Registration Dossier

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: Guideline study

Data source

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

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
GLP compliance:
no
Remarks:
GLP was not implemented at that time.

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals / tissue source

Species:
rabbit
Strain:
other: Russian White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Fa. Dr. Karl Thomae GmbH, Biberach, Germany
- Weight at study initiation: 2.0 kg
- Housing: individually in steel cage
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 14 d

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20°C +/- 1°C
- Humidity (%): 60% +/- 5%
- Air changes (per hr): 15/h
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: 15.10.1985 To: 18.10.1985

Test system

Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
Amount: 0.1 g
Duration of treatment / exposure:
72 h (experiment was stopped after 72 h due to severe lesions)
Observation period (in vivo):
72 h
Number of animals or in vitro replicates:
1
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): warm physiological saline solution
- Time after start of exposure: 72 h

SCORING SYSTEM: according to Draize

TOOL USED TO ASSESS SCORE: fluorescein

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
other: 24, 48, 72 h
Score:
1.66
Max. score:
4
Reversibility:
not reversible
Irritation parameter:
iris score
Basis:
animal #1
Time point:
other: 24, 48 and 72 h
Score:
1
Max. score:
2
Reversibility:
not reversible
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
other: 24, 48 and 72 h
Score:
3
Max. score:
3
Reversibility:
not reversible
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
other: 24, 48 and 72 h
Score:
1
Max. score:
4
Reversibility:
not reversible
Irritant / corrosive response data:
Bleeding of the conjunctivae, necrosis of the conjunctivae sac, detachment of mucous membranes. Due to the severe effects the study was terminated after 72 hours.

Applicant's summary and conclusion

Interpretation of results:
Category 1 (irreversible effects on the eye) based on GHS criteria
Remarks:
Migrated information
Conclusions:
Under the conditions of the study the test item caused serious damage to eyes.