Cyanoacetic acid

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1979-09-17 (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): §1500.41, 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

Species:

rabbit

Strain:

Vienna White

Details on test animals or test system and environmental conditions:

No further data.
TEST ANIMALS
2 male and 4 female Vienna White rabbits
- Source: Gaukler
- Weight at study initiation: mean body weights: 3.30 kg (males); 3.02 kg (females)
- Diet (ad libitum): Ssniff (Intermast)

ENVIRONMENTAL CONDITIONS: no data

No further data.

Test system

Type of coverage:

not specified

Preparation of test site:

other: shaved (one flank) and abraded (other flank); two test sites at each animal

Vehicle:

water

Controls:

no

Amount / concentration applied:

TEST MATERIAL
- Concentration (if solution): 80% aqueous suspension
Approximately 0.5 g of the test substance was applied to a skin area sized 2.5 cm x 2.5 cm.

Observation period:

72 hours

Number of animals:

6

Details on study design:

TEST SITE
- Area of exposure: flank (ca. 2.5 cm x 2.5 cm)

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 erythema and edema at both 24 and 72 h and for both intact and abraded skin were averaged. The sum of the average scores was then divided by 4, resulting in the primary irritation index.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

primary dermal irritation index (PDII)

Basis:

mean

Remarks:

(n=6)

Time point:

other: 24 - 72 hours

Score:

6.9

Remarks on result:

other: Study discontinued after 72 hours because of severe irritation

Results 2

Irritation parameter:

erythema score

Basis:

mean

Remarks:

(n=6)

Time point:

other: 24 - 72 h

Score:

4

Max. score:

4

Reversibility:

not reversible

Remarks on result:

other: necrosis observed in 6/6 animals

Results 3

Irritation parameter:

edema score

Basis:

mean

Remarks:

(n=6)

Time point:

other: 24 - 72 h

Score:

2.5 - 3.2

Max. score:

4

Reversibility:

not reversible

Irritant / corrosive response data:

The test substance was a strong irritant; primary irritation index was 6.9 (possible max.: 8.0).

Any other information on results incl. tables

Table: Draize scores and findings for both intact and abraded skin sites

		Individual scores						Mean	Remarks
Animal no.		1	2	3	4	5	6	1 - 6
Body weight [kg]		3.31	3.22	2.80	3.28	3.05	3.00
Gender		male	female	female	male	female	female
Intact skin
Erythema / Necrosis	24 h 72 h	4 / N:s 4 / N:s +	4/ N:s 4 / N:d +	4 / N:s 4 / N:d +	4 / N:s 4 / N:d +	4 / N:s 4 / N:o +	4 / N:s 4 / N:d	4.0 4.0	Study was terminated at 72 h due to severe skin findings.
Edema	24 h 72 h	3 2	3 3	3 3	4 2	3 3	3 2	3.2 2.5
Abraded skin
Erythema / Necrosis	24 h 72 h	4 / N:s 4 / N:s +	4/ N:s 4 / N:d +	4 / N:s 4 / N:d +	4 / N:s 4 / N:d +	4 / N:s 4 / N:s +	4 / N:s 4 / N:d	4.0 4.0	Study was terminated at 72 h due to severe skin findings.
Edema	24 h 72 h	3 2	3 3	3 3	4 3	3 3	3 2	3.2 2.7

Primary irritation index: 27.5 (sum of mean values) / 4 = 6.9

N:s = necrosis (soft)

N:d = necrosis (deep), reaching the muscle layer

N:o = necrosis (open)

+: finding confirmed by macroscopic pathology

Applicant's summary and conclusion

Interpretation of results:

Category 1B (corrosive) based on GHS criteria

Remarks:

Migrated information: considering the results of this study and also those of the BASF screening test, see entry BASF 78/833_screening.Skin irritation/corrosion in this section