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Diss Factsheets

Toxicological information

Repeated dose toxicity: dermal

Currently viewing:

Administrative data

Endpoint:
short-term repeated dose toxicity: dermal
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
4 (not assignable)

Data source

Reference
Reference Type:
secondary source
Title:
Reports of the Scientific Committee on Cosmetology (seventh series)
Author:
Scientific Committee on Cosmetology
Year:
1988
Bibliographic source:
Environment, Consumer Protection and Nuclear Safety, ISBN 92-825-8129-2, 1988, page no 37

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 410 (Repeated Dose Dermal Toxicity: 21/28-Day Study)
Principles of method if other than guideline:
Subacute repeated dose dermal toxicity study of 8-amino-2-phenyLazo-1-naphtoL-3,6-disuLphonic acid in rabbits
GLP compliance:
not specified
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Disodium 5-amino-4-hydroxy-3-(phenylazo)naphthalene-2,7-disulphonate
EC Number:
222-656-9
EC Name:
Disodium 5-amino-4-hydroxy-3-(phenylazo)naphthalene-2,7-disulphonate
Cas Number:
3567-66-6
Molecular formula:
C16H13N3O7S2.2Na
IUPAC Name:
disodium 5-amino-4-hydroxy-3-(phenylazo)naphthalene-2,7-disulphonate
Constituent 2
Reference substance name:
D&C Red 33
IUPAC Name:
D&C Red 33
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder
Details on test material:
- Name of test material (as cited in study report): Disodium saLt of 8-amino-2-phenyLazo-1-naphtoL-3,6-disuLphonic acid- Molecular formula (if other than submission substance): C16H11N3Na2O7S2- Molecular weight (if other than submission substance): 467 g/mole- Substance type: Organic - Physical state: Powder - Impurities (identity and concentrations): No data available

Test animals

Species:
rabbit
Strain:
not specified
Sex:
not specified
Details on test animals or test system and environmental conditions:
No data available

Administration / exposure

Type of coverage:
not specified
Vehicle:
other: 1% aqueous solution with 1.0% surface-active agents
Details on exposure:
PREPARATION OF DOSING SOLUTIONS: 20 mg/kg in 1% aqueous solution with 1.0% surface-active agents. TEST SITE- Area of exposure: No data available- % coverage: No data available- Type of wrap if used: No data available - Time intervals for shavings or clipplings: No data available REMOVAL OF TEST SUBSTANCE- Washing (if done): No data available - Time after start of exposure: No data available TEST MATERIAL- Amount(s) applied (volume or weight with unit): 20 mg/kg - Concentration (if solution): No data available - Constant volume or concentration used: yes- For solids, paste formed: No data available VEHICLE- Justification for use and choice of vehicle (if other than water): 1% aqueous soLution with 1.0% surface-active agents. - Amount(s) applied (volume or weight with unit): No data available - Concentration (if solution): No data available - Lot/batch no. (if required): No data available - Purity: No data available USE OF RESTRAINERS FOR PREVENTING INGESTION: No data available
Analytical verification of doses or concentrations:
not specified
Duration of treatment / exposure:
4 weeks
Frequency of treatment:
5 days/week
Doses / concentrations
Remarks:
Doses / Concentrations:20 mg/kgBasis:no data
No. of animals per sex per dose:
No data available
Control animals:
not specified
Details on study design:
No data available
Positive control:
No data available

Examinations

Observations and examinations performed and frequency:
No data available
Sacrifice and pathology:
No data available
Other examinations:
No data available
Statistics:
No data available

Results and discussion

Results of examinations

Clinical signs:
not specified
Dermal irritation:
not specified
Mortality:
not specified
Body weight and weight changes:
not specified
Food consumption and compound intake (if feeding study):
not specified
Food efficiency:
not specified
Water consumption and compound intake (if drinking water study):
not specified
Ophthalmological findings:
not specified
Haematological findings:
not specified
Clinical biochemistry findings:
not specified
Urinalysis findings:
not specified
Behaviour (functional findings):
not specified
Organ weight findings including organ / body weight ratios:
not specified
Gross pathological findings:
not specified
Histopathological findings: non-neoplastic:
not specified

Effect levels

Dose descriptor:
NOAEL
Effect level:
20 mg/kg bw/day (nominal)
Based on:
test mat.
Basis for effect level:
other: No any adverse effect

Target system / organ toxicity

Critical effects observed:
not specified

Applicant's summary and conclusion

Conclusions:
NOAEL was considered to be 25 mg/kg when rabbits were treated with Disodium saLt of 8-amino-2-phenyLazo-1-naphtoL-3,6-disuLphonic acid.
Executive summary:

In a Subacute repeated dose dermal toxicity study,rabbits were treated with Disodium saLt of 8-amino-2-phenylazo-1-naphtol-3,6-disulphonic acid in the concentration of 25 mg/kg in1% aqueous solution with 1.0% surface-active agents for5 days/week. No any adverse effects were observed in treated rabbits. Therefore, NOAEL was considered to be 25 mg/kg when rabbits were treated with Disodium salt of 8-amino-2-phenylazo-1-naphtol-3,6-disulphonic acid dermally for 4 weeks.