2,4-xylidine

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

supporting study

Study period:

1947

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Basic data given but sufficient to establish reliability as a supporting study.

Data source

Reference

Reference Type:

publication

Title:

Unnamed

Year:

1947

Materials and methods

Test guideline

Qualifier:

no guideline followed

Deviations:

not applicable

Principles of method if other than guideline:

The toxic effects of Xylidine were studied in dogs and cats following cutaneous application. An area of the backs of the animals was clipped and measured quantities of the chemical were spread on 2 1/4 by 3 1/2 inch gauze pads applied to the clipped areas, strapped to body with adhesive tape, covered with tinfoil which was fixed with gauze bandages, and the entire body was covered with a tightly fitting jacket, so that the animals were unable to interfere with the application. The material was left on the skin for 23 - 24 h and blood was tested for methemoglobine at intervals of 2.5 , 5, 7.5, 10 h.

GLP compliance:

no

Remarks:

study performed before GLP guidelines

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Xylidine

EC Number:

215-091-4

EC Name:

Xylidine

Cas Number:

1300-73-8

IUPAC Name:

2,3-dimethylaniline

Details on test material:

Xylidine, Isomeric ratio and composition not defined.

Test animals

Species:

other: dogs and cats

Strain:

not specified

Sex:

not specified

Administration / exposure

Type of coverage:

occlusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

Please refer to "Details on study design"

Duration of exposure:

23 -24 h

Doses:

500 and 2000 mg/kg for dogs, 1000 mg/kg for cats

No. of animals per sex per dose:

2 dogs, 4 cats

Control animals:

not specified

Details on study design:

The toxic effects of Xylidine were studied in dogs and cats following cutaneous application. An area of the backs of the animals was clipped and measured quantities of the chemical were spread on 2 1/4 by 3 1/2 inch gauze pads applied to the clipped areas, strapped to body with adhesive tape, covered with tinfoil which was fixed with gauze bandages, and the entire body was covered with a tightly fitting jacket, so that the animals were unable to interfere with the application. The material was left on the skin for 23 - 24 h and th blood was tested for methemoglobine at intervals of 2.5 , 5, 7.5, 10 h.

Statistics:

None

Results and discussion

Preliminary study:

no data

Effect levels

Effect levels 1

Sex:

not specified

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Remarks on result:

other: dog

Effect levels 2

Sex:

not specified

Dose descriptor:

LD50

Effect level:

< 2 000 mg/kg bw

Based on:

test mat.

Remarks on result:

other: cat

Effect levels 3

Sex:

not specified

Dose descriptor:

LD0

Effect level:

2 000 mg/kg bw

Remarks on result:

other: dog, 24 h exposure

Effect levels 4

Sex:

not specified

Dose descriptor:

LD100

Effect level:

2 000 mg/kg bw

Remarks on result:

other: cat, 24 h exposure

Mortality:

Please refer to "Executive summary"

Clinical signs:

other: Please refer to "Executive summary"

Gross pathology:

No data

Other findings:

Please refer to "Executive summary"

Applicant's summary and conclusion

Interpretation of results:

toxic

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Based on the reported effects/mortality the dermal LD50 (dog, 24 h exposure) is set at > 2000 mg/kg bw/d and the dermal LD50 (24 h exposure, cat) is considered to be < 2000 mg/kg bw/d.
Classification: Xn, R21; H302 - Harmful in contact with skin

Executive summary:

With xylidine the methemoglobine formation is slow or very moderate. The administration of 500 mg/kg caused only some vomiting after 2 h and moderate irritation of the skin although in one instance the jacket was left on for 48 h. With the application of 2000 mg/kg for 24 h one dog vomited after 2 h and both dogs developed muscular weakness but recovered after 9 h had elapsed and were apparently normal the next day. Xylidine with respect to methemoglobinemic action is less toxic than aniline, but definitely toxic.

2000 mg/kg Xylidine applied to the skin of cats over a period of 24 h are definitely toxic and produce marked methemoglobinemia and delayed death 24 to 76 h after discontinuation of experiment. Cats treated with xylidine developed early weakness and staggering gait ans lost their appetite, they recovered temporarily to a moderate extent after discontinuation of the exposure. However during subsequent days they became more and more comatoso until they died.

Classification: Xn, R21; H302 - Harmful in contact with skin