Registration Dossier

Toxicological information

Eye irritation

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Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
26-02-1980 to 04-03-1980
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
Remarks:
The restrictions was feeding conditions and analytical purity of the test substance was not provided in the study report.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1980
Report Date:
1980

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
yes
Remarks:
feeding condition and analytical purity was not stated in the study report.
Qualifier:
according to
Guideline:
other: Federal Hazardous Substances Act as stated in the Code of Federal Regulations, 16 CFR 1500.42.
Deviations:
yes
Remarks:
feeding condition and analytical purity was not stated in the study report.
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Dutchland Laboratory Animals, Inc., Denver, Pennsylvania.
- Age at study initiation: Not stated
- Weight at study initiation: 2625 - 3000 g
- Housing: Individually in elevated metal cages.
- Diet : Commerical rabbit ration (Purina Lab Rabbit Chow©).
- Water : Water (via automated watering system) were available ad libitum.
- Acclimation period: Approximately for a three-week period.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): Not stated
- Humidity (%): Not stated
- Air changes (per hr):Not stated
- Photoperiod (hrs dark / hrs light):Not stated

Test system

Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 ml
Duration of treatment / exposure:
Group 1 - Single exposure, without washing
Group 2- Single exposure, with washing after 20 - 30 seconds.
Observation period (in vivo):
Reading time points: 24, 48, 72h and on days 4 and 7.
Number of animals or in vitro replicates:
Group 1- 3 males and 3 females
Group 2 -2 males and 1 female
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): The rabbits in group 2 were given a washout 20 - 30 sec after instillation with lukewarm water for about 1 minute. The eyes of the animals in group 1 remained unwashed.
- Time after start of exposure: Approximately 20 - 30 seconds following administration of the dose.

SCORING SYSTEM: Draize scoring system.

TOOL USED TO ASSESS SCORE: fluorescein.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
out of all 3 animals in group 1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: reversibility: not applicable.
Irritation parameter:
iris score
Basis:
mean
Remarks:
out of all 3 animals
Time point:
24/48/72 h
Score:
0
Max. score:
2
Reversibility:
other: reversibility not applicable.
Irritation parameter:
conjunctivae score
Basis:
mean
Remarks:
out all 3 animals
Time point:
24/48/72 h
Score:
0
Max. score:
3
Reversibility:
other: reversibility not applicable.
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
out of all 3 animals
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: reversibility not applicable.
Irritant / corrosive response data:
No corneal opacity, iritis, conjuctival redness, chemosis, or discharge was noted in the washed or unwashed treated eyes of any of the animals.
Other effects:
Three animals phonated and three aniamls excessively blinked and rubbed the treated eye upon instillation of the compound.

Applicant's summary and conclusion

Interpretation of results:
other: CLP/EU GHS criteria are not met, no classification required according to Regulations (EC) No 1272/2008
Conclusions:
A reliable eye irritation study, conducted according to OECD TG 405 but not in compliance with GLP, showed the test material, phenyltrimethoxy silane, would not be considered an eye irritant.