Registration Dossier

Administrative data

Endpoint:
acute toxicity: inhalation
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
The paper was published in Russian but an english translation was presented by RIFM where: - the purity of the test substance was unknown. - the system of vapour generation was not described in details. - control animals were not mentioned. - the results were detailed. - the GLP were not mentioned but the study was performed before the GLP standard was established.

Data source

Referenceopen allclose all

Reference Type:
publication
Title:
Monographs on fragrance raw materials
Author:
Opdyke DL, Letizia C.
Year:
1982
Bibliographic source:
Food Chem Toxicol, 20, 697-701.
Reference Type:
publication
Title:
Toxicology of guaiacol vapors and of its resin
Author:
Ostrovsky M.M.
Year:
1964
Bibliographic source:
Journal Gigiena i Sanitariya, 29, 85-88. (Russian)
Reference Type:
review article or handbook
Title:
Gaiacol
Author:
RIFM ([url]: http://rifm.org/nd/mono.cfm?CASNumber=90-05-1)
Year:
1982
Bibliographic source:
Monograph: 9 (Published 1982: FCT,v20,p697, Special Issue VI)

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
Acute toxicity inhalation
GLP compliance:
not specified
Test type:
other: acute toxicity inhalation
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
The origin of guaiacol was not reported and its purity was unknown.

Test animals

Species:
mouse
Strain:
not specified
Sex:
not specified

Administration / exposure

Route of administration:
inhalation: vapour
Type of inhalation exposure:
not specified
Vehicle:
other:
Analytical verification of test atmosphere concentrations:
not specified
Duration of exposure:
2 h
Concentrations:
2.03, 3.6, 4, 6.13, 6.42, 7.57, 7.74, 7.76, 9.53, 12.64, 17.19 mg/L
No. of animals per sex per dose:
70 mice in the experiment
Control animals:
not specified

Results and discussion

Effect levelsopen allclose all
Sex:
not specified
Dose descriptor:
LC50
Effect level:
7.57 mg/L air
Exp. duration:
2 h
Remarks on result:
other: The survival rate of the animals was the criterion for evaluating toxicity.
Sex:
not specified
Dose descriptor:
LC50
Effect level:
3.78 mg/L air
Exp. duration:
4 h
Remarks on result:
other: Calculated
Mortality:
From 7.76 mg/L guaiacol vapours to 12.64 mg/L, the majority of animals died. At 17.19 mg/L, all the animals died and it was considered as LC100.
Clinical signs:
In the initial period of the substance effects, all the mice showed slight inflammation of respiratory tract and eye mucous membranes.
These symptoms were accompanied by short-term nervousness, followed by little activity. These clinical signs were reversible up to 4 mg/L.
Higher concentrations caused hair standing on end, poor reflexes, widening of the aural canals, shaky walk and interrupted breathing
Concentrations from 7.74-7.78 to 9.26-9.8 mg/L caused clonic and tonic convulsions.
Gross pathology:
Guaiacol vapors showed also damage to the vascularization of the internal organs and bleeding into the membrane and brain matter. Dystrophic
changes were rarer: protein dystrophy of the heart muscle and focal fat of the parenchyma of the liver.

Applicant's summary and conclusion

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

In an acute inhalation toxicity study (Ostrovsky, 1964), groups of mice were exposed by inhalation route to guaiacol for 2 hours at concentrations of 2.03, 3.6, 4, 6.13, 6.42, 7.57, 7.74, 7.76, 9.53, 12.64, 17.19 mg/L.

The LC50 = 7.57 mg/L for 2 hours (calculated as 3.78 mg/L for 4 hours) .

Based on this data, no conclusion on guaiacol classification can be drawn for this endpoint, since this study was performed in mice instead of rats and during only 2 hours instead of 4 as required in the OECD guideline.

Guaiacol was officially classified in the Regulation (EC) n°1272/2008 Annex VI table 3.1 and 3.2 and was not classified for acute toxicity by inhalation.