Registration Dossier

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1973-12-18 to 1975-03-06
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Scientifically acceptable, method equivalent or similar to guideline study.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1975
Report Date:
1975

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Version / remarks:
method applied according to BASF-internal standard
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals / tissue source

Species:
rabbit
Strain:
Vienna White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Gaukler, 6050 Offenbach/Main, Germany
- Age at study initiation: no data
- Weight at study initiation: 3.11 - 3.32 kg
- Housing: no data
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: no data

ENVIRONMENTAL CONDITIONS
- Temperature (°C): no data
- Humidity (%): no data
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): no data

IN-LIFE DATES: From: 1973-12-18 To: 1973-12-27

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: 0.05 mL of a NaCl solution was applied into the other eye of the same animal
Amount / concentration applied:
0.05 mL
Duration of treatment / exposure:
Single instillation into the conjunctival sac of the right eyelid
Observation period (in vivo):
8 days
Number of animals or in vitro replicates:
2
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing: the test substance was not washed out

SCORING SYSTEM: observed were the parameters redness conjunctivae, chemosis, cornea opacity, and necrosis
Grading system for cornea and chemosis:
"reizlos" Ø: considered as equivalent to Grade 0 according to OECD Guideline 405
"fraglich" (+): considered as equivalent to Grade 1 according to OECD Guideline 405
"leicht" +: considered as equivalent to Grade 2 according to OECD Guideline 405
"stark" ++: considered as equivalent to Grade 3 effect according to OECD Guideline 405
"sehr stark" +++: considered as equivalent to Grade 4 according to OECD Guideline 405

Grading system for conjunctivae:
"reizlos" Ø: considered as equivalent to Grade 0 according to OECD Guideline 405
"leicht" +: considered as equivalent to Grade 1 according to OECD Guideline 405
"stark" ++: considered as equivalent to Grade 2 effect according to OECD Guideline 405
"sehr stark" +++: considered as equivalent to Grade 3 according to OECD Guideline 405

TOOL USED TO ASSESS SCORE: fluorescein

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 24 h
Score:
1
Max. score:
3
Reversibility:
fully reversible within: 8 days
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
other: 24 h
Score:
1
Max. score:
3
Reversibility:
fully reversible within: 8 days
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
other: 24 h
Score:
1
Max. score:
3
Reversibility:
fully reversible within: 8 days
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 24 h
Score:
0
Max. score:
4
Reversibility:
other: no irritating effects observed
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
other: 24 h
Score:
0
Max. score:
4
Reversibility:
other: no irritating effects observed
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
other: 24 h
Score:
0
Max. score:
4
Reversibility:
other: no irritating effects observed
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 24 h
Score:
0
Max. score:
4
Reversibility:
other: no irritating effects observed
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
other: 24 h
Score:
0
Max. score:
4
Reversibility:
other: no irritating effects observed
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
other: 24 h
Score:
0
Max. score:
4
Reversibility:
other: no irritating effects observed
Irritant / corrosive response data:
After 1 h the treated eye was covered by a smeary layer (reversible after 8 days)

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU