2-methylpentane-2,4-diol

Repeated dose toxicity: inhalation

Administrative data

Endpoint:

short-term repeated dose toxicity: inhalation

Type of information:

experimental study

Adequacy of study:

other information

Reliability:

4 (not assignable)

Rationale for reliability incl. deficiencies:

other: Documentation insufficient for assessment

Data source

Reference

Reference 1

Reference Type:

secondary source

Title:

SIDS Initial Assessment Report for SIAM 13

Author:

OECD

Year:

2001

Bibliographic source:

UNEP PUBLICATIONS

Reference 2

Reference Type:

review article or handbook

Title:

Toxicity profile Hexylene glycol.

Author:

British Industrial Biological Research Association (BIBRA)

Year:

1991

Reference 3

Reference Type:

study report

Title:

Unnamed

Year:

1976

Report date:

1976

Materials and methods

Test guideline

Qualifier:

no guideline followed

GLP compliance:

no

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

2-methylpentane-2,4-diol

EC Number:

203-489-0

EC Name:

2-methylpentane-2,4-diol

Cas Number:

107-41-5

Molecular formula:

C6H14O2

IUPAC Name:

2-methylpentane-2,4-diol

Test material form:

other: liquid

Test animals

Species:

rat

Strain:

other: Harlan-Wistar derived

Sex:

male/female

Administration / exposure

Route of administration:

inhalation: aerosol

Remarks on MMAD:

MMAD / GSD: The mean particle size was 1 µm

Analytical verification of doses or concentrations:

yes

Details on analytical verification of doses or concentrations:

Gas chromatographic analysis

Duration of treatment / exposure:

7 hours/day for 9 days

Frequency of treatment:

9 days exposure in a 14 day period

Doses / concentrations

Remarks:

Doses / Concentrations:
0.7 mg/l
Basis:
analytical conc.

No. of animals per sex per dose:

10

Control animals:

no

Details on study design:

Post-exposure period: no

Examinations

Sacrifice and pathology:

Tissues collected at necropsy included the lung, trachea, heart, liver, kidneys, spleen, adrenals, thyroid, parathyroid, oesophagus, bronhci, thymus glands and cervical lymph nodes.

Statistics:

Body weight gain, kidney and liver weights were compared using Bartletts test and the Students t-test.

Results and discussion

Results of examinations

Details on results:

There were no overt signs of toxicity and no effects on body weight gain or absolute or relative liver or kidney weights. There were no microscopic lesions in major organs. Histological examination of the windpipe revealed mild lesions of the trachea, comprising tracheal congestion in 2 rats and a single instance of submucosal haemorrhage. Examination of tissues from the rabbit revealed 'mild hyperplasia of tracheal epithelium and tracheal congestion with patchy interstitial pneumonia'. These changes were considered by the authors as the result of a mild insult to the respiratory system which they considered would be reversible.

Target system / organ toxicity

Critical effects observed:

not specified

Applicant's summary and conclusion

Executive summary:

A group of 10 male and female Harlan-Wistar rats were exposed to an aerosol atmosphere of 700 mg/m3 (140 ppm) hexylene glycol for 7 hrs/day for a total of 9 exposures over a period of 2 weeks. Tissues collected at necropsy included the lung, trachea, heart, liver, kidneys, spleen, adrenals, thyroid, parathyroid, esophagus, bronchi, thymus glands, and cervical lymph nodes. No overt signs of toxicity, effects on body weight gain, or absolute or relative liver or kidney weights were observed. There were no microscopic lesions in the major organs. Upon histological examination, two rats demonstrated tracheal congestion and 1 had submucosal hemorrhage.