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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:
supporting study
Study period:
1970
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
secondary literature

Data source

Reference
Reference Type:
other: publication cited in NTP-CERHR 2004
Title:
Animal inhalation studies of ammonia, ethylene glycol, formaldehyde, dimethylamine, and ethanol
Author:
Coon RA, Jones RA, Jenkins LJ
Year:
1970
Bibliographic source:
cited in NTP-CERHR, 2004

Materials and methods

Principles of method if other than guideline:
Different mammalian species exposed 8 h/day for 6 weeks to up to 57 mg/m3
GLP compliance:
not specified
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
reagent-grade ethylene glycol

Test animals

Species:
other: see below
Strain:
other: see below
Sex:
male/female
Details on test animals and environmental conditions:
male and female Sprague-Dawley and Long-Evans rats (n = 15 per dlose), male and female Princeton-derived guinea pigs (n = 15), male New Zealand rabbits (n = 3), male beagle dogs (n = 2 per dose), and 2 male squirrel monkeys

Administration / exposure

Route of administration:
inhalation
Type of inhalation exposure:
whole body
Vehicle:
air
Remarks on MMAD:
MMAD / GSD: no details
Details on inhalation exposure:
no details
Analytical verification of doses or concentrations:
yes
Duration of treatment / exposure:
8h/day, 5 days/week for 6 weeks
Frequency of treatment:
8h/day, 5 days/week
Doses / concentrations
Remarks:
Doses / Concentrations:
0, 10, or 57 mg/m3
Basis:
nominal conc.
No. of animals per sex per dose:
see above
Control animals:
yes, concurrent vehicle
Details on study design:
Continuous 90-day exposures to 12 mg/m3 were also conducted in additional group

Examinations

Observations and examinations performed and frequency:
Serum biochemistry and haematology before and after exposure, clinical signs
Sacrifice and pathology:
Organs evaluated histologically in at least half the animals including heart, lung, liver, kidney, and spieen

Results and discussion

Results of examinations

Details on results:
subacute: no clinical signs; no effects in haematology and clinical chemistry; mild histopathological changes in liver noted in rats, guinea pigs, and monkeys but authors did not consider the effects treatment related; continuous exposure to 12 mg/m3 resulted in moderate to severe irritation in rabbits and corneal opacity and possible blindness in two rats (treatment relationship questionable in view on other data in Section 7.5.2 and 7.3.2).

Any other information on results incl. tables

Deaths were reported for one rabbit, three guinea pigs, and one rat exposed continuously to 12 mg/m3 , but the animals did not display any other types of toxicity.

Applicant's summary and conclusion

Conclusions:
No clear treatment-related effects were reported in different mammalian species exposed 8 h/day, 5 days per week for 6 weeks to up to 56 mg/m3.