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Toxicological information

Acute Toxicity: oral

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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:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
not specified
GLP compliance:
not specified
Test type:
other: acute oral toxicity

Test material

Reference
Name:
Unnamed
Type:
Constituent
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 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:
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).