4-methyl-4-phenylpentan-2-one

Endpoint summary

Description of key information

Oral (OECD 401), rat: LD50: > 2000 mg/kg bw (limit test)

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:

7 - 27 Dec 1994

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Version / remarks:

24 Feb 1987

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Remarks:

NIEDERSÄCHSISCHES UMWELTMINISTERIUM, Hannover, Germany

Test type:

standard acute method

Limit test:

yes

Species:

rat

Strain:

other: hsd/Win: WU

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Females nulliparous and non-pregnant: not specified
- Weight at study initiation: 201 - 237 g (males) and 177 - 203 g (females)
- Fasting period before study: 16 h before administration and 3 - 4 h after administration
- Housing: in groups of up to 5 animals per cage in Makrolon type III cages on Lignocel bedding
- Diet: pelleted rat diet Ssniff-R Alleindiät (Ssniff Spezialdiäten GmbH, Soest, Germany)
- Water: drinking water, ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3
- Humidity (%): 30 - 70
- Photoperiod (hrs dark / hrs light): 12 / 12

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

MAXIMUM DOSE VOLUME APPLIED: 2.02 mL/kg bw

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

Range-finding test: 2 females
Main study: 5 males and 5 females

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: The animals were examined 10 min, 1 h, 2 h, 6 h and 24 h after treatment and thereafter once daily up to Day 14. Body weights were recorded immediately before treatment (Day 0) and on Days 7 and 14.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, gross pathology

Preliminary study:

No mortality occured in the range-finding test.

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortality occured during the study period.

Clinical signs:

other: In some animals abnormal clinical signs were observed up to 24 h after treatment. The findings were abnormal gait (2/5 females and 1/5 males from 1 h to 6 h), squatting position (2/5 females from 1 h to 6 h after administration), reduced activity (2/5 fem

Gross pathology:

Gross pathological examinations at Day 14 revealed no findings.

Interpretation of results:

other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No 1272/2008

Conclusions:

In this acute oral toxicity study in male and female rats a LD50 value of > 2000 mg/kg bw was found.

Executive summary:

The acute oral toxicity of the test substance was assessed in a study according to OECD Guideline 401 and in compliance with GLP (1995).In this study, no mortality occured at 2000 mg/kg bw. Slight clinical signs were observed in some animals up to 24 h p.a. The most striking findings were abnormal gait, squatting position, reduced activity, piloerection and decreased respiratory rate. These signs were completely reversible within 24 h and terminal necropsy revealed no abnormalities. Thus, a LD50 of > 2000 mg/kg bw was derived.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Quality of whole database:

The available information comprises an adequate and reliable study, and is thus sufficient to fulfil the standard information requirements set out in Annex VII, 8.5, of Regulation (EC) No 1907/2006.

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 the test substance was assessed in a study according to OECD Guideline 401 and in compliance with GLP (1995). In this study, no mortality occured at 2000 mg/kg bw. Slight clinical signs were observed in some animals up to 24 h p.a. The most striking findings were abnormal gait, squatting position, reduced activity, piloerection and decreased respiratory rate. These signs were completely reversible within 24 h and terminal necropsy revealed no abnormalities. Thus, a LD50 of > 2000 mg/kg bw was derived.

Justification for classification or non-classification

The available data on acute oral toxicity do not meet the criteria for classification according to Regulation (EC) 1272/2008, and are therefore conclusive but not sufficient for classification.