3-chloropropyltrimethoxysilane

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1993/05/17-1993/06/08

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1993

Report date:

1993

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Test animals

Species:

rat

Strain:

other: Bor:WISW (SPF Cpb)

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS

- Source: Harlan Winkelman GmbH, 33176 Borchen, Gartenstr. 27

- Weight at study initiation: 200-300g

- Housing: The animals were individually caged in Type 3 Makrolon cages

- Diet: Ssnif R 10 Comprehensive diet for rats (ad libitum), Ssniff Specialfoods GmbH, 59494 Soest

- Water: ad libitum

- Acclimation period: minimum of 5 days


ENVIRONMENTAL CONDITIONS

- Temperature (°C): 20°C ± 3°C

- Humidity (%): 30-70

- Air changes (per hr): 15

- Photoperiod (hrs dark / hrs light): 12h/12h

Administration / exposure

Type of coverage:

semiocclusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

TEST SITE

- Area of exposure: the back

- Type of wrap if used: the area was covered and an acrylic bandage used as wrap and attached to the skin with plaster strips.

REMOVAL OF TEST SUBSTANCE

- Washing (if done): with warm water

- Time after start of exposure: 24h


TEST MATERIAL

- Amount(s) applied (volume or weight with unit): 1.85 cm3/kg

Duration of exposure:

24 hours

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

5/sex/group

Control animals:

not specified

Details on study design:

- Duration of observation period following administration: 14 days

- Frequency of observations and weighing: The animals were observed 30 minutes, 1,2,3,4,5 and 6 hours post application and daily for the 14 hour observation period. The animals were weighed at day 0, 7 and 14.

- Necropsy of survivors performed: yes

- Other examinations performed: clinical signs, body weight, organ weights, histopathology, other: All animals were subject to gross necropsy examination for any macroscopic abnormalities.

Statistics:

No statistical analysis of the results was deemed necessary.

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 mortalities in response to application of the test substance at 2000 mg/kg bw.

Clinical signs:

other: There was no evidence of systemic toxicity noted during the study period

Gross pathology:

There were no abnormalities noted at necropsy.

Other findings:

- Other observations: The sections and macroscopic examinations of the animals revealed no evidence of compound related changes in any organs.

Any other information on results incl. tables

There were no visible changes in the application area in the 14 day exposure period. There were no mortalities in response to the exposure to the test substance.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The LD50 value of >2000 mg/kg bw was determined in a reliable study conducted according to an appropriate test protocol, and in compliance with GLP.