Registration Dossier

Administrative data

Description of key information

Skin irritation: Not irritating (OECD 404)
Eye irritation: Not irritating (OECD 405)

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)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

The structural analogue, Hypo Lem is not considered to be irritating to skin or eyes according to CLP Regulation (EC) no. 1272/2008.

Skin irritation:

In the key study 0.5 ml of test material was applied to one intact site on the dorsal trunk on each of four rabbits for four hours. After patch removal animals were examined for erythema and edema and scored according to Draize at 30-60 minutes, 24, 48 and 72 hours after patch removal.

 

According to the criteria set out in CLP Regulation (EC) no. 1272/2008 the test substance is not classified to be irritating to the skin. Eye irritation: In the key study 0.1 ml of the test substance was placed into the eye of each of 3 animals. Examinations of the eyes were made after 1 hour and 1, 2, 3, 4 and 7 days after instillation. According to the classification criteria set out in CLP Regulation (EC) no. 1272/2008 the test substance is not considered to be irritating to eyes.

Justification for selection of skin irritation / corrosion endpoint:
Based on the results obtained in the key study and supporting study on two separate structural analogues (source substance), and in accordance with the classification criteria set out in CLP Regulation (EC) no. 1272/2008, the registration substance is not considered to be a skin irritant.

Justification for selection of eye irritation endpoint:
Based on the results obtained in the key study on the target substance and supporting studies on two separate structural analogues(Source substance), and in accordance with the classification criteria set out in CLP Regulation (EC) no. 1272/2008, the registration substance is not considered to be an eye irritant.

Justification for classification or non-classification

To address toxicological endpoints as part of the REACH registration of Lemonile (Target Substance) it is proposed to read-across to Citronellyl Nitrile and Hypo Lem (Source Substance).

The use of read-across works within the spirit of REACH and the stated aim of the legislation to reduce animal testing where possible.

The Target Substance and Source Substance have been characterised using the categories and databases present in the OECD [Q]SAR Toolbox. From the profiling, it can be seen that the two substances share structural similarities and also ‘mechanistic action’ similarities which are both general and endpoint specific. Therefore read across is justified and classification can be based on the structural analogue.

Skin irritation:

Based on the results obtained in the key study and supporting study on two separate structural analogues, and in accordance with the classification criteria set out in CLP Regulation (EC) no. 1272/2008, the registration substance is not considered to be a skin irritant.

Eye irritation:

Based on the results obtained in the key study on the registration substance and supporting studies on two separate structural analogues, and, in accordance with the classification criteria set out in CLP Regulation (EC) no. 1272/2008, the registration substance is not considered to be an eye irritant.