1-bromohexadecane

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

18th June 2002 to 02 July 2002

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: see 'Remark'

Remarks:

Study conducted in compliance with agreed protocols, with no deviations from standard test guidelines and no methodological deficiencies, which do not affect the quality of the relevant results. The study report was conclusive, done to a valid guideline and the study was conducted under GLP conditions.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2003

Report date:

2003

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))

Deviations:

no

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-bromohexadecane

EC Number:

204-008-7

EC Name:

1-bromohexadecane

Cas Number:

112-82-3

Molecular formula:

C16H33Br

IUPAC Name:

1-bromohexadecane

Details on test material:

- Substance type: White semi-solid block on arrival, which subsequently melts into a clear colourless liquid.
- Date received: 12th April
- Storage condition of test material: Room temperature, in the dark.

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., Margate, Kent, UK.
- Age at study initiation: 8-12 weeks.
- Weight at study initiation: at least 200g
- Housing: Housed in suspended soil-floor polypropylene cages. Animals were housed individually during exposure then in groups of 5, by sex, for the remainder of the study.
- Diet (e.g. ad libitum): Certified Rat and Mouse Diet (Code 5LF2) supplied by Nutrition International, Nottingham, UK and IPS Product Supplies Ltd, Northants, UK. Food was provided ad libitum throughout the study.
- Water (e.g. ad libitum): Mains drinking water ad libitum.
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature: 19-25°C
- Humidity: 30-70%
- Air changes: 15 per hr
- Photoperiod (hrs dark / hrs light): 12 hrs of light from 06:00 to 18:00, then 12 hrs of dark.

Administration / exposure

Type of coverage:

semiocclusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

TEST SITE
- Area of exposure: Back and flanks of the animals were used for exposure.
- % coverage: 10% of the total body surface
- Type of wrap if used: Surgical gauze attached with self-adhesive bandage.

TEST MATERIAL
- Test material was used as supplied.
- Volume: 2.01 ml/kg

REMOVAL OF TEST SUBSTANCE
- Washing (if done): Residue was removed with cotton wool moistened with distilled water.
- Time after start of exposure: 24 hrs.

Duration of exposure:

24 hr

Doses:

2000 mg/kg body wieght

No. of animals per sex per dose:

5 males and 5 females

Control animals:

no

Details on study design:

- Observations were made for deaths and signs of toxicity. At 30 minutes, 1, 2 and 4 hours post exposure, then daily for 14 days.

- Primary irritation was observed after patch removal then once daily for the 14 day observation period. Skin was scored according to the Draize scale (1977). The scoring system can be seen in table 1 in the field "Any other information on materials and methods incl. tables". Any other skin reactions were also recorded.

- Necropsy of survivors performed: yes

- Other examinations performed: body weight, macroscopic examination, internal examination of the abdominal and thoracic cavities.

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No deaths occurred.

Clinical signs:

other: No signs of systemic toxicity.

Gross pathology:

No abnormalities were noted at necropsy.

Other findings:

Very slight or well-defined erythema and crust formation were noted at the treatment sites of all animals. Very slight oedema was also noted at the treatment sites of two males. Treatment sites appeared normal eight to ten days after dosing.

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Under the conditions of the test, the acute dermal toxicity of the test material was determined to be LD50 > 2000 mg/kg.

Executive summary:

The acute dermal toxicity of the test material was determined in a GLP-compliant study according to OECD Guideline 402 and EU Method B.3. Ten Sprague Dawley rats were exposed to the test material for period of 24 hours, the test animals were then observed over a period of 14 days. The LD₅₀ of the test material was determined to be > 2000 mg/kg of body weight. During the observation period no mortalities were seen and no other systematic signs of toxicity were reported.

The test material does not require classification according to Regulation 1272/2008.