Registration Dossier
Registration Dossier
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EC number: 422-030-7 | CAS number: 91538-82-8
Acute Toxicity: oral
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:
- 1 996
- 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
- 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
Constituent 1
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.
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