Methyl 2,4-dihydroxy-3,6-dimethylbenzoate

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

15 February, 1980 - 29 February, 1980

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study

Remarks:

Study is not conducted under GLP

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)

Version / remarks:

1981

Deviations:

yes

Remarks:

No details on test material, no purity, no details on environmental conditions.

GLP compliance:

no

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

1

Reference substance name:

Methyl 2,4-dihydroxy-3,6-dimethylbenzoate

EC Number:

225-193-0

EC Name:

Methyl 2,4-dihydroxy-3,6-dimethylbenzoate

Cas Number:

4707-47-5

Molecular formula:

C10H12O4

IUPAC Name:

methyl 2,4-dihydroxy-3,6-dimethylbenzoate

Test material form:

other: solid

Test animals

Species:

rat

Strain:

other: Albino (TacN (SD) fBR)

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Taconic Farms (Germantown, N.Y.)
- Age at study initiation: Young adults
- Weight at study initiation: males: 160 - 200 g; females: 188 - 210 g
- Fasting period before study: Overnight
- Housing: Singly housed in wire cages
- Diet: Free access to Purina Rodent Laboratory Chow 5001
- Water: Free access to water
- Acclimation period: Seven days

ENVIRONMENTAL CONDITIONS
No data.

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

ethanol

Details on oral exposure:

MAXIMUM DOSE VOLUME APPLIED: 1.0 mL/100 g body weight

Doses:

5000 mg/kg bw

No. of animals per sex per dose:

10

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Animals were observed for mortality and pharmacotoxic signs at 1, 3, 5 and 24 hours following dosing and twice daily (once daily on weekends) for the remainder of the 14 day observation period. Surviving animals were weighed at the end of the observation period.
- Necropsy of survivors performed: yes, the animals were killed using ether inhalation.

Statistics:

Not performed.

Results and discussion

Preliminary study:

Two fasted rats (one of each sex) received a dose of 5000 mg/kg bw. There were no deaths over the 72 hour observation period.

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Based on:

test mat.

Mortality:

No deaths occurred.

Clinical signs:

other: There were no pharmacotoxic signs in any animal dosed. All the animals appeared normal in health and behaviour throughout the fourteen day observation period.

Gross pathology:

There were no signs indicative of toxicity in any of the ten animals necropsied at termination.

Applicant's summary and conclusion

Interpretation of results:

other: not classified

Remarks:

According to EU CLP (EC 1272/2008 and its amendments_.

Conclusions:

The acute oral toxicity test showed an LD50 of >5000 mg/kg bw.

Executive summary:

In this study performed equivalent to OECD TG 401 guideline without GLP, 20 rats (10 males and 10 females) were administered to the substance at a dose level of 5000 mg/kg bw. No deaths occurred. There were no toxicological otoxic signs in any animal dosed. All the animals appeared normal in health and behaviour throughout the fourteen day observation period. The animals all gained weight in a normal pattern. There were no signs indicative of toxicity in any of the ten animals necropsied at termination. The acute oral LD50 for the substance in male and female rats was determined to be >5000 mg/kg bw.