Reaction mass of 4,4'-Isopropylidenediphenol, 1-chloro-2,3-epoxypropane and ethylenediamine

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

6/30/82 to 9/3/82

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline 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:

yes (incl. QA statement)

Test type:

fixed dose procedure

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

EDA-BADGE-EDA

Cas Number:

854009-15-7

Molecular formula:

C25H40N4O4

IUPAC Name:

EDA-BADGE-EDA

Constituent 2

Reference substance name:

EDA-BADGE-EDA-BADGE-EDA

Molecular formula:

C48H72N6O8

IUPAC Name:

EDA-BADGE-EDA-BADGE-EDA

Constituent 3

Reference substance name:

EDA-BADGE α-glycol

Molecular formula:

C23H34N2O5

IUPAC Name:

EDA-BADGE α-glycol

Constituent 4

Reference substance name:

reaction product of 2,2'-[(1-methylethylidene)bis(4,1-phenyleneoxymethylene)]bisoxirane and ethylene diamine

IUPAC Name:

reaction product of 2,2'-[(1-methylethylidene)bis(4,1-phenyleneoxymethylene)]bisoxirane and ethylene diamine

Constituent 5

Reference substance name:

Unidentified reaction product of 2,2'-[(1-methylethylidene)bis(4,1-phenyleneoxymethylene)]bisoxirane and ethylene diamine

IUPAC Name:

Unidentified reaction product of 2,2'-[(1-methylethylidene)bis(4,1-phenyleneoxymethylene)]bisoxirane and ethylene diamine

Test material form:

liquid: viscous

Specific details on test material used for the study:

Pale yellow crystalline solid
Batch number: 375/386 supplied by Anchor Chemical Limited
Recieved 30th june 1982
Stored at ambient temperature
The test material was ground to a fine powder and prepared as a 20% w/v suspension in arachis oil b.p.
The stability and absorbtion of the test material were not determined.

Test animals

Species:

rabbit

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

Seven male and Seven female albino rats were obtained from a reputable breeder. They were in the weight range of 110-131 g for males and 108-135g for females and approximately four to six weeks of age at the start of the study. All the rats were acclimatised to the laboratory environment for a minimum period of five days prior to the start of the experiment.
The rats were randomly allocated to cages within treatment groups. They were housed in groups of five in polypropylene cages with sawdust bedding. A standard laboratory rodent diet and mains tap water were provided ad libitum. Access to food was only prevented overnight prior to and two hours after dosing.

The animal room temperature was maintained at 22 +- 3 degrees C and recorded daily on a maximum and minimum thermometer. The rate of air exchance was approximately 20 changes per hour. Lighting was controlled by means of a time switch to give a 12 hour light/dark cycle. Humidity was not controlled but remained within a range of 65-75%RH recorded daily on a wet and dry bulb hygrometer.
Each animal at each dose level was uniquely identified by experimental cage label and ear punching.

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

arachis oil

Details on oral exposure:

All animals were dosed by oral gavage using a metal dosing needle.

Doses:

Range finding:
5 g/kg
10 g/kg

Main study:
10 g/kg

No. of animals per sex per dose:

5 per sex per dose

Results and discussion

Preliminary study:

No mortalities were observed in the range finding study and so the high dose level of 10 g/kg was selected.

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 10 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortality obvserved

Clinical signs:

other: Pilo-erection, an abnormal body carriage (hunched posture) and lethargy were observed shortly after dosing in all rats. Recovery of treated rats, as judged by external appearance and behaviour was apparently complete by day 1.

Gross pathology:

No macroscopic abnormalities were observed in any animal killed on day 14.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The acute oral median lethal dose of EDA adduct 870 was found to be greater than 10000 mg/kg bodyweight.