Oxalonitrile

Endocrine disrupter mammalian screening – in vivo (level 3)

Administrative data

Endpoint:

endocrine disrupter mammalian screening – in vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

study well documented, meets generally accepted scientific principles, acceptable for assessment

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1984

Materials and methods

Test material

Test material information

Constituent 1

Reference substance name:

Oxalonitrile

EC Number:

207-306-5

EC Name:

Oxalonitrile

Cas Number:

460-19-5

Molecular formula:

C2N2

IUPAC Name:

carbononitridic cyanide

Test material form:

gas

Specific details on test material used for the study:

99%

Test animals

Species:

other: Rhesus monkey (Macacca mulatta), rat (Sprague-Dawley)

Sex:

male

Details on test animals and environmental conditions:

5 monkeys/exp. group
30 rats/exp. group

Administration / exposure

Route of administration:

other: inhalation

Details on route of administration:

Ethanedinitrile, 11 and 25 ppm, 6 months exposure, whole body exposure

Doses / concentrations

Doses / concentrations 1

Dose / conc.:

0 ppm

Doses / concentrations 2

Dose / conc.:

11 ppm

Doses / concentrations 3

Dose / conc.:

25 ppm

No. of animals per sex per dose:

5 monkeys
30 rats

Results and discussion

Endocrine disrupting potential:

negative

Results of examinations

Clinical biochemistry findings:

no effects observed

Description (incidence and severity):

No relevant changes in triiodothyronine and thyroxine blood levels

Applicant's summary and conclusion

Conclusions:

The active substance is not endocrine disruptor in respect to regulation EC 528/2012. The 6 months study in rats and monkeys revealed no adverse effect relevant for human health, as a change in the morphology, physiology, or, life span of organisms, that would result in an impairment of functional capacity, an impairment of the capacity to compensate for additional stress, or an increase in susceptibility to other influences. Further the study did not reveal an endocrine mode of action or the adverse effect relevant for human health as a consequence of the endocrine mode of action. There was no significant change in the measured blood levels of the thyroid hormones, triiodothyronine (T3) and its prohormone, thyroxine (T4), in exposed animals compared to control, or any pathological effect found on endocrine organs. There is no study reporting the endocrine disruption caused by ethanedinitrile.

Executive summary:

The active substance is not endocrine disruptor in respect to regulation EC 528/2012. The 6 months study in rats and monkeys revealed no adverse effect relevant for human health, as a change in the morphology, physiology, or, life span of organisms, that would result in an impairment of functional capacity, an impairment of the capacity to compensate for additional stress, or an increase in susceptibility to other influences. Further the study did not reveal an endocrine mode of action or the adverse effect relevant for human health as a consequence of the endocrine mode of action. There was no significant change in the measured blood levels of the thyroid hormones, triiodothyronine (T3) and its prohormone, thyroxine (T4), in exposed animals compared to control, or any pathological effect found on endocrine organs. There is no study reporting the endocrine disruption caused by ethanedinitrile.