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EC number: 230-089-3 | CAS number: 6940-78-9
Acute Toxicity: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1992 - 1993
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 992
- Report date:
- 1993
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- GLP compliance:
- yes
- Test type:
- fixed dose procedure
- Limit test:
- yes
Test material
- Reference substance name:
- 1-bromo-4-chlorobutane
- EC Number:
- 230-089-3
- EC Name:
- 1-bromo-4-chlorobutane
- Cas Number:
- 6940-78-9
- Molecular formula:
- C4H8BrCl
- IUPAC Name:
- 1-bromo-4-chlorobutane
- Test material form:
- liquid
Constituent 1
- Specific details on test material used for the study:
- Lot No. 0917
Test animals
- Species:
- rat
- Strain:
- other: CD strain
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: remote Sprague-Dawley origin
- Females (if applicable) nulliparous and non-pregnant: not applicable
- Age at study initiation: male: seven to eight weeks old, female: ten to eleven weeks old
- Weight at study initiation: male: 226 - 254 g, female: 223 - 247 g
- Fasting period before study: not applicable
- Housing:54 x 33 x 20 cm
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: At least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 C, (range: 18 - 25C)
- Humidity (%): 55% R.H. (range 40% - 70% R.H.)
- Air changes (per hr): 15 times per hour
- Photoperiod (hrs dark / hrs light): 12 hours dark/ 12 hours light
Administration / exposure
- Type of coverage:
- occlusive
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- TEST SITE
- Area of exposure: 5 cm x 5cm
- % coverage: 10 % of the body surface
- Type of wrap if used: the test material was applied to a gauze patch, placed on the dorsum and occulated with aluminium foil.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): wipe with wet disposal towels
- Time after start of exposure:24 hours
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2000 mg/kg
- Concentration (if solution): neat
- Constant volume or concentration used: no
- For solids, paste formed: no
VEHICLE
- Amount(s) applied (volume or weight with unit):not specified
- Concentration (if solution):
- Lot/batch no. (if required):
- Purity: - Duration of exposure:
- 24 hours
- Doses:
- 2000 mg/kg
- No. of animals per sex per dose:
- five male and five female
- Control animals:
- not specified
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing:The first hour after administration and two further inspections during the remainder of Day 1. From Day 2 onwards, the animals were inspected twice daily. Each dermal application site was examined at the morning observation.
The body weight was recorded on the day before dosing and on Days 1, 8 and 15.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight,organ weights, histopathology, other:none - Statistics:
- Not applicable
Results and discussion
- Preliminary study:
- A preliminary study was carried out using a group of one male and one female given TMCB at a dosage of 1000 mg/kg bodyweight. There was no death.
Effect levels
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- One animal died during the day after dosing.
- Clinical signs:
- Ante mortem signs comprised underactivity, staggering gait, hunched poisture and bulging eyes.
Signs of reaction to treatment in the surviving animals comprised underactivity, staggering gait, ungroomed appearance, pigmented staining of the snout, hunched posture, thin body conformation and bulging eyes. The female wer overtly normal by Day 3, while the males had recovered by Day 8.
There were no local signs of reaction to treatment at the dermal application site. - Body weight:
- Reduced bodyweight gain or slight bodyweight loss was recorded during the first week of observation for the majority of surviving animals. Increments during the second week were generally satisfactory.
- Gross pathology:
- Necropsy of the decedent and the surviving animals, revealed no significant macroscopic lesion.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the conditions of this study, the acute percutaneous median lethal dosage (LD50) of the test material was greater than 2000 mg/kg. Accordingly, 1-bromo-4-chlorobutane, TMCB, was assigned into the class ' low percutaneous toxicity',
- Executive summary:
Under the conditions of this study, the acute percutaneous median lethal dosage (LD50) of the test material was greater than 2000 mg/kg. Accordingly, 1-bromo-4-chlorobutane, TMCB, was assigned into the class ' low percutaneous toxicity',
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