Registration Dossier

Diss Factsheets

Toxicological information

Eye irritation

Currently viewing:

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1994
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Justification for type of information:
None

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1994
Report date:
1994

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
Deviations:
no
Principles of method if other than guideline:
Guidelines followed
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
[4-[(4,5-dihydro-3-methyl-5-oxo-1-phenyl-1H-pyrazol-4-yl)azo]-3-hydroxynaphthalene-1-sulphonato(3-)]chromium
EC Number:
271-352-2
EC Name:
[4-[(4,5-dihydro-3-methyl-5-oxo-1-phenyl-1H-pyrazol-4-yl)azo]-3-hydroxynaphthalene-1-sulphonato(3-)]chromium
Cas Number:
68541-72-0
Molecular formula:
C20H13CrN4O5S
IUPAC Name:
[4-[(4,5-dihydro-3-methyl-5-oxo-1-phenyl-1H-pyrazol-4-yl)azo]-3-hydroxynaphthalene-1-sulphonato(3-)]chromium
Test material form:
solid: particulate/powder
Specific details on test material used for the study:
- Test article: FAT 20042/D
- Additional specification: Neolan Rosa BE ZP feucht
- Batch No.: 276
- Purity/Contents: ca. 50 %
- Physical properties: solid; black-red humid lumps
- Storage conditions: room temperature
- Validity: October, 1998
- Safety precautions: gloves and face masks
- Test material received: November 19, 1993

Test animals / tissue source

Species:
rabbit
Strain:
other: Chbb:NZW
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Dr. K. Thomae GMBH,Chemisch-pharmazeutische Fabrik, D-7950 Biberach/Riss
- Weight at study initiation: 2030 to 2610 g.
- Housing: Housed individually in metal cages
- Diet: Nafag, No. 814, Gossau, Switzerland, ad libitum
- Water: ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature: 20±3 °C
- Humidity: 30-70 %
- Photoperiod: 12 hours light cycle day

IN-LIFE DATES: From: To: January 11, 1994 to February 15, 1994

Test system

Vehicle:
not specified
Controls:
other: untreated right eye
Amount / concentration applied:
- Amount(s) applied: 100 mg
Duration of treatment / exposure:
Unwashed eye: unspecified (not rinsed after single instillation)
Observation period (in vivo):
The ocular reactions were evaluated 1, 24, 48, and 72 hours after the instillation of FAT 20042/D
Duration of post- treatment incubation (in vitro):
None
Number of animals or in vitro replicates:
Three animals (one males and two females)
Details on study design:
PROCEDURE:
The test article was applied with a spatula. 100 mg of FAT 20042/D was placed into the conjunctival sac of the left eye of each animal, after gently pulling away the lower lid from the eyeball. The lids were then held together for about one second in order to prevent loss of the test article. The right eye remained untreated and served as a control. The animals were checked dailyfor systemic symptoms and mortality (only findings reported).

The ocular reactions were evaluated 1, 24, 48, and 72 hours after the instillation of FAT 20042/D according to the OECD scoring system. In order to determine the reversibility of the eye reactions additional evaluations of the ocular reactions were needed in this study. A slit-lamp was used to facilitate the evaluation. The irritant/corrosive potency of FAT 20042/D was classified according to Council Directive 67/548/EEC, adapted to technical progress by Commission Directive 93/21/EEC.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
conjunctivae score
Basis:
animal: 824
Remarks:
mean score
Time point:
24/48/72 h
Score:
1
Max. score:
3
Reversibility:
fully reversible within: 7 d
Irritation parameter:
cornea opacity score
Basis:
animal: 824
Remarks:
mean score
Time point:
24/48/72 h
Score:
0.33
Max. score:
4
Reversibility:
fully reversible within: 48 h
Irritation parameter:
iris score
Basis:
animal: 824
Remarks:
mean score
Time point:
24/48/72 h
Score:
0
Max. score:
2
Reversibility:
fully reversible within: 24 h
Irritation parameter:
chemosis score
Basis:
animal: 824
Remarks:
mean score
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible within: 24 h
Irritation parameter:
conjunctivae score
Basis:
animal: 086
Remarks:
mean score
Time point:
24/48/72 h
Score:
1.33
Max. score:
3
Reversibility:
fully reversible within: 7 d
Irritation parameter:
cornea opacity score
Basis:
animal: 086
Remarks:
mean score
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
iris score
Basis:
animal: 086
Remarks:
mean score
Time point:
24/48/72 h
Score:
0
Max. score:
2
Reversibility:
fully reversible within: 24 h
Irritation parameter:
chemosis score
Basis:
animal: 086
Remarks:
mean score
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible within: 24 h
Irritation parameter:
conjunctivae score
Basis:
animal: 025
Remarks:
mean score
Time point:
24/48/72 h
Score:
1
Max. score:
3
Reversibility:
fully reversible within: 7 d
Irritation parameter:
cornea opacity score
Basis:
animal: 025
Remarks:
mean score
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
iris score
Basis:
animal: 025
Remarks:
mean score
Time point:
24/48/72 h
Score:
0
Max. score:
2
Reversibility:
fully reversible within: 24 h
Irritation parameter:
chemosis score
Basis:
animal: 025
Remarks:
mean score
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible within: 24 h
Irritant / corrosive response data:
The mean values of the readings 24 to 72 hours after instillation are below the threshold of significance, and 0 for the conjunctivae.
Other effects:
None

Any other information on results incl. tables

None

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
FAT 20042/D is classified as non-irritant to the eyes of rabbit.
Executive summary:
Acute eye irritation/corrosion study in albino rabbits was performed to determine the irritant or corrosive potency of FAT 20042/D in the albino rabbit eye and the associated mucous membranes. This test was based on OECD Guideline 405. 100 mg of FAT 20042/D was placed into the conjunctival sac of the left eye of each animal, after gently pulling away the lower lid from the eyeball. The lids were then held together for about one second in order to prevent loss of the test article. Because reactions were observed till 72 hours after instillation of the test article, the observation period was extended to 7 days to determine the reversibility of the eye reactions. The mean values of the readings at 24, 48 and 72 hours after instillation were below the threshold of significance. Also changes observed were fully reversible within 7 days. Therefore, as per the Regulation (EC) No. 1272/2008, FAT 20042/D is not an eye irritant.

Categories Display