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Toxicological information

Eye irritation

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Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1997

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Version / remarks:
guideline adopted: February 24, 1987
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
Version / remarks:
Directive 92/69/EEC: Commission Directive of July 31, 1992 adapting to technical progress for the seventeenth time Council Directive 67/548/EEC on the approximation of the laws, regulations and administrative provisions relating to the classification, packaging and labeling of dangerous substances
Deviations:
no
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
liquid

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
Source: Charles River Deutschland GmbH 88353 Kißlegg
Age at study initiation: no data
Weight at study initiation: 3,9 kg
Diet (e.g. ad libitum): ssniff® K-H (V2333), ad libitum and hay (approx. 15 g daily)
Water (e.g. ad libitum): water from automatic water dispensers, ad libitum
Acclimation period: 1 week under study conditions
Housing: in fully air-conditioned rooms in separate cages arranged in a battery
Temperature (°C): 20 ± 3°C
Humidity (%): 50 ± 20 %
Photoperiod (hrs dark / hrs light): 12 h daily

Test system

Vehicle:
unchanged (no vehicle)
Amount / concentration applied:
0.1 ml
Duration of treatment / exposure:
24 h
Observation period (in vivo):
14 d
Number of animals or in vitro replicates:
1

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 1 h - 3 d
Score:
4
Max. score:
4
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 7 - 14 d
Score:
2
Max. score:
4
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 1 h - 3 d
Score:
2.66
Max. score:
4
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
7 d
Score:
3
Max. score:
4
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
24/48/72 h
Score:
3
Max. score:
4
Irritation parameter:
iris score
Basis:
mean
Time point:
24/48/72 h
Score:
2
Max. score:
4

Any other information on results incl. tables

One hour up to 14 days after administration the conjunctiva of the animal showed definitely injected blood vessels up to a diffuse beefy red color and an obvious swelling to a swelling with lids half closed to completely closed. 24 hours up to 14 days after administration the iris showed no reaction to light. Diffuse to opalescent areas of the cornea were observed one hour up to 14 days after administration. Additionally, clear-colorless and white-yellow viscous discharge, exfoliations of the conjunctiva and nictating membrane as well as blanched nictating membrane with hemorrhages were noted during the observation period. 14 days after administration the animal showed extreme vascularization.

Applicant's summary and conclusion

Interpretation of results:
Category 1 (irreversible effects on the eye) based on GHS criteria
Conclusions:
Testing of Crotonsäureanhydrid for primary eye irritation in the rabbit showed, that the substance is severely irritating to eye. Some effects were not reversible within 14 d.