Registration Dossier

Toxicological information

Eye irritation

Currently viewing:

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
migrated information: read-across based on grouping of substances (category approach)
Adequacy of study:
key study
Study period:
1981
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1981
Report Date:
1981

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: Fed. Reg. 38 No .187 § 1500.42; adopted 1973
Deviations:
no
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): XXVI/645
- Physical state: liquid
- Analytical purity: 99%
- pH: 9

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: own breed of the test laboratory
- Weight at study initiation: 2.3 - 2.8 kg
- Diet (e.g. ad libitum): ALTROMIN 2023, Altromin GmbH, Lage, D

ENVIRONMENTAL CONDITIONS
not reported

Test system

Vehicle:
other: olive oil
Controls:
other: the untreated eyes served as control
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL
Duration of treatment / exposure:
Treatment was once
Observation period (in vivo):
72 h
Number of animals or in vitro replicates:
6
Details on study design:
REMOVAL OF TEST SUBSTANCE
no

SCORING SYSTEM: OECD Draize scoring system

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 24 - 48 - 72 h
Score:
4
Max. score:
4
Reversibility:
not reversible
Remarks:
within 72 h
Remarks on result:
other: Effects already observed 1 h after treatment
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24 - 48 - 72 h
Score:
2
Max. score:
2
Reversibility:
not reversible
Remarks:
within 72 h
Remarks on result:
other: Probable values; effects already observed 1 h after treatment
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 24 - 48 - 72 h
Score:
3
Max. score:
3
Reversibility:
not reversible
Remarks:
within 72 h
Remarks on result:
other: Effects already observed 1 h after treatment
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 24 - 48 - 72 h
Score:
4
Max. score:
4
Reversibility:
not reversible
Remarks:
within 72 h
Remarks on result:
other: Effects already observed 1 h after treatment
Other effects:
Strong discharge (score 3) was observed in all readings.

Applicant's summary and conclusion

Interpretation of results:
Category 1 (irreversible effects on the eye)
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Under the conditions of the test the test substance is corrosive to the rabbit eye.
Executive summary:

An eye irritation/corrosion test was performed with six rabbits according to a FDA guideline. The animals were exposed to 0.1 ml of test substance. Strong corrosive effects were observed in all animals.