Registration Dossier
Registration Dossier
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EC number: 203-697-1 | CAS number: 109-70-6
Acute Toxicity: oral
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:
- 1 993
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
- 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
Constituent 1
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:
- other: 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
- 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.
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