Registration Dossier

Diss Factsheets

Administrative data

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

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1999
Report date:
2000

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
GLP compliance:
yes
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
[3-(2,3-epoxypropoxy)propyl]diethoxymethylsilane
EC Number:
220-780-8
EC Name:
[3-(2,3-epoxypropoxy)propyl]diethoxymethylsilane
Cas Number:
2897-60-1
Molecular formula:
C11H24O4Si
IUPAC Name:
diethoxy(methyl){3-[(oxiran-2-yl)methoxy]propyl}silane
Constituent 2
Reference substance name:
[3-(2,3-epoxypropoxy)propyl]diethoxy(methyl)silane
IUPAC Name:
[3-(2,3-epoxypropoxy)propyl]diethoxy(methyl)silane

Test animals

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

Administration / exposure

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.

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.
Clinical signs:
other: 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.
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.

Applicant's summary and conclusion

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.