Registration Dossier

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)
Rationale for reliability incl. deficiencies:
secondary literature
Justification for type of information:
data is from safety assessment reports

Data source

Reference
Reference Type:
secondary source
Title:
Fiber Reactive Dyes Toxicological Profiles December 1981
Author:
U.S. Consumer Product Safety Commission
Year:
1981
Bibliographic source:
Fiber Reactive Dyes Toxicological Profiles December 1981,PB83-168732

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: as mentioned below
Principles of method if other than guideline:
To assess the skin irritation potential of Reactive deep green KE-4BD in rabbits
GLP compliance:
not specified

Test material

Constituent 1
Chemical structure
Reference substance name:
Reactive deep green KE-4BD
EC Number:
612-760-6
Cas Number:
61931-49-5
Molecular formula:
C40H29Cl2N15O19S6.6Na•
IUPAC Name:
Reactive deep green KE-4BD
Test material form:
solid
Details on test material:
Name of the test chemical: Reactive deep green KE-4BD
Molecular Formula: C40H23Cl2N15Na6O19S6
Molecular Weight: 1418.909 g/mol
SMILES notation: C1=CC(=CC(=C1)S(=O)(=O)[O-])NC2=NC(=NC(=N2)Cl)NC3=CC(=C(C=C3)NN=C4C(=CC5=CC(=C(C(=C5C4=O)N)N=NC6=C(C=C(C=C6)NC7=NC(=NC(=N7)NC8=CC(=CC=C8)S(=O)(=O)[O-])Cl)S(=O)(=O)[O-])S(=O)(=O)[O-])S(=O)(=O)[O-])S(=O)(=O)[O-].[Na+].[Na+].[Na+].[Na+].[Na+].[Na+]
Substance Type: Organic
Physical State: Solid
Specific details on test material used for the study:
Name of the test chemical: Reactive deep green KE-4BD
Molecular Formula: C40H23Cl2N15Na6O19S6
Molecular Weight: 1418.909 g/mol
SMILES notation: C1=CC(=CC(=C1)S(=O)(=O)[O-])NC2=NC(=NC(=N2)Cl)NC3=CC(=C(C=C3)NN=C4C(=CC5=CC(=C(C(=C5C4=O)N)N=NC6=C(C=C(C=C6)NC7=NC(=NC(=N7)NC8=CC(=CC=C8)S(=O)(=O)[O-])Cl)S(=O)(=O)[O-])S(=O)(=O)[O-])S(=O)(=O)[O-])S(=O)(=O)[O-].[Na+].[Na+].[Na+].[Na+].[Na+].[Na+]
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:
no data available
Duration of treatment / exposure:
no data available
Observation period:
no data available
Number of animals:
no data available
Details on study design:
no data available

Results and discussion

In vitro

Other effects / acceptance of results:
no data available

In vivo

Results
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: no data available
Reversibility:
not specified
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
No irritation observed

Applicant's summary and conclusion

Interpretation of results:
other: not irritating
Conclusions:
No skin irritation effects were observed when Reactive deep green KE-4BD was applied to rabbit skin.
Hence, Reactive deep green KE-4BD can be considered to be not irritating to skin.
Executive summary:

The dermal irritation potential of Reactive deep green KE-4BD was assessed in rabbits.

Reactive deep green KE-4BD was applied to the skin of rabbits and observed for signs of irritation(dose, duration not mentioned).

No skin irritation effects were observed when Reactive deep green KE-4BD was applied to rabbit skin.

Hence, Reactive deep green KE-4BD can be considered to be not irritating to skin.