Guaiacol

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 purity of the test substance was unknown. A range of doses was only precised: the number of doses were unknown. The GLP were not mentioned but the study was performed before the GLP standard was established.

Data source

Reference

Reference Type:

publication

Title:

A comparison of the toxicity of some allyl, propenyl, and propyl compounds in the rat

Author:

Taylor J.M., Jenner P.M., Jones W.I.

Year:

1964

Bibliographic source:

Journal Toxicology and Applied Pharmacology, 6, 378-87.

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

not specified

GLP compliance:

not specified

Test type:

other: acute oral toxicity

Test material

Test material information

Constituent 1

Reference substance name:

Guaiacol

EC Number:

201-964-7

EC Name:

Guaiacol

Cas Number:

90-05-1

Molecular formula:

C7H8O2

IUPAC Name:

Phenol

Details on test material:

Guaiacol was purchased from K & K Laboratories, Inc. but its purity was unknown.

Test animals

Species:

rat

Strain:

other: Osborne-Mendel or Sherman

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS:
- Age at study initiation: young adult
No more data

ENVIRONMENTAL CONDITIONS: no data
In-life dates: no data

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Doses:

not detailed

No. of animals per sex per dose:

5 males and 5 females at each dose.

Control animals:

not specified

Details on study design:

- Duration of observation period following administration: until the survivors had return to normal in appearance and weight
- Frequency of observations and weighing: no data
- Necropsy of survivors performed: no data
- Other examinations performed: clinical signs

Statistics:

Litchfield and Wilcoxon method.

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

725 mg/kg bw

95% CL:

302 - 1 740

Mortality:

Death occurred from 1 hour to 4 days after the gavage

Clinical signs:

other: Marked depression and comatose were noted at higher doses.

Applicant's summary and conclusion

Interpretation of results:

Category 4 based on GHS criteria

Conclusions:

Based on this study, the substance is classified: Acute Tox. Category 4, H302 according to EU GHS criteria.

Executive summary:

In an acute oral toxicity study (Taylor, 1964), groups of young adults male/female Osborne-Mendel or Sherman rats were given a single oral dose of  guaiacol (doses unspecified), and were observed until survivors had return to normal in appearance and weight.
 
Oral LD50 Combined = 725 mg/kg  bw (with 302-1740 95% C.I.).

Guaiacol is harmful by ingestion (classified acute. Tox. Cat.4, H302) based on the LD50 of 725 mg/kg bw/day identified in both sex and according to the EU classification criteria (Annex VI of Directive 67/548/EEC and Annex I of Regulation (EC) n°1272/2208).