1-bromo-4-chlorobutane

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:

1992

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

Test material information

Constituent 1

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

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',