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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:
1970
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study without detailed documentation

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1970
Report Date:
1970

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
GLP compliance:
no
Remarks:
performed before OECD GLP regulation became effective

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
Three male White New Zealand rabbits were used.

TEST ANIMALS
- Source: E. Merck
- Age at study initiation: no infomation provided
- Weight at study initiation: mean 2,78 kg (2,61 - 2,91 kg)
- Housing: individual cages (Becker)
- Diet: Altromin, ad libitum
- Water: ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature, Humidity, Air changes, Photoperiod: no information provided

Test system

Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
100 mg per animal
Duration of treatment / exposure:
The applied test material was not rinsed off.
Observation period (in vivo):
The rabbits were examined for eye irritation daily up to day 7 of the study.
Number of animals or in vitro replicates:
3 animals
Details on study design:
Aliquots of 0.1 g DHA were applied into the conjunctival sac of the left eye of each rabbit. The right eye remained untreated and served as a control. After treatment the rabbits were examined for eye irritation daily up to one week. Eye reactions were evaluated and graded according to Draize (Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics, FDA Baltimore, 1959).

REMOVAL OF TEST SUBSTANCE
- Washing: not performed

SCORING SYSTEM: according to Draize (Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics, FDA Baltimore, 1959)

TOOL USED TO ASSESS SCORE: hand-slit lamp

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
2
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
2
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
2
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Remarks:
erythema
Basis:
animal #1
Time point:
24/48/72 h
Score:
0.33
Max. score:
3
Reversibility:
fully reversible within: 3 days
Irritation parameter:
conjunctivae score
Remarks:
erythema
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
3
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Remarks:
erythema
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
3
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
Eye reactions were evaluated and graded according to Draize scale. After instillation of the test material, no irritancy was observed in two animals. One animal showed a slight transient erythema of the conjunctiva from 24 hours after instillation up to day 3 of the observation period. Scores are established from the observations described in the report.The scores are not mentioned in the study report.
Other effects:
No clinical signs were observed. The development of body weight was inconspicious.

Any other information on results incl. tables

No individual scores on eye irritation were provided in the report. However, only one animal showed a slight reddening of the conjunctivae from day 1 to day 3. No irritating effects were observed in the two remaining animals. Therefore, the test material is evaluated as not irritating to the eyes.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: US CPSC / US FDA
Conclusions:
Based on the results of this study, undiluted test item is evaluated as non-irritating to the eyes
Executive summary:

The test material was tested for acute eye irritation in three male rabbits (New Zeeland). Aliquots of 0.1 g were applied into the conjunctival sac of the left eye of each rabbit. The right eye remained untreated and served as a control. The rabbits were examined for eye irritation daily up to day 7 of the study. Eye reactions were evaluated and graded according to Draize scale. After instillation of the test material, no irritancy was observed in two animals. One animal showed a slight transient erythema of the conjunctiva from 24 hours after instillation up to day 3 of the observation period. Based on the results of this study, undiluted test material is evaluated as non-irritating to the eyes.