4-trans-Methoxy-4-trans-propyl-[1,1-bicyclohexyl]

Endpoint summary

Description of key information

The acute oral LD50 was greater than 5000 mg/kg bw according to an OECD TG 401 compliant study in the rat (reference 7.2.1 -1).

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:

Nov 30, 1984 - Dec 14, 1984

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

GLP compliance:

yes (incl. QA statement)

Test type:

standard acute method

Limit test:

yes

Species:

rat

Strain:

Wistar

Remarks:

Wi-AF/Han (SPF)

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: E. Merck, Darmstadt, Germany
- Age at study initiation: young
- Weight at study initiation: 157 (150 - 164) g
- Fasting period before study: 17 hours before until up to 4 hours after treatment
- Housing: separately in type III Makrolon cages
- Diet: ad libitum, Altromin Standard Diet TPr 1324
- Water: ad libitum, tap water
- Acclimation period: 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 to 26
- Humidity (%): 40 to 49
- Photoperiod (hrs dark / hrs light): 12/12

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Doses:

Test Group: 6.0 mL/kg (equal to 5520 mg/kg bw)
Control Group: 5 mL/kg 0.25 % Methocel K4M Premium

No. of animals per sex per dose:

total 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.

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 6 mL/kg bw

Based on:

test mat.

Remarks on result:

other: eq.: > 5520 mg/kg bw based on density of 0.92

Mortality:

All rats survived the observation period.

Clinical signs:

other: No signs of toxicity were seen after treatment with 6 mL/kg.

Gross pathology:

The gross pathological examination revealed no organ alterations.

Interpretation of results:

GHS criteria not met

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 6 mL/kg (> 5000 mg/kg bw) after single oral administration in rats.

Executive summary:

In this study, the acute toxicity of the test material in rats after single oral administration of 6 mL/kg (equal to 5520 mg/kg bw) body weight was investigated. The study was performed according to the OECD Guideline for Testing of Chemicals, No. 401. No signs of toxicity were seen in the rats (5 males, 5 females) after treatment with the test item.
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.
There were no deaths during the course of the study.
The gross pathological examination revealed no organ alterations.

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 6 mL/kg bw after single oral administration in rats.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

discriminating dose

Value:

5 000 mg/kg bw

Quality of whole database:

OECD TG 401

Acute toxicity: via dermal route

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

Acute Oral

In this study, the acute toxicity of the test material in rats after single oral administration of 6 mL/kg (equal to 5520 mg/kg) body weight was investigated. The study was performed according to the OECD Guideline for Testing of Chemicals, No. 401. No signs of toxicity were seen in the rats (5 males, 5 females) after treatment with the test item.
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. There were no deaths during the course of the study.The gross pathological examination revealed no organ alterations. 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 6 mL/kg bw after single oral administration in rats.

Justification for classification or non-classification

Classification, Labeling, and Packaging Regulation (EC) No 1272/2008

The available data for acute oral toxicity are reliable and suitable for classification purposes under Regulation (EC) No 1272/2008. Based on this data, the substance is not classified for acute toxicity under Regulation (EC) No 1272/2008 (CLP), as amended for the twelfth time in Regulation (EU) 2019/521.