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
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2001
Report Date:
2001

Materials and methods

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

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: Harlan Winkelmann GmbH
- Age at study initiation: No data
- Weight at study initiation: No data
- Housing: ABS, plastic cages.
- Diet (e.g. ad libitum): Ad libitum
- Water (e.g. ad libitum): Ad libitum
- Acclimation period: Described as 'adequate'.


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18±3
- Humidity (%): 55±10
- Air changes (per hr): At least 10
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 ml


Duration of treatment / exposure:
No washing.
Observation period (in vivo):
72 Hours.
Number of animals or in vitro replicates:
Three
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): No washing


SCORING SYSTEM: As per OECD 405.


TOOL USED TO ASSESS SCORE: At the end of the observation period the eyes were examined with the aid of a fluoresceinsolution.

Results and discussion

In vivo

Results
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 24, 48 and 72 hours
Score:
ca. 0
Max. score:
0
Irritant / corrosive response data:
One hour after application, redness (grade 1/2) was visible in two animals, and chemosis (grade 1) of the conjunctivae was additionally visible in one animal. No corneal lesions were found upon fluorescein examination at 72 hours. There were no signs of irritation at 24, 48 and 72 hours.
Other effects:
No other clinical signs of toxicity were reported.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
In a good quality (reliability 1) study conducted according to OECD 405 and GLP, Wacker BS 1701 (alkylalkoxysilane) was not irritating to the eyes of rabbits.
Executive summary:

Wacker BS 1701 (alkylalkoxysilane) was applied to the lower conjunctival sac of one eye of three New Zealand white rabbits at a dose of 0.1 ml. The eye was held shut for one second to prevent loss of the test substance. The eyes were not rinsed. The untreated eye of each animal served as a control. At 1, 24, 48 and 72 hours after instillation the eyes were examined for signs of irritation. One hour after application, redness (grade 1/2) was visible in two animals, and chemosis (grade 1) of the conjunctivae was additionally visible in one animal. No corneal lesions were found upon fluorescein examination at 72 hours. There were no signs of irritation at 24, 48 and 72 hours.