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Administrative data

Description of key information

Acute oral toxicity

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records
Reference
Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1989
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Version / remarks:
1987
GLP compliance:
yes (incl. QA statement)
Test type:
standard acute method
Limit test:
no
Specific details on test material used for the study:
Abbreviation of test material: BEB
purity 98.7%
Species:
rat
Strain:
CD-1
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Charles River(UK) Limited
- Females (if applicable) nulliparous and non-pregnant: [yes/no]
- Age at study initiation: five week old
- Weight at study initiation: male: 100 - 160 g, female; 100-143g
- Fasting period before study: one day
- Housing:54x33x20cm
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum):ad libitum
- Acclimation period:at least 6 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18-25
- Humidity (%): 40-70
- Air changes (per hr): 15 complete air change without re-circulating
- Photoperiod (hrs dark / hrs light): 12 hrs dark/12hrs light

IN-LIFE DATES: From: 1 day To:15 day
Route of administration:
oral: feed
Vehicle:
maize oil
Details on oral exposure:
VEHICLE
- Concentration in vehicle: The trest material was prepared at appropriate concentration in maize oil to permit administration at a constant volume-dosage of the m10 ml/kg bodyweight.
- Purity: 98.7%

MAXIMUM DOSE VOLUME APPLIED: 10 mf/kg body weight
Doses:
200, 800, 2000 mg/kg bodyweight
No. of animals per sex per dose:
five male and five female rats per dose
Control animals:
not specified
Details on study design:
Preliminary study was carried out using three groups of one male and one female rat given a single oral administration of BEB at dosages in the range 200 - 800 mg/kg bodyweight, at a volume-dosage of 10 ml/kg in maize oil.

Dosage Mortality
(mg/kg ) Males Females

200 0/1 0/1
400 0/1 0/1
800 0/1 0/1

On the basis of this result the main study was carried out using four groups of five male and five female rats given a single oral administration of BEB within the range 800 - 2000 mg/kg
Statistics:
Prohibit analysis by the method of Finney(1952) was used to determine the acute median lethal dosage, 95% confidence interval and slope of the dose response curve of the test materila for both sexes. The calculations were performed by the GLIM statics program (Baker and Nelder, 1978) using a special macro program developed by Baker (Baker, 1980).

An adaption of the classification of Hodge and Sterner (1949) was used in assessing the toxicity rating of the test material and the acute toxicity is expressed descriptively according to the LD50 value, as follows:
Classification of acute toxicity
LD50 (mg/kg) Classification
< 5 extreme toxicity
5 - 50 high toxicity
50 - 500 moderate toxicity
500 - 2000 slightly toxicity
>2000 low toxicity
Preliminary study:
Preliminary study was carried out using three groups of one male and one female rat given a single oral administration of BEB at dosages in the range 200 - 800 mg/kg bodyweight, at a volume-dosage of 10 ml/kg in maize oil.

Dosage Mortality
(mg/kg ) Males Females

200 0/1 0/1
400 0/1 0/1
800 0/1 0/1
Key result
Sex:
male
Dose descriptor:
LD50
Effect level:
1 642 mg/kg bw
Based on:
test mat.
95% CL:
>= 1 247 - <= 2 036
Key result
Sex:
female
Dose descriptor:
LD50
Effect level:
1 340 mg/kg bw
Based on:
test mat.
95% CL:
>= 1 122 - <= 1 557
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
1 476 mg/kg bw
Based on:
test mat.
95% CL:
>= 1 271 - <= 1 680
Mortality:
Animal died at dosage of 1086 mg/kg or above. The deathe occurred on Days 2, 3, 4, 5 or 12.
Clinical signs:
other: Ante mortem signs comprised lethargy, decreased motor activiity, prone posture, blanching, ataxia, muscle spasticity, bradypnoea, hyperpnoea, gasping, piloerection, ungroomed appearannce, pigmented staining of the snout, pigmented orbital secretion, saliv
Gross pathology:
Necropsy of the decedents revealed body surface staining, altered stomach and small intestine contents and occasional or single cases of red fluid and clotted blood on the brain, dark thymic lymph nodes, liver or lungs, dark areas on thegladular muicosa of the stomach and green fluid in the urinary bladder.

Necropsy of the surviving animalswas unremarkable.
Interpretation of results:
Category 4 based on GHS criteria
Conclusions:
Under the conditions of this study the acute oral median lethal dosage (LD50) were:
Male LD50 1642 mg/kg
Female LD50 1340 mg/kg
combined LD50 1476 mg/kg

Accordingly, BEB was assigned to the class 'slightly oral toxiciy', and correpond to category 4 as GHS classification.
Executive summary:

Under the conditions of this study the acute oral median lethal dosage (LD50)  were:

    Male     LD50   1642 mg/kg

   Female  LD50   1340 mg/kg

   combined  LD50  1476 mg/kg

Accordingly, 1 -bromo-2 -phenylethane was assigned to the class 'slightly oral toxiciy', and correpond to category 4 as GHS classification.

Endpoint conclusion
Dose descriptor:
LD50
Value:
1 476 mg/kg bw

Additional information

Justification for classification or non-classification