2-benzylheptanol

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1985-05-24 to 1985-06-24

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 402 (Acute Dermal 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: 10-12 weeks
- Weight at study initiation: male: 324-353 g, female: 275-286 g
- Housing: individually for 24 h after exposure; 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

Type of coverage:

occlusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

TEST SITE
- Area of exposure: hair clipped dorsal, lateral and ventral regions (6 x 12 cm)
- % coverage: 10 % of complete body surface
- Type of wrap if used: 7 x 4 cm patch of surgical gauze, strip of elastic adhesive bandage wrapped around the trunk of the animal twice

REMOVAL OF TEST SUBSTANCE
- Washing: skin and surrounding hair were sponged thoroughly with warm water, rinsed and dried using absorbant paper
- Time after start of exposure: 24 h

TEST MATERIAL
- Amount(s) applied: 50 mg/kg bw (0.05 mL/kg), 400 mg/kg bw (0.43 mL/kg), 2000 mg/kg bw (2.13 mL/kg), 5000 mg/kg bw (5.32 mL/kg)
- Concentration: undiluted
- Constant volume or concentration used: yes, several animals were treated with constant concentrations and for within each concentration group a constant volume was used

Duration of exposure:

24 h

Doses:

50, 400, 2000 and 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: Animals were observed 0.5, 1, 2, 3, 4 and 5 h after application and afterwards at least once per day. The body weight was measured on day 0, 7 and 14.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs

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:

No animals died.

Clinical signs:

other: Animals showed no observable response to treatment.

Gross pathology:

No abnormalities detected.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

An acute dermal toxicity study in rats was performed. The animals showed no signs of toxicity and therefore it was concluded that the dermal LD50 was > 5000 mg/kg bw in rats.

Executive summary:

An acute dermal toxicity study in rats was performed according to OECD 402 with 50, 400, 2000 and 5000 mg/kg bw of the test substance. One female rat showed a small weight loss in the first week and reduced weight gain in the second week, while all other animals showed a normal weight gain. No mortality was observed and the animals showed no signs of toxicity. Due to these results it was concluded that the dermal LD50 was > 5000 mg/kg bw in rats.