Registration Dossier

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:
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
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rat
Strain:
other: Wistar (HsdCpb:WU/SPF)
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Harlan Winkelmann GmbH, 33176 Borchen, Germany.
- Weight at study initiation: 200-300 g
- Housing: Makrolon type III cages, grouped caged per sex, each cage containing maximum of five rats. The bedding used was soft wood type HW 300/500W, produced by JELU-WERK, Ludwigsmühle, 73494 Rosenberg.
- Diet: Ssniff R 10 diet pellet form (laboratory standard rat diet) produced by Ssniff Spezialfutter GmbH, 69494 Soest. Food was offered ad libitum.
- Water: The animals received tap water ad libitum, (Fa. Gelsenwasser, Wasserwerk, 45271 Haltern).
- Acclimation period: Animals were acclimatised for at least 5 days.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3
- Humidity (%): 30-70
- Photoperiod (hrs dark / hrs light): Artificial light, from 7.00 a.m. to 7.00 p.m.

Administration / exposure

Type of coverage:
semiocclusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST SITE
- Area of exposure: approximately 50 x 50 mm clipped skin of the Dorsolumbar area.
- % coverage: 10 %
- Type of wrap if used: The treated area was promptly covered with gauze which was held in place with a semiocclusive dressing encircled firmly around the trunk.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): At the end of the exposure period, the dressing were carefully removed and the treated area of skin was cleaned with corn oil and absorbent paper.
- Time after start of exposure: 24 h

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

Duration of exposure:
24 h
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Mortality: rats were checked at least twice daily for any mortality. Animals were observed for clinical signs soon after dosing and at frequent intervals for the remainder of Day 0 (a period of approximately six hours). On subsequent days animals were observed once a day. All animals were observed for 14 days after dosing. Individual bodyweights were recorded on Days 0 (prior to dosing), 7 and 14. Dermal response: Local dermal irritations as well as any other lesions were observed and recorded.
- Necropsy of survivors performed: yes. All surviving animals were killed on Day 14 by Carbon dioxide inhalation
- Other examinations performed: clinical signs, body weight,organ weights, histopathology, Macroscopic examinations of the abdominal and thoracic cavities.

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
No mortality occurred during the study period.
Clinical signs:
No clinical signs of toxicity were observed up to the end of the 14-day observation period.
Body weight:
Body weight gains in the dose groups were within the normal ranges in males and females during the whole study period.
Gross pathology:
Necropsy and histopathological examinations revealed no substance-related findings.
Other findings:
- Other observations:No local dermal irritations at the treatment site were observed following removal of the dressings until the end of the observation period.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
In this study performed in rats according to OECD 402 and GLP, the LD50 of (3-Chloropropyl)diethoxymethylsilane was found to be > 2000 mg/kg bw.