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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
Sep 17 - Oct 01, 1996
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1996
Report date:
1996

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.1 (Acute Toxicity (Oral))
Version / remarks:
92/69/EEC
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Test type:
standard acute method
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
1-bromo-4-(trans-4-ethylcyclohexyl)benzene
EC Number:
422-030-7
EC Name:
1-bromo-4-(trans-4-ethylcyclohexyl)benzene
Cas Number:
91538-82-8
Molecular formula:
Hill formula: C14H19Br CAS formula: C14H19Br
IUPAC Name:
1-bromo-4-(trans-4-ethylcyclohexyl)benzene
Test material form:
liquid: viscous

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: F. Winkelmann, 33178 Borchen
- Age at study initiation: 7 - 9 weeks
- Weight at study initiation: 164 (158 - 170) g
- Fasting period before study: 17 hours before dosing
- Housing: separately in Makrolon cages type III (floor area: 37.5 x 21 cm = 787.5 cm^2, height: 15 cm) placed on mobile racks
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 to 24°C
- Humidity (%): 42 to 60 %
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12 / 12 hours

IN-LIFE DATES: From: day 1 To: day 14

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
other: aqueous Methocel® K4M Premium solution
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 100 g/L
- Amount of vehicle (if gavage): 20 mL
- Justification for choice of vehicle: good performance & historical data
- Lot/batch no. (if required): --
- Purity: --

MAXIMUM DOSE VOLUME APPLIED: 20 mL/ kg bw
Doses:
2000 mg/kg
No. of animals per sex per dose:
5 (m) / 5 (f)
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: days 2, 4, 6, 8, 11, 13, and 15
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight
Statistics:
Standard statistical methods have been applied for data processing.

Results and discussion

Effect levels
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
No mortality was seen in rats treated with 2000 mg/kg bw.
Clinical signs:
Four rats showed pale feces only on day 2 of the study. All the other rats showed no signs of intoxication after treatment
Body weight:
The body weight development was inconspicuous throughout the study.
Gross pathology:
The gross pathological examination revealed no organ alterations.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Remarks:
Migrated information
Conclusions:
The test material can be considered to have no acute toxic potential and to have a LD50 value higher than 2000 mg/kg after oral application to rats.
Executive summary:

Objective

The objective of the present study was to identify potential toxic effects of the test item after single oral administration to rats in a stepwise procedure.

Study design

The test material was tested for acute toxicity in rats after single oral administration of 2000 mg/kg body weight. The study was performed according to the OECD Guideline for Testing of Chemicals, No. 401, the EEC Directive 91/325 and the Annex to commission Directive 92/69EEC.

Results

No severe signs of toxicity were seen in the rats (5 males, 5 females) after treatment with 2000 mg/kg of the test item.
The body weight development of the rats was inconspicuous during the study.
There were no deaths during the course of the study.
The gross pathological examination revealed no organ alterations.

Conclusion

The test material can be considered to have no acute toxic potential and to have a LD50 value higher than 2000 mg/kg after oral application to rats.