Registration Dossier

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:
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:
other: HanBrl:WIST
Sex:
male/female
Details on test animals 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:
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 day 5 to 8 and on one female on test day 8.
Body weight:
Body weights were within the range commonly recorded for this strain and age.
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.