Registration Dossier

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:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1980
Report Date:
1980

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Version / remarks:
1981
Deviations:
yes
Remarks:
no details on purity, no details on animal housing and environmental conditions.
Principles of method if other than guideline:
Modified Federal Hazardous Substances Labelling Act Method.
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
liquid
Specific details on test material used for the study:
Appearance: liquid

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Unilever Environmental Safety Division, Colworth Laboratory
- Age at study initiation: 7 weeks
- Weight at study initiation: 1.9 - 2.0 kg

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: One eye of each animal remained untreated and served as the reference control.
Amount / concentration applied:
0.1 mL
Duration of treatment / exposure:
Single instillation on Day 1
Observation period (in vivo):
5 days
Number of animals or in vitro replicates:
2 females and 1 male
Details on study design:
STUDY DESIGN
The test material was applied undiluted in 3 animals.

TREATMENT
The substance was applied to one eye of the rabbits by gently pulling the lower lid away from the eye ball and placing 0.1 mL in the sac.

REMOVAL OF TEST SUBSTANCE
-Washing: No

OBSERVATIONS
- Irritation: The eyes were examined 24 hours after treatment and thereafter at daily intervals and graded for corneal, conjunctival and iridial damage. Eyes were examined before application of materials and at daily intervals afterwards with a slit lamp and corneal swelling is measured. The irritation scores and a description of all other (local) effects were recorded. The irritation was assessed according to OECD 405 (1981).

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal: #1, #3
Time point:
24/48/72 h
Score:
0.17
Max. score:
4
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0.5
Max. score:
4
Reversibility:
fully reversible within: 4 days
Irritation parameter:
iris score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
2
Irritation parameter:
conjunctivae score
Basis:
animal: #1, #3
Time point:
24/48/72 h
Score:
0.33
Max. score:
3
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0.67
Max. score:
3
Reversibility:
fully reversible within: 4 days
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0.33
Max. score:
4
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
chemosis score
Basis:
animal: #2, #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritant / corrosive response data:
The substance caused slight to moderate corneal opacities in all three animals, with conjunctival swelling in two animals. All three animals had slight conjunctivitis. The observed effects were fully reversible within 4 days.

Applicant's summary and conclusion