Formaldehyde, oligomeric reaction products with aniline

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

migrated information: read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Comparable to guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1975

Report date:

1975

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

yes

Remarks:

Body weight was determined only before the start of the study

Principles of method if other than guideline:

BASF-TEST: Young adult laboratory rats were purchased from breeder. Several groups of 5 rats per sex and dose were treated simultaneously by gavage with preparations of the test substance in a 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 day study period. Body weight was determined before the start of the study only, as it was needed for determination of dose.

GLP compliance:

no

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

4,4'-methylenedianiline

EC Number:

202-974-4

EC Name:

4,4'-methylenedianiline

Cas Number:

101-77-9

Molecular formula:

C13H14N2

IUPAC Name:

4,4'-methylenedianiline

Constituent 2

Reference substance name:

4.4'-Diaminodiphenylmethan

IUPAC Name:

4.4'-Diaminodiphenylmethan

Constituent 3

Reference substance name:

Phenylbase

IUPAC Name:

Phenylbase

Details on test material:

- Name of test material (as cited in study report): 4,4'-Diaminodiphenylemethane
- Purity: >= 99%

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: SPF-breed: Wiga, Sulzfeld, Germany
- Weight at study initiation: male 195 g/ female 170 g
- Diet: Altromin-R, Lage, Germany, ad libitum
- Water: ad libitum

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

CMC (carboxymethyl cellulose)

Details on oral exposure:

4% suspension (W/V) in 0.5% carboxymethyl cellulose

Doses:

250, 400, 500, 640 mg/kg bw

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

- Mortality: after 1, 24, and 48 hours and after 7 and 14 days.
- Duration of observation period following administration: 14 days
- Necropsy of survivors performed: yes

Statistics:

Determination of LD50 according to Litchfield and Wilcoxon

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

444 mg/kg bw

95% CL:

398 - 495

Mortality:

No mortalities were observed at 250 mg/kg bw.
At 400 mg/kg bw mortalities were observed 48 h after application.
At the 500 - 640 mg/kg bw mortalities were observed within the first 24 h (see table 1).

Clinical signs:

other: 400 - 640 mg/kg bw: - apathy - ataxia - abdominal position - dyspnea - after 5-7 days disappearance of clinical signs 250 mg/kg bw: - slight apathy, at day 2 no findings

Gross pathology:

Animals which died:
- acute, obstructive hyperaemia, acute dilation of the heart, slight oedema of the lungs, hydrothorax and bloody ulceration of the stomach
Sacrificed rats at 400 -500 mg/kg bw.:
-pinhead-sized, grey, and in part, aggregating bodies in the liver, and splenomegaly.
Sacrificed rats at 250 mg/kg bw.:
- no pathological effects

Any other information on results incl. tables

Table 1: Mortality of animals after treatment with Phenylbase.

	250 mg/kg bw		400 mg/kg bw		500 mg/kg bw		640 mg/kg bw
	male	female	male	female	male	female	male	female
1 h	0/5	0/5	0/5	0/5	0/5	0/5	0/5	0/5
1 d	0/5	0/5	0/5	0/5	1/5	3/5	5/5	5/5
2 d	0/5	0/5	0/5	1/5	2/5	5/5	5/5	5/5
7 d	0/5	0/5	0/5	2/5	3/5	5/5	5/5	5/5
14 d	0/5	0/5	0/5	2/5	3/5	5/5	5/5	5/5