Registration Dossier
Registration Dossier
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EC number: 203-445-0 | CAS number: 106-94-5
Acute Toxicity: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2nd August 1995 - 16th August 1995
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study conducted in compliance with agreed protocols, with no or minor deviations from standard test guidelines and/or minor methodological deficiencies, which do not affect the quality of the relevant results.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 995
- Report date:
- 1995
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- 1-bromopropane
- EC Number:
- 203-445-0
- EC Name:
- 1-bromopropane
- Cas Number:
- 106-94-5
- Molecular formula:
- CH3CH2CH2Br
- IUPAC Name:
- 1-bromopropane
- Details on test material:
- Purity is 99.3 %
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Iffa Crédo, 69210 L'Arbreske, France
- Age at study initiation: ca. 8 weeks old
- Weight at study initiation: males 283 ± 16 g, female 233 ± 10 g.
- Fasting period before study: NDA
- Housing: Housed in polycarbonate cages measuring 48 cm x 27 cm x 20 cm containing between 4 and 7 animals of the same sex.
- Diet (e.g. ad libitum): Animals had free access to pelleted A04 C diet.
- Water (e.g. ad libitum): Filtered water provided ad libitum.
- Acclimation period: At least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 ± 2 ºC
- Humidity (%): 30 - 70 %
- Air changes (per hr): 12 of non-recycled air.
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: 2nd August 1995 To: 16th August 1995
Administration / exposure
- Type of coverage:
- semiocclusive
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- TEST SITE
- Area of exposure: 5 cm x 6 cm for females, 5 cm x 7 cm for males.Calculated according to Meeh's formula.
- % coverage: ca. 10 %
- Type of wrap if used: Hydrophilic gauze pad applied to skin and held in place by adhesive hypoallergenic aerated semi-occlusive dressing and restraining bandage. The dressing prevented the animals from ingesting the test substance.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): Not required as test substance was no longer present.
- Time after start of exposure: N/A
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2000 mg/kg bw
- Concentration (if solution): N/A
- Constant volume or concentration used: yes
- For solids, paste formed: N/A
VEHICLE
N/A - Duration of exposure:
- 24 hours.
- Doses:
- 2000 mg/kg bw.
- No. of animals per sex per dose:
- 5 per sex per dose
- Control animals:
- other: historical data.
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Frequent observations of clinical signs made during the hours after exposure. Thereafter, observations made at least once per day.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, macroscopic examination. - Statistics:
- NDA
Results and discussion
Effect levelsopen allclose all
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Sex:
- male/female
- Dose descriptor:
- LD0
- Effect level:
- >= 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortality during the observation period.
- Clinical signs:
- other: No clinical signs or cutaneous reactions observed during the study.
- Gross pathology:
- No abnormalities obderved.
- Other findings:
- N/A
Applicant's summary and conclusion
- Interpretation of results:
- practically nontoxic
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The 24 hours dermal LD50 for 1-bromopropane was found to be > 2000 mg/kg/bw in rats.
- Executive summary:
In an acute dermal toxicity study (13113 TAR), 5 male and 5 female 8 week old Sprague Dawley rats with males weighing 283 ± 16 g and females weighing 233 ± 10 g were dosed with a limit dose of 2000 mg/kg bw. A gauze pad was applied and then held in place with a semi-occlusive dressing. No dose related changes occurred during the 14 day observation period.
The 24 hours dermal LD50 for 1-bromopropane was found to be > 2000 mg/kg/bw in rats.
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