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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
11 June to 01 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
Qualifier:
according to guideline
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Test type:
acute toxic class method
Limit test:
yes

Test material

Constituent 1
Chemical structure
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 melts into a clear colourless viscous liquid.
- Date received: 12th April 2002
- Storage condition of test material: Room temperature in a dark room

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
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 old.
- Weight at study initiation: 182 - 206 g at day 0.
- Fasting period before study: Overnight fast before dosing then 3-4 hours after dosing.
- Housing: In groups of three in suspended solid floor polypropylene cages.
- Diet (e.g. ad libitum): Certified rat and mouse diet (Code 5LF2) supplied by PMI Nutrition International provided ad libitum.
- Water (e.g. ad libitum): Mains water ad libitum.
- Acclimation period: At least 5 days.

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

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Doses:
Level: 2000 mg/kg body weight
Volume: 2.01 ml/kg body weight
No. of animals per sex per dose:
Two groups consisiting of three individuals. Six rats were tested in total.
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations: 0.5, 1, 2 and 4 hours post dosing, then once daily for the 14 day duration.
- Frequency of weighing: Day 0 prior to dosing, then on days 7 and 14.
- Additional observations: Clinical and behavioural.
- Necropsy of survivors performed: yes
- Other examinations performed: All animals were subjected to gross pathological examination including: external examination, opening of the abdominal and thoracic cavities allowing examination of the major organs. Macroscopic abnormalities were recorded.

Results and discussion

Effect levels
Sex:
female
Dose descriptor:
LD50
Effect level:
> 2 500 mg/kg bw
Based on:
test mat.
Remarks on result:
other: No reliability limits were given.
Mortality:
No deaths.
Clinical signs:
other: No systemic signs of toxicity.
Gross pathology:
No abnormalities recorded.

Applicant's summary and conclusion

Interpretation of results:
study cannot be used for classification
Remarks:
Migrated information
Conclusions:
Under the conditions of the test, the LD50 of the test material was determined to be >2500 mg/kg body weight. The test material is therefore is unclassified according to Regulation 1272/2008.
Executive summary:

In a GLP-compliant acute toxicity study conducted in accordance with standardised guideline OECD 423, the LD₅₀ of the test material was calculated by exposing six female Sprague Dawley rats to a dose of 2000 mg/kg of body weight via oral gavage. Under the conditions of the test no systemic signs of toxicity were reported over a period of 14 days and the LD₅₀ was determined to be >2500 mg/kg.

 

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

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