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:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2001
Report Date:
2001

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

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
- Fasting period before study: Not stated.
- Housing: Individually in Macrolon cages.
- Diet (e.g. ad libitum): Ad libitum
- Water (e.g. ad libitum): Ad libitum
- Acclimation period: 'Adequate'. Period not stated.


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22± 3
- Humidity (%): 55 ±10
- Air changes (per hr): at least 10
- 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: Not stated
- % coverage: At least 10% of total body surface
- Type of wrap if used: Semi-occlusive gauze dressing and non-irritating tape, with a bandage that wrapped around the abdomen.


REMOVAL OF TEST SUBSTANCE
- Washing (if done): Yes, with water
- Time after start of exposure: 24 hours.


TEST MATERIAL
- Amount(s) applied (volume or weight with unit): No data
- Constant volume or concentration used: no data



Duration of exposure:
24 hours
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
Five
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Animals were weighed prior to application of test substance and on Day 7 and 15. Cageside observations were made several times per day on the day of application and once per day thereafter.
- Necropsy of survivors performed: yes
- Other examinations performed: Macroscopic examination following necropsy.
Statistics:
No statistics were performed.

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:
No clinical signs were observed.
Body weight:
Weight gain of the male animals was within the expected range. The female animals lost weight within the first week after application, but had a normal weight gain during the second week. This was probably due to the stress of the manipulation procedure, which means a big physical strain for the animals. This was more visible for the female animals because they had already reached their adult weights at the beginning of the study.
Gross pathology:
There were no findings.
Other findings:
No other findings were reported.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
In a good quality (reliability score 1) acute dermal toxicity study conducted according to OECD 402 and GLP, the LD50 for Wacker BS 1701 (alkylalkoxysilane) was greater than 2000 mg/kg bw.
Executive summary:

Wacker BS 1701 (alkylalkoxysilane) was applied unchanged to the skin of Wistar rats (five/sex) under a semi-occlusive dressing for 24 hours at a dose of 2000 mg/kg bw. After 24 hours the skin was washed with water to remove excess test substance. Animals were then observed daily for 14 days. Body weights were measured on the day before treatment (Day 1) and on Days 7 and 15. On Day 15 animals were sacrificed and a macroscopic examination was conducted. There were no deaths, clinical signs of toxicity or abnormal findings at necropsy. Weight gain of the male animals was within the expected range. The female animals lost weight within the first week after application, but had a normal weight gain during the second week. This was probably due to the stress of the manipulation procedure, which means a big physical strain for the animals. This was more visible for the female animals because they had already reached their adult weights at the beginning of the study. Therefore the LD50 for Wacker BS 1701 was greater than 2000 mg/kg bw.