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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:
weight of evidence
Study period:
1984
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP guideline study
Cross-referenceopen allclose all
Reason / purpose:
reference to same study
Reason / purpose:
reference to other study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1984
Report Date:
1984

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder
Details on test material:
None

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source:Kleintierfarm Madoerin AG, CH-4414 Fuellinsdorf
- Age at study initiation: 12 - 14 weeks
- Weight at study initiation: 1890-2090 g
- Housing: Animals were housed individually in metal cages.
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20±3
- Humidity (%): 30-70
- Air changes (per hr): approximately 15 air changes/h.
- Photoperiod (hrs dark / hrs light): 12 hours light/day

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: right eye remained untreated and served as a control
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 g
Duration of treatment / exposure:
one second
Observation period (in vivo):
1, 24, 48, and 72 hours
Number of animals or in vitro replicates:
3 males
Details on study design:
SCORING SYSTEM:
The ocular reactions were examined 1, 24, 48, and 72 hours after substance instillation and again during the following observation period by means of a slit-lamp. The ocular irritation scores were evaluated according to the scoring system presented in the following table.
The irritating and/or corrosive potential of the test article (theoretical range: non irritant - extremely irritant) was assessed on the basis of the maximum irritant effect observed
- in one or several of the ocular tissues (conjunctiva, iris, cornea), observed over the range of observation time
- in one or more animals and taking into account the reversibility of the effect.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 1 h , 24 h and 72 h
Score:
1 - 2
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 1 h , 24 h and 72 h
Score:
1 - 2
Max. score:
2
Reversibility:
fully reversible
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 1 h , 24 h and 72 h
Score:
1 - 4
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 1 h , 24 h and 72 h
Score:
1 - 4
Max. score:
4
Reversibility:
fully reversible
Irritant / corrosive response data:
None
Other effects:
The animals showed a normal body weight development.

Any other information on results incl. tables

None

Applicant's summary and conclusion

Interpretation of results:
irritating
Remarks:
Migrated information With fully reversible effects Criteria used for interpretation of results: OECD GHS
Conclusions:
It can be concluded, that FAT 46014/F is irritant and not corrosive when applied to the rabbit eye mucosa; the animals had recovered at the end of the observation period of 11 days.
Executive summary:

A study was performed to determine the eye irritation potential of FAT 46'014/F with purity of 35.7 % on rabbits. The test was performed in GLP compliance and done in accordance of the " OECD test Guideline 405. The substance was found to be severely irritant and not corrosive when applied to the rabbit eye mucosa, however the animals had recovered at the end of the observation period of 11 days. Based on fully reversible results the substance is considered to be mild irritant.