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Toxicological information

Repeated dose toxicity: inhalation

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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

Referenceopen allclose all

Reference Type:
secondary source
Title:
SIDS Initial Assessment Report for SIAM 13
Author:
OECD
Year:
2001
Bibliographic source:
UNEP PUBLICATIONS
Reference Type:
review article or handbook
Title:
Toxicity profile Hexylene glycol.
Author:
British Industrial Biological Research Association (BIBRA)
Year:
1991
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

Reference
Name:
Unnamed
Type:
Constituent
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.