1-(4-trans-Pentylcyclohexyl)-4-propylbenzene

Endpoint summary

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:

23.10.-06.11.1984

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: This study was performed according to GLP and the methods applied are fully compliant with OECD TG 401.

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS- Source: E. Merck, Darmstadt- Age at study initiation: young- Weight at study initiation: 161 (152 - 171) g - Fasting period before study: 17 hours before until up to 4 hours after treatment- Housing: separately in type III Makrolon cages - Diet (e.g. ad libitum): ad libitum- Water (e.g. ad libitum): ad libitum- Acclimation period: 7 days ENVIRONMENTAL CONDITIONS- Temperature (°C): 17 to 26 °C - Humidity (%): 36 to 45 %- Photoperiod (hrs dark / hrs light): 12 hour light - 12 hour dark regimeIN-LIFE DATES: From: day 1 To: day 15

Route of administration:

oral: gavage

Vehicle:

other: Methocel KM4 Premium

Details on oral exposure:

Test materialVolume of administrationDose levelin g/100 mLml/100 gmg/kg----------------------------------------------------10550005control

Doses:

5000 mg/kg bwcontrol

No. of animals per sex per dose:

test group: 10: 5 (m) / 5 (f)control group: 10: 5 (m) / 5 (f)

Control animals:

yes

Details on study design:

- Duration of observation period following administration: 15 days- Frequency of observations and weighing: on days 2, 4, 6, 8, 11, 13, and 15 of the experimental part.- Necropsy of survivors performed: yes- Other examinations performed: clinical signs, body weight, gross pathology

Statistics:

Standard statistical methods have been applied for data processing.

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Based on:

test mat.

Mortality:

One female rat died on the second day. All other animals survived the observation periond up to day 15.

Clinical signs:

No signs of toxicity were seen after treatment.

Interpretation of results:

not classified

Remarks:

Migrated informationCriteria used for interpretation of results: EU

Conclusions:

Based on the result of this study, it is concluded that the test material has no acute toxic potential and that the LD50 value is higher than 5000 mg/kg bw after single oral administration in rats.

Executive summary:

Study design

In this study, the acute toxicity of the test material in rats after single oral administration of 5000 mg/kg body weight was investigated. The study was performed according to the OECD Guideline for Testing of Chemicals, No. 401.

Results

No signs of toxicity were seen in the rats (5 males, 5 females) after treatment with the test item. One female rat died on the second day. All other animals survived the observation periond up to day 15.
There was a small difference in body weight gain between treated and control group on the second day of the study. Otherwise the body weight development of the rats was inconspicuous during the study.
The female rat died on day 2 had changes in the gaster, locally blood content in the small intestine and a moderate hydrometra. No findings have been recorded for the rats killed after the observation period (day 15).

Conclusion

Based on the result of this study, it is concluded that the test material has no acute toxic potential and that the LD₅₀value is higher than 5000 mg/kg bw after single oral administration in rats.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

5 000 mg/kg bw

Acute toxicity: via inhalation route

Endpoint conclusion

Endpoint conclusion:

no study available

Acute toxicity: via dermal route

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

Justification for selection of acute toxicity – oral endpoint
This study was performed according to GLP and the methods applied are similar to those described in the OECD TG 401.

Justification for selection of acute toxicity – inhalation endpoint
The oral LD50 exceeds 2000 mg/kg bw. Therefore no further testing for acute toxicity is justified.

Justification for selection of acute toxicity – dermal endpoint
On 15 July 2014 the Competent Authorities for REACH and CLP (Caracal) have agreed that substances that are not toxic in acute oral tests need no longer be tested for acute dermal toxicity. Caracal agreed on proposals to amend REACH Annex VIII (point 8.5.3) so that substances that have not shown oral acute toxicity up to a limit dose of 2000mg/kg bodyweight would not also require dermal data. The test material does not provide evidence for acute oral toxicity. The LD50 exceeds 2000 mg/kg bw. Therefore no further testing for dermal toxicity is justified.

Justification for classification or non-classification

According to the results of the acute oral test, a classification and labelling is not required for this substance.