2,2'-[(3,3'-dichloro[1,1'-biphenyl]-4,4'-diyl)bis(azo)]bis[N-(2-methylphenyl)-3-oxobutyramide]

Endpoint summary

Description of key information

The test material was non-irritant in in-vivo studies in rabbits examining skin as well as eye irritation.

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Reference

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

From 14 MAR 1978 to 17 MAR 1978.

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Acceptable, well-documented study report which meets basic scientific principles.

Reason / purpose for cross-reference:

reference to same study

Qualifier:

according to guideline

Guideline:

other: FDA-guidelines

Deviations:

not specified

Remarks:

no further information

GLP compliance:

not specified

Species:

rabbit

Strain:

Himalayan

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Housing: individually
- Diet: mixed feed ERKA 8300 (Robert Koch, Hamm), ad libitum
- Water: tap water, ad libitum

Type of coverage:

occlusive

Preparation of test site:

other: clipped, partially scarified

Vehicle:

unchanged (no vehicle)

Controls:

no

Amount / concentration applied:

TEST MATERIAL
- Amount applied: 0.5 ml

Duration of treatment / exposure:

24 h

Observation period:

48 h

Number of animals:

6

Details on study design:

TEST SITE
- Area of exposure: 2.5x2.5 cm² gauze patch
- Type of wrap if used: PVC foil, elastic bandage

REMOVAL OF TEST SUBSTANCE
- Time after start of exposure: 24 h

SCORING SYSTEM: described in § 1500.41 in Fed. Reg. 38, No. 187, 27.09.1973, p.27019, in accordance with OECD TG 404.
Scores were assessed 24, 48 and 72 h after start of exposure, which lasted for 24 h. For classification, the readings are stated here as immediately, 24 and 48 h after end of exposure.

Irritation parameter:

edema score

Basis:

mean

Time point:

other: 24, 48 h.

Score:

0

Max. score:

4

Remarks on result:

other: intact skin sites

Irritation parameter:

erythema score

Basis:

animal: #1, #4, #6

Time point:

other: 24, 48 h.

Score:

0

Max. score:

4

Remarks on result:

other: intact skin sites

Irritation parameter:

erythema score

Basis:

animal: #3, #5

Time point:

other: 24, 48 h.

Score:

0.5

Max. score:

4

Reversibility:

fully reversible

Remarks:

48 h after exposure.

Remarks on result:

other: intact skin sites

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

other: 24, 48 h.

Score:

1

Max. score:

4

Reversibility:

not reversible

Remarks:

48 h after exposure

Remarks on result:

other: intact skin site

Irritant / corrosive response data:

Immediately after exposure erythema score 1 was noted in 4/6 intact skin sites and in 5/6 scarified skin sites. Erythema score 1 persisted in animal #2 until 48 h after exposure. Every other skin response was fully reversible by 48 h. Edema score 1 was noted immediately after exposure in 5/6 intact skin sites and in 4/6 scarified skin sites, fully reversible by 48 h after exposure.

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: other: CLP regulation

Conclusions:

According to the classification criteria of Regulation (EC) No 1272/2008 the test material is not irritating to skin under these test conditions. This conclusion is legitimate even though the applied testing regime differs from today's standard methods, as the observed skin responses were fully reversible in 5/6 animals 48 h after after exposure, which lasted 20 h longer than required by OECD TG 404. The test material contains relevant amounts of Permanent-Gelb G, which is identical to the submission substance. Therefore the test results are considered adequate to fulfil the endpoint requirements.

Executive summary:

The test material was tested for skin irritancy according to FDA guidelines. Both intact and scarified skin sites of six rabbits were exposed to 0.5 ml test substance for 24 h under occlusive conditions and the skin responses were watched for 48 hours after end of exposure. Very slight erythema were noted in 5/6 animals immediately after end of exposure, fully reversible in 4/6 animals by 48 h after end of exposure. Very slight edema were noted in 5/6 animals immediately after end of exposure, fully reversible by 48 h after end of exposure. Therefore, the test item has not to be classified for skin irritation according to Regulation (EC) No. 1272/2008.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records

Reference

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1974

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Acceptable, well-documented study report which meets basic scientific principles.

Qualifier:

according to guideline

Guideline:

other: described in the "Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics" (1959) of the US Association of Food and Drug Officials (AFDO)

Deviations:

not specified

GLP compliance:

not specified

Species:

rabbit

Strain:

other: Russian breed

Vehicle:

unchanged (no vehicle)

Controls:

not required

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied: 0.1 g

Duration of treatment / exposure:

No rinsing of eyes in group 1 (3 animals); rinsing of eyes 30 seconds after application in group 2 (3 animals)

Observation period (in vivo):

7 days

Number of animals or in vitro replicates:

6

Details on study design:

SCORING SYSTEM: on the basis of the "Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics" (1959) of the AFDO (basically in accordance with OECD TG 405)

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

other: 24, 48, 72 h

Score:

0

Max. score:

4

Remarks on result:

other: group 1 + group 2

Irritation parameter:

iris score

Basis:

mean

Time point:

other: 24, 48, 72 h

Score:

0

Max. score:

2

Remarks on result:

other: group 1 + group 2

Irritation parameter:

conjunctivae score

Remarks:

( no differentiation between redness and chemosis)

Basis:

mean

Time point:

other: 24, 48, 72 h

Score:

0

Max. score:

3

Remarks on result:

other: group 1 + group 2

Irritant / corrosive response data:

No eye responses were noted in any animal at any time point.

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: other: CLP regulation

Conclusions:

The test material is not irritating to eyes under these test conditions. This conclusion is legitimate as three animals (group 1) were tested basically in accordance with today's standard methods regarding dosing, exposure duration, scoring system, reading time points and no eye responses were noted in any animal at any time point.

Executive summary:

The test material was tested for eye irritancy according to a procedure described in the "Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics" (1959) of the US Association of Food and Drug Officials (AFDO). 0.1 g neat test substance was applied to the conjunctival sac of one eye each of 6 animals (no washing in 3 animals, group 1, washing after 30 seconds in 3 animals, group 2) and eye responses were watched for seven days. No eye responses were noted in any animal at any time point. The test item is not irritating to eyes and has not to be classified as irritating to eyes according to the criteria of Regulation (EC) No 1272/2008.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no study available

Justification for classification or non-classification

No classification

Neither skin nor eye irritation were detected in in vivo studies in rabbits.