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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Toxicological information

Skin irritation / corrosion

Currently viewing:

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
4 (not assignable)

Data source

Reference
Reference Type:
review article or handbook
Title:
REPORT BY THE SCIENTIFIC COMMITTEE ON COSMETOLOGY(Opinion expressed on 1. July 1986) CONCERNING CERTAIN COLOURING AGENTS
Author:
Directorate-General Environment, Consumer Protection and Nuclear Safety
Year:
1988
Bibliographic source:
Commission of the European Communities REPORTS of the Scientific Committee on Cosmetology (seventh series),1988

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: as per mentioned below
Principles of method if other than guideline:
Skin irritation test for chemical FD and C Red 4 was performed.
GLP compliance:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Disodium 3-[(2,4-dimethyl-5-sulphonatophenyl)azo]-4-hydroxynaphthalene-1-sulphonate
EC Number:
224-909-9
EC Name:
Disodium 3-[(2,4-dimethyl-5-sulphonatophenyl)azo]-4-hydroxynaphthalene-1-sulphonate
Cas Number:
4548-53-2
Molecular formula:
C18H16N2O7S2.2Na
IUPAC Name:
disodium 3-[(2,4-dimethyl-5-sulfonatophenyl)diazenyl]-4-hydroxynaphthalene-1-sulfonate
Constituent 2
Reference substance name:
FD and C Red 4
IUPAC Name:
FD and C Red 4
Details on test material:
- Name of test material (as cited in study report):FD and C Red 4- Molecular formula (if other than submission substance):C18H14N207s2Na2- Molecular weight (if other than submission substance):480- Substance type:Organic- Physical state:Solid

Test animals

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

Test system

Type of coverage:
not specified
Preparation of test site:
not specified
Vehicle:
not specified
Controls:
not specified
Amount / concentration applied:
Amount/concentration applied1.0% in formulations
Duration of treatment / exposure:
Daily exposure
Observation period:
No data available
Number of animals:
No data available
Details on study design:
No data available

Results and discussion

In vivo

Results
Irritation parameter:
overall irritation score
Basis:
mean
Reversibility:
no data
Remarks on result:
other: No skin irritation
Irritant / corrosive response data:
No data available
Other effects:
No data available

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated informationCriteria used for interpretation of results: EU
Conclusions:
Not irritating effects were known in skin irritation test of chemical FD and C red 4 exposed to the skin of rabbit.
Executive summary:

Skin irritation test was conducted on rabbits exposed to chemical ED and C Red with 1% test chemical concentration for daily exposure.

Not irritating effects were known in skin irritation test of chemical FD and C red 4 exposed to the skin of rabbit.