2-cyano-N-methylacetamide

Skin irritation / corrosion

Administrative data

Endpoint:

skin 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 certified GLP compliance

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1981

Report date:

1981

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: Fed.Reg.38, No.187, Para.1500.41, S.27019 (1973-09-27)

GLP compliance:

not specified

Test material

Test material information

Constituent 1

Reference substance name:

2-cyano-N-methylacetamide

EC Number:

228-705-0

EC Name:

2-cyano-N-methylacetamide

Cas Number:

6330-25-2

Molecular formula:

C4H6N2O

IUPAC Name:

2-cyano-N-methylacetamide

Details on test material:

- Name of test material: N-Methylcyanacetamid
- Substance number: 81 / 97
- Physical state: 80 % aqueous preparation

Test animals

Species:

rabbit

Strain:

Vienna White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Firma Gaukler, Offenbach / Main
- Weight at study initiation (mean): male: 2.89 kg / female: 3.01 kg
- Housing: Stainless steel cage with wire shelves, ground area: 40 x 51 cm
- Diet (ca. 130 g/animal): Ovator Solikanin 4mm, Muskator-Werke Düsseldorf
- Water (ca. 250 mL/animal): VE-water on week days, tapwater on holidays
- Acclimation period: about 8 days
- Shaving: at least 15 h before application

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 26
- Humidity (%): ca. 30 - 70
- Photoperiod (hrs dark / hrs light): 12 / 12

Test system

Type of coverage:

occlusive

Preparation of test site:

shaved

Vehicle:

water

Controls:

not required

Amount / concentration applied:

TEST MATERIAL:
- Concentration (if solution): 80 %

Duration of treatment / exposure:

Single application

Observation period:

7 d

Number of animals:

6 (4 males and 2 females)

Details on study design:

TEST SITE
- Area of exposure: upper third of the back or flank region
-Applikation: The substance (80 % grind) is applied onto the test lobe as an ~ 0.5 mm thick layer.

REMOVAL OF TEST SUBSTANCE
- Washing: not performed

FURTHER INVESTIGATIONS
Sacrified animals pathological examined afterwards and especially investigated for necrosis.

Results and discussion

In vivo

Results

Irritation parameter:

other: Primary Irritation Index

Basis:

other: Sum of all single stimulus values

Time point:

other: 24h, 72h

Score:

1

Reversibility:

no data

Remarks on result:

other: No erythema and edema were observed at the 7 day reading. One animal showed scuffing.

Irritant / corrosive response data:

Only one animal showed at the scarified skin a slight redness 24 h after test substance application. All other investigations were recorded as "doubtful" (intact and scarified skin, redness and edema).

Other effects:

Scuffing was observed at one animal after 7 days at the intact as well as at the scarified skin.

Any other information on results incl. tables

Table 1: Results Skin Irritation

(according to FED. REG. 38, NO. 187, PARA. 1500.41, S. 27019 (1973 -09 -27))
Animal		1		2	3	4		5	6
Number of Animal		0335		0354	0384	0326		0293	0288
Weight (kg)		3.59		3.09	2.92	2.88		2.60	2.49
Sex		male		female	female	male		male	male
Time	Animal	Intact Skin				Scarified Skin			Single Stimulus Value
		R	OE	Symptoms		R	OE	Symptoms
24 h	1	1	0			1	0		1.0
	2	1	0			1	1		1.5
	3	1	1			2	1		2.5
	4	1	0			1	1		1.5
	5	1	0			1	1		1.5
	6	1	0			1	0	Redness	1.0
72 h	Mean value	1.0	0.2			1.2	0.7		1.5
	1	0	0			1	0		0.5
	2	0	0			0	0		0.
	3	1	0			1	0		1.0
	4	0	0			1	0		0.5
	5	0	0			1	0		0.5
	6	0	0			0	0		0.
7 d	Mean value	0.2	0.			0.7	0.		0.4
	1	0	0			0	0		0.
	2	0	0			0	0		0.
	3	0	0	Scuffing		0	0	Scuffing	0.
	4	0	0			0	0		0.
	5	0	0			0	0		0.
	6	0	0			0	0		0.
	Mean value	0 .	0 .			0.	0.		0.
11.5 / 12 = 1.0
Primary Irritation Value = 1.0

R = redness

OE = edema

Calculation of the Irritation Index:

Single Stimulus Value = (R + OE of intact and scarified skin) / 2

The Primary Irritation Index is the sum of all single stimulus values of all animals and the time points of 24 h and 72 h divided by 2 x the number of animals.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Only one animal showed at the scarified skin a slight redness 24 h after test substance application. All other investigations were recorded as "doubtful" (intact and scarified skin, redness and edema). The calculation of the Primary Irritation Index was performed according to Draize (1965), resulting in a value of 1, thus indicating a no irritation potential for the skin.

Executive summary:

The test substance 2 -cyano-N-methylacetamide was investigated for its potential to cause irritation on the rabbit skin according to Fed.Reg.38, No.187, Para.1500.41, S.27019 (1973) with one single application. At least 15 h before application the rabbits (6 animals, 4 males and 2 females) were shaved and the 80 % test solution was applied to intact and scarified skin under occlusion. The test duration was 7 days, and the sacrified animals were pathologically examined, especially in context of necrosis. Only one animal showed at the scarified skin a slight redness 24 h after test substance application. All other investigations were recorded as "doubtful" (intact and scarified skin, redness and edema). Scuffing was observed at one animal after 7 days at the intact as well as at the scarified skin. The Primary Irritation Index was calculated according to the scheme of Draize (1965), resulting in a value of 1.0, indicating no irritation potential of the test substance.