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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
May - July 1995
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1995
Report date:
1995

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: U.S. EPA FIFRA/TSCA and Japanese MAFF guidelines
GLP compliance:
yes
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
3-(triethoxysilyl)propyl methacrylate
EC Number:
244-239-0
EC Name:
3-(triethoxysilyl)propyl methacrylate
Cas Number:
21142-29-0
Molecular formula:
C13H26O5Si
IUPAC Name:
3-(triethoxysilyl)propyl 2-methylprop-2-enoate
Test material form:
liquid
Remarks:
clear, colourless

Test animals

Species:
rat
Strain:
other: Crl:CDBR
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Charles River, NY
- Age at study initiation: young adult
- Weight at study initiation: 239 - 269 g
- Housing: Individual housing, suspended wire mesh cages
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: minimum of 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°F): 71.3-72.1
- Humidity (%): 42.3-62.5
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Type of coverage:
not specified
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST SITE
- Area of exposure: back and flank
- % coverage: 20-25
type of wrap: gauze bandage
:
Duration of exposure:
24 hours
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
5 males, 5 females
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: the rats were observed 1, 3 and 4 hours post-dose on day 0 and twice daily thereafter. Body weights were obtained and recorded on study days 0, 7 and 14. The application sites were examined for erythema, edema and other dermal findings ca. 30-60 minutes after bandage removal and daily thereafter for thirteen days. The rats were clipped to facilitate dermal observations on study days 7 and 14.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, organ weights, histopathology, other: Major organ systems of the cranial, thoracic and abdominal cavities were examined for all animals.

Results and discussion

Effect levels
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
There were no deaths during the study.
Clinical signs:
other: Clinical findings were limited to wet yellow urogenital staining for five rats and dried red material around the eye(s) and/or nose for four rats. These findings are typically noted in association with the bandage/collar application procedures and were no
Gross pathology:
Dark, red lungs were present for one female. There were no gross necropsy findings for all examined tissues.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
An LD50 of >2000 mg/kg bw is reported in a study which was conducted according to current guideline and in compliance with GLP.