Formaldehyde, oligomeric reaction products with aniline

Acute Toxicity: inhalation

Administrative data

Endpoint:

acute toxicity: inhalation

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: Study meets generally accepted scientific principles, acceptable for assessment.

Data source

Reference

Reference 1

Reference Type:

study report

Title:

Unnamed

Year:

1977

Report date:

1977

Reference 2

Reference Type:

publication

Title:

A new dust-feed mechanism

Author:

Wright BM

Year:

1950

Bibliographic source:

J.Sci.Instrum. 27 (1): 12-5

Reference 3

Reference Type:

publication

Title:

Über Vorkommen von Sulfoniumverbindungen in Metasystox (i) und Metasystox R und ihre physiologische Wirkung

Author:

Niessen H, Tietz H, Hecht G & Kimmerle G

Year:

1963

Bibliographic source:

Arch.Toxicol. 20, (1): 44-60

Materials and methods

Principles of method if other than guideline:

Male and female Sprague-Dawley rats were exposed to a dust/aerosol of 0.46 mg/l phenylbase for 6 h. Animals were observed for 7 or 14 days for mortality, clinical signs and body weight.

GLP compliance:

no

Test type:

standard acute method

Limit test:

yes

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:

Phenylbase

IUPAC Name:

Phenylbase

Details on test material:

- Name of test material (as cited in study report): Phenylbase
- Physical state: White powder
- Analytical purity: 98%

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

Weight: male 235 g (195-275 g); female 175 g (157-200 g)
Diet: Altromin-R (Altrogge), tab water ad libitum.
Housing: 2/3 animals per cage.

Administration / exposure

Route of administration:

inhalation: dust

Type of inhalation exposure:

whole body

Vehicle:

other: unchanged (no vehicle)

Details on inhalation exposure:

Substance was pulverised and 5% talcum was added. Substance was nebulized by an equipment according to Wright (1950). Exposition of rats was performed according to Kimmerle (1963). Air stream 1000 l per hour.
Gravimetric determination of test substance concentration in exposure atmosphere: sampling using membrane filters (0.3µm pore diameter), determination of particle size distribution using a cascade impactor (Modell CS-6, Scientific Advances).

Analytical verification of test atmosphere concentrations:

yes

Remarks:

gravimetrically

Duration of exposure:

6 h

Concentrations:

0.46 mg/l

No. of animals per sex per dose:

10

Control animals:

yes

Details on study design:

Observations:
Body weight: twice a week
Clinical symptoms: daily
Mortality: daily
Clinical chemistry: total protein, total lipid, bilirubin, GOT (glutamate-oxalacetate-transaminase), GPT (glutamate-pyruvate-transaminase), AP (alkaline phosphatase), plasma-cholinesterase
Heamatology and urinalysis.

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LC50

Effect level:

> 0.46 mg/L air

Exp. duration:

6 h

Mortality:

no mortality occured

Clinical signs:

other: Animals were in a good physical state.

Body weight:

No influence of exposure on body weight was observed.

Gross pathology:

no data,

Other findings:

Total lipid, bilirubin, GOT and AP levels were increased. Total protein and plasma-cholinesterase leves were decreased. Additionally an increase of segmented leukocytes. Effects were observed 24-48h following application of the test substance in both sexes and were reversible within the 7-14 day observation period.

Result of test atmosphere analysis:
82% of particles were determined to be <8µm therefore respirable