Dimethyl sulphide-borane

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

weight of evidence

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other: GLP compliant guideline study, available as unpublished report, no restrictions, fully adequate for assessment.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

other: OECD Guideline 402 (Acute Dermal Toxicity)

Test guideline 2

Qualifier:

according to guideline

Guideline:

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

Test guideline 3

Qualifier:

according to guideline

Guideline:

other: EPA OPPTS 870.1200 (Acute Dermal Toxicity)

GLP compliance:

yes (incl. QA statement)

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

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.)

Test system

Type of coverage:

semiocclusive

Preparation of test site:

clipped

Vehicle:

unchanged (no vehicle)

Controls:

no

Amount / concentration applied:

To obtain a dose of 2000 mg/kg bw, 2.5 mL/kg of the test substance is applied.

Duration of treatment / exposure:

24 hours

Observation period:

14 days

Number of animals:

10 (5 males, 5 females)

Details on study design:

TEST SITE
- Area of exposure: 40 cm2
- % coverage: at least 10% of the body surface
- Clipping of the fur: About 24 hours before the beginning of the study (dorsal and dorsolateral parts of the trunk).
- 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

Results and discussion

In vivo

Results

Irritation parameter:

other: skin findings

Remarks on result:

other: No local effects were observed.

Irritant / corrosive response data:

No systemic clinical observations or skin effects were noted in the animals in this acute toxicity study in which rats were exposed with 2000 mg/kg.

Applicant's summary and conclusion

Interpretation of results:

other: not irritating