Registration Dossier

Toxicological information

Eye irritation

Currently viewing:

Administrative data

Endpoint:
eye 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 report.

Data source

Reference
Reference Type:
other: secondary source
Title:
To evaluate skin irritation potential of the given test chemical.
Author:
European Commission (EC) - Scientific Committee on Cosmetology (SCC)
Year:
1988
Bibliographic source:
European Commission (EC) - Scientific Committee on Cosmetology (SCC),1988

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: as mentioned below
Principles of method if other than guideline:
To evaluate ocular irritation potential of test chemical on guinea pig eye.
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
IUPAC name: chromium(3+) ion hydrogen bis([(6E)-6-{2-[(4Z)-3-methyl-5-oxo-1-phenyl-4 ,5-dihydro-1H-pyrazol-4-ylidene]hydrazin-1 -ylidene}cyclohexa-2,4-dien-1- ylidene]methanebis(olate))
comman name:Acid yellow 121
Molecular formula :C34H24CrN8O6.H
Molecular weight :695.633 g/mol
Substance type:organic
Physical state:solid
Smiles:c12[N]3=N[C@@-]4C(N(N=C4C)c4ccccc4)=O[Cr+3]453([N](=N[C@@-]3C(N(N=C3C)c3ccccc3)=O5)c3c(C(=O)[O-]4)cccc3)[O-]C(c1cccc2)=O
InChI:1S/2C17H13N4O3.Cr/c2*1-11-15(16(22)21(20-11)12-7-3-2-4-8-12)19-18-14-10-6-5-9-13(14)17(23)24;/h2*2-10H,1H3,(H,23,24);/q2*-1;+3/p-1/b2*19-18+;

Test animals / tissue source

Species:
guinea pig
Strain:
not specified
Details on test animals or tissues and environmental conditions:
not specified

Test system

Vehicle:
other: Cremophor EL water mixture
Controls:
not specified
Amount / concentration applied:
0.1ml of 0.1%
Duration of treatment / exposure:
Not specified
Observation period (in vivo):
Not specified
Number of animals or in vitro replicates:
Not specified
Details on study design:
Not specified

Results and discussion

In vivo

Results
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: Not specified
Reversibility:
not specified
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
No ocular irritation reactions were observed.
Other effects:
Not specified

Applicant's summary and conclusion

Interpretation of results:
other: Not irrtating
Conclusions:
No positive ocular irritation reactions were observed. Hence, the test chemical was considered to be not eye irritant to the rabbits’ eye.
Executive summary:

The eye irritation study of test chemical was conducted on guinea pigs to assess its eye irritation potential. About 0.1ml of 0.1% test chemical in a Cremophor EL/water mixture was instilled into the eyes of each rabbit. No positive ocular irritation reactions were observed. Hence, the test chemical was considered to be not eye irritant to the rabbits’ eye.