(E)-2-methoxy-4-(prop-1-enyl)phenol

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

weight of evidence

Study period:

28 May to 31 October 1980

Reliability:

4 (not assignable)

Rationale for reliability incl. deficiencies:

documentation insufficient for assessment

Remarks:

Pre-guideline and pre-GLP study. Only basic data given for this range-finding study and only two animals used per dose (one male and one female), but considered sufficiently reliable in a weight of evidence for the purpose of hazard assessment.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1980

Report date:

1980

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

yes

Remarks:

no. of animals were lesser than 5 per dose (1/sex/dose); no details on environmental conditions, only 7 days observation period followed

Principles of method if other than guideline:

Not applicable

GLP compliance:

no

Remarks:

pre-GLP

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Isoeugenol

EC Number:

202-590-7

EC Name:

Isoeugenol

Cas Number:

97-54-1

IUPAC Name:

2-methoxy-4-prop-1-en-1-ylphenol

Test material form:

liquid

Details on test material:

- Physical state: Lemon clear liquid

Test animals

Species:

mouse

Strain:

not specified

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: not reported
- Age at study initiation: 4-5 weeks
- Weight at study initiation: 17-21 g
- Fasting period before study: for four hours
- Housing: individual cages
- Diet (e.g. ad libitum): not reported
- Water (e.g. ad libitum): not reported
- Acclimation period: not reported

ENVIRONMENTAL CONDITIONS: not reported

IN-LIFE DATES: not reported

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

other: Groundnut oil

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 10% v/v in Groundnut oil

DOSE VOLUME APPLIED: 0.1, 0.2, 0.5, 1.0 and 2.0 mL/kg bw

Doses:

0.1, 0.2, 0.5, 1.0 and 2.0 mL/kg bw

No. of animals per sex per dose:

1/sex/dose

Control animals:

no

Details on study design:

- Duration of observation period following administration: 7 days
- Necropsy of survivors performed: Yes; all survivors were killed by CO2 asphyxiation and examined post mortem after 7 days. All animals dying were autopsied.

Statistics:

None

Results and discussion

Preliminary study:

Not applicable

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

0.5 mL/kg bw

Based on:

test mat.

Remarks on result:

other: Corresponding to 450 mg/kg bw

Mortality:

- Mortality was observed in 1/2, 2/2 and 2/2 animals at 0.5, 1 and 2 mL/kg bw, respectively.
- No mortality was observed at 0.1 and 0.2 mL/kg bw.

Clinical signs:

other: Most mice were showing signs of stress within 30 minutes-1 hour after treatment. The mice dosed at 1 and 2 mL/kg bw, and one animal dosed at 0.5 mL/kg bw, became semicomatose/comatose, hypothermic and showed laboured breathing within 1 hour. All these ani

Gross pathology:

Autopsy of the mice that died revealed:
- Irritation of the stomach and small intestines, dark spleen, congested lungs and mottled liver.
- Histological examination did not reveal liver necrosis.

Other findings:

None

Any other information on results incl. tables

None

Applicant's summary and conclusion

Interpretation of results:

Category 4 based on GHS criteria

Conclusions:

Under the test conditions, test material is classified Category 4 (H302: Harmful if swallowed) according to the Regulation (EC) No. 1272/2008 and of the GHS as the LD50 value is comprised between 300 and 2000 mg/kg bw.

Executive summary:

In an acute oral toxicity study, mice (1/sex/dose) were given a single oral (gavage) dose of test item at 0.1, 0.2, 0.5, 1.0 and 2.0 mL/kg bw. Animals were then observed for mortality, clinical signs and bodyweights for 7 days and were all sacrificed for macroscopic examination.

Mortality was observed in 1/2, 2/2 and 2/2 animals at 0.5, 1 and 2 mL/kg bw, respectively. No mortality was observed at 0.1 and 0.2 mL/kg bw. Most mice were showing signs of stress within 30 minutes-1 hour after treatment. The mice dosed at 1 and 2 mL/kg bw, and one animal dosed at 0.5 mL/kg bw, became semi-comatose/comatose, hypothermic and showed laboured breathing within 1 hour. All these animals died within 2-24 hours. The surviving animal dosed at 0.1 and 0.2 mL/kg bw recovered within 18 hours. Apart from the male mouse dosed at 0.5 mL/kg bw, all surviving animals gained weight during the 7 day observation period.

Autopsy of the mice that died revealed: Irritation of the stomach and small intestines, dark spleen, congested lungs and mottled liver. Histological examination did not reveal liver necrosis.

Mice oral LD50 = 0.5 mL/kg bw (corresponding to 541.5 mg/kg bw).

Under the test conditions, test material is classified Category 4 (H302: Harmful if swallowed) according to the Regulation (EC) No. 1272/2008 and of the GHS as the LD50 value is comprised between 300 and 2000 mg/kg bw..