Registration Dossier

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2005-12-08 to 2006-02-13
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2006
Report date:
2006

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.3 (Acute Toxicity (Dermal))
GLP compliance:
yes (incl. QA statement)
Test type:
fixed dose procedure
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 10 to 12 weeks
- Weight at study initiation: 202 - 259 g (mean 226 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: 46 - 72 %
- Air changes: not specified
- Photoperiod: 12 / 12 hrs dark / hrs light

Administration / exposure

Type of coverage:
occlusive
Vehicle:
other: aqua pro injectione
Details on dermal exposure:
The backs and abdomens of the rats were shaved with an electric hair clipper not later than one hour before treatment.The test material was prepared, spread on the shaven skin in an area of 6 x 6 cm, and covered with a gauze patch. This was kept in place by a self-adhesive fabric (Fixomull® stretch, Beiersdorf). The time of exposure was 24 hours. Then the gauze and adhesive fabric were removed and any remaining test material was wiped off carefully.
Duration of exposure:
24 hours
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
5 (m) / 5 (f)
Control animals:
no
Details on study design:
- Observation for clinical symptoms: On the day of treatment the general condition and motility of the rats were slightly affected by the tape. It was difficult to distinguish between slight clinical findings and reactions due to fixation by the tape. The behavior and general condition of all rats were monitored for at least 6 hours after administration and then checked daily.

- Body weight: All animals were weighed before treatment and on days 2, 4, 6, 8, 11, 13, and 15 of the experimental part.

- Pathology: All rats were sacrificed at the end of the experimental part by C02-asphyxia. They were subjected to a gross pathological investigation.

- Statistics and evaluation: The body weight data were recorded with a PC-program. The body weight development of each rat and group was determined. The group mean value was calculated for each measurement and printed on tables.
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:
All rats survived the observation period. The lethal dose was regarded to be > 2000 mg/kg.
Clinical signs:
No signs of toxicity were detected in the 5 male and 5 female rats after dermal treatment with 2000 mg/kg bw.
Body weight:
The body weight development of the treated rats was inconspicuous.
Gross pathology:
At necropsy, no organ alterations were seen.
Other findings:
None

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Based on the result of this study, the test item can be considered to have no acute toxic potential and to have a LD50 value higher than 2000 mg/kg after dermal application to rats.
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 dermal toxicity of the test item in man. The test material was tested for acute toxicity in 5 male and 5 female rats after dermal administration of 2000 mg/kg body weight. Directly before administration the test material was moistened with aqua pro injectione, spread on the shaven skin in an area of 6 x 6 cm, and covered with a gauze patch. This was kept in place by a self-adhesive fabric (Fixomull® stretch, Beiersdorf), The time of exposure was 24 hours. Then the gauze and adhesive fabric were removed and any remaining test material was wiped off carefully. No signs of toxicity were detected in the rats (5 males and 5 females) after treatment with 2000 mg/kg. There were no deaths during the course of the study. The body weight development was inconspicuous. The gross pathological examination revealed no organ alterations. Based on the result of this study, the test item can be considered to have no acute toxic potential and to have a LD50 value higher than 2000 mg/kg after dermal application to rats.