Registration Dossier

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1984-10-23 to 1984-10-26
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Complete guideline conform study report available. Study is performed under GLP.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1984
Report Date:
1984

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
other: liquid
Details on test material:
- Name of test material (as cited in study report): Hostacerin DGO
- Physical state: liquid, yellow
- Density: 0.97 g/cm3
- Composition of test material, percentage of components: 100% Diglycerinsesquoleat, 0.2% Antoxidant
- Lot/batch No.: FMFP355
-Storage condition: in the dark at about 22 °C

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White

Test system

Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
0.1 mL
Duration of treatment / exposure:
1 hour
Observation period (in vivo):
72 hours
Number of animals or in vitro replicates:
3
Details on study design:
In order to assess the eye irrtating potential of the test substance, 0.1 g of the undiluted test item was applied into the conjunctival sac of the left eye of each rabbit. The untreated eye serves as control.

Results and discussion

In vivo

Results
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 72 hours
Score:
0.06
Max. score:
1
Reversibility:
fully reversible within: 48 hours

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Under the conditions of this test and the results obtained, it is concluded, that the test substance is not irritant to the eye.
Executive summary:

In order to assess the eye irritating potential of the test substance, 0.1 ml of the undiluted test item was applied into the conjunctival sac of the left eye of each of 3 rabbits. The untreated eye serves as control. After one hour the treated eye was washed. The assessment of possible effects to the eyes was performed with the assistance of a lamp 60 minutes, 24, 48 and 72 hours after application of test item. The eye reactions were assessed according to the numerical scoring system (acc. to Draize). The description of the degree and nature of irritation and the presence of serious damage were noted as follows:

- No mortality or signs of systemic toxicity occurred.

- Hyperemia was observed in two of three animals at the 24 hour time point (score 1 -1 -0). This effect was reversible within 48 hours.

- No Chemosis of the conjunctiva was observed in all animals 24, 48 and 72 hours after application (score 0-0-0).

- No Corneal opacity were observed in all three animals 24, 48 and 72 hours after application of the test substance (score 0-0-0).

- No effects at Iris was observed in all animals 24, 48 and 72 hours after application of the test substance (score 0-0-0).

Under the conditions of this test and the results obtained, it is concluded, that the test substance is not irritant to the eye.