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Diss Factsheets

Toxicological information

Repeated dose toxicity: dermal

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Administrative data

Endpoint:
sub-chronic toxicity: dermal
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
4 (not assignable)

Data source

Referenceopen allclose all

Reference Type:
publication
Title:
90–day dermal toxicity data for Acid Orange 7
Author:
Toilet Goods Association
Year:
1962
Bibliographic source:
Color Additive Master File No. 9; Entry 54; Submitted to the Toilet Goods Association; 1962 (sample 82574)
Reference Type:
publication
Title:
OPINION ON Acid Orange 7
Author:
European Commission
Year:
2011
Bibliographic source:
Scientific Committee on Consumer Safety SCCS OPINION ON Acid Orange 7 COLIPA n° C15;22 March 2011

Materials and methods

Principles of method if other than guideline:
The repeated dose toxicity study was conducted to evaluate the toxic effects of administration of Acid Orange 7 to rabbits by the dermal route for 90 days.
GLP compliance:
not specified

Test material

Constituent 1
Chemical structure
Reference substance name:
Sodium 4-[(2-hydroxy-1-naphthyl)azo]benzenesulphonate
EC Number:
211-199-0
EC Name:
Sodium 4-[(2-hydroxy-1-naphthyl)azo]benzenesulphonate
Cas Number:
633-96-5
Molecular formula:
C16H12N2O4S.Na
IUPAC Name:
sodium 4-[(2-hydroxy-1-naphthyl)diazenyl]benzenesulfonate
Constituent 2
Reference substance name:
633-69-5
IUPAC Name:
633-69-5
Details on test material:
- Name of test material (as cited in study report):Acid Orange 7
- Substance type:organic

Test animals

Species:
rabbit
Strain:
not specified
Sex:
not specified

Administration / exposure

Type of coverage:
open
Vehicle:
other: water as well as USP White Ointment
Analytical verification of doses or concentrations:
not specified
Duration of treatment / exposure:
For abraded skin for 21 days
For intact skin for 90 days.
Frequency of treatment:
Daily
Doses / concentrations
Remarks:
Doses / Concentrations:
0,0.1 and 1.0% (Equivalent to 1000 and 10000 mg/kg)
Basis:

No. of animals per sex per dose:
0 mg/l = 3 animals
1000 mg/l =3 animals
10000 mg/l =3 animals
Control animals:
yes, concurrent vehicle

Examinations

Observations and examinations performed and frequency:
DETAILED CLINICAL OBSERVATIONS: Yes
HAEMATOLOGY: Yes
URINALYSIS: Yes
Sacrifice and pathology:
GROSS PATHOLOGY: Yes
HISTOPATHOLOGY: Yes

Results and discussion

Results of examinations

Clinical signs:
no effects observed
Description (incidence and severity):
no mortality was observed.
Dermal irritation:
not specified
Mortality:
no mortality observed
Description (incidence):
no mortality was observed.
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:
no effects observed
Description (incidence and severity):
Haematological values was normal
Clinical biochemistry findings:
not specified
Urinalysis findings:
no effects observed
Description (incidence and severity):
urinary components were normal
Behaviour (functional findings):
not specified
Organ weight findings including organ / body weight ratios:
not specified
Gross pathological findings:
no effects observed
Description (incidence and severity):
Gross autopsies disclosed no dose-related findings.
Histopathological findings: non-neoplastic:
no effects observed
Description (incidence and severity):
no effects observed
Histopathological findings: neoplastic:
not specified

Effect levels

Dose descriptor:
NOAEL
Effect level:
10 000 other: mg/kg
Based on:
test mat.
Sex:
not specified
Basis for effect level:
other: Effects: There was no mortality or any evidence of systemic toxicity. Haematological values, growth responses and urinary components were normal. Gross autopsies disclosed no dose-related findings.

Target system / organ toxicity

Critical effects observed:
not specified

Applicant's summary and conclusion

Conclusions:
The 90 days subchronic repeated dose dermal study on rabbit indicated that no effects observed on mortality, urinalysis, haematology and histopathology.
Thus, on the basis of study results the NOAEL (no observed adverse effect level) was observed to be 10000 mg/kg.
Executive summary:

In order to determined the repeated dermal toxicity of Acid Orange 7, a 90 days repeated dose toxicity study in rabbits was conducted at dose levels of 0(control),0.1 and 1.0% (Equivalent to 1000 and 10000 mg/kg) by dermal route .

From experimental study there was no mortality or any evidence of systemic toxicity. Hematological values, growth responses and urinary components were normal. Gross autopsies disclosed no dose-related findings.

Thus, on the basis of above results the NOAEL (no observed adverse effect level) for Acid Orange 7 considered to be 10000 mg/kg.