dibenzylbenzene, ar-methyl derivative, hydrogenated

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

October - December 2016

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Remarks:

GLP compliant

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2017

Report date:

2017

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Remarks:

Certificate Good Laboratory Practice: The Department of Health of the Government ot the United Kingdom, Statement of compliance in accordance with Directive 2004/9/EC, date of inspection 05/07/2016

Test type:

acute toxic class method

Test material

Test material information

Constituent 1

Reference substance name:

dibenzylbenzene, ar-methyl derivative, hydrogenated

EC Number:

943-342-4

Molecular formula:

C21H38

IUPAC Name:

dibenzylbenzene, ar-methyl derivative, hydrogenated

Test material form:

liquid

Specific details on test material used for the study:

- Lot/batch No.of test material: hydrogenius 005
- Expiration date of the lot/batch: > 3 years (unlimited shelf life)
- Storage condition of test material: room temperature in the dark
- Purity: 100%

Test animals

Species:

rat

Strain:

Wistar

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Envigo RMS (UK) Limited
- Females nulliparous and non-pregnant: yes
- Age at study initiation: 8 - 12 weeks
- Weight at study initiation: 161 - 177 g
- Fasting period before study: yes, overnight befor dosing, after dosing approx. 3-4 hours
- Housing: in groups of 3 in suspended solid-floor polypropylene cages furnished with wood flakes
- Diet: free access to 2014C Teklad Global Rodent diet supplied by Envigo RMS (UK) Limited
- Water: free access to mains drinking water
- Acclimation period: 5 days at least

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-25
- Humidity (%): 30-70
- Air changes (per hr): 15 at least
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: 2016-10 26 To: 2016-12-05

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

ADMINISTRATION:
- Doses: single doses of 2000 mg/kg bw
- Volume administered: 2.20 ml/kg bw due to specific gravity of 0.913

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

6

Control animals:

no

Details on study design:

- Post dose observation period: 14 days
EXAMINATIONS: Observation for clinical signs after 30 minutes, 1, 2, 4 hours after dosing and daily thereafter. Mortality and morbidity check twice daily, early and later during normal working days, and once daily at weekends or public holidays. Individual body weights were recorded prior to dosing and 7 and 14 days after. After 14 days the animals were killed by cervical dislocation and subjected to gross pathological examination, consisiting of an external examination and opening of the abdominal and thoracic cavities for examination of major organs. The appearance of any macroscopic abnormalities were recorded, no tissues were retained.

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 animal died during the 14 day post-dose observation period.

Clinical signs:

No signs of systemic toxicity were noted during the observation period.

Body weight:

Changes in body weight observed during the period of the study were within the range expected for this strain and age of animal.

Gross pathology:

No abnormalities were found on necropsy of animals performed on tennination of the study.

Applicant's summary and conclusion

Interpretation of results:

practically nontoxic

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The lack of mortality demonstrates the LD50 to be in excess of 2000 mg/kg body weight.

Executive summary:

The study wss performed to assess the acute oral toxicity of the test item in the Wistar strain rat. A group of 3 fasted females was treated with the test item at a dose level of 2000 mg/kg body weight. This was followed by a further group of 3 fasted females at the same dose level. Dosing was performed sequentially. The test item was administered orally undiluted. Clinical signs and body weight development were monitored during the study. All animals were subjected to gross necropsy.

There were no deaths. There were no signs of systemic toxicity. All animals showed expected gains in body weight. No abnormalities were noted at necropsy.

The acute oral median lethal dose (LD50) of the test item in the female Wistar strain rat after a single oral administration, observed over a period of 14 days was estimated to be greater than 2000 mg/kg body weight.