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

Study period:

1973

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Non-GLP study performed without analytical measurements.

Cross-reference

Reason / purpose for cross-reference:

reference to same study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1973

Materials and methods

Test guideline

Qualifier:

no guideline followed

Principles of method if other than guideline:

Vapour generated by an air-stream was passed through a inhalation chamber in which rats were exposed (whole body exposure) to the vapour stream for 4 hours. Observation was for 14 days post exposure.

GLP compliance:

no

Test type:

fixed concentration procedure

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. L-80028

Test animals

Species:

rat

Strain:

other: Charles River albino rats

Sex:

male/female

Details on test animals or test system and environmental conditions:

Younf male and female rats (average weight 209 gm) were checked for health before entering the test. Animals were housed individually , and food and water was supplied ad libitum.

Administration / exposure

Route of administration:

inhalation: vapour

Type of inhalation exposure:

whole body

Vehicle:

other: unchanged (no vehicle)

Details on inhalation exposure:

Exposure was in a 70l plexiglass chamber in which all rats were exposed by whole-body-exposure.
Cold air (-40°C) was passed through the test substance at a flow rate of 4.9 l/min, at a pressure of 29.92 inches of Hg at 25°C.
The average nominal vspour conc. was 30 mg/m3 air . This was the highest technically achievable concentration.

Analytical verification of test atmosphere concentrations:

yes

Duration of exposure:

>= 4 h

Concentrations:

30 mg/m3 air (average)

No. of animals per sex per dose:

5 ales and 5 females

Control animals:

yes

Statistics:

no statistics was applied

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LC50

Effect level:

> 30 mg/m³ air (nominal)

Exp. duration:

4 h

Remarks on result:

other: whole body exposure

Mortality:

no mortality occurred during the exposure and during the 14-day observation period.

Clinical signs:

other: no substance-related clinical signs were recorded.

Body weight:

body weight development was equal to that of the air control group.

Gross pathology:

Compared to the control group, a slight discoloration of the liver of all treated animals was observed.

Other findings:

none

Applicant's summary and conclusion

Interpretation of results:

relatively harmless

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

under the conditions of the test (30 mg/ MY720 per m3 air, for 4 hours) no signs of toxicity were recorded during the 14-day observation period.
The concentration used was the highest technically achievable concentration with this compound.
The LC50 is > 30 mg/m3 air as no mortality occurred and no adverse effects were noted.

Executive summary:

under the conditions of the test (30 mg/ MY720 per m3 air, for 4 hours) no signs of toxicity were recorded during the 14-day observation period. The concentration used was the highest technically achievable concentration with this compound. The LC50 is > 30 mg/m3 air as no mortality occurred and no adverse effects were noted.