N-(1-cyanoethyl)formamide

Eye irritation

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:

other: Study well documented, meets generally accepted scientific principles, acceptable for assessment.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1980

Report date:

1980

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: Federal Register 38, No. 187, Para.1500.41, S. 27019, 27.09.73

Principles of method if other than guideline:

Test method according to Federal Register 38, No. 187, Para.1500.41, S. 27019, 27.09.73 (Draize Test).

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

N-(1-cyanoethyl)formamide

EC Number:

248-440-4

EC Name:

N-(1-cyanoethyl)formamide

Cas Number:

27394-99-6

Molecular formula:

C4H6N2O

IUPAC Name:

N-(1-cyanoethyl)formamide

Details on test material:

N-Formylalaninnitril (purity 98%)

Test animals / tissue source

Species:

rabbit

Strain:

not specified

Details on test animals or tissues and environmental conditions:

no data

Test system

Vehicle:

unchanged (no vehicle)

Controls:

other: untreated eyes of the same animals

Amount / concentration applied:

undiluted
Amount applied: 0.1 ml

Duration of treatment / exposure:

singel application

Observation period (in vivo):

15 days

Number of animals or in vitro replicates:

6

Details on study design:

no data

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

chemosis score

Basis:

mean

Time point:

other: 24h-48h-72h

Score:

0.89

Reversibility:

fully reversible within: 15 days

Results 2

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

other: 24h-48h-72h

Score:

1.39

Reversibility:

not fully reversible within: 15 days

Results 3

Irritation parameter:

iris score

Basis:

mean

Time point:

other: 24h-48h-72h

Score:

0.17

Reversibility:

fully reversible within: 15 days

Results 4

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

other: 24h-48h-72h

Score:

0.89

Reversibility:

fully reversible within: 15 days

Remarks on result:

other: 4/6 animals with score >= 1

Any other information on results incl. tables

RS-Freetext:
Observations after 24 h:
The cornea of 5 of 6 animals showed a slight opacity, the area ranged  
between 1/4 and 3/4 of the cornea. In one of these animals a ciliar  
injection in the iris was observed. Slight (1 animal) to clear (5  animals)
 redness and slight (4 animals) to clear (2 animals) swelling of  
the conjunctivae as well as slightly (2 animals) or clearly (4 animals)  
increased secretion were observed. In addition, scarring was observed in  
2 animals.

Observations after 48 h:
The cornea of 4 of 6 animals showed slight, the cornea of a further  
animal clear opacity, the area ranged between 1/4 and 3/4 of the cornea.  
In one of these animals a ciliar injection in the iris was observed.  
Slight (4 animals) to clear (2 animals) redness and slight (3 animals) to  
clear (1 animal) swelling of the conjunctivae as well as slightly (3  animals), 
clearly (1 animal) or strongly (1 animal) increased secretion  were observed. 
In addition, scarring was observed in 3 animals, from  which one animals also 
showed a constricted pupil and ulceration.

Observations after 72 h:
The cornea of 3 of 6 animals showed slight, the cornea of a further  
animal clear opacity, the area ranged between 1/4 and 3/4 of the cornea.  
In one of these animals a ciliar injection in the iris was observed.  
Slight (4 animals) to clear (1 animal) redness and slight (1 animal) to  
clear (1 animal) swelling of the conjunctivae as well as slightly (4  animals) 
or strongly (1 animal) increased secretion were observed. In  addition, 
scarring was observed in 3 animals, from which one animals also  
showed a constricted pupil and ulceration.

Observations after 8 days:
The cornea of 1 animal showed clear opacity, the area was >= 1/4 and <  1/2 of 
the cornea. In this animal also a ciliar injection in the iris was  observed. 
Slight (3 animals) to clear (1 animal) redness and clear  swelling (1 animal) 
of the conjunctivae as well as slightlyincreased  secretion in one animal were 
observed. In addition, scarring was observed  in 3 animals, from which one 
animals also showed a constricted pupil and  alopecia.

Observations after 15 days:
Slight redness of the conjunctivae was observed in 2 animals. In  addition, 
scarring was observed in 3 animals, from which one animal also  
showed alopecia. All other symptoms were reversible.

Applicant's summary and conclusion

Interpretation of results:

irritating

Remarks:

Migrated information Criteria used for interpretation of results: OECD GHS

Conclusions:

Classification: irritating