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Diss Factsheets

Administrative data

acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
July from 02nd to 11th, 2001
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
test procedure in accordance with generally accepted scientific standards and described in sufficient detail

Data source

Reference Type:
study report
Report date:

Materials and methods

Test guidelineopen allclose all
according to guideline
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Version / remarks:
adopted on 22th March, 1996
according to guideline
EU Method B.1 (Acute Toxicity (Oral))
GLP compliance:
yes (incl. QA statement)
Test type:
acute toxic class method
Limit test:

Test material

Constituent 1
Chemical structure
Reference substance name:
tert-butyl bromoacetate
EC Number:
EC Name:
tert-butyl bromoacetate
Cas Number:
Molecular formula:
tert-butyl bromoacetate
Specific details on test material used for the study:
For the purpose of the 2000 mg/kg b.w. dose level the test material was used as supplied.
For the purpose of the 200 mg/kg b.w. dose level the test material was freshly prepared as required as a solution in arachidis oil.

Test animals

Details on test animals or test system and environmental conditions:
- Source: Charles River (UK) Ltd.
- Females nulliparous and non-pregnant: yes.
- Age at study initiation: ca. 8 weeks old.
- Weight at study initiation: at least 200 g.
- Acclimation period: at least 5 days.
- Housing: in group of three by sex, in solid-floor polypropylene cages furnished with woodflakes.
- Identification: ink-marking on the tail.
- Fasting period before study: overnight before dosing.
- Diet: ad libitum, rat and mouse Expended Diet no. 1.
- Water: free access to drinking water.

- Temperature: 19 - 25 °C
- Humidity: 30 - 70 %
- Air changes: at least 15 ACH
- Photoperiod: 12 hours dark

Administration / exposure

Route of administration:
oral: gavage
arachis oil
Details on oral exposure:
- Concentration: 20 mg/ml at dose level of 200 mg/kg bw
- Dose volume: 1.54 ml/kg at dose level of 2000 mg/kg bw; 10 ml/kg at dose level of 200 mg/kg bw
2000 and 200 mg/kg bw
No. of animals per sex per dose:
3 females at 2000 mg/kg bw
3 females and 3 males at 200 mg/kg bw
Details on study design:
- Duration of observation period following administration: 14 days.
- Frequency of observations and weighing: animals were observed for death or overt signs of toxicity 1/2, 1, 2 and 4 hours after dosing and subsequent once daily for up to 14 days. Individual bodyweights were recorded prior to dosing and 7 and 14 days after treatment or at death.
- Necropsy of survivors performed: yes. all animals were subjected to gross necropsy. External examination and opening of the abdominal and thoracic cavities for examination of major organs were performed. The appearance of any macroscopic abnormalities was recorded. No tissues were retained.

Results and discussion

Effect levels
Dose descriptor:
approximate LD50
Effect level:
300 - 500 mg/kg bw
Based on:
test mat.
All females treated at 2000 mg/kg bw and one female treated at the dose level of 200 mg/kg bw were found dead during the day of dosing.
Clinical signs:
other: Signs of systemic toxicity noted in animals treated at 2000 mg/kg bw were hunched posture, lethargy, ataxia, decreased respiratory rate, laboured respiration, ptosis, tiptoe gait and coma. Hunched posture was noted in surviving females treated at a dose l
Gross pathology:
Abnormalities noted at necropsy of animals that died during the study were haemorrhagic and abnormally red lungs, dark liver, dark kidneys, haemorrhage and sloughing of the gastric mucosa, non-glandular region of the stomach and small and large intestines.

No abnormalities were noted at necropsy of animals that were killed at the end of the study.

Any other information on results incl. tables

Mortality data

Dose level mg/kg b.w. Sex No. animals Deaths during day of dosing (hours) Deaths during day of dosing (days) Deaths
1/2 1 2 4 1 2 3 4 5 6 7 8 until 14
2000 F 3 1 0 1 1 - - - - - - - - 3/3
200 F 3 1* 0 0 0 0 0 0 0 0 0 0 0 1/3
M 3 0 0 0 0 0 0 0 0 0 0 0 0 0/3

Applicant's summary and conclusion

Interpretation of results:
other: Acute Tox. 4 (H302), according to the CLP Regulation (EC 1272/2008)
LD50 in the range of 300 - 500 mg/kg bw
Executive summary:

The study was performed according to OECD 423 (1996). A group of three females were treated orally by gavage with the test material at a dose level of 2000 mg/kg bw and, subsequently, three females and three males were treated at 200 mg/kg bw

At the higher dose level 3/3 females were found dead; while at the lower dose level 5/6 animal survived (1 female dead). Based on the present results, the acute oral median LD50 was estimated to be in the range of 300 - 500 mg/kg bw.


LD50 is in the range of 300 - 500 mg/kg b.w.