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Toxicological information

Acute Toxicity: oral

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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1993
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1993

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
EU Method B.1 (Acute Toxicity (Oral))
GLP compliance:
yes (incl. QA statement)
Test type:
standard acute method

Test material

Constituent 1
Chemical structure
Reference substance name:
1-bromo-3-chloropropane
EC Number:
203-697-1
EC Name:
1-bromo-3-chloropropane
Cas Number:
109-70-6
Molecular formula:
C3H6BrCl
IUPAC Name:
1-bromo-3-chloropropane
Details on test material:
Batch number : 9207093
Expiry : stable for at least three months
Purity : 99,6%
Appearence : colourless liquid
Storage conditions : room temperature in the dark

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals or test system and environmental conditions:
Equal number of healthy male and female rats, in the weight range 94 to 121 g, aged 4 to 7 weeks.
A standard laboratory rodent diet (Biosure LAD 1) and drinking water were provided ad libitum. Access to food only was prevented overnight prior to and approximately 4 hours after dosing.
The mean daily minimum and maximum temperatures of the animal room were 20°C to 22°C respectively and the mean daily relative humidity value was 52% R.H. Air exchange was maintened at 10 to 15 air changes per hour and lighting was controlled by means of a time switch to provide 12 hours of artificial light (07:00-19:00 hours) in each 24 hours period.

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Doses:
Preliminary study : 1,0 g g/kg bodyweight
Main study : 0,8 ; 1,0 & 1,6 g/kg bodyweight
No. of animals per sex per dose:
Preliminary study : 2 males & 2 females
Main study : 5 males & 5 females
Control animals:
no

Results and discussion

Preliminary study:
The results of the preliminary study indicated that the acute lethal oral dose of 1-bromo-3-chloropropane was in the region of 1,0 g/kg bodyweight for male rats and less thann 1,0 g/kg bodyweight for female rats.
Effect levelsopen allclose all
Sex:
male/female
Dose descriptor:
LD50
Effect level:
1 100 mg/kg bw
Based on:
test mat.
95% CL:
1 000 - 1 300
Remarks on result:
other: A fixed slope of 8,2 was assumed
Sex:
male
Dose descriptor:
LD50
Effect level:
1 100 mg/kg bw
Based on:
test mat.
95% CL:
900 - 1 400
Remarks on result:
other: A fixed slope of 8,2 was assumed
Sex:
female
Dose descriptor:
LD50
Effect level:
1 200 mg/kg bw
Based on:
test mat.
95% CL:
1 100 - 1 500
Remarks on result:
other: A fixed slope of 8,2 was assumed
Mortality:
There were deaths following a single oral dose of 1-bromo-3-chloropropane among rats of both sexes dosed at 1,0 g/kg bodyweight and above. Deaths occured at intervals from within 4 hours of dosing until day 7.
Clinical signs:
Pilo-erection and increased salivation were observed in rats within five minutes of dosing. Also observed at this time were abnormal body carriage (hunched posture) and pallor of the extremities among rats treated at 1,0 g/kg. Pilo-erection persisted and was accompanied on day 1 and/or later intervals by :
- abnormal body carriage (hunched posture) and pallor of the extremity in all rats dosed at 0,8 and 1,6 g/kg
- abnormal gait (waddling), lethargy and decreased respiratory rate in all rats
- ptosis and pink extremities in all rats dosed at 1,0 and the majority of animals at 1,6 g/kg
- swollen nictating membrane in four males and one female treated at 1,0 g/kg and all males and four females treated at 1,6 g/kg
- body tremors in one female dosed at 1,0 g/kg
- ptosis in all rats dosed at 0,8 g/kg
- ataxia and postation in the majority of rats dosed at 1,6 g/kg
Body weight:
Among surviving rats, a slightly low bodyweight gain was recorded on day 8 for one male at 1,0 g/kg ; this animal achieved the anticipated gain on day 15. All other rats achieved anticipated bodyweight gains throughout the study.
Gross pathology:
Terminal examination revealed a pale, mottled liver for one female dosed at 0,8 g/kg.

Applicant's summary and conclusion

Interpretation of results:
Toxicity Category IV
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
When a fixed slope of 8,2 was assumed the acute median lethal oral dose of 1-bromo-3-chloropropane and its 95% confidence limits were estimated to be :
- males and females combined : 1,1 (1,0 to 1,3) g/kg bodyweight
- males only : 1,1 (0,9 to 1,4) g/kg bodyweight
- females only : 1,2 (1,0 to 1,5) g/kg bodyweight
1-bromo-3-chloropropane does require labelling with the hazard statement H302 "Harmful if swallowed" in accordance with the CLP regulation.