Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Toxicological information

Repeated dose toxicity: inhalation

Currently viewing:

Administrative data

Endpoint:
sub-chronic toxicity: inhalation
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1933
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:
publication
Title:
Experimentelle Untersuchung über die Frage der Organschädigung nach Gasnarkose (Acetylen, Äthylen und Stickstoff)
Author:
Franken, H., Miklos, L.
Year:
1933
Bibliographic source:
Zentralblatt für Gynäkologie Nr 42, p. 2493-2498

Materials and methods

Test guideline
Qualifier:
no guideline available
Principles of method if other than guideline:
Possible organ damage from the administration of acetylene at anesthetic concentrations has been evaluated in rats, mice, guinea pigs, rabbits, and dogs. Animals were exposed to acetylene in oxygen for 0.5 - 2h per day for up to 93 days; no guideline available at that time
GLP compliance:
no
Limit test:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Acetylene
EC Number:
200-816-9
EC Name:
Acetylene
Cas Number:
74-86-2
Molecular formula:
C2H2
IUPAC Name:
acetylene
Test material form:
other: gas

Test animals

Species:
rat
Strain:
not specified
Sex:
not specified

Administration / exposure

Route of administration:
inhalation: gas
Type of inhalation exposure:
whole body
Vehicle:
oxygen
Analytical verification of doses or concentrations:
not specified
Duration of treatment / exposure:
0,5 - 2 h/d
Frequency of treatment:
daily up to 93 days
Doses / concentrations
Dose / conc.:
25 000 ppm (nominal)
Remarks:
Doses / Concentrations:
25%
No. of animals per sex per dose:
2 - 47
Control animals:
yes

Results and discussion

Results of examinations

Clinical signs:
no effects observed
Mortality:
no mortality observed
Body weight and weight changes:
no effects observed
Organ weight findings including organ / body weight ratios:
no effects observed
Gross pathological findings:
no effects observed

Effect levels

Key result
Dose descriptor:
NOAEC
Effect level:
250 000 ppm
Based on:
test mat.
Sex:
not specified
Basis for effect level:
gross pathology
Remarks on result:
not determinable
Remarks:
no NOAEC identified

Target system / organ toxicity

Key result
Critical effects observed:
not specified

Any other information on results incl. tables

In treated animals that survived to termination, no evidence of cellular injury to the parenchymatous cells of the heart, lungs, liver, kidneys, or spleen was reported. However, capillary hyperemia of the liver, kidneys and spleen was observed in some rats exposed to 25%. This effect was observed until at least the second day after the last exposure to the gas but was not evident in animals killed later (up to 5 days after the last exposure). Since capillary hyperemia was not observed in rats exposed to higher concentrations of acetylene, it does not appear to be test-material related.

Applicant's summary and conclusion

Conclusions:
Repeated exposure of rats to a concentration of 25% acetylene (1h/day for up to 93 days) did not cause any organ toxicity.
Executive summary:

In a non-guideline subchronic inhalation toxicity study, acetylene was administered to 2 -47 rats/sex/concentration by whole body exposure at concentrations of 0 and 25,000 ppm daily for 1 hour for up to 93 days.

In treated animals that survived to termination, no evidence of cellular injury to the parenchymatous cells of the heart, lungs, liver, kidneys, or spleen was reported. However, capillary hyperemia of the liver, kidneys and spleen was observed in some rats exposed to 25%. This effect was observed until at least the second day after the last exposure to the gas but was not evident in animals killed later (up to 5 days after the last exposure). Since capillary hyperemia was not observed in rats exposed to higher concentrations of acetylene, it does not appear to be test-material related.

Based on the results of this study, the NOAEC is considered to be 25,000 ppm.