2-benzylheptanol

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1985-05-24 to 1985-06-25

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study with acceptable restrictions

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1985

Report date:

1985

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Version / remarks:

1981

Deviations:

no

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

2-benzylheptanol

EC Number:

296-229-0

EC Name:

2-benzylheptanol

Cas Number:

92368-90-6

Molecular formula:

C14H22O

IUPAC Name:

2-benzylheptan-1-ol

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Age at study initiation: 4-6 weeks
- Weight at study initiation: male: 91-113 g, female: 102-112 g
- Housing: up to 5 animals per dose per sex in polypropylene cages
- Diet: ad libitum, no food over night before treatment and 2 h after treatment, Rat & Mouse Expanded Diet No. 1, supplied by Special Diet Services Limited, Witham, Essex
- Water: ad libitum, tap water
- Acclimation period: min. 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20.5 ± 2.5
- Humidity (%): 45-66
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

arachis oil

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 2.5, 20, 200, 500 mg/mL
- Amount of vehicle: 10 mL

MAXIMUM DOSE VOLUME APPLIED: 10 mL

Doses:

25, 200, 2000, 5000 mg/kg bw

No. of animals per sex per dose:

2 for range finding test, 5 for main study

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: The animals were observed 0.5, 1, 2, 3, 4, 5 h and afterwards once per day after treatment. The bodyweight was measured on day 0, 7 and 14.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight,organ

Statistics:

No data provided.

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Based on:

test mat.

Mortality:

One male animal (5000 mg/kg bw) died between day 2 and 3.

Clinical signs:

other: Hunched posture and pilo erection were observed in all rats and all dose levels. Diarrhoea was observed in single rats at 25 and 200 mg/kg bw levels. Respiratory decrease (≥ 200 mg/kg bw), lethargy and increased salvivation (≥ 2000 mg/kg bw) were observed

Gross pathology:

Animal that died: congestion of the lungs, ulceration and haemorrhage of glanular region of the stomach and haemorrhage of intestinal tract
Animals sacrified: No macroscopic abnormalities

Other findings:

No other observations were made.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

An acute oral toxicity study in rats was conducted. The acute oral LD50 was established to be greater than 5000 mg/kg bw.

Executive summary:

An acute oral toxicity using the standard acute method according to OECD 401 was performed with rats. 25, 200, 2000 and 5000 mg/kg bw of the test substance were administered to rats by gavage. They were observed for 14 days and afterwards sacrificed and necropsy was performed. All dose levels of the test substance produced signs of toxicity like a hunched posture and piloerection. Other signs like lethargy and increased salivation were observed for high doses only. The animals were symptom free starting from day 2 after treatment. One animal of the dose group 5000 mg/kg bw died between day 2 and 3. Due to these results the test substance was considered to be practically nontoxic and the oral LD50 > 5000 mg/kg bw was derived for rats.