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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:
key study
Study period:
22 April 2002 to 19 May 2002
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

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:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
other: liquid

Test animals / tissue source

Species:
rabbit
Strain:
Himalayan
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: LPT, Germany
- Age at study initiation: approx. 10 months
- Weight at study initiation: 2.1 to 3.0 kg
- Housing: individually in cages (W EHRET GmbH, Germany)
- Diet (ad libitum): ssniff K-H (ssniff Spezialdiaten GmbH, Germany)
- Water (ad libitum): test facility drinking water
- Acclimation period: at least 20 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 3
- Humidity (%): 55 +/- 15
- Air changes (per hr): not stated
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: 22 April 2002 To: 19 May 2002

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: other eye
Amount / concentration applied:
TEST MATERIAL
- Amount applied: 0.1 mL

Duration of treatment / exposure:
single instillation
Observation period (in vivo):
72 hours
Number of animals or in vitro replicates:
3 females
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing: no

SCORING SYSTEM: Modified Draize

TOOL USED TO ASSESS SCORE: hand-slit lamp fluorescein
The eyes were examined ophthalmoscopically with a slit lamp prior to administration and 1, 24, 48 and 72 hours after administration. Also, 24 hours after administration the eyes were treated additionally with fluorescein and examined.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal: #1, #2 and #3
Time point:
other: 24/48/72 hours
Score:
0
Max. score:
4
Remarks on result:
other: all scores 0 at all timepoints
Irritation parameter:
iris score
Basis:
animal: #1, #2 and #3
Time point:
other: 24/48/72 hours
Score:
0
Max. score:
2
Remarks on result:
other: all scores 0 at all timepoints
Irritation parameter:
conjunctivae score
Basis:
mean
Remarks:
individual
Time point:
other: 24/48/72 hours
Score:
0.3
Max. score:
3
Reversibility:
fully reversible
Irritation parameter:
chemosis score
Basis:
animal: #1, #2 and #3
Time point:
other: 24/48/72 hours
Score:
0
Max. score:
4
Remarks on result:
other: 0 for all animals at 24, 48 and 72 hours, at 1 hour score of 2 for 1 animal and score of 1 for 2 animals
Other effects:
None noted.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Triethylsilane was found to be not irritating to rabbit eyes.