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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Eye irritation

Currently viewing:

Administrative data

Endpoint:
eye irritation: 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:
publication
Title:
Unnamed
Year:
1960

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
Humans were exposed to the gas in the sealed room. Ages ranged from 21 to 65 years, and all were in good health except one who had mild cold symptoms.
GLP compliance:
no

Test material

Constituent 1
Chemical structure
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:
99.5 %

Test animals / tissue source

Species:
human
Details on test animals or tissues and environmental conditions:
Humans were exposed to the gas in the sealed room. Ages ranged from 21 to 65 years, and all were in good health except one who had mild cold symptoms.

Test system

Vehicle:
other: air
Amount / concentration applied:
a) 8 ppm for 6 minutes
b) 16 ppm for 6 and 8 minutes
Duration of treatment / exposure:
a) 8 ppm for 6 minutes
b) 16 ppm for 6 and 8 minutes
Observation period (in vivo):
a) 8 ppm for 6 minutes
b) 16 ppm for 6 and 8 minutes
Number of animals or in vitro replicates:
a) 8 ppm for 6 minutes - three males and two females
b) 16 ppm for 6 and 8 minutes - four males and three females

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
chemosis score
Basis:
mean
Time point:
24/48/72 h
Score:
>= 0 <=
Max. score:
0
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
24/48/72 h
Score:
>= 0 <=
Max. score:
0
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
mean
Time point:
24/48/72 h
Score:
>= 0 <=
Max. score:
0
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
24/48/72 h
Score:
>= 0 <=
Max. score:
0
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
In human volunteers, no irritation was observed during a 6-min exposure to 18 mg/m3 (8 ppm) while eye and nasal irritation (exhibited by lacrimation – no damage observed) were experienced at 35 mg/m3 (16 ppm).

Applicant's summary and conclusion

Interpretation of results:
other: CLP criteria not met
Conclusions:
Data on humans and rats indicate that ethanedinitrile can cause nasal and/or eye irritation. In human volunteers, no irritation was observed during a 6-min exposure to 18 mg/m3 (8 ppm) while eye and nasal irritation (exhibited by lacrimation – no damage observed) were experienced at 35 mg/m3 (16 ppm).
Executive summary:

Data on humans and rats indicate that ethanedinitrile can cause nasal and/or eye irritation. In human volunteers, no irritation was observed during a 6-min exposure to 18 mg/m3 (8 ppm) while eye and nasal irritation (exhibited by lacrimation – no damage observed) were experienced at 35 mg/m3 (16 ppm) (Table 1).

Table 1: Irritation effect of ethanedinitrile upon human subjects

Ethanedinitrile concentration (ppm)

Exposure time (minutes)

No. of subjects

No. of subjects experiencing effects

Irritation

Eye

Nasal

8

6

7

0

0

16

6

5

5

4

16

8

7

7

7