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: Guideline study without detailed documentation.

Data source

Reference

Reference 1

Reference Type:

publication

Title:

Unnamed

Year:

1992

Reference 2

Reference Type:

publication

Title:

An objective method for the evaluation of eye irritation in vivo.

Author:

Jacobs GA and Martens MA

Year:

1989

Bibliographic source:

Food Chem. Toxicol. 27(4), 255-258.

Reference 3

Reference Type:

publication

Title:

Evaluation of the in vitro uridine uptake inhibition assay in comparison with the in vitro eye irritation test as prescribed by the EEC.

Author:

Jacobs GA, Dierickx PJ, and Martens MA

Year:

1988

Bibliographic source:

Altern. Test. Lab. Anim. (ATLA) 15, 290-296.

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

not specified

GLP compliance:

not specified

Test material

Test material information

Constituent 1

Reference substance name:

Formamide

EC Number:

200-842-0

EC Name:

Formamide

Cas Number:

75-12-7

Molecular formula:

CH3NO

IUPAC Name:

formamide

Details on test material:

Formamide p.a.; purity >99%

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Test system

Vehicle:

unchanged (no vehicle)

Controls:

not required

Amount / concentration applied:

- Amount applied: 0.1 mL

Observation period (in vivo):

96 hrs

Number of animals or in vitro replicates:

6

Details on study design:

Comment: not rinsed
REMOVAL OF TEST SUBSTANCE
- Washing: no

SCORING SYSTEM:
- Erythema, chemosis, iritis and corneal opacity were scored according to Draize scores. The mean scores of each endpoint were calculated for all six rabbits, and the scores at the three observation times, 24, 48 and 72 h, were pooled.

TOOL USED TO ASSESS SCORE: fluorescein

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

other: 24-72 hours

Score:

0.2

Max. score:

4

Reversibility:

fully reversible within: 4 days

Results 2

Irritation parameter:

iris score

Basis:

mean

Time point:

other: 24-72 hours

Score:

0.23

Max. score:

2

Reversibility:

fully reversible within: 3 days

Results 3

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

other: 24-72 hours

Score:

1.93

Max. score:

3

Reversibility:

not fully reversible within: 4 days

Results 4

Irritation parameter:

chemosis score

Basis:

mean

Time point:

other: 24-72 hours

Score:

0.43

Max. score:

4

Reversibility:

fully reversible within: 4 days

Irritant / corrosive response data:

The test substance produced only  slight irritation with respect to chemosis and corneal opacity. The pooled score over all three time points for erythema was calculated to be 1.93 indicating some primary eye irritation without gaining a degree requiring classification. All effects were reversible. 

Any other information on results incl. tables

 

Table: mean scores (n=6) of eye irritation reactions

 

 

Eye reaction	Time after application
	4 hr	24 hr	48 hr	72 hr	96 hr	24-48-72 hr
Conjunctivitis  (3 maximum)	2.0	2.3	1.9	1.6	1.3	1.93
Chemosis  (4 maximum)	1.3	0.8	0.5	0.0	0.0	0.43
Iritis  (2 maximum)	0.7	0.5	0.2	0.0	0.0	0.23
Corneal opacity  (4 maximum)	0.7	0.2	0.2	0.2	0.0	0.2
Surface of corneal damage  (%)	22	35	16	16	7
Evaluation
Result 67/548 EEC						Not irritating to eyes
Result 67/548 EEC						Not irritating to eyes

 

Applicant's summary and conclusion

Interpretation of results:

slightly irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Executive summary:

Conclusion:

 

In an eye irritation study conducted according to OECD TG No. 405, 0.1 mL of formamide was applied into the lower conjunctival sac of 6 New Zealand White rabbits. The eye reactions were scored according to the table of Draize contained in the test guideline at 4, 24, 48, 72, and 96 after treatment. Conjunctivitis was the most prominent effect, the other effects were milder. The effects were reversible. The mean scores at 24, 48, and 96 hours were as follows: cornea score: 0.2; iritis 0.2; conjunctivitis: 1.93; and chemosis 0.43. Thus, there was reversible mild eye irritation seen at a level not requiring classification according to the regulations 67/548/EC and 1272/2008/EC (Jacobs, 1992).