Reaction mass of N-[(5-methyl-1H-pyrazol-1-yl)methyl]acetamide AND N-[(3-methyl-1H-pyrazol-1-yl)methyl]acetamide

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2007-05-10 - 2007-06-04

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2007

Report date:

2007

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

Reaction mass of N-[(5-methyl-1H-pyrazol-1-yl)methyl]acetamide AND N-[(3-methyl-1H-pyrazol-1-yl)methyl]acetamide

EC Number:

700-208-8

Molecular formula:

C7H11N3O

IUPAC Name:

Reaction mass of N-[(5-methyl-1H-pyrazol-1-yl)methyl]acetamide AND N-[(3-methyl-1H-pyrazol-1-yl)methyl]acetamide

Test material form:

solid: crystalline

Details on test material:

Chemical name: N-(3(5)-Methyl-1 H-pyrazol-1 -yl-methyl)-acetamid
Code of the sponsor: P 70/05 Formula: C7H11N3O
Description: white, amorphous solid
Purity: > 99 % (HPLC and NMR)

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

The study room and cages were cleaned and disinfected before the animals arrived. During the study, the room and cages were cleaned at regular intervals.
Cages of stainless steel with bottom grid of oval steel and with tub for
faeces, dimensions of the cages: 50 x 55 x 40 cm.
The animals were housed individually.
Air conditioned: temperature: 19.5 - 23.0 °C relative humidity: 30 - 50 % artificial light was set to give a cycle of 12 hours light and 12 hours dark; the light phase was from 6.30 a.m. - 6.30 p.m.

Test system

Type of coverage:

occlusive

Preparation of test site:

shaved

Vehicle:

other: Tylose MH 1000 in deionised water

Controls:

not required

Amount / concentration applied:

0.5 g

Duration of treatment / exposure:

4 hours

Observation period:

72 hours

Number of animals:

3

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Results 2

Irritation parameter:

edema score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Any other information on results incl. tables

Ani­	Expo­	Observed grades of skin alterations at each observation time
mal	sure	Erythema					Oedema
No.	period	hours after administration				X	hours after administration				X
		1	24	48	72	Test item	1	24	48	72	Test item
1	3 min	0	0	0	0		0	0	0	0
	lh	0	0	0	0		0	0	0	0
	4 h	0	0	0	0	0	0	0	0	0	0
	Control	0	0	0	0		0	0	0	0
2	4 h	0	0	0	0	0	0	0	0	0	0
	Control	0	0	0	0		0	0	0	0
3	4 h	0	0	0	0	0	0	0	0	0	0
	Control	0	0	0	0		0	0	0	0

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The acute dermal irritation/corrosion of N-(3(5)-Methyl-1H-pyrazol-l-yl-methyl)- acetamid (P 70/05) was tested in three albino rabbits according to OECD Guideline 404 (Acute Dermal Irritation / Corrosion). The test item was applied as the original substance after grinding in a mortar at a dose of 0.5 g to a shaved dorsal area of trunk and covered with a gauze patch and aluminium foil which was held in contact with the skin with an occlusive dressing. The test was started with one rabbit with exposure periods of three minutes, one hour and four hours. Because no serious skin reaction was observed in this animal the result was confirmed using two further animals with a four-hour exposure. After each exposure the administration area was cleaned with deionised water.
Animals were examined for mortality, clinical signs and signs of irritation response 60 minutes, 24, 48, 72 hours after patch removal. The grading of skin reaction given in the guideline was used for the evaluation of the dermal irritation.
The administration of 0.5 g of N-(3(5)-Methyl-lH-pyrazoM-yl-methyl)-acetamid (P 70/05) to shaved dorsal area of the trunk of albino rabbits did not cause any skin irritation at any observation time. No systemic toxic effects were observed.

Executive summary:

The acute dermal irritation/corrosion of N-(3(5)-Methyl-1H-pyrazol-l-yl-methyl)- acetamid (P 70/05) was tested in three albino rabbits according to OECD Guideline 404 (Acute Dermal Irritation / Corrosion). The test item was applied as the original substance after grinding in a mortar at a dose of 0.5 g to a shaved dorsal area of trunk and covered with a gauze patch and aluminium foil which was held in contact with the skin with an occlusive dressing. The test was started with one rabbit with exposure periods of three minutes, one hour and four hours. Because no serious skin reaction was observed in this animal the result was confirmed using two further animals with a four-hour exposure. After each exposure the administration area was cleaned with deionised water.

Animals were examined for mortality, clinical signs and signs of irritation response 60 minutes, 24, 48, 72 hours after patch removal. The grading of skin reaction given in the guideline was used for the evaluation of the dermal irritation.

The administration of 0.5 g of N-(3(5)-Methyl-lH-pyrazoM-yl-methyl)-acetamid (P 70/05)

to shaved dorsal area of the trunk of albino rabbits did not cause any skin irritation at any observation time.

No systemic toxic effects were observed.