Registration Dossier

Administrative data

Description of key information

Key value for chemical safety assessment

Repeated dose toxicity: via oral route - systemic effects

Link to relevant study records
Reference
Endpoint:
repeated dose toxicity: oral
Data waiving:
exposure considerations
Justification for data waiving:
other:
Critical effects observed:
not specified
Endpoint conclusion
Endpoint conclusion:
no study available

Repeated dose toxicity: inhalation - systemic effects

Link to relevant study records
Reference
Endpoint:
sub-chronic toxicity: inhalation
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Reference:
Composition 0
Qualifier:
no guideline followed
Principles of method if other than guideline:
6-months exposure period(5 days/week, 6 hrs/day) to 0, 11 and 25 ppm of cyanogen
GLP compliance:
no
Test material information:
Composition 1
Species:
other: rat, monkey
Route of administration:
inhalation: gas
Type of inhalation exposure:
whole body
Clinical signs:
no effects observed
Mortality:
no mortality observed
Body weight and weight changes:
effects observed, treatment-related
Organ weight findings including organ / body weight ratios:
effects observed, treatment-related
Details on results:
One monkey died due to exposure unrelated reason, apart from that, all animals lived through whole experiment.
Rats exposed to 25 ppm of cyanogen showed statistically significant lowered body weight (470 g vs. 543 g in control group). Monkeys exposed to 25 ppm of cyanogen showed lower moisture content in lungs.
Dose descriptor:
NOAEC
Effect level:
11 ppm
Based on:
test mat.
Dose descriptor:
LOAEC
Effect level:
25 ppm
Based on:
test mat.
Critical effects observed:
not specified
Conclusions:
Rats exposed to 25 ppm of cyanogen showed statistically significant lowered body weight (470 g vs. 543 g in control group). Monkeys exposed to 25 ppm of cyanogen showed lower moisture content in lungs.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
NOAEC
23.43 mg/m³
Study duration:
subchronic
Species:
rat

Mode of Action Analysis / Human Relevance Framework

Additional information

Justification for selection of repeated dose toxicity via oral route - systemic effects endpoint:
Physical properties of EDN (true gas @ 25 °C and 101.325 kPa) rule out possibility of oral exposure.

Justification for classification or non-classification