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Description of key information

The key studies for acute oral and dermal toxicity were conducted according to appropriate OECD guidelines and in compliance with GLP. The acute oral and dermal LD50 values are concluded to be >2000 mg/kg (Dow Corning Corporation, 2008, WIL, 1999).

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records
Reference
Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
5 June to 3 July 2008
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EPA OPPTS 870.1100 (Acute Oral Toxicity)
Deviations:
no
GLP compliance:
yes
Test type:
acute toxic class method
Limit test:
yes
Species:
rat
Strain:
other: Crl:CD (SD) IGS BR VAF/Plus
Sex:
female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Charles River Laboratories Inc., USA
- Age at study initiation: 8 weeks
- Weight at study initiation: 154.4 to 181.2g
- Fasting period before study: yes
- Housing: individually in wire mesh cages
- Diet (ad libitum): LabDiet 5002, PMI
- Water (ad libitum): municipal water
- Acclimation period: 6 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19.81 to 22.09
- Humidity (%): 40 to 66
- Air changes (per hr): 14.5
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: 17 June 2008 To: 3 July 2008
Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Details on oral exposure:
MAXIMUM DOSE VOLUME APPLIED: not stated

CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: not stated
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
6 female
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations: twice daily
- Frequency of weighing: day of dosing, weekly thereafter including the day of necropsy
- Necropsy of survivors performed: yes
Statistics:
Body weight was reported as groups means and standard deviations, computed by Provantis v6.5
Key result
Sex:
female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
None
Clinical signs:
None
Body weight:
All animals gained weight from study day 1 to 15.
Gross pathology:
No findings
Interpretation of results:
GHS criteria not met
Conclusions:
Administration of methyl(glycidoxypropyl) diethoxysilane to female rats at 2000 mg/kg bw did not result in any remarkable findings and the LD50 was considered to be greater than 2000 mg/kg bw.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
2 000 mg/kg bw

Acute toxicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no study available

Acute toxicity: via dermal route

Link to relevant study records
Reference
Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
GLP compliance:
yes
Limit test:
yes
Species:
rat
Strain:
other: Crl:CD(SD)IGS BR
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Charles River Laboratories, Raleigh, NC
- Age at study initiation: 9 (males) and 10 (females) weeks old
- Weight at study initiation: 296-336 grams (males), 223-262 grams (females)
- Housing: individual suspended wire-mesh cages
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: minimum 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°F): 71.5-72.1
- Humidity (%): 48.2-62.1
- Photoperiod (hrs dark / hrs light): 12/12
Type of coverage:
semiocclusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST SITE
- Area of exposure: backs and flank
- % coverage: 16-20
- Type of wrap if used: gauze binder

REMOVAL OF TEST SUBSTANCE
- Washing (if done): the site of exposure was wiped
- Time after start of exposure: 24 hours


Duration of exposure:
24 hours
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
5m/5f
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Observations ca. 1, 3 and 4 hours post-application on day 0 and twice daily thereafter. Body weights were recorded on study days 0, 7 and 14. The application sites were examined for erythema, edema and other dermal findings beginning ca. 30-60 minutes after bandage removal and daily thereafter throughout day 14. The areas of application were clipped free of hair to facilitate dermal observations on the day prior to dosing and study days 2, 6, 7, 11 and/or 14.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight,organ weights, histopathology.
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
There were no deaths.
Clinical signs:
Various discoloured areas due to discharge and excretions were noted for six animals. These were not considered test material related. There were no other clinical findings. All erythema had subsided by day 3.
Body weight:
There were no remarkable changes in body weight during the study period.
Gross pathology:
One male was found to have abnormalities of the right testis and epididymis. This was considered to be a pre-existing condition and was not related to test article application. There were no other gross necropsy findings.
Other findings:
Very slight erythema as observed for four animals. There was no oedema. Desquamation was noted for six animals. A single animal had focal eschar noted on day 11. There were no other dermal findings. All erythema completely subsided by day 3.
Interpretation of results:
GHS criteria not met
Conclusions:
The LD50 was concluded to be >2000 mg/kg when test material was administered once for 24 hours to the clipped, unbraded sin of male and female rats. In addition 2000 mg/kg dose level was found to be a NOEL for systemic toxicity under the condition of this study.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
2 000 mg/kg bw

Additional information

The key study for acute oral toxicity reports the administration of [3-(2,3 -epoxypropoxy)propyl]diethoxy(methyl)silane to female rats at 2000 mg/kg bw to result in no remarkable findings, with an LD50 of >2000 mg/kg bw (Dow Corning Corporation, 2008). There were no deaths, no clinical findings and no adverse changes to body weight reported in the study. The study was conducted according to an OECD test guideline and in compliance with GLP.

A supporting study was also available for acute oral toxicity, for the registered substance. The study reports no deaths, remarkable body weight changes or gross necropsy findings (WIL, 2000a). Single animals were noted with dried yellow material around their mouth and impaired muscle coordination at one hour post-dosing. There were no other clinical findings. The LD50 was found to be >2000 mg/kg bw/day when administered orally to fasted male and female rats, in a study conducted according to an appropriate OECD guideline and in compliance with GLP.

A supporting study from the structurally analogous substance [3-(2,3-epoxypropoxy)propyl]trimethoxysilane (CAS 2530-83-8) is included for completeness, to demonstrate that the registered substance and the read across substance have similar toxicological profiles. Please see Section 5.9.3 in the CSR Repeated dose toxicity for further information on read-across approach. The acute oral toxicity study for the read across substance [3-(2,3-epoxypropoxy)propyl]trimethoxysilane (CAS 2530-83-8)), was conducted according to an appropriate guideline, but not to GLP (Dow Corning Corporation 1976). The LD50 value was 7.5 ml/kg bw (equivalent to 8025 mg/kg bw, density1.07 g/cm3).

The key study for acute dermal toxicity reports no deaths, remarkable body weight changes or gross necropsy findings (WIL 1999). Very slight erythema was observed for four animals. There was no oedema. Desquamation was noted for six animals. A single animal had focal eschar noted on day 11. There were no other dermal findings. All erythema completely subsided by day 3. The LD50 was concluded to be >2000 mg/kg when test material was administered once for 24 hours to the clipped, unabraded skin of male and female rats.


Justification for classification or non-classification

Based on the available data, no classification is required for [3-(2,3-epoxypropoxy)propy;]diethoxy(methyl)silane (CAS 2897-60-1) acute toxicity in accordance with Regulation (EC) No. 1272/2008.

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