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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:
11 Jun - 04 Jul 1996
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1996
Report Date:
1996

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Version / remarks:
adopted in 1981
Deviations:
no
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Version / remarks:
adopted in 2017
Deviations:
yes
Remarks:
no rationale for in vivo testing, no initial testing with one animal, no topical anesthetics
Qualifier:
according to
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
Version / remarks:
adopted in 1992
Deviations:
not specified
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Remarks:
albino rabbit, Chbb: NZW (SPF)
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Chemical pharmaceutical factory Dr. K. Thomae, Biberach, Germany
- Weight at study initiation: 2.6 - 3.6 kg
- Housing: in fully air-conditioned rooms in separate cages arranged in a battery
- Diet: commercial (ssniff K-H (V2333)), ad libitum and hay (approx. 15 g daily)
- Water: from automatic water dispensers, ad libitum
- Acclimation period: 1 week

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 3
- Humidity (%): 50 ± 20
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: 11 - 21 Jun 1996

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: the untreated eye served as control
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied: 100 mg of the unchanged dry test substance was applied once to the conjunctival sac of the left eye.
Duration of treatment / exposure:
Single instillation
Observation period (in vivo):
The eyes were examined 1, 24, 48 and 72 hours after application of the test substance. At 24 and 72 hours as well as after 7 days, the eyes were also examined for corneal lesions under UV light after instillation of one drop of 0.01% fluorescein sodium solution.
Details on study design:
REMOVAL OF TEST SUBSTANCE
24 hours after application and at all other designated examination times at which the treated eyes still showed discharge or at which a corneal examination with fluorescein sodium solution took place, the treated eyes were washed out thoroughly with isotonic saline at approx. 37 °C.

SCORING SYSTEM: Draize scoring system

TOOL USED TO ASSESS SCORE: fluorescein
About 24 hours before the start of the study the test eyes of all animals were examined under UV light for corneal lesions after instillation of one drop of a 0.01% fluorescein-sodium solution. Only animals without ocular abnormalities were used.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal: #1, #2, #3
Remarks:
individual mean after
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: reversibility not applicable
Irritation parameter:
iris score
Basis:
animal: #1, #2, #3
Remarks:
individual mean after
Time point:
24/48/72 h
Score:
0
Max. score:
2
Reversibility:
other: reversibility not applicable
Irritation parameter:
conjunctivae score
Basis:
animal #1
Remarks:
individual mean after
Time point:
24/48/72 h
Score:
1.66
Max. score:
3
Reversibility:
fully reversible within: 7 days
Irritation parameter:
conjunctivae score
Basis:
animal: #2, #3
Remarks:
individual mean after
Time point:
24/48/72 h
Score:
0.33
Max. score:
3
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
chemosis score
Basis:
animal #1
Remarks:
individual mean after
Time point:
24/48/72 h
Score:
1.33
Max. score:
4
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
chemosis score
Basis:
animal: #2, #3
Remarks:
individual mean over
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: reversiblity not applicable

Applicant's summary and conclusion

Interpretation of results:
other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No 1272/2008.