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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: see 'Remark'
Remarks:
Study was carried out under at a certified GLP laboratory using the OECD Guidelines for the Testing of Chemicals No. 423 “Acute Oral Toxicity – Acute Toxic Class Method” (adopted 17 December 2001) and Method B1 tris Acute Toxicity (Oral) of Commission Directive 2004/73/EC guidelines.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2004
Report date:
2004

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Deviations:
no
GLP compliance:
yes
Test type:
acute toxic class method
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Methyl bromoacetate
EC Number:
202-499-2
EC Name:
Methyl bromoacetate
Cas Number:
96-32-2
Molecular formula:
C3H5BrO2
IUPAC Name:
methyl 2-bromoacetate
Test material form:
other: Liquid
Details on test material:
Material from production 98% min pure

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, Margate, Kent, UK
- Age at study initiation: eight to twelve weeks
- Weight at study initiation: 195 - 205 g
- Fasting period before study: overnight
- Housing: suspended solid-floor polypropylene cages furnished with woodflakes
- Diet (e.g. ad libitum): free access to food
- Water (e.g. ad libitum): free access to mains drinking water
- Acclimation period: at least five days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 to 25°C
- Humidity (%): 30 to 70%
- Air changes (per hr): at least fifteen
- Photoperiod (hrs dark / hrs light): twelve hours continuous light and twelve hours darkness

IN-LIFE DATES: From: To:

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
arachis oil
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 30 mg/ml & 5 mg/ml
- Amount of vehicle (if gavage): 10 ml/Kg
- Justification for choice of vehicle: test material did not dissolve/suspend in distilled water
- Lot/batch no. (if required):
- Purity:

MAXIMUM DOSE VOLUME APPLIED: 10 mg/ml

- Rationale for the selection of the starting dose: absence of data regarding the toxicity of the test material
Doses:
Group 1 - 300 mg/kg
Group 2 - 50 mg/Kg
Group 3 - 50 mg/Kg
No. of animals per sex per dose:
3
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: The animals were observed for deaths or overt signs of toxicity ½, 1, 2 and 4 hours after dosing
and subsequently once daily for up to fourteen days. Individual bodyweights were recorded prior to dosing and seven and fourteen days after
treatment or at death.
- Necropsy of survivors performed: yes

Results and discussion

Preliminary study:
The acute oral median lethal dose (LD50) of the test material in the female Sprague-Dawley CD strain rat was estimated to be in the range of 50 - 200 mg/kg bodyweight
Effect levels
Sex:
female
Dose descriptor:
LD50
Effect level:
> 50 - < 300 mg/kg bw
Based on:
test mat.
Mortality:
Animals treated at a dose level of 300 mg/kg were found dead during the day of dosing or one day after dosing. There were no deaths noted at a dose level of 50 mg/kg
Clinical signs:
other: Signs of systemic toxicity noted in animals treated at a dose level of 300 mg/kg were hunched posture, lethargy, decreased respiratory rate, laboured respiration, ataxia, pilo-erection, diarrhoea, diuresis and tiptoe gait. There were no signs of systemic
Gross pathology:
Abnormalities noted at necropsy of animals that died during the study were haemorrhagic or
abnormally red lungs, dark liver or patchy pallor of the liver, dark kidneys, haemorrhage of the
gastric mucosa and epithelial sloughing of the non-glandular region of the stomach. 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:
Toxicity Category II
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
LD50 - 50 - 200 mg/Kg