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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. The number of doses was unknown and the GLP were not mentioned. The results were described in details.

Data source

Referenceopen allclose all

Reference Type:
publication
Title:
A Toxicological and pharmacological study of ibuprofen guaiacol ester (AF 2259) in the rat
Author:
Cioli V., Putzolu S., Rossi V., Corradino C.
Year:
1980
Bibliographic source:
Journal Toxicology and Applied Pharmacology, 54, 332-339.
Reference Type:
publication
Title:
AF-2259
Author:
De Angelis L.
Year:
1988
Bibliographic source:
Drugs of the Future, 5, 539-540.
Reference Type:
publication
Title:
No information
Author:
Kirwin C.J., Galvin J.B.
Year:
1982
Bibliographic source:
Journal Patty's Industrial Hygiene and Toxicology. 4th ed. New York: John Wiley Sons, 448-449, 481-485. Ethers: chapter 8.

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:
standard acute method

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
From Prodotti Gianni, Milan Italy. The purity was unknown.

Test animals

Species:
mouse
Strain:
Swiss
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Sex: male/female
- Source: no data
- Age at study initiation: no data
- Weight at study initiation: 20-25 g
- Fasting period before study: no data
- Housing: no data
- Food consumption: ad libitum
- Water consumption: ad libitum
- Acclimation period: no data

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

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
other: 0.5% methylcellulose solution
Details on oral exposure:
* Vehicle:
- Concentration in vehicle: 0.5%
* Maximum dose volume applied: 20 mL/kg bw
Doses:
Not detailed
No. of animals per sex per dose:
56 animals for all test
Control animals:
yes
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: no data
- Necropsy of survivors performed: no data
- Other examinations performed: clinical signs
Statistics:
Litchfield and Wilcoxon

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
621 mg/kg bw
95% CL:
565 - 682
Clinical signs:
Lacrimation and motor incoordination were observed at low doses (301 mg/kg bw), and tremor and dyspnea were noted at higher doses (421 mg/kg bw).

Applicant's summary and conclusion

Interpretation of results:
harmful
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
- Interpretation of results: Acute Toxicity Category IV
- Criteria used for interpretation of results: other: EU GHS
Executive summary:

In an acute oral toxicity study (Cioli, 1980), groups of Swiss mice (male/female) were given a single oral dose of  guaiacol at 0.5% in methylcellulose. Doses were not specified, and animals were observed for 14 days.
 
Oral LD50 Combined = 621 mg/kg
  bw (with 565-682 95% C.I.).

Guaiacol is harmful by ingestion based on the LD50 of 621 mg/kg bw/day identified in both sex and according to the EU classification criteria
(Annex VI of the Directive 67/548/EEC and Annex I of the Regulation (EC) n°1272/2008).

This classification is in accordance with the official classification according to Annex VI tables 3.1 and 3.2 of the Regulation (EC) n°1272/2008.