Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Performed using the OECD Guidelines for the Testing of Chemicals No. 423 "Acute Oral Toxicity - Acute Toxic Class Method" and Method B1 tris Acute Oral Toxicity (Oral - Acute Toxic Class Method)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2000
Report date:
2000

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
GLP compliance:
yes (incl. QA statement)
Test type:
acute toxic class method

Test material

Constituent 1
Chemical structure
Reference substance name:
Methyl 2-bromohexanoate
EC Number:
226-643-9
EC Name:
Methyl 2-bromohexanoate
Cas Number:
5445-19-2
Molecular formula:
C7H13BrO2
IUPAC Name:
methyl 2-bromohexanoate
Test material form:
other: Liquid

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 weeks
- Weight at study initiation: 209 - 232 g (Female), 240 - 275 g (Male)
- Fasting period before study: Overnight
- Housing: Solid-floor polypropylene cages
- Diet (e.g. ad libitum): Free access
- Water (e.g. ad libitum): Free access
- Acclimation period: 5 days

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

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
arachis oil
Doses:
2000 mg/Kg (undiluted) & 200 mg/Kg (diluted in arachis oil)
No. of animals per sex per dose:
3 Female @ 2000 mg/Kg
3 Female & 3 male @ 200 mg/Kg
Details on study design:
Details on study design
- Duration of observation period following administration: 14 days (or other?) 14 days
- Frequency of observations and weighing: ½, 1, 2 & 4 hrs and daily
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight,organ weights, histopathology

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 300 - < 500 mg/kg bw
95% CL:
> 300 - < 500
Mortality:
All animals treated with 2000 mg/Kg were found dead tow or four hours after dosing.
There were no deaths noted at a dose level of 200 mg/Kg
Clinical signs:
Signs of systematic toxicity at a dose level of 2000 mg/Kg were ataxia, hunched posture, lethargy, pilo-erection, decreased respiratory rate, laboured respiration and loss of righting reflex.
Signs of systematic toxicity noted in females at a dose level of 200 mg/Kg were haunched posture and diarrhoea. Th females treated with 200 mg/Kg recovered two days after dosing.
There were no signs of systemic toxicity noted in males at a dose level of 200 mg/Kg.
Body weight:
The surviving animals showed expected gains in bodyweight over the study period.
Gross pathology:
Abnormalities noted at necropsy of animals that died during the study were haemorrhagic lungs, dark liver and dark kidneys.
No abnormalities were noted at necropsy of animals that were killed at the end of the study.

Applicant's summary and conclusion

Interpretation of results:
harmful
Remarks:
Migrated information 300 - 500 mg/Kg Criteria used for interpretation of results: EU