2'-methylacetoacetanilide

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1999

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: The study was conducted and reported according to the OECD Guideline for the testing of chemicals 401 and principles of GLP.

Cross-reference

Cross-reference 1

Reason / purpose for cross-reference:

reference to same study

Cross-reference 2

Reason / purpose for cross-reference:

reference to other study

Data source

Reference

Reference Type:

publication

Title:

Unnamed

Year:

2003

Report date:

2003

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

no

Principles of method if other than guideline:

Not applicable

GLP compliance:

yes

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

2'-methylacetoacetanilide

EC Number:

202-267-0

EC Name:

2'-methylacetoacetanilide

Cas Number:

93-68-5

Molecular formula:

C11H13NO2

IUPAC Name:

N-(2-methylphenyl)-3-oxobutanamide

Test material form:

solid: particulate/powder

Remarks:

migrated information: powder

Details on test material:

TS: Mitsuboshi Chemical Co., Ltd.
Purity: 99.9%

Test animals

Species:

rat

Strain:

Crj: CD(SD)

Sex:

male/female

Details on test animals or test system and environmental conditions:

Source: Japan Charles River Co. Ltd.
Age: 5 weeks old
Weight at initiation: 120-137g for males, 106-118g for females
Pellet food: free take till 17:00 on the day before test and from 3 hours after dose onward
Water: free take

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

other: 1% Methylcellulose solution

Details on oral exposure:

Vehicle: 1% Methylcellose water solution
Route: 1.0mL/100g body weight by gavage
Post dose observation: till 14 days after administration

Doses:

0, 819, 1024, 1280, 1600, 2000, 2500 mg/kg for both sexes

No. of animals per sex per dose:

5 animals per sex per dose

Control animals:

yes

Details on study design:

Post dose observation: till 14 days after administration
No further data available.

Statistics:

No data available.

Results and discussion

Preliminary study:

Not applicable

Effect levels

Effect levels 1

Sex:

male

Dose descriptor:

LD0

Effect level:

1 024 mg/kg bw

Based on:

test mat.

Effect levels 2

Sex:

male

Dose descriptor:

LD50

Effect level:

1 854 mg/kg bw

Based on:

test mat.

95% CL:

1 549 - 2 298

Effect levels 3

Sex:

male

Dose descriptor:

LD100

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Effect levels 4

Sex:

female

Dose descriptor:

LD0

Effect level:

1 280 mg/kg bw

Based on:

test mat.

Effect levels 5

Sex:

female

Dose descriptor:

LD50

Effect level:

1 945 mg/kg bw

Based on:

test mat.

95% CL:

1 654 - 2 318

Effect levels 6

Sex:

female

Dose descriptor:

LD100

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

MORTALITY
number of number of deaths
dose animals male female
mg/kg per sex
-----------------------------------------------------------------------------------------------
0 5 0 0
819 5 0 0
1024 5 0 0
1280 5 1(Hr.3) 0
1600 5 0 1(Day3)
2000 5 3(Hr.3, Day3) 2(Hr.3,6)
2500 5 5(Hr.3, Day3) 5(Hr.3,6,Day2,3)
-----------------------------------------------------------------------------------------------
Hr.: hours after dose,
Day: days from dose

Clinical signs:

other: From 10 minutes after dose, decreased locomotor activity and adoption of prone position were observed in all treated groups, and hypomyotonia, ptosis and deep respiration were observed in many of treated groups. From 1 to 3 hours later, piloerection, hypo

Gross pathology:

At necropsy, bloody material in the stomach and intestine, petechiae in the glandular stomach and
distension of the urinary bladder were observed in the animals that died.

Other findings:

No other findings available.

Applicant's summary and conclusion

Interpretation of results:

harmful

Remarks:

Migrated information Criteria used for interpretation of results: OECD GHS

Conclusions:

The LD50 value by oral for rat is 1854 mg/kg for male and 1945 mg/kg for female.

Executive summary:

The study was published in the OECD SIDS dossier in year 2003 conducted and reported in year 1999 according to the OECD Guideline for the testing of chemicals 401 and principles of GLP. The first mortality was oberserved at 1280 mg/kg dose level for males and at 1600 mg/kg for females, further deaths at 2000 mg/kg dose level for males and females.

Dead animals showed serious those clinical signs and weak respiration before die.

Therefore, the LD50 value by oral for rat is 1854 mg/kg for male and 1945 mg/kg for female.

The substance will be classified as harmful (H 302) according to GHS.