Cyclohex-1,4-ylenedimethanol

Acute Toxicity: inhalation

Administrative data

Endpoint:

acute toxicity: inhalation

Type of information:

experimental study

Adequacy of study:

weight of evidence

Study period:

6-hour exposure followed by 14-day observation period

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: see 'Remark'

Remarks:

Study was conducted prior to introduction of the Good Laboratory Practices regulations. The study was conducted according to an internal Eastman Kodak Company method, developed prior to established guidelines, but according to acceptable scientific methods in use at the time the study was conducted.

Data source

Reference

Reference Type:

other: Eastman Kodak Company Summary Report

Title:

Unnamed

Year:

1957

Report date:

1957

Materials and methods

Test guideline

Qualifier:

no guideline available

Deviations:

not specified

Principles of method if other than guideline:

Method is an in vivo study using a group of three rats (sex, strain, and weights not available) exposed to an atmosphere containing the test material for a period of six hours. After termination of exposure, the animals were observed for mortality and adverse clinical signs for a period of 14 days. Body weights were measured prior to exposure and at termination of the 2-week observation period.

GLP compliance:

no

Test type:

other: Study conducted according to an internal Eastman Kodak Company laboratory method, using a 6-hour inhalation exposure period to rats.

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Cyclohex-1,4-ylenedimethanol

EC Number:

203-268-9

EC Name:

Cyclohex-1,4-ylenedimethanol

Cas Number:

105-08-8

Molecular formula:

C8H16O2

IUPAC Name:

cyclohexane-1,4-diyldimethanol

Constituent 2

Reference substance name:

[4-(hydroxymethyl)cyclohexyl]methanol

IUPAC Name:

[4-(hydroxymethyl)cyclohexyl]methanol

Constituent 3

Reference substance name:

Cyclohexane-1,4-dimethanol; 1,4-Bis(hydroxymethyl)cyclohexane; CHDM

IUPAC Name:

Cyclohexane-1,4-dimethanol; 1,4-Bis(hydroxymethyl)cyclohexane; CHDM

Details on test material:

no data

Test animals

Species:

rat

Strain:

not specified

Sex:

not specified

Details on test animals or test system and environmental conditions:

no data

Administration / exposure

Route of administration:

inhalation

Type of inhalation exposure:

whole body

Vehicle:

other: air

Details on inhalation exposure:

Rats were exposed (whole-body) to an atmosphere containing 1.25 mg/L (calculated 212 ppm) of the test material for a period of six hours. The atmosphere was generated by heating the test material to 100 °C in a washing bottle and passing air through at a rate of 2.0 L/minute. The atmosphere generated in this manner was then passed into the chamber containing the rats.

Analytical verification of test atmosphere concentrations:

not specified

Duration of exposure:

6 h

Concentrations:

1.25 mg/L (calculated 212 ppm)

No. of animals per sex per dose:

3 (sex not specified)

Control animals:

no

Details on study design:

Three rats (sex, strain, and weights not available) were exposed (whole-body) to an atmosphere containing 1.25 mg/L (calculated 212 ppm) of the test material for a period of six hours. The atmosphere was generated by heating the test material to 100 °C in a washing bottle and passing air through at a rate of 2.0 L/minute. The atmosphere generated in this manner was then passed into the chamber containing the rats. Animals were observed for mortality and adverse effects for a period of 14 days. Body weights were recorded prior to exposure to the test material and at termination of the observation period.

Results and discussion

Effect levels

Sex:

not specified

Dose descriptor:

LCLo

Effect level:

> 1.25 mg/L air

Exp. duration:

6 h

Remarks on result:

other: calculated atmospheric concentration of 212 ppm

Mortality:

None

Clinical signs:

other: No signs of systemic toxicity or abnormal clinical signs were noted during the study.

Body weight:

All animals gained weight over the 14-day observation period.

Gross pathology:

not performed

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: expert judgment

Conclusions:

Under conditions used in this study, 1,4-cyclohexanedimethanol was not acutely toxic by the inhalation route in rats exposed to a concentration of 1.25 mg/L of air for 6 hours. This exposure level was the highest atmosphere that could be generated by heating the test material to 100 °C in a vessel and passing air through at a rate of 2.0 L/minute. Since no mortality was noted at this exposure level, the LCLo in rats was greater than 1.25 mg/L of air/6 h.

Based on an acute inhalation LCLo value > 1.25 mg/L of air/6h in rats, 1,4-cyclohexanedimethanol is not expected to be classifiable for Acute Toxicity by the inhalation route according to the UN Globally Harmonized System of Classification and Labelling of Chemicals (GHS) or the EU Classification, Labeling and Packaging of Substances and Mixtures (CLP) Regulation No. 1272/2008. Based on the absence of abnormal clinical signs, 1,4-cyclohexanedimethanol is not expected to be classifiable for Specific Target Organ Toxicity – Single Exposure at this exposure concentration.

Executive summary:

In an acute inhalation toxicity study, three rats were exposed to 1,4-cyclohexanedimethanol at a concentration of 1.25 mg/L of air for a period of 6 hours. Under the conditions of this study, no deaths occurred and the LCLo was considered to be greater than 1.25 mg/L. No abnormal clinical signs or signs of systemic toxicity were evident during a 14-day observation period. Based on the results of this study, 1,4-cyclohexanedimethanol is not classified for toxicity by the inhalation route at this exposure concentration.