Reaction mass of 1-(4-aminophenyl)-1,3,3-trimethylindan-5-amine and 3-(4-aminophenyl)-1,1,3-trimethyl-2,3-dihydro-1H-inden-5-amine

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

April 1973

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1973

Report date:

1973

Materials and methods

Test guideline

Qualifier:

no guideline available

Principles of method if other than guideline:

Study carried out prior to guideline and GLP

GLP compliance:

no

Remarks:

Study conducted prior to GLP

Test material

Test material information

Constituent 1

Reference substance name:

Diamino Trimethylphenylindane

IUPAC Name:

Diamino Trimethylphenylindane

Test material form:

solid: particulate/powder

Details on test material:

Purity:
97.6% (49.9% 6-4’ isomer, 47.7 5-4’ isomer; per Protocol)

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

Young albino rats of the Sprague-Dawlcy strain* were used as test animals. All animals were kept under observation for five days prior to experimental use, during which period they were checked for general physical health and suitability as test animals. The animals were housed in stock cages and were permitted a standard laboratory diet plus water ad libitum, except during the 16-hour period immediately prior to oral intubation when food was withheld.

Administration / exposure

Route of administration:

other: hypodermic syringe with ball tipped intubating needle

Vehicle:

corn oil

Details on oral exposure:

Initial screening was conducted in order to determine the general
level of toxicity of the test material. Selected groups of four albino rats
each (two males and two females) were administered the test material at
several dose levels. All doses were administered directly into the stomachs
of the r a t s using a hypodermic syringe equipped with a ball-tipped intubating
needle.

Doses:

400, 600, 900, 1350 mg/kg

No. of animals per sex per dose:

2

Control animals:

no

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

600 mg/kg bw

Based on:

test mat.

Mortality:

See data table

Clinical signs:

other: 600 mg/kg dose level: Hypoactivity Ruffed fur Muscular weakness Salivation Lacrimation Prostration 900 mg/kg dose level: Hypoactivity Ruffed fur Muscular weakness Salivation Lacrimation Prostration Hypothermia Shallow breathing Emaciation 1350 dose leve

Any other information on results incl. tables

Mortality and Body Weight Data

Dose (mg/kg)	Animal Number and Sex	Individual Body Weight Day 0	Individual Body Weight Day 14	Number Dead/Number tested	Precent dead
400	1M	212	310	0/4	0
	2M	201	308
	3F	179	225
	4F	167	208
600	5M	208	(2days)	3/4	75
	6M	205	(2days)
	7M	174	(2 days)
	8F	183	224
900	9M	197	(5 days)	3/4	75
	10M	204	(1 day)
	11F	152	187
	12F	173	(1 day)
1350	13M	203	(6 -22 hours)	4/4	100
	14M	217	(1day)
	15F	161	(6 -22 hours)
	16F	167	(6 -22 hours)

Applicant's summary and conclusion

Interpretation of results:

Category 4 based on GHS criteria

Conclusions:

an LD50 of 600 mg/kg was calculated for acute oral toxicity using the techniques of Weil and Thompson.

Executive summary:

Young albino rats of the Sprague-Dawlcy strain* were used as

test animals. All animals were kept under observation for five days prior

to experimental use, during which period they were checked for general

physical health and suitability as test animals. The animals were housed in

stock cages and were permitted a standard laboratory diet plus water ad

libitum, except during the 16-hour period immediately prior to oral intubation

when food was withheld.

Initial screening was conducted in order to determine the general

level of toxicity of the test material. Selected groups of four albino rats

each (two males and two females) were administered the test material at

several dose levels. All doses were administered directly into the stomachs

of the r a t s using a hypodermic syringe equipped with a ball-tipped intubating

needle.

After oral administration of the test material, the rats were housed

individually in suspended, wire-mesh cages and observed for the following

14 days. Initial and final body weights, mortalities, and reactions were r e corded.

A necropsy was conducted on any animal which died during the

study and on all animals sacrificed at the end of the 14-day observation

period.

At the end of the observation period, the acute oral median lethal

dose (LD50) of 600 mg/kg was calculated.