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:
other: GLP Guideline study with acceptable restrictions: - no data on purity of the test substance

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1986
Report Date:
1986

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Version / remarks:
(adopted may 1981)
Deviations:
no
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Purity: Lab sample
- Storage: room temperature
- Physical state: solid, insoluble in water
- Stability: guaranteed by sponsor
- Safety precautions: gloves and face masks

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
- Further description: KFM-NZW
- Source: Kleintierfarm, Madoerin AG, CH-4414, Fuellindorf
- Age at study initiation: 12 - 14 weeks
- Weight at study initiation: 2030 - 2120 g (within ± 20% of mean value)
- Fasting period before study: no
- Housing: individually in metal cages
- Diet: ad libitum; standard rabbit pellet - Nafag No. 814, Gossau, Switzerland (Routine analysis of diet for nutritive contents and for contamination indicated no significant deviations expected to influence the study outcome);
- Water: ad libitum (Routine analysis for contamination indicated no significant deviations expected to influence the study outcome)
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 3
- Humidity (%): 30 - 70
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: untreated eye of the same animal
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied: 70 mg of the test substance (corresponding to ca. 0.1 mL bulk volume)
Duration of treatment / exposure:
single application
Observation period (in vivo):
10 days.
- readings were performed at 1, 24, 48 and 72 hours after application
Number of animals or in vitro replicates:
3
Details on study design:
REMOVAL OF TEST SUBSTANCE:
- Washing: no

SCORING SYSTEM: OECD scoring method

TOOL USED TO ASSESS SCORE: Slit lamp

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
(animal # 1, 2 and 3)
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: At the 1 hour observation, well scattered/diffuse areas of opacity (score = 2) was evident in the treated eye of animal # 1 only. The effect was fully reversible by the 24 hour observation
Irritation parameter:
iris score
Basis:
mean
Remarks:
(animal # 1, 2 and 3)
Time point:
24/48/72 h
Score:
0
Max. score:
2
Reversibility:
other: not applicable
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
24/48/72 h
Score:
1.33
Max. score:
3
Reversibility:
fully reversible within: 10 days
Remarks on result:
other: Score; at 1 hour observation = 1, after 7 days = 1
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
24/48/72 h
Score:
1
Max. score:
3
Reversibility:
fully reversible within: 10 days
Remarks on result:
other: Score; at 1 hour observation = 1, after 7 days = 1
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
24/48/72 h
Score:
1.33
Max. score:
3
Reversibility:
fully reversible within: 7 days
Remarks on result:
other: Score at 1 hour observation = 1
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24/48/72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 72 hours
Remarks on result:
other: Score at 1 hour observation = 1
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0.33
Max. score:
4
Reversibility:
fully reversible within: 48 hours
Remarks on result:
other: Score at 1 hour observation = 1
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0.33
Max. score:
4
Reversibility:
fully reversible within: 48 hours
Remarks on result:
other: Score at 1 hour observation = 1

Any other information on results incl. tables

Table 1: Body weights

Animal No.

1

2

3

At start of test

2030 g

2100 g

2120 g

After 3 days

2170 g

2160 g

2200 g

After 7 days

2280 g

2300 g

2290 g

After 10 days (end)

2380 g

2370 g

2340 g

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met