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Endpoint summary

Description of key information

Skin irritant 

Eye irritant

Key value for chemical safety assessment

Skin irritation / corrosion

Endpoint conclusion

Endpoint conclusion:

adverse effect observed (irritating)

Eye irritation

Endpoint conclusion

Endpoint conclusion:

adverse effect observed (irritating)

Additional information

The eye and skin irritation of the test item was assessed by data on its single  component and read across substance. Details on similarity is reported in section 13.

Skin irritation

Experimental data obtained from the dermal irritation study after a single administration of 0.5 mL of Similar Subtstance 1 in the New Zealand White rabbit (3 animals) show that no untoward clinical signs or behavioral alterations were observed. Signs of dermal irritancy were observed in all treated rabbits. The test article, when administered by dermal route to rabbits under the experimental conditions adopted, has to be considered IRRITANT for the skin.

A study on component 1 is also available. Determination of the irritant and corrosive effects on skin was conducted in accordance with the OECD 404. 6 New Zealand White adult albino rabbits were used in the study.

At the end of the study, dermal irritation was scored and recorded at 24, 48 and 72 h, 7 d and 14 d. According to the criteria set up in the CLP Regulation n. 1272/2008, no classification for skin irritation is applied. However, serious lesions and toxic effects other than dermal irritation were also recorded.

Eye irritation

The eye irritation of Similar Substance 1 was tested according to the U.S. Consumer Product Safety Commission, Code of federal regulations, title 16, section 1500.42 (test for eye irritants). The right eye of six white New Zealand Albino rabbits was exposed to the test substance, while the left eye was used as control. Eyes were checked after 24h, 48h and 72h of exposure using a ophthalmoscope. A final check was done after 8 days and slight irritation had practically disappeared. Under test conditions the substance resulted to be irritant to the eye.

A study for irritant/corrosive potential on the rabbit's eye is alaso available for component 1. The test was conducted in accordance with OECD Guideline for Testing of Chemical n. 405. Under test condition, the test substance resulted to be not irritant to the rabbit's eye.

 

Justification for classification or non-classification

Two studies for skin irritation and two for eye irritation were considered; two were carried out on similar substance 1 and two on component 1 of the target substance. In order to derive a classification fot the target substance, results on the most concerning substance were considered, namely Similar Substance 1.

Skin irritation

According to the CLP Regulation (EC 1272/2008), a substance is considered skin irritant and allocated to category 2 if:

(1) Mean score of ≥ 2,3 and ≤ 4,0 for erythema/ eschar or for oedema in at least 2 of 3 tested animals from gradings at 24, 48 and 72 hours after patch removal or, if reactions are delayed, from grades on 3 consecutive days after the onset of skin reactions; or

(2) Inflammation that persists to the end of the observation period normally 14 days in at least 2 animals, particularly taking into account alopecia (limited area), hyperkeratosis, hyperplasia, and scaling reactions; or

(3) In some cases where there is pronounced variability of response among animals, with very definite positive effects related to chemical exposure in a single animal but less than the criteria above.

Under test conditions Similar Substance 1 exerted effects to the skin with a mean score value below 2.3. However, the signs were not fully reversible within 14 days therefore a classification as Skin Irritant Category 2 was applied.

Eye irritation

According to the CLP Regulation (EC 1272/2008), a substance is considered eye irritant and allocated to category 2 if:

- it produces in at least 2 of 3 tested animals a positive response of:

(a) corneal opacity ≥ 1; and/or

(b) iritis ≥ 1; and/or

(c) conjunctival redness ≥ 2; and/or

(d) conjunctival oedema (chemosis) ≥ 2

calculated as the mean scores following grading at 24, 48 and 72 hours after instillation of the test material, and which fully reverses within an observation period of normally 21 days.

Under test conditions, conjunctiva redness and chemosis resulted to have a score of 2, according to Draize, in at least four animals over six and no reversibility was observed after 8 days. No data at 21 days is available. Due to the gap between the two observation periods, no corrosivity effect can be attributed to the substance, but an irritating effect was nevertheless observed and for this reason, the substance can be considered as Irritant to the Eye Category 2.