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

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2007-04-27 - 2007-05-22

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: The study was conducted according to an internationally accepted guideline. All study parameters are based on the specific guideline.

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 402 (Acute Dermal Toxicity)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test type:

fixed dose procedure

Limit test:

yes

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:

rat

Strain:

Wistar

Sex:

female

Details on test animals or test system and environmental conditions:

Species / Strain: rat/Wistar Crl:WI
Rationale:The rat is a suitable rodent species for acute toxicity
studies and is acceptable to regulatory authorities.
Sex:male, female (nulliparous, non-pregnant)
Supplier:Charles River Wiga GmbH,
D-97320 Sulzfeld
Hygiene status upon supply: SPF
Age at start of acclimatisation: approximately 8 weeks
Randomisation / Acclimatisation:5 days before start of dosing the animals were assigned to cages according to random numbers corresponding the planned treatment groups. In this time no signs were observed which indicated an illness or other injury.
Mean body weight at administration: Males: 218.2 g± 5.5 g (2.5%) n=5 Females: 211.8 g ± 4.6 g (2.2%) n = 5

Administration / exposure

Type of coverage:

occlusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

The test item was moistened with a 0.5 % (m/v) solution of Tylose MH 1000 in deionised water, applied to the shaved skin area and covered with a layer of a gaze patch and then with aluminium foil (6.5x6.5 cm). This patch was held in contact with the skin by occlusive dressing (Elastoplast, BSN medical), single administration on May 08, 2007,7.268 - 7.48 a.m. After 24 hours the patch was removed and the application area was cleaned with deionised water.

Duration of exposure:

24 hours

Doses:

2.000 mg/kg b.w.

No. of animals per sex per dose:

5 males, 5 females

Control animals:

not required

Results and discussion

Effect levels

Key result

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

None of the animals died during the course of investigation.

Clinical signs:

other: None of the animals showed alterations of the general state of well-being during the course of investigation. Not any alteration of the skin at the administration area was observed.

Gross pathology:

There were no macroscopic pathological findings in the animals.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Acute dermal toxicity of N-(3(5)-MethyI-lH-pyrazol-l-yl-methyl)-acetamid (P 70/05) was tested in 5 male and 5 female Charles River Wistar rats according to OECD Guideline 402 (Acute Dermal Toxicity). The test item was applied at a single dose of 2000 mg/kg body weight to a shaved dorsal area of the trunk of the animals and was then covered with a gauze patch which was held in contact with the skin with an occlusive dressing. The exposure was for 24 hours.
Animals were examined for mortality, clinical signs, alterations of the administration area, body weight gain and pathological alterations of organs at the end of a 14-day observation period.
None of the animals died during the course of the investigation. The LD5O dermal rat is > 2000 mg/kg b.w.
Clinical signs were not observed during the observation period. Not any alteration of the skin at the administration area was observed.
The body weight gain of the animals was not affected by the test item administration. Pathological findings were not observed at necropsy.

Executive summary:

Acute dermal toxicity of N-(3(5)-MethyI-lH-pyrazol-l-yl-methyl)-acetamid (P 70/05) was tested in 5 male and 5 female Charles River Wistar rats according to OECD Guideline 402 (Acute Dermal Toxicity). The test item was applied at a single dose of 2000 mg/kg body weight to a shaved dorsal area of the trunk of the animals and was then covered with a gauze patch which was held in contact with the skin with an occlusive dressing. The exposure was for 24 hours.

Animals were examined for mortality, clinical signs, alterations of the administration area, body weight gain and pathological alterations of organs at the end of a 14-day observation period.

None of the animals died during the course of the investigation.

The LD50 dermal rat is > 2000 mg/kg b.w.

Clinical signs were not observed during the observation period.

Not any alteration of the skin at the administration area was observed.

The body weight gain of the animals was not affected by the test item administration.

Pathological findings were not observed at necropsy.