Registration Dossier

Diss Factsheets

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: well performed GLP and OECD guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1990
Report date:
1990

Materials and methods

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

Test material

Constituent 1

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: SAVO, med. Versuchstierzuchten GmbH, Stolzenseeweg 32-36, D-7964 Kisslegg im Allgäu
- Age at study initiation: male 14 weeks, female 15 weeks
- Weight at study initiation: male 2.4 kg, female 2.4 kg
- Housing: Individually in stainless steel cages equipped with an automatic cleaning and drinking system
- Diet (e.g. ad libitum): Pelleted standard Kliba 341 rabbit maintenance diet, ad libitum
- Water (e.g. ad libitum): Community tap water from Itingen, ad libitum.
- Acclimation period: Four days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20+/-3
- Humidity (%): relative humidity 40-70 %
- Air changes (per hr): 10-15 air changes per hour
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: The right eye remained untreated and served as reference control
Amount / concentration applied:
100 mg / animal
Duration of treatment / exposure:
once
Observation period (in vivo):
examination 1, 24, 48 and 72 hours after treatment
Number of animals or in vitro replicates:
3
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): not rinsed

SCORING SYSTEM:
- CORNEAL IRRITATION: 0-4
- IRIDIC IRRITATION: 0-2
- CONJUNCTIVAL Redness: 0-3
- CONJUNCTIVAL Chemosis: 0-4

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
other: mean of 24, 48 and 72 h
Score:
0
Max. score:
4
Reversibility:
other: reversibility not relevant since no effects occured
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
other: mean of 24, 48 and 72 h
Score:
0
Max. score:
4
Reversibility:
other: reversibility not relevant since no effects occured
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
other: mean of 24, 48 and 72 h
Score:
0
Max. score:
4
Reversibility:
other: reversibility not relevant since no effects occured
Irritation parameter:
iris score
Basis:
animal #1
Time point:
other: mean of 24, 48 and 72 h
Score:
0
Max. score:
2
Reversibility:
other: reversibility not relevant since no effects occured
Irritation parameter:
iris score
Basis:
animal #2
Time point:
other: mean of 24, 48 and 72 h
Score:
0
Max. score:
2
Reversibility:
other: reversibility not relevant since no effects occured
Irritation parameter:
iris score
Basis:
animal #3
Time point:
other: mean of 24, 48 and 72 h
Score:
0
Max. score:
2
Reversibility:
other: reversibility not relevant since no effects occured
Irritation parameter:
conjunctivae score
Remarks:
(redness)
Basis:
animal #1
Time point:
other: mean of 24, 48 and 72 h
Score:
0.33
Max. score:
3
Reversibility:
fully reversible within: 48 h
Irritation parameter:
conjunctivae score
Remarks:
(redness)
Basis:
animal #2
Time point:
other: mean of 24, 48 and 72 h
Score:
0
Max. score:
3
Reversibility:
other: reversibility not relevant since no effects occured
Irritation parameter:
conjunctivae score
Remarks:
(redness)
Basis:
animal #3
Time point:
other: mean of 24, 48 and 72 h
Score:
0.33
Max. score:
3
Reversibility:
fully reversible within: 48 h
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
other: mean of 24, 48 and 72 h
Score:
0
Max. score:
4
Reversibility:
other: initial slight signs of irritation were fully reversible within 24 h
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
other: mean of 24, 48 and 72 h
Score:
0
Max. score:
4
Reversibility:
other: initial slight signs of irritation were fully reversible within 24 h
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
other: mean of 24, 48 and 72 h
Score:
0
Max. score:
4
Reversibility:
other: initial slight signs of irritation were fully reversible within 24 h
Irritant / corrosive response data:
No corrosion was observed at any of the measuring intervals.
Other effects:
Orange staining of the eyelashes of the treated eyes by coloration of the test article was observed in all animals until termination of test.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
All calculated mean scores were well below the threshold for classification.
Therefore the test item is not subject to classification and labelling.
Executive summary:
The test item was tested for primary skin irritation according to OECD TG 405.

 

Under the conditions of this experiment, the test item was found to cause mean primary irritation scores of 0.0 for cornea, iris, and conjunctivae chemosis. Mean primary irritation scores for conjunctivae redness were 0.3 in two and 0.0 in one rabbit. No corrosion was observed at any of the measuring intervals. Orange staining of the eyelashes of the treated eyes by coloration of the test article was observed in all animals until termination of test. All signs of irritation were fully reversible within 48 h.