4-methyl-4-phenylpentan-2-ol

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

09 February 2004 - 25 February 2004

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Study conducted in accordance with standard test guidelines (OECD TG423) and GLP

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2004

Report date:

2004

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)

Test type:

acute toxic class method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

4-methyl-4-phenylpentan-2-ol

EC Number:

218-002-7

EC Name:

4-methyl-4-phenylpentan-2-ol

Cas Number:

2035-93-0

Molecular formula:

C12H18O

IUPAC Name:

4-methyl-4-phenylpentan-2-ol

Test material form:

other: clear liquid

Details on test material:

- Name of test material: 4-Methyl-4-phenyl-pentan-2-ol
- CAS number: 2035-03-0
- EC number: 218-002-7

Test animals

Species:

rat

Strain:

Wistar

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River
- Age at study initiation: approximately 5 weeks
- Weight at study initiation:204.5g +/- 6.1g
- Fasting period before study: none
- Housing: Groups of 3 in Makrolon Type 3 cages
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 6 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20.5-21.5
- Humidity (%): RH 30-50%
- Air changes (per hr):
- Photoperiod (hrs dark / hrs light): (12/12)

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

MAXIMUM DOSE VOLUME APPLIED: 0.207mL/100g bw = approximately 0.45mL


CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: OECD guidleins for Limit Test

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

6 females

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: day of administration (day 1) and days 7 and 14
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight,organ weights, histopathology, other: general clinical condition especially skin , fur, eyes and mucous membrane, gait and posture, respiratory,circulatory,autonomic and central nervous system, occurrence of secretions and excretions , presence of clonic or tonic movements and stereotypes or bizarre behaviour.

Statistics:

Body weight and body weight gain ; group mean values and standard deviation.

Results and discussion

Effect levels

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Mortality:

None of the animals died during the course of the study

Clinical signs:

other: All animals reacted quickly (30 minutes to 2 hours after administration) to the administration of the test item with clinical signs (apathy, rough hair coat, staggering gait, squatting or abdominal position) which are considered demonstrable of an effect

Gross pathology:

There were no macroscopic pathological findings in the animals.

Applicant's summary and conclusion

Interpretation of results:

practically nontoxic

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

None of the animals died after a single oral administration of 2000 mg/kg bw.
The LD50 p.o. rat is > 2000 mg/kg bw.

Executive summary:

None of the animals died after a single oral administration of 2000 mg/kg bw. The LD50 p.o. in rat is > 2000 mg/kg bw. All animals reacted quickly (30 minutes to 2 hours after administration) to the administration of the test item with clinical signs (apathy, rough hair coat, staggering gait, squatting or abdominal position) which are considered demonstrable of an effect on the autonomic nervous system. These signs were observed on the day of administration only. There were no alterations in the general state of well-being observed in all animals during the further course of investigation. The body weight gain of the animals was not affected.