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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:
1972
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Non GLP, little details on test item

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1972
Report Date:
1972

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
yes
Remarks:
no housing details provided, body weights not determined before and after study, simultaneous testing in multiple animals
GLP compliance:
no
Remarks:
Study pre-dates GLP requirements.

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): TK 10047

Test animals / tissue source

Species:
rabbit
Strain:
not specified
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Not reported.
- Age at study initiation: Not reported.
- Weight at study initiation: Not reported.
- Housing: Not reported.
- Diet (e.g. ad libitum): Not reported.
- Water (e.g. ad libitum): Not reported.
- Acclimation period: Not reported.


ENVIRONMENTAL CONDITIONS
- Temperature (°C): Not reported.
- Humidity (%): Not reported.
- Air changes (per hr): Not reported.
- Photoperiod (hrs dark / hrs light): Not reported.

Test system

Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 100 mg.
Duration of treatment / exposure:
Single exposure.
Observation period (in vivo):
7 days.
Number of animals or in vitro replicates:
6
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): Not reported.
- Time after start of exposure: Not reported.


SCORING SYSTEM: The method described by J. H. Draize in "Appraisal of the Safety of Chemicals in Foods, Drugs, and Cosmetics" (p 51) was used.


TOOL USED TO ASSESS SCORE: Not reported.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
overall irritation score
Remarks:
-Cornea, iris, and conjunctivae
Basis:
mean
Time point:
other: 1 day
Score:
2
Max. score:
110
Reversibility:
fully reversible within: 7 days
Remarks on result:
other: None
Irritation parameter:
overall irritation score
Remarks:
-Cornea, iris, and conjunctivae
Basis:
mean
Time point:
other: 2 days
Score:
1
Max. score:
110
Reversibility:
fully reversible within: 7 days
Remarks on result:
other: None
Irritation parameter:
overall irritation score
Remarks:
-Cornea, iris, and conjunctivae
Basis:
mean
Time point:
other: 3 days
Score:
< 1
Max. score:
110
Reversibility:
fully reversible within: 7 days
Remarks on result:
other: None
Irritation parameter:
overall irritation score
Remarks:
-Cornea, iris, and conjunctivae
Basis:
mean
Time point:
other: 4 days
Score:
< 1
Max. score:
110
Reversibility:
fully reversible within: 7 days
Remarks on result:
other: None
Irritation parameter:
overall irritation score
Remarks:
-Cornea, iris, and conjunctivae
Basis:
mean
Time point:
other: 7 days
Score:
0
Max. score:
110
Remarks on result:
other: None
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 0-72h
Score:
1
Max. score:
20
Remarks on result:
other: no conjunctivae findings in 4 of 6 animals, no separate values for chemosis, redness or discharge given
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: all time points (1,2,3,4 and 7 days)
Score:
0
Max. score:
80
Remarks on result:
other: no cornea findings observed in any animal at any time point. This includes chemosis.
Irritation parameter:
iris score
Basis:
mean
Time point:
other: all time points (1,2,3,4 and 7 days)
Score:
0
Max. score:
10
Remarks on result:
other: no iris findings observed in any animal at any time point.
Irritant / corrosive response data:
Temporary mild conjunctival reactions were observed in two animals only. In the remaining four animals, there was no observed response to treatment.
Other effects:
None reported.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met