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

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1985
Report Date:
1985

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
yes
Remarks:
; purity not reported
GLP compliance:
no
Remarks:
test was performed prior to GLP-requirement

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals / tissue source

Species:
rabbit
Strain:
Himalayan
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Asta-Werke AG
- Age at study initiation: approx. 6 months
- Weight at study initiation: 2.15-2.25 kg
- Housing: individually Stainless steel cage type ASTA
- Diet: ssniff K
- Water: tap water ad libitum
- Acclimation period: 1 day, in-hose breeding


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 2
- Humidity (%): 55 +/- 15
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: left eye served as control
Amount / concentration applied:
undiluted
Amount applied: 0.1 mL prewarmed to 30°C
Duration of treatment / exposure:
single treatment, eye not rinsed
Observation period (in vivo):
1, 24, 48 and 72 h
Number of animals or in vitro replicates:
3
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing: no

SCORING SYSTEM: according to Draize

TOOL USED TO ASSESS SCORE: hand-slit lamp

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
other: average over 24 h/ 48 h/ 72 h
Score:
0
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
other: average over 24 h/ 48 h/ 72 h
Score:
0
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
other: average over 24 h/ 48 h/ 72 h
Score:
0
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
other: average over 24 h/ 48 h/ 72 h
Score:
0
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
other: average over 24 h/ 48 h/ 72 h
Score:
0
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
other: average over 24 h/ 48 h/ 72 h
Score:
0
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
other: average over 24 h/ 48 h/ 72 h
Score:
0
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
other: average over 24 h/ 48 h/ 72 h
Score:
0
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
other: average over 24 h/ 48 h/ 72 h
Score:
0
Irritation parameter:
iris score
Basis:
animal #1
Time point:
other: average over 24 h/ 48 h/ 72 h
Score:
0
Irritation parameter:
iris score
Basis:
animal #2
Time point:
other: average over 24 h/ 48 h/ 72 h
Score:
0
Irritation parameter:
iris score
Basis:
animal #3
Time point:
other: average over 24 h/ 48 h/ 72 h
Score:
0
Other effects:
The test substance caused hypersecretion of the eye in all 3 animals 1 h p.a. but was reversible within 24 h.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The test item showed no irritation when applied on the rabbit eye mucosa. Thus, according to Regulation (EC) 1272/2008 the data are conclusive but not sufficient for classification.