Registration Dossier

Administrative data

Endpoint:
sub-chronic toxicity: other route
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
other: Limited information available

Data source

Referenceopen allclose all

Reference Type:
secondary source
Title:
Environmental Health Criteria for Acetonitrile. Unedited 1st draft. Internal Technical Report
Author:
IPCS
Year:
1992
Bibliographic source:
International Programme for Chemical Safety. WHO, Geneva, Switzerland PCS/EHE/92.12.
Reference Type:
publication
Title:
Further studies on the etiology of goitre with particular reference to the action of cyanides.
Author:
Marine, D. et al.
Year:
1932
Bibliographic source:
Proc. Soc. exp. Biol. Med. 29: 772-775 (cited in IPCS, 1992).
Reference Type:
publication
Title:
Production of goitre and exophthalmos in rabbits by administration of cyanide.
Author:
Marine, D. et al.
Year:
1932
Bibliographic source:
Proc. Soc. exp. Biol. Med. 29: 822-823 (cited in IPCS, 1992).
Reference Type:
publication
Title:
Production of thyroid hyperplasia in rats and mice by administration of methyl cyanide.
Author:
Spence, A.W. and Marine, D.
Year:
1932
Bibliographic source:
Proc. Soc. exp. Biol. Med. 29: 967-968 (cited in IPCS, 1992).

Materials and methods

Principles of method if other than guideline:
Subchronic subcutaneous toxicity
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Acetonitrile

Test animals

Species:
rat
Strain:
not specified
Sex:
female

Administration / exposure

Route of administration:
subcutaneous
Duration of treatment / exposure:
28 days
Frequency of treatment:
daily
Doses / concentrations
Remarks:
Doses / Concentrations:
0.02, 0.04, 0.08 ml/animal (ca. 45-181 mg/kg bw/d)
Details on study design:
Post-exposure period: none

Results and discussion

Effect levels

Basis for effect level:
other: Thyroid hyperplasia developed in all groups in a dose-dependant manner
Remarks on result:
not measured/tested
Remarks:
Effect level not specified (migrated information)

Target system / organ toxicity

Critical effects observed:
not specified

Any other information on results incl. tables

Thyroid hyperplasia developed in all groups in a dose-dependant manner. At ca. 339 mg/kg there were still no overt effects (Spence and Marine, 1932).

Applicant's summary and conclusion

Executive summary:

Spence and Marine (1932) reported thyroid hyperplasia in rats administered acetonitrile sc daily for 28 days at doses up to 0.08 mL. These investigators also reported similar thyroid effects in mice and rabbit, with rabbits being most susceptible.