Registration Dossier

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:
other: This study design follows OECD guideline 405. The conduct and the findings of the study are well reported. However, some individual data were not included in the report.

Data source

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

Materials and methods

Test guideline
Qualifier:
equivalent or similar 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

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
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).

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
conjunctivae score
Remarks:
erythema
Basis:
mean
Time point:
other: 24 h
Score:
0.33
Max. score:
1
Irritation parameter:
conjunctivae score
Remarks:
erythema
Basis:
mean
Time point:
other: 48h
Score:
0.33
Max. score:
1
Irritation parameter:
conjunctivae score
Remarks:
erythema
Basis:
mean
Time point:
other: 72h
Score:
0
Max. score:
0
Reversibility:
fully reversible
Remarks on result:
other: Findings were observed in one of three animals.
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: all time points
Score:
0
Max. score:
0
Irritation parameter:
iris score
Basis:
mean
Time point:
other: all time points
Score:
0
Max. score:
0
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.

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, dihydroxyacetone 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 DHA is evaluated as non-irritating to the eyes
Executive summary:

Neat DHA was tested for acute eye irritation in three female 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 DHA is evaluated as non-irritating to the eyes.