Registration Dossier

Administrative data

Description of key information

Skin: The mean total scores for erythema and oedema were 2 and 1.67 respectively.All erythema and oedema was reversible by the 14 day observation period.
Eye: a mean score of 2 for conjunctival redness following grading at 24, 48 and 72 hours after installation of the test material. Effects were fully reversed by the 21-day observation

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:
adverse effect observed (irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Dermal

Test Guidance

OECD Guideline No. 404 and EU Method B4

Method and materials

An acute dermal irritation study was conducted using undiluted test substance on New Zealand white rabbits. Initially, one rabbit was used and three patches of 0.5 ml test substance/site was applied on to clipped unabraded skin under a 2.5 cm x 2.5 cm cotton guaze patch. One patch was removed following 3 minutes, 1 hour and 4 hours after application. After consideration of the skin reactions observed in animal 1, one further animal was treated. The test substance was administered once and the patch remained in contact with the skin for 4 hours and then followed by removal of the patch containing the test article. Following the exposure periods, the bandages were removed and the application sites were evaluated in accordance with the method of Draize at approximately 24, 48, and 72 hours after patch removal and daily through day 14.

Results

The mean total scores for erythema and oedema were 2 and 1.67 respectively.All erythema and oedema was reversible by the 14 day observation period.

A single 4 -hour, semi-occluded application of the test item to intact skin of two rabbits produced well-defined erythema and slight oedema. Other dermal reactions noted were loss of skin elasticity and flexibility, light brown disolouration of the epidermis, superficial cracking of the epidermis, crust formation and glossy skin. On one occassion the reactions noted prevented the accurate evaluation of erythema and oedema. No corrosive effects were noted.

Conclusion

In accordance with EU CLP Regulation (EC) No. 1272/2008, classification of this substance is not required for dermal irritation as the primary effects, erythema and edema, were reversed by the end of the observation period and the scores for erythema and oedema did not fall within the range requiring classification.

Eye

Test Guidance

The study was performed in accordance with OECD Guideline No. 405 to assess the irritancy potential of the test item to the eye of the New Zealand White rabbit.

Method

A volume of 0.1 mL of the test item was placed into the conjunctival sac of the right eye, formed by gently pulling the lower li d away from the eyeball. The upper and lower eyelids were held together for about one second immediately after treatment, to prevent loss of the test item, and then released. The left eye remained untreated and was used for control purposes. Immediately after administration of the test item, an assessment of the initial pain reaction was made . Eight hours after test item application, a subcutaneous injection of post-dose analgesia, buprenorphine 0.01 mg/kg and meloxicam 0.5 mg/kg, was administered to provide a continued therapeutic level of systemic analgesia. The treated animal was checked for signs of pain and suffering approximately 0.5 hours later. No further analgesia was required. After consideration of the ocular responses produced in the first treated animal, a second animal was similarly treated. Assessment of ocular damage/irritation was made approximately 1 hour and 24, 48 and 72 hours following treatment, according to the numerical evaluation (Draize, J.H, 1977).

Results

A single application of the test item to the non-irrigated eye of two rabbits produced diffuse corneal opacity, iridial inflammation and moderate to severe conjunctival irritation. One treated eye appeared normal at the 7 -day observation and the the other treated eye appeared normal at the 21 -day observation.

Conclusion

The test item produced a maximum mean group score of 24.0 and a mean score of 2 for conjunctival redness following grading at 24, 48 and 72 hours after instillation of the test material. This observation was fully reversed within the observation period of 21 days. In accordance with CLP Regulation 1272/2008 the test material is classified as a Category 2 eye irritant: Reversible effects on the eye (Category 2).


Effects on eye irritation: irritating

Justification for classification or non-classification

Skin: In accordance with EU CLP Regulation (EC) No. 1272/2008, classification of this substance is not required for dermal irritation as the primary effects, erythema and edema, were reversed by the end of the observation period and the scores for erythema and oedema did not fall within the range requiring classification.

Eye: The test item produced a maximum mean group score of 24.0 and a mean score of 2 for conjunctival redness following grading at 24, 48 and 72 hours after instillation of the test material. This observation was fully reversed within the observation period of 21 days. In accordance with CLP Regulation 1272/2008 the test material is classified as a Category 2 eye irritant: Reversible effects on the eye (Category 2).