Registration Dossier

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
06 Nov 1986 - 26 Nov 1986
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Remarks:
The study was conducted according to an appropriate OECD test guideline, and in compliance with GLP.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1987
Report Date:
1987

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Version / remarks:
adopted 1981
Deviations:
no
GLP compliance:
yes
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): Catalyseur 30 532 – vinyltris(méthyléthylcétiminoxy)silane
- Substance type: Ketoxime
- Physical state: Liquid
- Storage condition of test material: Original container

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Iffa-Crédo, FRANCE
- Age at study initiation: 5-7 wk
- Weight at study initiation: (mean, g) 196 (m) 178 (f)
- Fasting period before study: no data
- Housing: 1/stainless steel mesh cage
- Diet: rat pelleted complete maintenance diet (U.A.R. formula "A.04), ad libitum
- Water: drinking water ad libitum
- Acclimation period: 1 wk

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22±3
- Humidity (%): 30-70
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: (initial and main study) from: 1986-11-06 To: 1986-11-26

Administration / exposure

Type of coverage:
semiocclusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST SITE
- Area of exposure: 10%
- Type of wrap if used: perforated bandage on gauze bandage

REMOVAL OF TEST SUBSTANCE
- Washing: wiped at end of exposure with gauze
- Time after start of exposure: 24 h

TEST MATERIAL
- Amount applied: 2.05 ml/kg bw
Duration of exposure:
24 h
Doses:
pre-study: 1000, 2009 mg/kg bw
main study: 2009 mg/kg bw
No. of animals per sex per dose:
Pre-study: 2
Main study: 5
Control animals:
yes
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: observations at 0, 1, 2, 4 h, then daily for 14 days; weighing weekly
- Necropsy of survivors performed: yes
Statistics:
Bliss
Litchfield & Wilcoxon

Results and discussion

Effect levels
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 009 mg/kg bw
Based on:
test mat.
Remarks on result:
other: No mortality occurred.
Mortality:
none
Clinical signs:
none
Body weight:
No treatment-related effects were observed.
Gross pathology:
No treatment-related effects were observed.
Other findings:
No local erythema and oedema were observed.

Applicant's summary and conclusion

Interpretation of results:
other: Not classified (CLP Regulation EC no. 1272/2008)
Conclusions:
A reliable dermal acute limit study conducted in compliance with a standard guideline and in accordance with GLP (reliability score 1), identified an LD50 > 2009 mg/kg bw in male and female rats. No local effects were reported.
Executive summary:

A limit study conducted in compliance with OECD 402 and in accordance with GLP, butan-2-one O,O',O''-(vinylsilanetriyl)oxime identified a LD50 for of > 2009 mg/kg bw in male and female rats. No effects were reported.