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Toxicological information

Acute Toxicity: dermal

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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:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
no
GLP compliance:
yes (incl. certificate)
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
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 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:
There were no clinical signs.
Body weight:
One female rat showed a slight body weight loss on Day 7. The other four female rats showed no change in body weight gain. All female rats showed minimal body weight gain by the end of the study. The variation in body weights was not thought to be treatment-related.
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.