4-methyl-4-phenylpentan-2-ol

Endpoint summary

Description of key information

No mortality was observed in 6 female Wistar rats in an acute oral toxicity study conducted according to the acute toxic class method (OECD TG 423) at a limit dose of 2000 mg/kg. The LD50 was identified as >2000mg/kg p.o.   

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:

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

Qualifier:

according to guideline

Guideline:

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

Deviations:

no

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

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)

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.

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.

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.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

2 000 mg/kg bw

Quality of whole database:

Reliable without restrictions
the actual LD50 was given as >2000 mg/kg b.w.

Acute toxicity: via inhalation route

Endpoint conclusion

Endpoint conclusion:

no study available

Acute toxicity: via dermal route

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

The acute oral toxicity of 4-methyl-4-phenylpropan-2-ol was evaluated in Wistar rats.

None of the animals died after a single oral administration of 2000 mg/kg bw. The oral LD50 in the 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 any of the animals during the further course of investigation. The body weight gain of the animals was not affected.

Justification for selection of acute toxicity – oral endpoint
According to REACH Annex VIII section 8.5, column 2, acute oral toxicity is required unless the substance is classified as corrosive

Justification for classification or non-classification

Based on the results of the acute oral toxicity study, it can be concluded that 4-methyl-4-phenylpentan-2-ol demonstrates very low toxicity to rats after a single oral administration. According to regulation (EC) No 1272/2008, no classification is needed with respect to its acute oral toxicity, as the LD50 values for this endpoint exceeds the range given for all four categories of the EU-CLP system. No risk phrase is required.

A classification of 4-methyl-4-phenylpentan-2-ol with respect to its acute inhalation or dermal toxicity is not possible, as no data for these endpoints are available and the requirement for the studies has been waived.