Triethoxy(3-thiocyanatopropyl)silane

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

29 September 2011 to 18 October 2011

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2011

Report date:

2011

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

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

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Triethoxy(3-thiocyanatopropyl)silane

EC Number:

252-161-3

EC Name:

Triethoxy(3-thiocyanatopropyl)silane

Cas Number:

34708-08-2

Molecular formula:

C10H21NO3SSi

IUPAC Name:

[3-(cyanosulfanyl)propyl]triethoxysilane

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Harlan Laboratories B.V., Kreuzelweg 53, 5961 NM Horst / The Netherlands
- Age at study initiation: 9 weeks (males), 11 weeks (females)
- Weight at study initiation: 225.1 to 234.5 g (males), 201.3 to 216.2 g (females)
- Fasting period before study: no data
- Housing: in groups of three in Makrolon type 4 cages
- Diet (e.g. ad libitum): pellet diet ad libitum
- Water (e.g. ad libitum): tap water ad libitum
- Acclimation period: at least five days

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

IN-LIFE DATES: From: 29 September 2011 To: 18 October 2011

Administration / exposure

Type of coverage:

semiocclusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

TEST SITE
- Area of exposure: ~ 5 x 5 cm
- % coverage: 10
- Type of wrap if used: gauze pad held in place by adhesive hypoallergenic aerated dressing and elastic adhesive restrainer bandage

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

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 4 ml/kg bw
- Constant volume or concentration used: no

Duration of exposure:

24 h

Doses:

4000 mg/kg bw

No. of animals per sex per dose:

5M, 5F

Control animals:

not required

Details on study design:

- Duration of observation period following administration: 15 days (day of treatment (day 1) and up until 14 days after patch removal (days 2 to 15))
- Frequency of observations and weighing: Clinical signs and mortality assessed within first 30 minutes and 1, 2, 3 and 5 hours after treatment, and on days 2 to 15 (daily for clinical signs, twice daily for mortality). Skin observed daily during test days 2 to 15 (re-clipped on days 4, 8, 10 and 14). Body weights recorded on day 1 (prior to treatment), 8 and 15.
- Necropsy of survivors performed: yes

Statistics:

No statistical analysis was performed

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 4 000 mg/kg bw

Based on:

test mat.

Remarks on result:

other: no mortality observed throughout the study

Mortality:

There were no deaths over the course of the study.

Clinical signs:

other: Slightly increased activity noted in all males and females 1 and 2 hours after treatment on day 1.5 hours after treatment, dragging of limbs seen in all animals and still seen on day 2 in all males and four females, persisting up to day 3 in two males. Sl

Gross pathology:

No macroscopic findings recorded at necropsy.

Other findings:

- Other observations: Slight erythema was seen in four males during the first days after treatment. Focal crusts were additionally seen in three of these males and slight desquamation in one. All these symptoms reverted by day 8. Slight to moderate erythema in females, persisting up until day 13/14 in two animals. Slight to severe focal crusts were seen in all animals, and persisted in two females up until test day 15. Slight to severe desquamation was seen in four females, and slight to moderate necrosis in two females. In one female, desquamation was still seen at day 15.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

In a study carried out in accordance with OECD Test Guideline 402 and in compliance with GLP (reliability score 1), triethoxy(3-thiocyanatopropyl)silane was of low toxicity to Wistar rats following a 24-hour dermal application under semi-occlusive conditions. The acute dermal LD50 was determined to be greater than 4000 mg/kg bw.