Cyanoacetic acid

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1979-08-27 (application of the test substance)

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Comparable to guideline study, no GLP.

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 (187): §1500.42, p. 27029, 1973-09-27

GLP compliance:

no

Remarks:

pre-GLP study

Test material

Test material information

Constituent 1

Reference substance name:

Cyanoacetic acid

EC Number:

206-743-9

EC Name:

Cyanoacetic acid

Cas Number:

372-09-8

Molecular formula:

C3H3NO2

IUPAC Name:

cyanoacetic acid

Details on test material:

- Name of test material (as cited in study report): Cyanessigsäure (cyanoacetic acid)
- Analytical purity: not given
No further data

Test animals / tissue source

Species:

rabbit

Strain:

Vienna White

Details on test animals or tissues and environmental conditions:

No further data.
TEST ANIMALS
5 male and 1 female Vienna White rabbits
- Source: Gaukler
- Weight at study initiation: mean body weight: 2.82 kg, range: 2.60 - 3.09 kg (males); 2.60 kg (female)
- Diet (ad libitum): Ssniff (Intermast)

ENVIRONMENTAL CONDITIONS: no data

No further data.

Test system

Vehicle:

unchanged (no vehicle)

Controls:

no

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 62 mg of the unchanged, powdered test substance, equivalent to 0.1 ml bulk volume

Duration of treatment / exposure:

single application

Observation period (in vivo):

8 days

Number of animals or in vitro replicates:

6

Details on study design:

SCORING SYSTEM: Draize system according to Draize JH (1959). Dermal Toxicity. In: FDA Appraisal of the Safety of the Chemicals in Foods, Drugs and Cosmetics.
For the estimation of the primary irritation index, the individual scores for all animals from the readings at 24, 48, and 72 h were summarized and divided by (3 x no. of animals). If a score could not be read, the respective mean score was set at zero.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

animal #6

Time point:

other: 24-72h

Score:

3

Max. score:

3

Reversibility:

not reversible

Results 2

Irritation parameter:

chemosis score

Basis:

animal #6

Time point:

other: 24-72h

Score:

2.67

Max. score:

3

Reversibility:

not reversible

Remarks on result:

other: suppuration, loss of hair, scar formation

Irritant / corrosive response data:

The test substance was strongly irritating to corrosive; primary irritation index was >= 71 (possible max.: 110).
conjunctivae score: animal #6: 24-72h : score could not be determined because of the coloration of the eye with the tets substance
iris score animal: #6 24-72h: score could not be determined because of the coloration of the eye with the tets substance

Other effects:

Coloration of the eye with test substance

Any other information on results incl. tables

Table: Draize scores and findings

Reading	Animal no.	Cornea		Iris	Conjunctivae			Other findings
		Opacity	Area		Redness	Swelling	Secretion
24 h	1 2 3 4 5 6	3 3 3 3 3 3	4 4 4 4 4 4	** ** ** ** ** **	** ** ** ** ** **	3 3 3 3 3 3	2 3 3 3 3 3	SC S/SC S/SC S/SC S/SC/N S/SC/N
48 h	1 2 3 4 5 6	3 3 3 3 3 3	4 4 4 4 4 4	** ** ** ** ** **	** ** ** ** ** **	2 2 2 2 2 2	2 3 3 3 3 3	SC/N S/SC/N S/SC/N S/SC/N S/SC/N S/SC/N
72 h	1 2 3 4 5 6	3 3 3 3 3 3	4 4 4 4 4 4	** ** ** ** ** **	** ** ** ** ** **	3 3 3 3 3 3	3 3 3 3 3 3	S/SC S/SC/N S/SC/N S/SC/N S/SC/N S/SC/N
8 d	1 2 3 4 5 6	* * * * * *	* * * * * *	* * * * * *	* * * * * *	3 3 2 3 2 3	3 3 3 3 3 3	S/N S/N/LH S/N/LH S/N/LH S/N/LH S/N

Primary irritation index >= 71 (estimated as 280 [=sum of individual scores] / 18)

* : score could not be determined due to suppuration

**: score could not be determined due to coloration of the eye with the test substance

S: suppuration,

LH: loss of hair

N: necrosis at the rim of the eyelid

SC: formation of scars

Applicant's summary and conclusion

Interpretation of results:

Category 1 (irreversible effects on the eye) based on GHS criteria

Remarks:

Migrated information