Registration Dossier

Administrative data

Description of key information

The potential for skin and eye irritation of the test substance was not assessed. Information on irritation are derived from a strucutral analogue. Two GLP and OECD guideline conform studies (OECD 404 and 405) in rabbits were conduceted to evaluate the irritating potential of the analogue. As a result, the analogue is not irritating to skin or eyes. Clinical signs or mortalities were not observed.

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

The irritation-potential of the test item (intermediate) was not determined. There are reliable studies of an analogue substance (final product) available to assess the potential for skin and eye irritation. The toxicity profile of the analogue as well as of the test item is determined by the main component; the side products (5 -6%) are structural analogues of the main product without influence on substance toxicity. Both substances share high similarity in structure, are poorly soluble in water and have a logPow >8. It is, therefore acceptable to derive information on skin and eye irritation from experimental data of this read across substance. A detailed risk assessment and read across justification was send to the german chemical agency BAuA in 2007 with the purpose of a national substance notification (VIIA). The read across justification was accepted by the national agency.

In a GLP conform study the primary skin irritation potential of the analogue (purity: > 98 weight-%) was investigated by topical semi-occlusive application of 0.5 g to the intact left flank of each of three young adult New Zealand White rabbits (RCC Ltd, 2002). The duration of treatment was four hours. The scoring of skin reactions was performed 1, 24, 48 and 72 hours after removal of the dressing. The test item did not elicit any skin reactions at the application site of any animal at any of the observation times (all scores 0). The individual mean score for erythema/eschar and oedema for each of the three animals was therefore 0. The test item caused no staining of the treated skin. No corrosive effects were noted on the treated skin of any animal at any measuring interval. The test substance is considered to be "not irritating" to rabbit skin.

 

In a GLP conform study the primary eye irritation potential of the analogue (purity: > 98 weight-%) was investigated by instillation of 0.1 g into one eye of each of three young adult New Zealand White rabbits (RCC Ltd, 2002). Scoring of irritation effects was performed approximately 1, 24, 48 and 72 hours after test item application. The scores of each animal at the following reading times (24, 48 and 72 hours) were used in calculating the respective mean values for each type of lesion. The primary eye irritation score was calculated by totaling the mean cumulative scores at 24, 48 and 72 hours and then dividing the resulting total by the number of data points. The primary eye irritation score was 0.33 (max. 13). The eye reactions (mean values from 24 to 72 hours) consisted of grade 0.00 corneal opacity, grade 0.00 iris lesions, grade 0.33 redness of the conjunctivae and grade 0.00 chemosis of the conjunctivae. The instillation of the test substance into the eye resulted in mild, early-onset and transient ocular changes, such as swelling and reddening of the conjunctivae and sclerae. These effects were reversible and were no longer evident 72 hours after treatment, the end of the observation period for all animals. No abnormal findings were observed in the cornea or iris of any animal at any reading. No corrosion was observed at any of the measuring intervals. No staining of the treated eyes by the test item was observed. Thus, the test item did not induce significant or irreversible damage to the rabbit eye. The test substance is considered to be "not irritating" to the rabbit eye.

 

Justification for classification or non-classification

Dangerous Substance Directive (67/548/EEC)

The available studies are considered reliable and suitable for classification purposes under 67/548/EEC. As a result the substance is not considered to be classified as irritating for skin or eyes under Directive 67/548/EEC, as amended for the 30th time in Directive 2008/58/EC.

                                             

Classification, Labelling, and Packaging Regulation (EC) No. 1272/2008

The available experimental test data are reliable and suitable for classification purposes under Regulation 1272/2008. As a result the substance is not considered to be classified for irritation under Regulation (EC) No. 1272/2008, as amended for the second time in Directive (EC 286/2011).