Registration Dossier

Toxicological information

Acute Toxicity: dermal

Currently viewing:

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:
1995
Report Date:
1995

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
no
GLP compliance:
yes (incl. certificate)
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Purity is 99.3 %

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals 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:
No clinical signs or cutaneous reactions observed during the study.
Body weight:
One female lost weight during the first week of observation. No other effects were observed. SImilar weight gains were observed compared to historical control data.
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.