritant to rabbit skin according to the Draize classification scheme.

The test item did not meet the criteria for classification according to the Classification, Labelling and Packaging Regulation or the Globally Harmonised Classification System.

Eye Irritation

The objective of the study was to determine the irritative potential of the test material following a single dose to the eye of albino rabbits.

The study utilized one dose level (0.1 ml) administered to the right eye of each rabbit, the left eye served as the untreated control. A total of nine rabbits were used (6 not rinsed and 3 rinsed).

When the test substance was instilled into one eye of each of nine albino rabbits (6 not rinsed and 3 rinsed). No signs of systemic toxicity or mortality were observed and the primary irritation index of 0.33 classifies the test substance as non-irritating. Irrigation with water increased the score to 2.0 at 1 hour and the classification to practically non-irritating.

Based on the results the substance does not meet the criteria for classification according to CLP.


Justification for selection of skin irritation / corrosion endpoint:
The study has been conducted according to OECD Guideline 404 and GLP and is adequately reported. The study has been assigned a reliability 1.

Justification for selection of eye irritation endpoint:
The study has been conducted according to standard guidelines and GLP and is adequately reported. The study has been assigned a reliability 1.

Justification for classification or non-classification

The results from skin irritation and eye irritation studies were evaluated according to the Classification, Labelling and Packaging Regulation (CLP).

Skin irritation:

The test item produced a maximum individual mean score of 0.33 for erythema and oedema (based on scores at 24, 48 and 72) in one animal only and all effects resolved by 48 hours. The substance therefore does not meet the criteria for classification according to the Classification, Labelling and Packaging Regulation (CLP), which requires a mean score for erythema and oedema of ≥2.3 - ≤4.0 in at least 2 of 3 animals or inflammation to persist for 14 days in at least 2 animals.

Eye irritation:

The results of the study were also evaluated separately according to the Classification, Labelling and Packaging (CLP) Regulation, based on the mean scores of individual animals for corneal opacity, iritis, conjunctival redness and chemosis (based on scores at 24, 48 and 72 hours). The scores were all below the threshold values for a 'positive respones'. All effects were fully reversible. The substance therefore does not meet the criteria for classification according to the Classification, Labelling and Packaging (CLP) Regulation.