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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: dermal
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Conducted according to OECD Guidelines for Testing of Chemicals No. 402 "Acute Dermal Toxicity" and EEC method B3 Acute Toxicity (Dermal)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Report date:
2001

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
GLP compliance:
yes (incl. QA statement)
Test type:
standard acute method
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Ethyl 2-bromobutyrate
EC Number:
208-574-6
EC Name:
Ethyl 2-bromobutyrate
Cas Number:
533-68-6
Molecular formula:
C6H11BrO2
IUPAC Name:
ethyl 2-bromobutanoate
Test material form:
other: Liquid

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 weeks
- Weight at study initiation: 222 - 242g (Male), 214 - 247g (Female)
- Fasting period before study: none
- Housing: Suspended 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

Type of coverage:
semiocclusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST SITE
- Area of exposure: 10%
- % coverage: 10
- Type of wrap if used: self adhesive bandage

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

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 1.52 ml/Kg
Doses:
1.52 ml/Kg
No. of animals per sex per dose:
5 male and 5 female
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: ½, 1, 2, 4Hrs and daily
- Necropsy of survivors performed: yes

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
ca. 2 000 mg/kg bw
Based on:
test mat.
Mortality:
None
Clinical signs:
There were no signs of systemic toxicity
Body weight:
All animals showed expected gains in bodyweight over the study period
Gross pathology:
No abnormalities were noted at necropsy

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU