Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1981
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: The study was conducted according to a test protocol that is comparable to the appropriate OECD test guideline. It was not compliant with GLP and the applied dose was smaller than current guideline requirements.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1981
Report date:
1981

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
GLP compliance:
not specified
Remarks:
Although a GLP statement was not included with the report, it is known that Bushy Run Research Center (BRRC) operated as a GLP-facility at the time the testing was conducted.

Test material

Constituent 1
Chemical structure
Reference substance name:
Trichloro(methyl)silane
EC Number:
200-902-6
EC Name:
Trichloro(methyl)silane
Cas Number:
75-79-6
Molecular formula:
CH3Cl3Si
IUPAC Name:
trichloro(methyl)silane

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
The sex of the rabbits used in this study was not specified.

Test system

Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
undiluted
Amount applied: 0.005 ml
Duration of treatment / exposure:
Eyes were held closed for one second after application. The eyes were not rinsed.
Observation period (in vivo):
21 days
Number of animals or in vitro replicates:
6
Details on study design:
The dose was instilled into the lower conjunctival sac of one eye per animal. The eyelids were held together for one second. The eyes were scored by the Draize scale at one hour, approximately 6 hours, and at 1, 2, 3, 7, 14, 21 or 36 days after dosing. Fluorescein (2%) staining was used to determine corneal injury before dosing at readings after one day.

Comment: not rinsed

Results and discussion

Any other information on results incl. tables

Instillation of the smallest volume included in the standard eye test, 0.005 ml, resulted in moderate to severe reddening and swelling of the conjunctivae with mild to severe corneal injury.  The corneal opacities prevented an accurate assessment of the condition of the iris.  Effects on the conjunctivae and cornea appeared within an hour of the application and persisted in many cases for 14 days.  One dosed rabbit died at 13 days.  The cause of death was uncertain.  Injury to the remaining rabbit eyes persisted for more than 21 days, although it had become less severe.

Applicant's summary and conclusion

Interpretation of results:
corrosive
Remarks:
Migrated information Criteria used for interpretation of results: expert judgment
Conclusions:
Administration of the undiluted material resulted in severe eye injury.