Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
May 24 - June 08, 2000
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2000
Report date:
2000

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Version / remarks:
1984
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
Deviations:
no
Principles of method if other than guideline:
None
GLP compliance:
yes (incl. QA statement)
Test type:
acute toxic class method
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
(trans(trans))-4'-vinyl-4-(4-methylphenyl)bicyclohexyl
EC Number:
439-730-3
EC Name:
(trans(trans))-4'-vinyl-4-(4-methylphenyl)bicyclohexyl
Cas Number:
155041-85-3
Molecular formula:
Hill formula: C21H30 CAS formula: C21H30
IUPAC Name:
(1r,1'r,4r,4'r)-4-ethenyl-4'-(4-methylphenyl)-1,1'-bi(cyclohexane)

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals or test system and environmental conditions:
Test Animals
- Females nulliparous and non-pregnant: not specified
- Age at study initiation: about 6 to 8 weeks
- Weight at study initiation: 150 - 192 g (mean 168 g; f & m)
- Fasting period before study: 17 hrs before dosing
- Housing: individually
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 7 days

ENVIRONMENTAL CONDITIONS
- Temperature: 21 - 23 °C
- Humidity: 52 - 70 %
- Air changes: not specified
- Photoperiod: 12 / 12 hrs dark / hrs light

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
other: Methocel K4M Premium
Details on oral exposure:
The rats received the test material preparations orally by means of a stomach tube.
Doses:
The test material concentration was 100 g/L.The dose was 20 mL/kg or 2000 mg/kg bw.
No. of animals per sex per dose:
3 (m) / 3 (f)
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observationsbehavoir and general condition of all rats were monitored for at lease 6 hours after the administration and then checked daily
- weighing: before treatement and on days 2, 4, 6, 8, 11, 13, and 15
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight
Statistics:
The body weight development of each rat and group was determined. The group mean value was calculated for each measurement and printed on tables.

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 observed. All rats survived the observation period.
Clinical signs:
No signs of toxicity were detected in the 3 male and 3 female rats after treatment with 2000 mg/kg bw of the test item.
Body weight:
Body weight development of the treated rats was inconspicuous.
Gross pathology:
At necropsy no organ alterations were seen.
Other findings:
None

Any other information on results incl. tables

No signs of toxicity were detected in the 3 male and 3 female rats after treatment with 2000 mg/kg bw of the test item.

All rats survived the observation period. Body weight development of the treated rats was inconspicuous. At necropsy no organ alterations were seen.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Based on the result of this study, it is concluded, that the test item has no acute toxic potential and that the LD50 value is higher than 2000 mg/kg bw following oral treatment in rats. According to the results of this study the test material can be allocated to ATC class 0 i.e. the LD50 value is expected to exceed 2000 mg/kg.
Executive summary:

The purpose of this assay was to provide information on possible health hazards for the test material and serve as a rational basis for risk assessment to the potential of acute oral toxicity of the test item in man.

The test material was tested for acute toxicity in rats after oral administration of 2000 mg/kg body weight. Directly before the administration the test material was prepared with aqueous Methocel K4M Premium solution as vehicle. This study was performed according to the ,,Acute toxic class method" (ATC; OECD TG 423). No signs of toxicity were detected in the 3 male and 3 female rats after treatment and no rat died. The gross pathological examination revealed no organ alterations. According to the results of this study the test material can be allocated to ATC class 0 i.e. the LD50 value is expected to exceed 2000 mg/kg.