Dicyclopentyldimethoxysilane

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

16.02.1995 to 02.03.1995

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1995

Report date:

1995

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

EU Method B.3 (Acute Toxicity (Dermal))

GLP compliance:

yes (incl. QA statement)

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Dicyclopentyldimethoxysilane

EC Number:

404-370-8

EC Name:

Dicyclopentyldimethoxysilane

Cas Number:

126990-35-0

Molecular formula:

C12H24O2Si

IUPAC Name:

dicyclopentyldimethoxysilane

Test material form:

liquid

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Harlan Olac, UK
- Age at study initiation: 7-10 weeks
- Weight at study initiation: 225-290 g
- Fasting period before study: No
- Housing: Individually in metal cages with wire mesh floors
- Diet (e.g. ad libitum): Ad libitum
- Water (e.g. ad libitum): Ad libitum
- Acclimation period: Seven days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22± 3
- Humidity (%): 30-70
- Air changes (per hr): 10-15
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: 16.02.1995 To: 02.03.1995

Administration / exposure

Type of coverage:

semiocclusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

TEST SITE
- Area of exposure: Dorso-lumbar region
- % coverage: Approximately 10%
- Type of wrap if used: Gauze held in place with non-irritating dressing

REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes, with warm water and blotted dry with absorbent paper.
- Time after start of exposure: 24 hours

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2.01 ml/kg bw

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: Twice daily for mortality. For clinical effects, animals were observed soon after dosing and at frequent intervals on the day of dosing (Day 1). On subsequent days the animals were observed twice daily. Individual body weights were recorded on Day 1 (prior to dosing), 8 and 15. Individual weekly bodyweight changes and group mean body weights were calculated.
- Necropsy of survivors performed: yes/no
- Other examinations performed: Local dermal effects scored, macroscopic examination

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Remarks on result:

other: No deaths

Mortality:

No deaths occurred.

Clinical signs:

other: There were no signs of systemic toxicity.

Gross pathology:

There were no abnormal findings.

Other findings:

Slight erythema (with or without oedema) was noted in one animal following the removal of the dressings and persisting for the following two days. This was accompanied by spot/scab formation in this and one other rat during the study. In addition desquamation (characterised by dryness/sloughing/scaling) was evident in up to four animals during the latter stage of week 1 and resolving in all instances by day 10.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Remarks:

Criteria used for interpretation of results: EU

Conclusions:

In an acute dermal toxicity study conducted to an EU guideline (with a protocol comparable to OECD Test Guideline 402) and in compliacne with GLP, the LD50 for dicyclopentyl(dimethoxy)silane was greater than 2000 mg/kg bw in rats. There were no signs of systemic toxicity, and only mild dermal irritation in a few animals.