Registration Dossier

Diss Factsheets

Toxicological information

Acute Toxicity: dermal

Currently viewing:

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Study period:
07.10.1996 to 24.10.1996
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: The study was conducted according to the appropriate OECD test guideline, and in compliance with GLP.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1997
Report date:
1997

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Test type:
standard acute method
Limit test:
yes

Test material

Constituent 1
Reference substance name:
(3-chloropropyl)diethoxymethylsilane
EC Number:
236-828-6
EC Name:
(3-chloropropyl)diethoxymethylsilane
Cas Number:
13501-76-3
Molecular formula:
C8H19ClO2Si
IUPAC Name:
3-chloropropyl(diethoxy)methylsilane
Details on test material:
- Name of test material (as cited in study report): Dynasylan CPMDEO (3-chloropropyl)methyldiethoxysilan
- Substance type: Chloroalkoxysilane
- Physical state: Liquid
- Stability under test conditions: < 1 year (6 months)
- Storage condition of test material: In closed glass containers in exhaust hood, under inert gas.

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Harlan Winkelmann GmbH
- Age at study initiation: No data
- Weight at study initiation: 200-300 g (variation did not exceed ±20% of mean body weight)
- Fasting period before study: No data
- Housing: Individually in Makrolon type II cages.
- Diet (e.g. ad libitum): Ad libitum
- Water (e.g. ad libitum): Ad libitum
- Acclimation period: At least five days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ±3
- Humidity (%): 30-70
- Air changes (per hr): No data
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: 07.10.1996 To: 24.10.1996

Administration / exposure

Type of coverage:
semiocclusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST SITE
- Area of exposure: dorsolumbar
- % coverage: 10 % of body surface clipped
- Type of wrap if used: Semi-occlusive


REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes, with corn oil
- Time after start of exposure: 24 hours


TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2.03 cm3/kg bw



Duration of exposure:
24 hours
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
Five
Control animals:
not required
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Animals were checked at least daily for mortalities, they were observed for clinical signs soon after dosing and at regular intervals for the remainder of Day 0 (day of dosing), then daily until the end of the 14 day observation period. Body weights were recorded on days 0, 7 and 14.
- Necropsy of survivors performed: yes
- Other examinations performed: macroscopic examinations.
Statistics:
None done

Results and discussion

Effect levels
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: There were no clinical signs.
Gross pathology:
No findings.
Other findings:
There were no other findings.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
In an acute dermal limit study (reliability score 1) conducted to OECD 402 and GLP, the dermal acute LD50 for (3-chloropropyl)diethoxymethylsilane was greater than 2000 mg/kg bw in Wistar rats. There were no significant clinical effects.