Dimethyl sulphide-borane

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP compliant guideline study, available as unpublished report, no restrictions, fully adequate for assessment.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2005

Report date:

2005

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Test guideline 2

Qualifier:

according to guideline

Guideline:

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

Test guideline 3

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.1200 (Acute Dermal Toxicity)

GLP compliance:

yes (incl. QA statement)

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Dimethyl sulphide-borane

EC Number:

236-313-6

EC Name:

Dimethyl sulphide-borane

Cas Number:

13292-87-0

Molecular formula:

C2 H9 B S

IUPAC Name:

Dimethylsulfide -- borane

Details on test material:

- Name of the test substance used in the study report: Dimethylsulfide borane
- Substance No.: 05/0010-1
- Batch No.: 101169913
- Homogeneity: The test substance was homogeneous by visual inspection.
- Purity: 93.7%

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: RCC Ltd Laboratory Animal Services, Wölferstrasse 4, CH-4414 Füllinsdorf, Switzerland.
- Age at study initiation: Male animals approx. 8-10 weeks, female animals approx. 12-14 weeks
- Weight at study initiation: Males 258-291g, females 201-224g
- Housing: One rat per cage was housed in fully air-conditioned rooms in stainless steel wire mesh cages, type DK-lll (Becker & Co., Castrop-Rauxel, FRG).
- Diet: Kliba-Labordiät (Maus / Ratte Haltung "GLP"), Provimi Kliba SA, Kaiseraugst, Basel, Switzerland, ad libitum
- Water: tap water, ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 24
- Humidity (%): 30 - 70
- Photoperiod (hrs dark / hrs light): 12 h/ 12 h (6.00 a.m. - 6.00 p.m. / 6.00 p.m. - 6.00 a.m.)

Administration / exposure

Type of coverage:

semiocclusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

TEST SITE
- Area of exposure: dorsal and dorsolateral parts of the trunk (approx. 40 cm2)
- % coverage: at least 10% of the body surface
- Clipping of the fur: About 24 hours before the beginning of the study.
- Type of wrap: Semi-occlusive dressing (the bandage consists of four Iayers absorbent gauze, Ph. Eur. Lohmann GmbH & Co. KG and Fixomull stretch (adhesive fleece), Beiersdorf AG)

REMOVAL OF TEST SUBSTANCE
- Washing (if done): Rinsing of the application site with warm water.
- Time after start of exposure: 24 hours

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2.5 mL/kg (to correspond with 2,000 mg/kg body weight)
- Time of day of administration: In the morning

Duration of exposure:

24 hours

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

- Observation period: at least 14 days
- Body weight determination: shortly before application (day 0), weekly thereafter and at the end of the study.
- Recording of signs and symptoms: Several times on the day of administration, at least once each workday for the individual animals.
- Scoring of skin findings: Individual readings 30 - 60 minutes after removal of the semi-occlusive dressing (day 1), as a rule weekly thereafter and at the end of the study (last day of the observation period).
- Assessment of skin findings: According to Draize, J. H. (1959): Appraisal of the safety of chemicals in foods, drugs and cosmetics. The association of food and drug officials of the United States Austin, Texas.
- Mortality: A check for any dead or moribund animal was made twice each workday and once on weekends and on public holidays.
- Pathology: Necropsy with gross-pathology examination on the last day of the observation period after killing with CO2.

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

None

Clinical signs:

other: No systemic clinical observations were observed during clinical examination. No local effects were observed.

Gross pathology:

No macroscopic pathologic abnormalities were noted in the animals examined at termination of the study.

Applicant's summary and conclusion

Interpretation of results:

other: practically nontoxic