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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:
2002
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2002
Report Date:
2002

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Version / remarks:
(Version Feb. 1987)
Deviations:
no
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals / tissue source

Species:
rabbit
Strain:
other: Little Russian
Details on test animals or tissues and environmental conditions:
Source: BI Phrama KG, D88397 Biberach
Sex: female
Age/weight at study initiation: 2.9 kg
Housing: individual housing
Certified diet and tape water (periodically analysed for contaminations).


Photoperiod (hrs dark / hrs light): 12 h light and 12 h darkness,
Relative humidity: 40-70%,
Temperature: 17-23°C

Test system

Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
0.1 ml
Duration of treatment / exposure:
24 h
Observation period (in vivo):
Up to 28 days
Number of animals or in vitro replicates:
1

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
24/48/72 h
Reversibility:
not reversible
Remarks on result:
other: Cornea opacity score (7d - 28 d): 4
Irritation parameter:
iris score
Basis:
animal #1
Time point:
24/48/72 h
Score:
1
Reversibility:
fully reversible within: 7 days
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
24/48/72 h
Score:
>= 0 - <= 3
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24/48/72 h
Score:
>= 1 - <= 4
Irritation parameter:
other: discharge
Basis:
animal #1
Time point:
other: 7 d - 28 d
Score:
>= 2 - <= 3
Reversibility:
not reversible

Any other information on results incl. tables

Cornea Serious damage, not reversible

Iris Score 1 but scoring not possible at some readings

Conjunctiva

Redness Highest scores observed at several readings

Chemosis Highest scores observed at several readings

Discharge Highest scores observed at several readings, not reversible

Applicant's summary and conclusion

Interpretation of results:
Category 1 (irreversible effects on the eye) based on GHS criteria
Conclusions:
The test substance causes serious damage to the eye which was not reversible.
Classification as eye damaging is indicated according to Regulation (EC) No 1272/2008: H318 - Causes serious eye damage.
Executive summary:

In a test according to OECD guideline 405 the eye irritating portential of the test item was determined. 0.1 mL of the undiluted test substance was instilled into the conjunctival sac of one female rabbit. Readings were performed at 1, 24, 48, 72 h, 7 days, 14 days, 21 days, and 28 days after instillation. The test substance causes serious damage to the eye which was not reversible.