Registration Dossier

Toxicological information

Eye irritation

Currently viewing:

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: read across substance, no inormation about test substance, in life dates not given

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
Guideline:
other: see below
Principles of method if other than guideline:
"Hazardous Substances Regulations" under the U.S.A. Federal- Hazardous Substances Labelling Act Sect. 191.12 (February 1965), with
slight modification
GLP compliance:
not specified

Test material

Constituent 1
Reference substance name:
5280-70-6
Cas Number:
5280-70-6
IUPAC Name:
5280-70-6

Test animals / tissue source

Species:
rabbit
Strain:
Californian
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Hylyne Commercial Rabbits Ltd.
- Age at study initiation: 12-16 weeks
- Weight at study initiation: 2.21 kg male, 2.11 kg female
- Housing: singly
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): sterile water ad libitum
- Acclimation period: 1 week

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 16 +/- 1
- Humidity (%): 50-70
- Air changes (per hr): /
- Photoperiod (hrs dark / hrs light): 10h, 8-18.00 o`clock

IN-LIFE DATES: From: To:

Test system

Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 100 mg
- Concentration (if solution): /
Duration of treatment / exposure:
unwashed 72h, washed after 30 sec
Observation period (in vivo):
72h
Number of animals or in vitro replicates:
3 per sex
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): 200 ml warm water
- Time after start of exposure: 30sec

SCORING SYSTEM: scored by the method described in "Appraisal of the Safety of Chemicals in Food Drugs and Cosmetics" page 51, published by the Association of Food and Drug Officials of the U.S.A.

TOOL USED TO ASSESS SCORE: fluorescein

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 1h
Score:
1
Max. score:
3
Remarks on result:
other: washed and unwashed eyes
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 24h
Score:
1
Max. score:
3
Remarks on result:
other: unwashed eye
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 48h
Score:
0
Max. score:
3
Remarks on result:
other: washed and unwashed eyes
Irritation parameter:
conjunctivae score
Remarks:
redness, chemosis and discharge
Basis:
mean
Time point:
other: 1h
Score:
1
Max. score:
4
Remarks on result:
other: washed and unwashed
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
mean
Time point:
other: 24h
Score:
1
Max. score:
4
Remarks on result:
other: washed and unwashed eyes
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
mean
Time point:
other: 48h
Score:
1
Max. score:
4
Remarks on result:
other: unwashed
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 72h
Score:
0
Max. score:
4
Remarks on result:
other: washed and unwashed
Irritant / corrosive response data:
Con.junctiva
Reactions were slight in 3/3 unwashed and 3/3
washed eyes at 1 hour. Improvement was apparent at 24- hours and 1/3
washed eyes was normal. At 48 hours 1/3 unwashed and 1 /3 washed
eyes were normal. All eyes were normal at 72 hours.

Cornea
Slight opacity and damage to the surface
epithelium was seen in all eyes at 1 hour. At 24 hours 3/3
washed and 2/3 unwashed eyes were normal. All eyes were normal
at 48 hours.

There was very little difference between the reactions in unwashed
and washed eyes.

Applicant's summary and conclusion

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