2-Propenoic acid, tris(1-methylethyl)silyl ester

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

30 September 2004 to 30 November 2004

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2004

Report date:

2004

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Triisopropylsilyl acrylate

Cas Number:

157859-20-6

Molecular formula:

C12H24O2Si

IUPAC Name:

Triisopropylsilyl acrylate

Test animals

Species:

rat

Strain:

other: HanBrl:WIST

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: RCC Ltd, Laboratory Animal Services, CH-4414 Fullinsdorf, Switzerland
- Age at study initiation: 8 weeks (males), 12 weeks (females)
- Weight at study initiation: 263.6-275.6 g (males), 199.7-213.2 g (females)
- Fasting period before study: No data
- Housing: Individually in Makrolon type-3 cages with standard softwood bedding
- Diet: Pelleted standard Provimi Kliba 3433 rat/mouse maintenance diet, ad libitum
- Water: Community tap water, ad lbitum
- Acclimation period: 6 days under laboratory conditions, after health examination

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: 30-Sep-2004 To: 21-Oct-2004

Administration / exposure

Type of coverage:

semiocclusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

TEST SITE
- Area of exposure: backs of the animals
- % coverage: approx. 10% of total body surface
- Type of wrap if used: Elastic adhesive bandage

REMOVAL OF TEST SUBSTANCE
- Washing: skin flushed with lukewarm tap water and dried with disposable paper towels
- Time after start of exposure: 24 hours

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2.2 ml/kg bw
- Concentration (if solution): 0.91 g/ml (density)
- Constant volume or concentration used: yes
- For solids, paste formed: Not required

Duration of exposure:

24 hours

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

5/sex

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Mortality and viability assessed approximately 1, 2, 3 and 5 hours after administration on test day 1 and twice daily during days 2-15.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, other: macroscopic examination

Statistics:

No statistical analysis was used.

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Remarks on result:

other: No deaths at 2000 m g/kg bw

Mortality:

No deaths occurred during the study.

Clinical signs:

other: Very slight erythema observed in all male and female animals on test day 2 and persisted in all males up to test day 4 and in two females up to test day 6 and 7 respectively. Slight crusts were noted on one male on test day 5, in another male from test da

Gross pathology:

No macroscopic findings observed at necropsy.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

In an acute dermal toxicity study (limit test) in male and female rats, conducted according to OECD Test Guideline 402 and in compliance with GLP, the LD50 was >2000 mg/kg bw, the only dose tested.

Executive summary:

Tri(isopropyl)silyl acrylate was tested in an acute dermal toxicity study, conducted to OECD test guideline 402 and in compliance with GLP.

2000 mg/kg bw was applied under semi-occluded contact for 24 hours and the animals were observed for 14 days.

All of the animals survived until the end of the study but very slight erythema and slight crusting of the skin were noted in both males and females. All symptoms were reversible by test day 8.

The dermal LD₅₀ for tri(isopropyl)silyl acrylate in male and female rats was >2000 mg/kg bw under the conditions of the test.