N-[2-[(2-chloro-4,6-dinitrophenyl)azo]-5-(diethylamino)-4-methoxyphenyl]acetamide

Endpoint summary

Description of key information

Eye irritation: Not irritating

Skin irritation: Not irritating

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

No studies on the "Irritation/Corrosion" are available for the substance in itself.

Nevertheless studies have been conducted with analogue molecules (Similar Substance 02 and 05) and have been taken into account for the assessment. Due to the greater structural similarity between the Target Substance and Similar Substance 03, the studies carried out on it have been chosen as key studies for both skin and eye irritation end-points. Further information are reported in the Read Across justification attached to section 13.

 

Skin Irritation

In the key study the substance (Similar Substance 05) has been tested according to a procedure similar to the OECD guideline 404. Under test conditions the substance did not cause any signs of irritation on rabbit skin.

In the supporting study the test substance (Similar Substance 02) was evaluated in the key study for its skin irritation potential according to the Federal Register 1973, Volume 38, No 187, 1500.41", similar to the OECD guideline 404.

The observation period for this test was 72 hours. In many cases the symptoms scored were not reversible in 72 hours. As there isn't an observation window of 21 days and as the scores registered never lead to an increase of the intensity of the symptoms, the test substance was classified as not irritant.

Moreover the mean score of observed values of irritation/corrosion , calculated for each rabbit, after 24, 48, 72 hours, were always under the limit for irritation potential set out in the OECD guideline.

 

Eye Irritation 

In the key study the substance (Similar Substance 05) has been tested according to a procedure similar to the OECD guideline 405. Under test conditions the substance did not cause signs of irritation (cornea opacity, iris) but weak conjunctival signs which were fully reversible within 72 h.

In the supporting study the test substance (Similar Substance 02) was evaluated in the key study for its eye irritation potential according to the Federal Register 1973, Volume 38, No 187, 1500.42", similar to the OECD guideline 405.

The mean score of observed values of irritation/corrosion , calculated for each rabbit, after 24, 48, 72 hours, were always under the limit for irritation/corrosion potential set out in the OECD guideline, therefore the test item doesn’t show irritation potential.

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.

Three subcategories are provided within the Corrosive category 1:

Subcategory 1A where responses are noted following up to 3 minutes exposure and up to 1 hour observation;

Subcategory 1B where responses are described following exposure between 3 minutes and 1 hour and observations up to 14 days;

Subcategory 1C where responses occur after exposures between 1 hour and 4 hours and observations up to 14 days

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.

The substance is not classified as skin irritant because in the performed studies, the tested similar substances don't meet the classification criteria of the CLP regulation 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.

These observations include animals with grade 4 cornea lesions and other severe reactions (e.g., destruction of cornea) observed at any time during the test, as well as persistent corneal opacity, discoloration of the cornea by a dye substance, adhesion, pannus, and interference with the function of the iris or other effects that impair sight. In this context, persistent lesions are considered those which are not fully reversible within an observation period of normally 21 days. Substances are also classified in Category 1 if they fulfil the criteria of corneal opacity ≥ 3 or iritis > 1,5 detected in a Draize eye test with rabbits, recognising that such severe lesions usually do not reverse within a 21-day observation period.

The substance does not meet the requirements to be classified in Category 1.

Irritating to eyes (Category 2)

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

- at least in 2 of 3 tested animals, a positive response of: corneal opacity ≥ 1 and/or iritis ≥ 1, and/or conjunctival redness ≥ 2 and/or conjunctival oedema (chemosis) ≥ 2

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

The substance is not classified as eye irritant because in the performed studies, the tested similar substances don't meet the classification criteria of the CLP regulation n. 1272/2008.