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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:
January 1987
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: 1a: Guideline study (non GLP)

Data source

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

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Version / remarks:
1981
Deviations:
yes
Remarks:
1 animal tested only.
GLP compliance:
no
Remarks:
GLP procedures not established at that time in the UK. The testing laboratory was certified later on.

Test material

Constituent 1
Details on test material:
UROPOL G790 CTL ref Y05915/001/001 (CAS 26316-40-5):
Ethylenediamine ethoxylated propoxylated.
Molecular Mass of the test material as specified by the manufacturer: 790 g/mol (not given in the report). The molecular mass represents a low molecular mass polymer.

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
- Strain: New Zealand White rabbit
- Sex: not specified
- Source: Nottingham University School of Agriculture, Sutton Bonington, Leicestershire, U.K.
- Age: 12-16 weeks
- Weight at study initiation: 2.34 kg

Test system

Vehicle:
unchanged (no vehicle)
Controls:
not specified
Amount / concentration applied:
undiluted
Amount applied: 0.1 ml
Duration of treatment / exposure:
unspecified
Observation period (in vivo):
7 days
Number of animals or in vitro replicates:
1
Details on study design:
Comment: not rinsed

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
other: 24 hrs
Score:
1
Max. score:
4
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
other: 48 hrs
Score:
3
Max. score:
4
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
other: 72
Score:
1
Max. score:
4
Irritation parameter:
cornea opacity score
Time point:
other: mean
Score:
1.7
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
iris score
Basis:
animal #1
Time point:
other: 24
Score:
1
Max. score:
2
Irritation parameter:
iris score
Basis:
animal #1
Time point:
other: 48
Score:
1
Max. score:
2
Irritation parameter:
iris score
Basis:
animal #1
Time point:
other: 72
Score:
1
Max. score:
2
Irritation parameter:
iris score
Basis:
animal #1
Time point:
other: mean
Score:
1
Max. score:
2
Reversibility:
fully reversible
Remarks:
7 days
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
other: 24
Score:
3
Max. score:
3
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
other: 48
Score:
3
Max. score:
3
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
other: 72
Score:
2
Max. score:
3
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
other: mean
Score:
2.7
Max. score:
3
Reversibility:
fully reversible within: 7 days
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
other: 24 hrs
Score:
3
Max. score:
4
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
other: 48
Score:
3
Max. score:
4
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
other: 72
Score:
2
Max. score:
4
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
other: mean
Score:
2.7
Max. score:
4
Reversibility:
fully reversible within: 7 days

Any other information on results incl. tables

DESCRIPTION OF LESIONS:  
A small area of diffuse corneal opacity, with sloughing of the corneal epithelium, was noted one hour after treatment; the area of diffuse corneal opacity had increased at the 24-hour observation. A small area of opalescent corneal opacity was noted at the 48-hour observation, but regressed to diffuse opacity at the 72 -hour observation. The cornea was normal on day seven.
Iridia inflammation was noted one hour after treatment and subsequent 24, 48 and 72 hour observation. No iridial effects were noted on day seven. Severe conjunctivitis was noted at the one and the 24-hour observations. The conjunctivitis gradually regressed to moderate at the 48 and the 72-hour observation. Petechial haemorrhage of the nictitating membrane capillaries was noted up to and including the 72-hour observation. Individual scores provided in the attached document.

The test material was considered a 'severe irritant',

REVERSIBILITY:  
The treated eye was normal on day seven.

Applicant's summary and conclusion

Interpretation of results:
Category 2A (irritating to eyes)
Remarks:
Migrated information Criteria used for interpretation of results: EU