Guaiacol

Acute Toxicity: inhalation

Administrative data

Endpoint:

acute toxicity: inhalation

Type of information:

experimental study

Adequacy of study:

other information

Reliability:

4 (not assignable)

Rationale for reliability incl. deficiencies:

other: see 'Remark'

Remarks:

The paper was published in Russian but an English translation was presented by RIFM. The purity of the test substance is unknown, the system of vapour generation was not described in details and control animals were not mentioned. Furthermore, this study is performed on mice and only after 2 hours of exposure. For these reasons, a reliability 4 was assigned. The GLP were not mentioned but the study was performed before the GLP standard was established.

Data source

Reference

Reference 1

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 2

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 3

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

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:

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 levels

Effect levels 1

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.

Effect levels 2

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:

other: 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 rever

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:

study cannot be used for classification

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 and was not classified for acute toxicity by inhalation.