Registration Dossier

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:
From Jun. 1978 to Mar. 6, 1980
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1980
Report Date:
1980

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
yes
Remarks:
-data for single animals not given
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals / tissue source

Species:
rabbit
Strain:
other: Chbb: HM-SPF
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Purchased animals
- Age at study initiation: Not reported
- Weight at study initiation: 1.99 to 2.39 kg (mean weight of 2.19 kg)
- Fasting period before study: Not reported
- Housing: standard cages (manufactured by Becker) on metal floor grids
- Diet (e.g. ad libitum): Brand-Purina mixed feed manufactured by Kraftfutterwerke GmbH, Wiesbaden-Schierstein branch ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: Not reported
- Only females were used

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 27 ± 7
- Humidity (%): 52 ± 20
- Air changes (per hr): Not reported
- Photoperiod (hrs dark / hrs light): Not reported

Test system

Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL

Duration of treatment / exposure:
Single dose administration
Observation period (in vivo):
7 days
Number of animals or in vitro replicates:
4 females
Details on study design:
REMOVAL OF TEST SUBSTANCE
-Not rinsed

SCORING SYSTEM: Local changes in the area of application were assessed according to DRAIZE (1959).
Cornea:
A = degree of opacity
B = region
Iris:
A = severity of the irritation
Conjunctiva:
A = erythema
B = swelling
C = secretion


TOOL USED TO ASSESS SCORE: Not reported

The behavior and general condition of the animals, as well as the occurrence of any local changes, were checked daily for 7 days and were recorded. All of the rabbits were weighed prior to the beginning of the experiment and also twice a week during the experiment.

Pathologico-anatomical examinations were made only when rabbits dided during the trial period. It was not found necessary to sacrfice and dissect the surviving animals.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Remarks:
degree of opacity
Basis:
mean
Time point:
24 h
Score:
0.75
Max. score:
4
Reversibility:
fully reversible within: 3 days
Irritation parameter:
cornea opacity score
Remarks:
degree of opacity
Basis:
mean
Time point:
48 h
Score:
0.25
Max. score:
4
Reversibility:
fully reversible within: 3 days
Irritation parameter:
cornea opacity score
Remarks:
degree of opacity
Basis:
mean
Time point:
72 h
Score:
0
Max. score:
4
Irritation parameter:
cornea opacity score
Remarks:
region
Basis:
mean
Time point:
24 h
Score:
2.5
Max. score:
4
Reversibility:
fully reversible within: 3 days
Irritation parameter:
cornea opacity score
Remarks:
region
Basis:
mean
Time point:
48 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 3 days
Irritation parameter:
cornea opacity score
Remarks:
region
Basis:
mean
Time point:
72 h
Score:
0
Max. score:
4
Irritation parameter:
iris score
Remarks:
severity of the irritation
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
2
Irritation parameter:
conjunctivae score
Remarks:
erythema
Basis:
mean
Time point:
24 h
Score:
1.5
Max. score:
3
Reversibility:
fully reversible within: 3 days
Irritation parameter:
conjunctivae score
Remarks:
erythema
Basis:
mean
Time point:
48 h
Score:
0.5
Max. score:
3
Reversibility:
fully reversible within: 3 days
Irritation parameter:
conjunctivae score
Remarks:
erythema
Basis:
mean
Time point:
72 h
Score:
0
Max. score:
3
Irritation parameter:
chemosis score
Remarks:
swelling
Basis:
mean
Time point:
24 h
Score:
0.25
Max. score:
4
Reversibility:
fully reversible within: 2 days
Irritation parameter:
chemosis score
Remarks:
swelling
Basis:
mean
Time point:
48 h
Score:
0
Max. score:
4
Irritation parameter:
chemosis score
Remarks:
swelling
Basis:
mean
Time point:
72 h
Score:
0
Max. score:
4
Irritation parameter:
conjunctivae score
Remarks:
secretion
Basis:
mean
Time point:
24 h
Score:
0.5
Max. score:
3
Reversibility:
fully reversible within: 2 days
Irritation parameter:
conjunctivae score
Remarks:
secretion
Basis:
mean
Time point:
48 h
Score:
0
Max. score:
3
Irritation parameter:
conjunctivae score
Remarks:
secretion
Basis:
mean
Time point:
72 h
Score:
0
Max. score:
3
Irritant / corrosive response data:
In the test for primary irritation of the mucous membrane in rabbits, there was slight reversible irritation for as long as 2 days after application of the substance.
Other effects:
All of the rabbits were clinically normal. The body weight did not differ from rabbits of the same age that had not been treated. All of the animals survived the 7-day treatment period. It was not found necessary to sacrifice and dissect the surviving animals. Pathologico-anatomical examinations would have been made if any rabbits died during the trial period.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The test item was not found to be irritant to the eyes under the test conditions.
Executive summary:

(Awaiting report as results table needs to be sorted)