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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
Study period:
January 09 to March 26, 1987
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Study according OECD Guideline 405; Study under GLP Regulations;

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1987
Report Date:
1987

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
other: colorless liquid
Details on test material:
See information in the field "Confidential details on test material"

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Abbaye de Bellefontaine, F49122 Begrolles en Mauges, France;
- Weight at study initiation: 2.5 ± 0.1 kg
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum):ad libitum
- Acclimation period:5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 3
- Humidity (%): 50 ± 20
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 ml;
Duration of treatment / exposure:
one time application of test article to eye
Observation period (in vivo):
1h after application, followed by daily observation for 3 days (minimum) to 21 days (maximum);
Number of animals or in vitro replicates:
3 animals
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): not specified

SCORING SYSTEM: Scoring according to Kay and Calandra (1962) J. Soc. Cosmet. Chem 13, 281-289.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
other: 1h
Score:
0
Max. score:
0
Reversibility:
fully reversible within: 1d
Remarks on result:
other: 1d
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
other: 1h
Score:
1
Max. score:
1
Reversibility:
fully reversible within: 1d
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
other: 1h
Score:
3
Max. score:
3
Reversibility:
fully reversible within: 1d
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
other: 1h
Score:
2
Max. score:
2
Reversibility:
fully reversible within: 2d
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
other: 1h
Score:
2
Max. score:
2
Reversibility:
fully reversible within: 2d
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
other: 1h
Score:
3
Max. score:
3
Reversibility:
fully reversible within: 2d

Any other information on results incl. tables

The observed effects on the conjuctivae and on chemosis 1 hour after application were moderate in two animals and marked in one animal.Two days after the applicaton of the test article, all ocular effects have disappeared.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: OECD GHS
Conclusions:
Under the conditions of this study, the test article RP/DE is considered not irritating.
Executive summary:

The eye irritating potential of the test article RP/DE has been investigated in the rabbit under the OECD Guideline 405 and under GLP Regulations. Moderate effects on the conjunctiva and on chemosis were observed in two animals 1 hour after application of the test article while the same effects were marked in one animal. Two days after application of the test article, the effects had disappeared. Under the conditions of this study, the test article RD/DE was considered not irritating to the eye.