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EC number: 222-111-5 | CAS number: 3351-05-1
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
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- Density
- Particle size distribution (Granulometry)
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- Endpoint summary
- Stability
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- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
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- Terrestrial toxicity
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- Toxicological Summary
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- Acute Toxicity
- Irritation / corrosion
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- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data

Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1976
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Study well documented, test procedure in accordance with OECD 406 methods, meets generally accepted scientific principles, acceptable for assessment. Not GLP compliant.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 976
- Report date:
- 1976
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: "Hazardous Substances Regulations" - US Federal Hazardous Substances Labelling Act Sect. 191.11 (February 1965)
- Deviations:
- no
- GLP compliance:
- no
Test material
- Reference substance name:
- Sodium 8-phenylamino-5-(4-(3-sulphonatophenylazo)-1-naphthylazo)naphthalenesulphonate
- EC Number:
- 222-111-5
- EC Name:
- Sodium 8-phenylamino-5-(4-(3-sulphonatophenylazo)-1-naphthylazo)naphthalenesulphonate
- Cas Number:
- 3351-05-1
- Molecular formula:
- C32H23N5O6S2.2Na
- IUPAC Name:
- disodium 8-(phenylamino)-5-[(1E)-2-{4-[(1E)-2-(3-sulfonatophenyl)diazen-1-yl]naphthalen-1-yl}diazen-1-yl]naphthalene-1-sulfonate
- Test material form:
- solid: particulate/powder
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- The rabbits were caged singly in an experimental room maintained at a temperature of 20°C. (± 1°) and a relative humidityof 50-70%. Animals were exposed to artificial light for 10 hours daily from 08.00 - 18.00 hours. A commercial irradiated diet (Styles-Oxoid) was fed ad lib. Sterile filtered water was available at all times.
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- other: shaved and abraded
- Vehicle:
- water
- Controls:
- other: intact skin was used as control
- Amount / concentration applied:
- Test solution: 10 g of the test compound in 10 ml of water0.75 ml of the test solution was applied to each test site on a 2.5 square cm gauze pad.
- Duration of treatment / exposure:
- 24 h
- Observation period:
- up to 14 days
- Number of animals:
- 6 (3 males; 3 females)
- Details on study design:
- Twenty-four hours prior to the dermal application, the backs of the rabbits were shaved over an area consisting of at least 10% ofthe total body surface. Two test sites lateral to the mid line of the back were used on each rabbit. Immediately before theapplication of the test compound, the right hand site was abraded uith the point of a sterile hypodermic needle. The abrasions weresufficiently deep to penetrate the stratum corneum but not to damage the dermis. The left hand site remained intact.10g. of the test compound was mixed with 10 ml of water to make solution of 15 ml., 0.75 ml of which was applied to each testsite on a 2.5 cm. square gauze pad. These were covered with aluminium foil secured with "Sleek" adhesive tape. The test sites were then covered by a 6" wide "Cohan" self adhesive bandage in order to retain the test substance in close contace with the skin.After 24 hours the dressing was removed and the intact and abraded application sites were assessed for oedema and erythema.A further assessment was made at 72 hours and for any further period considered necessary up to 14 days.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Remarks:
- Intact
- Basis:
- mean
- Time point:
- other: 24h
- Score:
- ca. 1.17
- Reversibility:
- fully reversible within: 72 hours
- Irritation parameter:
- erythema score
- Remarks:
- Abraded
- Basis:
- mean
- Time point:
- other: 24 h
- Score:
- ca. 1.5
- Reversibility:
- other: 3 fully reversible within 72 hours
- Irritation parameter:
- edema score
- Remarks:
- Intact
- Basis:
- mean
- Time point:
- other: 24 h
- Score:
- ca. 2.67
- Reversibility:
- fully reversible within: 72 hours
- Irritation parameter:
- edema score
- Remarks:
- Abraded
- Basis:
- mean
- Time point:
- other: 24
- Score:
- ca. 3
- Reversibility:
- other: 4 fully reversible within 72 hours
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 48 h
- Remarks on result:
- not measured/tested
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 72 h
- Remarks on result:
- not measured/tested
- Irritation parameter:
- erythema score
- Time point:
- 24/48/72 h
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Time point:
- 24/48/72 h
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- The primary irritation index as the measure of the acute irritation to the skin of rabbits was found to be 2.29.
Any other information on results incl. tables
Erythema formation
No/sex |
Intact |
Abraded |
||
24 hours |
72 hours |
24 hours |
72 hours |
|
11 male |
1 |
0 |
1 |
0 |
13 |
1 |
0 |
2 |
0 |
15 |
1 |
0 |
2 |
1 |
12 female |
2 |
0 |
2 |
0 |
14 |
1 |
0 |
1 |
1 |
16 |
1 |
0 |
1 |
0 |
Mean |
1.17 |
0 |
1.5 |
0.33 |
Edema Formation
No/sex |
Intact |
Abraded |
||
24 hours |
72 hours |
24 hours |
72 hours |
|
11 male |
3 |
0 |
3 |
0 |
13 |
3 |
0 |
3 |
0 |
15 |
2 |
0 |
3 |
2 |
12 female |
3 |
0 |
3 |
0 |
14 |
3 |
0 |
3 |
1 |
16 |
2 |
0 |
3 |
0 |
Mean |
2.67 |
0 |
3 |
0.5 |
Total: 9.17
Primary irritation index: 2.29
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- non-irritant to the skin
- Executive summary:
The primary irritation index as the measure of the acute irritation to the skin of rabbits was found to be 1.17 for Erythema and 2.67 for Edema based on US Federal Hazardous Substances Labelling Act Sect. 191.11 (February 1965).
Therefore the tested item is to be considered as non-irritant to the skin of rabbits.
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