Registration Dossier

Administrative data

Description of key information

Several studies were conducted to examine the skin and eye irritating potential of the test substance. The skin irritation studies were performed prior GLP and according AFDO guidelines. In the majority of the tests the compound did not provoke any skin reaction. A study on test material with an active ingredient content below 80% resulted in transient, slight effects. It is presumed that the observed effects originate from solvents or impurities. The eye irritation studies were performed prior GLP and according Fed.Reg. 38 No 187.  In the majority of the tests the compound did not cause irritation after installation into rabbits eyes. Treatment with material of low purity (active ingredint content < 80%) resulted in slight, reversible effects on iris, conjunctiva and in chemosis. Is is presumed that the effects observed originate from solvents or impurities. In conclusion, the substance is not considered to be irritating to skin or eyes.

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

Procedure and observation

Three studies each were conducted to determine the skin and eye irritating potential of the test item.

In the course of the key study (according AFDO guideline, prior GLP), 0.5g of the test material dissolved in PEG were applied to intact and scarified skin of 3 male and 3 female rabbits for 24h under occlusive conditions. Skin reactions were evaluated after removal of the patch and after 72h. The substance did not provoke erythema or edema; the irritation index was therefore 0.

The skin irritation potential was evaluated in two other studies in rabbits. 0.5g of the test material were applied to intact and scarified skin of 6 rabbits for 24h under occlusive conditions. Skin reactions were scored after 24h and after 72h. In one of the studies (1976, Ciba), the material caused slight erythema and edema which were reversible after 72h. No effects were seen in the last study (1975, Ciba, supporting).

The eye irritation potential was determined by installation of 0.1g of the test substance into rabbits eyes (one treated eye, untreated served as control). At three of the six animals the treated eyes were rinsed 30 sec after installation. Scoring of the reaction was carried 24h, 48h and 72h after treatment; neither chemosis nor effects on conjunctiva were observed up to 7d after treatment.

The second and third study were performed in a comparable manner in rabbits: 0.1g undiluted test material was installed in one eye, 3/6 eyes were rinsed 30sec after treatment, scoring of treated and untreated eyes 24h, 48h and 72h after installation and observation for 7d. In the course of the second study (Ciba, 1975, supp), the material did not provoke any reaction into the rabbit eyes. Application of the compound in the third study (Ciba, 1976, disreg) caused slight effects on iris and conjunctiva as well as chemosis. All symptoms were reversible within the post observation period.

Results and discussion

In two of three studies the test item did not provoke any skin reaction after 24h exposure to intact and scarified skin under occlusive conditions. In one of the studies transient, slight erythema and edema were observed. However, the purity of the substance was below 80%. The effects observed may originate from solvents or impurities.

In two of three studies the test item did not cause irritation in rabbits eyes. In one of the studies transient, slight effects in iris and conjunctiva and chemosis were observed. However, the purity of the substance was below 80%. The effects observed may originate from solvents or impurities.

The test substance is therefore regarded as not-irritating to skin or eyes.

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).