Veratrole

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: The study is not performed to an international test guideline and is pre-GLP. No detailed information has been provided on test conditions and observations, but the data is sufficient to accept the results of the study.

Data source

Reference

Reference Type:

publication

Title:

Unnamed

Year:

1964

Materials and methods

Test guideline

Qualifier:

no guideline followed

Guideline:

other:

Principles of method if other than guideline:

Animals recieved test substance per intubation. Animals were maintained under close observation for recording toxic signs and time of death. The observations were continued until the animals appeared normal and showed weight gain. The LD50's were computed by the method of Litchfield & Wilcoxon.

GLP compliance:

no

Remarks:

pre-GLP

Test type:

fixed dose procedure

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Veratrole

EC Number:

202-045-3

EC Name:

Veratrole

Cas Number:

91-16-7

Molecular formula:

C8H10O2

IUPAC Name:

1,2-dimethoxybenzene

Details on test material:

1,2-dimethoxybenzene
Veratrole

Test animals

Species:

rat

Strain:

Osborne-Mendel

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: no data
- Age at study initiation:young adults
- Weight at study initiation: no data
- Fasting period before study: yes, 18 hrs
- Housing: no data
- Diet (e.g. ad libitum): food replaced after receiving dose
- Water (e.g. ad libitum):ad libitum
- Acclimation period: no data


ENVIRONMENTAL CONDITIONS
- Temperature (°C): no data
- Humidity (%): no data
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): no data

Administration / exposure

Route of administration:

other: Oral intubation

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

VEHICLE: no vehicle
MAXIMUM DOSE VOLUME APPLIED: no data
DOSAGE PREPARATION (if unusual): no data

Doses:

undiluted test material
no data on the tested doses

No. of animals per sex per dose:

10 (5 females, 5 males)

Control animals:

not specified

Details on study design:

- Duration of observation period following administration: 2 weeks (in a few cases (where no acute toxic signs were seen) the animals were observed for only a week).
- Other examinations performed: toxic signs, death time (DT)

Statistics:

LD50's were computed by the method of Litchfield and Wilcoxon.

Results and discussion

Preliminary study:

No data

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

ca. 1 360 mg/kg bw

95% CL:

>= 980 - <= 1 870

Mortality:

Death time was 1-4 days

Clinical signs:

other: Coma within 10 min after treatment, salivation, porphyrin-like deposit, around the eyes, diarrhoea, scrawny appearance for 3-4 days.

Gross pathology:

Not given

Other findings:

No data on recovery

Applicant's summary and conclusion

Interpretation of results:

Category 4 based on GHS criteria

Conclusions:

Since the substance has an LD50 of 1360 mg/kg bw the substance can be classified as harmful (Acute Tox. Oral. Cat.4, H302) under the conditions of the current study and according to the Regulation (EC) 1272/2008.

Executive summary:

Oral dosages of the test substance were adminstrated by intubation to rats. Animals were observed usually for 2 weeks during which time to development of toxic signs was followed and time of death (TD) recorded. The acute oral LD50 for rat was 1360 mg/kg bw (95% CL = 980 - 1870 mg/kg bw).