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Diss Factsheets

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:
02/01/99-21/02/99
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1999
Report date:
1999

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
not specified
GLP compliance:
yes (incl. QA statement)

Test material

Constituent 1
Test material form:
solid
Details on test material:
name: SEPIFEEL ONE
batch: 98174300
aspect: white solid
Specific details on test material used for the study:
Container: plastic flask
Batch n° 98174300
Form: white wax flakes
Storage: dark, Room temperature

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
Animals
One male albino New Zealand rabbit were supplied by the Elevage Charles RIVER (76410 Saint-Aubin-Les-Elbeuf, France).
They were kept during a minimal 5-day acclimatisation period. The day before application of the substance, the weight was superior to 1.8 kg.
Housing
Each animal was kept in an individual box (60 cm x 45 cm x 32 cm) installed in conventional air conditioned.
The environmental conditions were:
- temperature : between 17°C and 23°C
- relative humidity : between 30% and 70%
- lighting time: 12 hours daily
Feeding: the complete diet was supplied under pelleted form ERGILAP Anco delivered by COFNA (37018 TOURS, France)
Drinking: tap water distributed in polypropylene feeding-bottles with stainless steel teat. A sample of water is taken after each technical intervention from the pipes and every 6 months at least and sent for chemicophysical and bacteriological analysis to a specialized control organization.

Test system

Vehicle:
unchanged (no vehicle)
Controls:
yes
Amount / concentration applied:
0.1 g into the conjunctival sac of one eye.
Duration of treatment / exposure:
1 hour
Observation period (in vivo):
Ocular examinations were performed on both right and left eyes 1 hour, 24, 48 and 72 hours and until 21 days following
treatment
Number of animals or in vitro replicates:
One animal
Initially, a single animal was treated. After consideration of the ocular responses produced in the first
treated animal, two additional animals were not treated.
Details on study design:
Grading of reactions
Ocular examinations were performed on both right and left eyes 1 hour, 24, 48 and 72 hours following
treatment.
NOTE :
If no reaction is observed 72 hours after instillation, the study is terminated. In case of persistent reactions, additional
observations can be carried out from D4 to D21 in order to determine the reversible character of the lesions observed.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24/48/72 h
Score:
ca. 4
Max. score:
4
Reversibility:
fully reversible within: 13 days
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
animal #1
Time point:
24/48/72 h
Score:
ca. 3
Max. score:
3
Reversibility:
fully reversible within: 21 days
Irritation parameter:
iris score
Basis:
animal #1
Time point:
24/48/72 h
Score:
ca. 1.3
Max. score:
2
Reversibility:
fully reversible within: 10 days
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
24/48/72 h
Score:
ca. 2
Max. score:
2
Reversibility:
fully reversible within: 11 days
Irritant / corrosive response data:
Due to the serious eye damages caused to the first animal, the test was not extended on two other animals.
The test substance is classified among the substances irritant to the eyes with risks of severe ocular lesions foreseeable.

Applicant's summary and conclusion

Interpretation of results:
Category 1 (irreversible effects on the eye) based on GHS criteria
Conclusions:
The test substance is classified among the substances irritant to the eyes with risks of severe ocular lesions foreseeable.
Executive summary:

Test product: SEPIFEEL ONE

Principle of the study:

The aim of the study was to assess qualitatively and quantitatively irritancy or corrosion and the delay of appearance of the effects after single application of 0.1 g of the test substance as such on eye in 1 rabbit.

The eye irritation reactions (redness and chemosis of conjunctivae, iris and cornea lesions) were scored 1h, 24h, 48h and 72h until 21 days, after instillation.

The test substance was classified in accordance with the EEC 67/548 Directive and its amendments.

Dates of the study: from 01/02/1999 to 21/02/1999

Results

            Mean score 24h, 48h and 72h after instillation
      Conjonctivae Iris   Cornea
 Animals  Chemosis  Redness    
 7926  4  3  1.3  2

Conclusion

The test substance is classified among the substances irritant to the eyes with risks of severe ocular lesions foreseeable.