Sodium 4-chloro-3-[4-[[5-chloro-2-(2-chlorophenoxy)phenyl]azo]-4,5-dihydro-3-methyl-5-oxo-1H-pyrazol-1-yl]benzenesulphonate

Endpoint summary

Description of key information

Non skin irritating 
Non irritating to eye

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Reference

Endpoint:

skin irritation / corrosion, other

Remarks:

in vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: The test was performed following official guideline and meets generally accepted scientific principles, acceptable for assessment.

Qualifier:

according to guideline

Guideline:

other: Appraisal of the safety of Chemicals in Food, Drugs and Cosmetics (1959) of the US association AFDO

Deviations:

not specified

GLP compliance:

no

Species:

rabbit

Strain:

other: russian breed

Details on test animals or test system and environmental conditions:

TEST ANIMALS- Age at study initiation: adult animals- Weight at study initiation: 1.3- 2.7 kg- Housing: single housing in V2A wire cages- Diet: standard rabbit food ad libitum (NAFAG, No. 814, Gossau SG)- Water: ad libitum

Type of coverage:

occlusive

Preparation of test site:

other: shaved intact and scarified skin

Vehicle:

not specified

Controls:

other: untreated skin of same animal

Amount / concentration applied:

TEST MATERIAL- Amount applied: 0.5 g

Duration of treatment / exposure:

24 hours

Observation period:

72 hours

Number of animals:

6 (3 males + 3 females)

Details on study design:

TEST SITE- Area of exposure: 2.5 cm x 2.5 cm on back and flank- Type of wrap: plastic films of 5 x 5 cm fixed to the body with adhesive tape

Irritation parameter:

erythema score

Basis:

mean

Time point:

other: 24, 48, 72 hours

Score:

0

Max. score:

4

Reversibility:

other: not applicable

Irritation parameter:

edema score

Basis:

mean

Time point:

other: 24, 48, 72 hours

Score:

0

Max. score:

4

Reversibility:

other: not applicable

Irritant / corrosive response data:

No irritant response data after a 24-hours occlusive exposure to intact skin. The primary irritaion index is 0.

Interpretation of results:

GHS criteria not met

Conclusions:

The test material is not irritating to the rabbit skin.

Executive summary:

The test item was tested for skin irritation and the test results showed a primary irritation index of 0 in all the trated animals.

The tested substance could be considered as a not skin irritant.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records

Reference

Endpoint:

eye irritation, other

Remarks:

in vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: The test was performed following official guideline and meets generally accepted scientific principles, acceptable for assessment.

Qualifier:

according to guideline

Guideline:

other: Appraisal of the safety of chemicals in Foods, Drugs and Cosmetics (1959) of the association (AFDO).

Deviations:

not specified

GLP compliance:

not specified

Species:

rabbit

Strain:

other: Russian Breed

Details on test animals or tissues and environmental conditions:

TEST ANIMALS- Source: Exp. Toxicology, CIBA-Geigy Ltd.- Housing: single housing in V2A wire cages - Diet: standard rabbit food ad libitum (NAFAG, No. 814, Gossau SG)- Water: ad libitum

Vehicle:

unchanged (no vehicle)

Controls:

other: untreated eye of same animal

Amount / concentration applied:

TEST MATERIAL- Amount applied: 0.1 g

Duration of treatment / exposure:

few seconds

Observation period (in vivo):

7 days

Number of animals or in vitro replicates:

6 (3 males + 3 females)

Details on study design:

REMOVAL OF TEST SUBSTANCE- Washing: In 3 of the 6 rabbits approximately 30 seconds after treatment the treated eye was flushed with 10 ml of physiological saline.SCORING SYSTEM: according to DraizeTOOL USED TO ASSESS SCORE: hand-slit lamp

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

other: 24, 48, 72 hours

Score:

0.44

Max. score:

4

Reversibility:

other: not applicable

Remarks on result:

other: unrinsed and rinsed

Irritation parameter:

iris score

Basis:

mean

Time point:

other: 24, 48, 72 hours

Score:

0.665

Max. score:

2

Reversibility:

other: not applicable

Remarks on result:

other: unrinsed and rinsed

Irritation parameter:

conjunctivae score

Remarks:

redness

Basis:

mean

Time point:

other: 24, 48, 72 hours

Score:

0.77

Max. score:

3

Reversibility:

fully reversible within: 96 hours

Remarks on result:

other: unrinsed

Irritation parameter:

chemosis score

Basis:

mean

Time point:

24/48/72 h

Score:

0.33

Max. score:

2

Reversibility:

fully reversible

Remarks on result:

other: unrinsed

Irritant / corrosive response data:

The tested substance showed some irritating effect of conjunctivae (redness) during the first 24 hours but the irritation signs were fully reversible within 96 hours for the unrinsed eyes. No effects on iris and on cornea and for chemosis.

Interpretation of results:

other: not irritating

Conclusions:

Under the conditions of this experiment the test material was found to cause a minimal irritation during the first 24 hours, the irritation effects were fully reversible. The test material is considered to be not irritating to the eye.

Executive summary:

Based on the test results, the test material is considered to be not irritating to the eye.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

Respiratory irritation

Tests on this pourpose have not been conducted; nevertheless the tested substance is not expected to be a respitatory irritant.

Justification for classification or non-classification

Based on indication on the Regulation CE 1272/2008:

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 thecorrosive category 1:

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

Subcategory 1Bwhere 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 grading 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 exposure in a single animal but less than the criteria above.

The substance is not classified as skin irritant because in the performed tests it doesn'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 does not meet the requirements to be classified in Category 2.

Based on the available tests, the substance should be considered as not eye irritant.