2',4'-dimethylacetoacetanilide

Specific investigations: other studies

Administrative data

Endpoint:

methaemoglobinaemia

Type of information:

experimental study

Adequacy of study:

supporting study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Acceptable, well documented study report which meets basic scientific principles. Study was conducted priore to GLP implementation.

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: company guideline

Deviations:

no

Principles of method if other than guideline:

Test animal: cat
Route of exposure: gavage
Examinations/observations: Clinical signs, lethality, Methemoglobin concentration

GLP compliance:

no

Remarks:

prior to GLP implementation

Type of method:

in vivo

Endpoint addressed:

acute toxicity: oral

Test material

Test material information

Constituent 1

Reference substance name:

2',4'-dimethylacetoacetanilide

EC Number:

202-576-0

EC Name:

2',4'-dimethylacetoacetanilide

Cas Number:

97-36-9

Molecular formula:

C12H15NO2

IUPAC Name:

2',4'-dimethylacetoacetanilide

Details on test material:

- Name of test material (as cited in study report): Acetessig-m-xylidid

Test animals

Species:

cat

Strain:

not specified

Sex:

male/female

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

water

Details on exposure:

VEHICLE

- Concentration in vehicle: 2.0 or 0.5 % (aqueous suspension)

Analytical verification of doses or concentrations:

not specified

Duration of treatment / exposure:

observation period: 14 d

Frequency of treatment:

once

Post exposure period:

14 d

Doses / concentrations

Remarks:

Doses / Concentrations:
200 or 50 mg/kg bw
Basis:
actual ingested

No. of animals per sex per dose:

200 mg/kg bw: 2 male, 4 female
50 mg/kg bw: 1 male, 1 female

Control animals:

other: blood sampling before treatment

Examinations

Examinations:

Clinical signs, lethality, Methemoglobin concentration

Positive control:

no

Results and discussion

Details on results:

200 mg/kg bw:
Lethality: 3/6
MetHb concentration: Slightly increased except one surviving animal which showed a distinct increase
Clinical signs: Apathy, salivation, ataxic gate, crying, prone position, lateral position, decreased feed consumption

50 mg/kg bw:
Lethality: 0/2
MetHb concentration: Very slightly increased
Clinical signs: no abnormal findings

Any other information on results incl. tables

Dose	Animal no / sex	Fate	Methemoglobin concentration (%)
			Before application	4 h post apllication	3 d post application, cardiac aspiration
200 mg/kg bw	70 / m	survived	0.0	2.1	/
	88 / f	died	0.0	8.6	0.0
	12 / m	died	0.8	6.3	0.6
	24 / f	survived	0.9	3.1	/
	18 / f	died	0.6	2.9	0.1
	23 / f	survived	0.5	50.7	/
50 mg/kg bw	82 / m	survived	0.0	1.6	/
	62 / f	survived	0.0	1.3	/

Applicant's summary and conclusion

Conclusions:

The oral LD50 for cat approximately amounts to 200 mg/kg bw. Lethality was not caused by MetHb formation.

Executive summary:

In order to assess the methemoglobin-forming potential of Acetessig-m-xylidid male and female cats received single oral doses of 50 or 200 mg/kg bw. Blood samples were taken before and after treatment.

In the high dose group cats showed apathy, salivation, ataxic gate, crying, prone position, lateral position, and decreased feed consumption. MetHb concentrations were slightly increased. 3 of 6 animals died.

In the low dose group no abnormalities were observed. MetHb concentration was very slightly increase. All animals survived.

Based on that the oral LD50 approximately amounts to 200 mg/kg bw. and lethality was not considered to be caused by MetHb formation.