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Diss Factsheets

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1981
Report date:
1981

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
GLP compliance:
not specified
Limit test:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Ethyl 2-bromopropionate
EC Number:
208-609-5
EC Name:
Ethyl 2-bromopropionate
Cas Number:
535-11-5
Molecular formula:
C5H9BrO2
IUPAC Name:
ethyl 2-bromopropionate

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals or test system and environmental conditions:
Animals weigh 150-180 g and were fed and drunk ad libitum.
Animals were submitted to a water diet of 17-19 hours before receiving the treatment and feed/water.
Temperature of 22°C, hygrometry of 50% and ventilation of 8 air renewals/hour.

Administration / exposure

Route of administration:
oral: unspecified
Vehicle:
CMC (carboxymethyl cellulose)
Doses:
Preliminary test: 100, 500, 1000, 2500, 5000 mg/kg
Definitive test: 400, 440, 480, 580, 700 mg/kg
No. of animals per sex per dose:
Preliminary test: 2 rats/sex/dose
Definitive test: 5 rats/sex/dose
Control animals:
yes
Details on study design:
1 preliminary test and 1 definitive test
Statistics:
3 methods:
- Probit
- Litchfield and Wilcoxon
- Arcsinus

Results and discussion

Preliminary study:
At dose of 100 mg/kg, 0% of cumulated mortality after 14 days of observation.
At dose of 500 mg/kg, 50% of cumulated mortality after 14 days of observation.
At doses of 1000, 2500 and 5000 mg/kg, 100% of cumulated mortality after 14 days of observation.
Effect levels
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
ca. 439 mg/kg bw
Based on:
test mat.
95% CL:
>= 416 - <= 462
Remarks on result:
other: according to Litchfield and Wilcoxon method
Mortality:
At dose of 400 mg/kg, 20% of cumulated mortality after 14 days of observation.
At dose of 440 mg/kg, 50% of cumulated mortality after 14 days of observation.
At dose of 480 mg/kg, 80% of cumulated mortality after 14 days of observation.
At doses of 580 and 700 mg/kg, 100% of cumulated mortality after 14 days of observation.
Clinical signs:
other: At dose of 400 mg/kg: from 1h to 6h, reduced spontaneous activity, apathy, ptosis. At day 1, normal behavior. At doses of 440 and 480 mg/kg: from 1h to day 1, reduced/no spontaneous activity, apathy, ptosis. At day 2, persistence of apathy. At day 3, norm
Gross pathology:
Observations during autopsy of dead animals under test:
At dose of 400 mg/kg: hemorrhagic lungs and thymus
At doses of 440 and 480 mg/kg: irritated stomach, hemorrhagic lungs and thymus in most of the animals
At doses of 580 and 700 mg/kg: same kind of symptoms as above.

Observations during autopsy of surviving animals at the end of the test:
At dose of 480 mg/kg: pale kidneys. This anomaly was not observed at doses of 400 and 440 mg/kg.

Applicant's summary and conclusion

Interpretation of results:
Category 4 based on GHS criteria
Conclusions:
Under experimental conditions, the LD50 by oral route in rats of Ethyl-2-bromopropionate is 439 mg/kg (416-462) according to Litchfield and Wilcoxon method.