Formaldehyde, oligomeric reaction products with aniline

Acute Toxicity: other routes

Administrative data

Endpoint:

acute toxicity: other routes

Type of information:

experimental study

Adequacy of study:

supporting study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Study predates the current guideline and study methods are not fully documented; however the results of the study may be used for a comparison of toxicity by alternative routes.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1973

Materials and methods

Principles of method if other than guideline:

BASF-Test: The substance was injected into the peritoneal cavity. Young adult laboratory mice were purchased from breeder. Usually the source and strain of animals were not documented. Several groups of 5 mice per sex and dose were treated simultaneously with preparations of the test substance in suitable vehicle. The concentrations of these preparations were used to achieve comparable volumes per kg body weight. Group-wise documentation of clinical signs was performed over the 14- days study period.

GLP compliance:

no

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

mixture of 4,4'-methylenedianiline (also known as phenylbase) isomers and higher oligomers

IUPAC Name:

mixture of 4,4'-methylenedianiline (also known as phenylbase) isomers and higher oligomers

Details on test material:

- Name of test material (as cited in study report): MDA (auch polyamin genannt)
- Physical state: liquid
- Composition of test material, percentage of components: mixture of 4,4'-methylenedianiline (also known as phenylbase) isomers and higher oligomers

Test animals

Species:

mouse

Strain:

not specified

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- body weight at study initiation:
200 mg/kg bw: male 24-31 g, female 21-25 g
400 mg/kg bw: male 30-34 g, female 22-25 g
500 mg/kg bw: male 24-26 g, female 20-24 g
640 mg/kg bw: male 23-26 g, female 22-25 g
800 mg/kg bw: male 27-31 g, female 22-24 g
1600 mg/kg bw: male 18-32 g, female 22-28 g

Administration / exposure

Route of administration:

intraperitoneal

Vehicle:

CMC (carboxymethyl cellulose)

Details on exposure:

DOSAGE PREPARATION:
- Stock solutions prepared:
2 % for 200 mg/kg bw dose group,
4 % for 400 and 500 mg/kg bw dose group,
8 % for 640 and 800 mg/kg bw dose groups, and
16 % for 1600 mg/kg bw dose group.

Doses:

200, 400, 500, 640, 800 and 1600 mg/kg bw

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: mortality and clinical signs of toxicity were observed several times on the application day and thereafter once each working day, body weights were only recorded at the beginning of the study.
- Necropsy of survivors performed: yes

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

500 mg/kg bw

Mortality:

see free text

Clinical signs:

Shortly after injection, tremor, partly dyspnea and intermittent respiration were observed. Few moments later, abdominal position, irregular respiration, apathy were observed. In the following days, the symptoms were weaker and no symptoms were observed 4 days after injection.

Gross pathology:

substance deposits in the intraabdominal cavity, hypertrophy of liver and kidney

Any other information on results incl. tables

Dose (mg/kg bw)	Sex	Mortality in
		1 h	24 h	48 h	7 days	14 days
1600	Male	0/5	5/5	5/5	5/5
	Female	0/5	5/5	5/5	5/5
800	Male	0/5	3/5	4/5	4/5	4/5
	Female	0/5	4/5	4/5	4/5	4/5
640	Male	0/5	0/5	0/5	2/5	2/5
	Female	0/5	0/5	5/5	5/5	5/5
500	Male	0/5	0/5	0/5	0/5	0/5
	Female	0/5	0/5	2/5	5/5	5/5
400	Male	0/5	0/5	0/5	0/5	0/5
	Female	0/5	0/5	0/5	1/5	1/5
200	Male	0/5	0/5	0/5	0/5	0/5
	Female	0/5	0/5	0/5	0/5	0/5