[2-(cyclohexyloxy)ethyl]benzene

Endpoint summary

Description of key information

Acute oral toxicity: OECD TG 401: > 5000 mg/kg bw.

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:

The study was conducted between 10 and 24 May 1982.

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Remarks:

Reliability 2 is assigned because although the study was conducted similar to the current OECD TG 401, the guideline is not referenced and there is no documentation on experimental conditions. However, this did not influence the reliability of the results.

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test type:

standard acute method

Limit test:

yes

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

Rats were in the weight range 180-280 g at the initiation of the study. They were randominzed for the study based on the body weight. Rats were housed in cages marked with an animal group number and dose level. Rats were ear tagged. They were group housed, according to sex, in stainless steel wire mesh cages. The size of the cages was in accordance with the guidelines. The light cycle was: 12 hours light, 12 hours dark. The temperature was attempted to be maintained at the level of 22 ± 3°C and the humidity in the range of 30-70%. The waste material was removed daily. Cages and feeders were sanitized every two weeks. The food (checked for contaminants) was provided ad libitum and checked daily. Fresh tap water (checked for contaminants) was provided ad libitum.

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

Phenafleur was administered at a volume of 5 ml/kg bw. The appropriate dose volume of the test substance was administered to each rat by oral gavage.

Doses:

One dose was used in the study: 5000 mg/kg bw. This dose was selected based on the dose-range-finding test.

No. of animals per sex per dose:

5 rats per sex per dose

Control animals:

no

Details on study design:

- The dose used in the study was selected based on the dose-range-finding test
- Duration of observation period following administration: 14 days
- Frequency of observations: The animals were observed immediately and at 1, 4 and 24 hours after application and thereafter twice daily
- Necropsy of survivors performed: yes, at the end of the observation period the animals were killed by CO2 asphyxia, necropsied and subjected to examination for gross pathological changes.
- Body weights: Individual body weights were recorded before treatment and then on the 14th day of the observation period.

Preliminary study:

Dose-range-finding study was performed with four fasted rats, two per sex, which were administered 500, 1600 and 5000 mg/kg bw. orally by gavage. None of the animals died at any dose.

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Based on:

test mat.

Mortality:

There were no deaths during the study.

Clinical signs:

Male rats receiving the dose of 5000 mg/kg bw were noted with salivation immediately after the dosing, decreased activity and body tone after 1 hour, very soft yellowish brown feces and yellow discoloration of the anal area after 24 hours and decreased body tone after 2 and 3 days. These signs resolved by day 4.
Female rats receiving the dose of 5000 mg/kg bw were noted with salivation immediately after the dosing, decreased activity and body tone after 1 hour, very soft yellowish brown feces and yellow discoloration of pelvic, genital and anal area after 24 hours and poor grooming after 2 days. These signs resolved by day 3.

Body weight:

The weight of all animals increased during the study.

Gross pathology:

Terminal necropsy revealed no visible lesions in any of the animals.

Other findings:

No other findings were noted.

Interpretation of results:

other: Not classified: criteria not met.

Remarks:

According to EU CLP 1272/2008 and its amendments.

Conclusions:

Under the conditons of this study, performed similar to the guideline OECD TG 401, the acute oral LD50 for the substance in male and female rats was determined to be higher than 5000 mg/kg bw.

Executive summary:

An acute oral toxicity study was performed similar to the guideline OECD TG 401. Ten rats (5 males and 5 females) were administered the substance at dose level of 5000 mg/kg bw. None of the rats died during the study. The clinical signs observed at the dose of 5000 mg/kg bw included: salivation, decreased activity, decreased body tone, soft feces and poor grooming. The signs had resolved in all rats by day 4. Terminal necropsy revealed no visible lesions in any of the animals. The acute oral LD50 for the substance in male and female rats was determined to be higher than 5000 mg/kg bw.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Additional information

An acute oral toxicity study was performed similar to the guideline OECD TG 401. Ten rats (5 males and 5 females) were administered the substance at dose level of 5000 mg/kg bw. None of the rats died during the study. The clinical signs observed at the dose of 5000 mg/kg bw included: salivation, decreased activity, decreased body tone, soft feces and poor grooming. The signs had resolved in all rats by day 4. Terminal necropsy revealed no visible lesions in any of the animals. The acute oral LD50 for the substance in male and female rats was determined to be higher than 5000 mg/kg bw.

Justification for classification or non-classification

According to the criteria outlined in EU CLP 1272/2008/EC (and its amendments), the substance does not have to be classified as acute toxic by the oral route.