4,4'-methylenebis[N,N-bis(2,3-epoxypropyl)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

Study period:

1982

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: No GLP, but according to guideline OECD 401

Cross-reference

Reason / purpose for cross-reference:

reference to same study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1982

Report date:

1982

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

no

GLP compliance:

no

Test type:

other: limit test

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

4,4'-Methylenedianiline, oligomeric reaction products with 1-chloro-2,3-epoxypropane

EC Number:

500-062-3

EC Name:

4,4'-Methylenedianiline, oligomeric reaction products with 1-chloro-2,3-epoxypropane

Cas Number:

28390-91-2

IUPAC Name:

4-[(4-aminophenyl)methyl]aniline; 2-(chloromethyl)oxirane

Details on test material:

Araldite MY 720, TK 10884, batch no. 4356

Test animals

Species:

mouse

Strain:

other: Tif:MAG (SPF)

Sex:

male/female

Details on test animals or test system and environmental conditions:

4-5 week old mice, the mice were kept in groups of 2, in Macrolon cages type 2, with standarized soft wood bedding.
The animal room was air conditioned at 22 +/-3 °C, a relative humidity of 55 +/- 15%, a 12-hour light/dark cycle, and approximately 15 air changes per hour. Mouse standard food and water was supplied ad libitum.

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

polyethylene glycol

Details on oral exposure:

-rior to dosing the animals were fasted over night.

Doses:

males and females were exposed to 5000 mg/kg body weight (single application)

No. of animals per sex per dose:

5 males and 5 females

Control animals:

no

Details on study design:

Observation for mortality was on every day, mortality was checked daily, and body weight was determined on days 1, 7, 14, and at death

Statistics:

LD50 calculated including 95% confidence limits by the logit method (J. Berkson, J. Am. Stat. Ass. 39, 357 - 365 (1944)

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Mortality:

1/5 male mice died after 24 hours, no female mouse died at all (0/5)

Clinical signs:

other: sedation, dyspnoera, ruffeld fur, curved body position were the only symptoms observed, they disappeared on day 11 completely.

Gross pathology:

no gross pathological findings were recorded.

Applicant's summary and conclusion

Interpretation of results:

practically nontoxic

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The oral LD50 in mice is > 5000 mg/kg body weight with only one dead male mouse.

Executive summary:

The oral LD50 in mice is > 5000 mg/kg body weight with only one dead male mouse.