1-bromobutane

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

16 May 2002- 30 May 2002

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2003

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))

Version / remarks:

Commission Directive

GLP compliance:

yes (incl. QA statement)

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

1-bromobutane

EC Number:

203-691-9

EC Name:

1-bromobutane

Cas Number:

109-65-9

Molecular formula:

C4H9Br

IUPAC Name:

1-bromobutane

Specific details on test material used for the study:

No further details specified in the study report.

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River UK Ltd.
- Age at study initiation: 8-12 weeks
- Weight at study initiation: their weight were: at least 200 g.
- 5 days of acclimatisation before start of study.
-Free access of water and food (certified rat and mouse diet- code 5LF2)
- Housing: suspended polypropylene cages furnished with woodflakes. The animals were housed individually during the 24-hr exposure period and in groups of five, by sex, for the reminder of the study.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-25 ºC
- Humidity (%): 30-70 %
- Air changes (per hr): at least 15 changes per hr.
- Photoperiod (hrs dark / hrs light): 12 / 12

Administration / exposure

Type of coverage:

semiocclusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

TEST SITE
Area of exposure:
- % coverage: ca. 10 %
- Type of wrap if used: surgical gauze pad applied to skin with a semi-occluded with a piece of self-adhesive bandage.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): treated skin and surrounding hair wiped with cotton wool moistened with distilled water to remove any residual test material.
- Time after start of exposure: 24-hr

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2000 mg/kg bw
- Concentration (if solution): N/A
- Constant volume or concentration used: yes
- For solids, paste formed: N/A

VEHICLE
N/A

Duration of exposure:

24 hours.

Doses:

2000 mg/kg bw.

No. of animals per sex per dose:

5 per sex per dose

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Frequent observations of clinical signs were made 1/2, 1, 2, and 4 hours after dosing. Thereafter, observations were made at least once daily for 14 days.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, gross lesions, bodyweight changes, mortality and any other toxicological effects.

Statistics:

Not specified

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortality during the observation period.

Clinical signs:

other: There were no signs of systemic toxicity.

Gross pathology:

No abnormalities obderved.

Other findings:

N/A

Applicant's summary and conclusion

Interpretation of results:

practically nontoxic

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The 24 hours dermal LD50 for 1-bromobutane was found to be > 2000 mg/kg/bw in rats . Therefore, the substance does not meet the criteria for classification and will not require labelling for dermal toxicity in accordance with EU labelling regulations Commission Directive 93/21/EEC for classification and
labelling og dangerous substances and preparations.

Executive summary:

In an acute dermal toxicity study, 5 male and 5 female 8-12 weeks Sprague Dawley rats weighing at least 200 g dosed with a limit dose of 2000 mg/kg bw. A gauze pad was applied and then held in place with a semi-occlusive dressing. No dose related changes occurred during the 14 day observation period.

The 24 hours dermal LD₅₀ for 1-bromobutane was found to be > 2000 mg/kg/bw in rats. Therefore, does not meet the critera for classification.