Trisodium bis[2-[[2,4-dihydroxy-3-[(2-methyl-4-sulphophenyl)azo]phenyl]azo]benzoato(3-)]chromate(3-)

Endpoint summary

Description of key information

After single occlusive exposure of intact as well as abraded clipped skin for 24 hours with 500 mg of moistened test material per site none of 6 animals showed irritation reactions. Neither erythemas nor edemas were observed at any treated site. 
The instillation of 100 mg of the solid analogous substance produced positive  effects in the conjunctivae of the 3 animals 1 and 24 hours after treatment. The test article was regarded as a mild irritant to the rabbit eye but the effects were not sufficient for classification. 

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

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: method not exactly as in standard, no GLP; short report with limited data

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

yes

Remarks:

intact an abraded skin; 6 Animals; evaluation at 24 and 72 hours only

GLP compliance:

no

Remarks:

predates GLP regulation

Species:

rabbit

Strain:

not specified

Details on test animals or test system and environmental conditions:

No data

Type of coverage:

occlusive

Preparation of test site:

clipped

Vehicle:

water

Controls:

not required

Amount / concentration applied:

500 mg per patch

Duration of treatment / exposure:

24 hours

Observation period:

72 hours

Number of animals:

6

Details on study design:

TEST SITE
- Area of exposure: 1 square inch per patch
- Type of wrap if used: the gauze patches were held in place by a rubberized cloth.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): no data
- Time after start of exposure: 24 hours

SCORING SYSTEM: according to US CFR title 16, section 1500.41; similar to Draize system.

Irritation parameter:

erythema score

Basis:

mean

Remarks:

all animals showed identical reactions

Time point:

other: 24 h and 72 h

Score:

0

Max. score:

0

Reversibility:

other: not applicable

Irritation parameter:

edema score

Basis:

mean

Remarks:

all animals showed identical reactions

Time point:

other: 24 h and 72 h

Score:

0

Max. score:

0

Reversibility:

other: not applicable

Irritation parameter:

primary dermal irritation index (PDII)

Basis:

mean

Time point:

other: 24h and 72 h

Score:

0

Max. score:

0

Irritant / corrosive response data:

No irritation

Other effects:

none

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The test material did not induce skin irritation.

Executive summary:

After single occlusive exposure of intact as well as abraded clipped skin for 24 hours with 500 mg of moistened test material per site none of 6 animals showed irritation reactions. Neither erythema nor edema were observed at any treated site.

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:

migrated information: read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Short report, no GLP

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

GLP compliance:

no

Remarks:

pre-dates GLP regulation

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Morton commercial rabbits, Parsonage farm, Stansted, UK
- Age at study initiation: 12 to 14 weeks
- Weight at study initiation: 2,44 to 2,7 kg
- Housing: single, grid floor cages
- Diet (e.g. ad libitum): ad lib.
- Water (e.g. ad libitum):ad lib.
- Acclimation period: 15 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17 to 21
- Humidity (%): 48 to 62
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 10/ 14

Vehicle:

unchanged (no vehicle)

Controls:

not required

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 100 mg

Duration of treatment / exposure:

24 hours

Observation period (in vivo):

7 days

Number of animals or in vitro replicates:

3

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing (if done): warm water
- Time after start of exposure: 24 h after instillation

SCORING SYSTEM: acc. to Draize (1949)

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

other: 1 hr

Score:

2

Max. score:

2

Reversibility:

fully reversible within: 7 days

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

other: 1 hr

Score:

0

Max. score:

0

Irritation parameter:

iris score

Basis:

mean

Time point:

other: 1 hr

Score:

0

Max. score:

0

Irritant / corrosive response data:

Conjunctival irritation, identified by moderate redness, slight to moderate swelling and discharge, was noted in the 3 treated animals one hour after treatment. At the 24 hour observation all 3 rabbits showed moderate redness of the conjunctival membranes. The conjunctival irritation regressed and all eyes appeared normal on day 7.
No corneal opacity or iridtal inflarnmation was noted during the study period.
The hair adjacent to the eye was stained brown by the test article.

Interpretation of results:

not irritating

Remarks:

Migrated information slight effects not sufficient for classification Criteria used for interpretation of results: EU

Conclusions:

The test material was a mild irritant to the rabbit eye.

Executive summary:

A study was performed to assess the irritant effects of the test material on the eye of the New Zealand White rabbit. The protocol was designed to meet the requirements of Annex Vof the EEC Council Directive 79/831/EEC, the Organisatfon for Economic Co-operation and Development (OECD) and the HSE Approved Code of Practice Notification of New Substances Regulations 1982.

The instillation of 100 mg of solid Brown HH 469 produced positive eye effects in the conjunctivae of the 3 animals one and 24 hours after treatment. The test article was regarded as a mild irritant to the rabbit eye.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

No irritant effects were observed after dermal application of the test item for 24 hours. Ocular application produced slight transient irritation of the conjunctivae. Recovery was achieved within 2 days. Effects were not sufficient for classification.

Justification for selection of skin irritation / corrosion endpoint:
target substance tested

Justification for selection of eye irritation endpoint:
sole valid study

Justification for classification or non-classification

Not classified.

Classification is not needed as the criteria are not fulfilled, neither after dermal nor after ocular treatment. The slight ocular effects were not sufficient for classification.