Bis[5-[[4-[benzylmethylamino]phenyl]azo]-1,4-dimethyl-1H-1,2,4-triazolium] tetrachlorozincate(2-)

Endpoint summary

Description of key information

Not irritating for skin
Corrosive for eye

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

Skin Irritation

The skin irritation potential of the target substance was evaluated by means of Read Across approach. The complete justification for the Read Across approach is detailed at section 13.

No studies are available on the substance in itself, therefore the whole data set of the most similar substances were considered in order to perform the assessment. The substances considered for the evaluation are different salification of the Target substance.

A complete summary of the available data is attached. The results of the tests are concordant.

The study selected as the most representative and conservative was performed on Similar Substance 04 [DyStar Colours Distribution GmbH, 1985]. The test was conducted according to the OECD Guideline 404 and, under the test condition, the similar substance showed a very low interaction with rabbit skin.

All values of erythema and oedema are zero, therefore the substance is considered as not irritating for rabbit skin.

 

Eye Irritiation 

The eye irritation potential of the target substance was evaluated by means of Read Across approach. The complete justification for the Read Across approach is detailed at section 13.

No studies are available on the substance in itself, therefore the whole data set of the most similar substances were considered in order to perform the assessment. The substances considered for the evaluation are different salification of the Target substance; the results of the available tests are variable from not irritant to corrosive as described in the complete summary attached.

The study selected as the most representative and conservative was performed on Similar Substance 02 [Huntsman Textile Effects GmbH, 1973]. The test was conducted according to U.S.A FDA Federal Register (17 September,1964 § 191.12), the value reported in the summary table derived from the following calculation:

 

Cornea Score * Area of cornea involved*5

Iris score *5

Conjunctivae*Chemosis*Discharge*2

 

therefore no extrapolation is possible to the single score associated to the grading after 24 48 and 72 hours, according to the CLP Regulation.

Nevertheless, at the end of the observation period (21 days ) all the animals showed effects not fully reversible, therefore an evaluation according to the CLP Regulation is possible.

Justification for classification or non-classification

SKIN IRRITATION/CORROSION

A corrosive substance is a substance that produces destruction of skin tissue, namely, visible necrosis through the epidermis and into the dermis, in at least 1 tested animal after exposure up to 4 hour duration.

To classify a substance as irritant, the major criterion is that at least 2 of 3 tested animals have a mean score of ≥ 2,3 - ≤ 4,0.

Category 2:

- Mean value of ≥ 2,3 - ≤ 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

- 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; or

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

No dermal effects were observed under the test conditions and the mean values from gradings at 24, 48 and 72 hours were 0 for all the animals.

Based on the esperimental results, the substance is not classified as skin irritant because in the performed tests it doesn't meet the classification criteria of the CLP Regulation EC n. 1272/2008.

EYE IRRITATION

Serious eye damage means the production of tissue damage in the eye, or serious physical decay of vision, following application of a test substance to the anterior surface of the eye, which is not fully reversible within 21 days of application.

Eye irritation means the production of changes in the eye following the application of test substance to the anterior surface of the eye, which are fully reversible within 21 days of application.

Irreversible effects on the eye (Category 1):

If, when applied to the eye of an animal, a substance produces:

- at least in one animal effects on the cornea, iris or conjunctiva that are not expected to reverse or have not fully reversed within an observation period of normally 21 days; and/ or

- at least in 2 of 3 tested animals, a positive response of corneal opacity ≥ 3 and/or iritis > 1,5 calculated as the mean scores following grading at 24, 48 and 72 hours after installation of the test material.

The effects on rabbit eye are not fully reversible within the observation period of 21 days, therefore the substance is classified as Eye Damage 1, H318: Causes serious eye damage, according to the CLP regulation 1272/2008.