Registration Dossier

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1998/01/19-1998/01/23
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: The study was conducted according to the appropriate OECD test guideline, and in compliance with GLP.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1998
Report Date:
1998

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
GLP compliance:
yes

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, 33176 Borchen, Gartenstrasse 27

- Age at study initiation: adult animals

- Weight at study initiation: 2.6-3.1 kg

- Housing: conventional, single housing in stainless steel cages

- Diet: Ssniff K 4 complete feed for rabbits, ad libitum. Supplied by Fa. Gelsenwasser, Wasserwerk, 45721 Haltern

- Water: Tap water, ad libitum

- Acclimation period:minimum 14 days


ENVIRONMENTAL CONDITIONS

- Temperature (°C): 20 +/- 3

- Humidity (%): 30-70

- Air changes (per hr): 15

- Photoperiod (hrs dark / hrs light): 12/12

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: Untreated eye
Amount / concentration applied:
TEST MATERIAL

- Amount(s) applied (volume or weight with unit): 0.1 cm3

- Concentration (if solution): undiluted

Duration of treatment / exposure:
24 hours
Observation period (in vivo):
1, 24, 48, 72 hours
Number of animals or in vitro replicates:
3 males
Details on study design:
REMOVAL OF TEST SUBSTANCE

- Washing (if done): with warm physiological saline

- Time after start of exposure: 24 and 48 h


SCORING SYSTEM: According to OECD


TOOL USED TO ASSESS SCORE: hand-slit lamp/ fluorescein

Results and discussion

In vivo

Results
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 24/48/72 h
Score:
1
Max. score:
0
Reversibility:
fully reversible within: 24 hours
Irritant / corrosive response data:
The administration of the test substance caused, within one hour, some definitely hyperaemic (injected) blood vessels. 24 to 72 hours after administration of the test substance, the animals did not show any more irritation on eye and mucous membranes.
Other effects:
None reported.

Any other information on results incl. tables

All scores were zero at all times other than at 1 hour, when the score for conjunctival redness was 1 for all three animals.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
In a reliable study conducted according to the appropriate OECD test guideline and in compliance with GLP, tetramethylsilane was found to be non-irritant to rabbit eyes.