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Toxicological information

Eye irritation

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Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
migrated information: read-across based on grouping of substances (category approach)
Adequacy of study:
weight of evidence
Study period:
14 - 16 Jan 2002
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: GLP-guideline study with acceptable restrictions (analytical purity of test substance not specified).

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2002
Report date:
2002

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
yes
Remarks:
analytical purity of test substance not specified
Qualifier:
according to guideline
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
Deviations:
yes
Remarks:
analytical purity of test substance not specified
GLP compliance:
yes (incl. QA statement)
Remarks:
The Department of Health of the Government of the United Kingdom

Test material

Constituent 1
Reference substance name:
163961-32-8
Cas Number:
163961-32-8
IUPAC Name:
163961-32-8
Details on test material:
- Name of test material: only trade name given
- Physical state: amber coloured liquid
- Analytical purity: no data
- Storage condition of test material: RT in the dark

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: David Percival Ltd, UK
- Age at study initiation: 12-16 weeks
- Weight at study initiation: 2.0 - 3.5 kg
- Housing: single accomodation in suspended metal cages
- Diet: ad libitum, Certified rabbit diea (Code 5322), PMI Nutrition International, UK
- Water: ad libitum
- Acclimation period: at least 5 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17 - 23
- Humidity (%): 30 - 70
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: the untreated eye served as control
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied: 0.1 mL

Duration of treatment / exposure:
24 h
Observation period (in vivo):
72 h
Reading time points: 1, 24, 48 and 72 h
Number of animals or in vitro replicates:
3
Details on study design:
SCORING SYSTEM: according to Draize scale for scoring ocular lesions.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
mean out of all 3 animals
Time point:
other: mean over 24, 48 and 72h
Score:
0
Max. score:
4
Reversibility:
other: reversibility: not applicable
Irritation parameter:
iris score
Basis:
mean
Remarks:
out of all 3 animals
Time point:
other: mean over 24, 48 and 72h
Score:
0
Max. score:
2
Reversibility:
other: reversibility: not applicable
Irritation parameter:
conjunctivae score
Basis:
mean
Remarks:
out of all 3 animals
Time point:
other: mean over 24, 48 and 72h
Score:
0.33
Max. score:
3
Reversibility:
fully reversible within: 48 h
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
out of all 3 animals
Time point:
other: mean over 24, 48 and 72h
Score:
0
Max. score:
4
Reversibility:
other: reversibility: not applicable
Irritant / corrosive response data:
Minimal to moderate conjunctival irritation was noted in all treated eyes one hour after treatment with minimal conjunctival irritation in two treated eyes at the 24-hour observation. One treated eye appeared normal at the 24-hour observation and the two remaining treated eyes appeared normal at the 48-hour observation.
Other effects:
One animal showed slight discharge at 24 hours.

Any other information on results incl. tables

Table 1: Individual Irritation Scores:

Animal Number

Hours after application

1

24

48

72

A

B

C

D

A

B

C

D

A

B

C

D

A

B

C

D

1

0

0

1

1

0

0

0

0

0

0

0

0

0

0

0

0

2

0

0

2

1

0

0

1

0

0

0

0

0

0

0

0

0

3

0

0

2

1

0

0

1

0

0

0

0

0

0

0

0

0

A = Cornea Score

B = Iris Score

C = Conjunctiva Score

D = Chemosis Score

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
CLP: not classified
DSD: not classified