1,4-Benzenediamine, N,N'-mixed Ph and tolyl derivs.

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Guideline study with GLP and according to internationally accepted guideline.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1994

Report date:

1994

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

EPA OTS 798.1175 (Acute Oral Toxicity)

Deviations:

not specified

Principles of method if other than guideline:

Initial doses were considered range-finding, then limit test conducted.

GLP compliance:

yes (incl. QA statement)

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

1,4-Benzenediamine, N,N'-mixed Ph and tolyl derivs.

EC Number:

273-227-8

EC Name:

1,4-Benzenediamine, N,N'-mixed Ph and tolyl derivs.

Cas Number:

68953-84-4

Molecular formula:

C18-20H16-20N2

IUPAC Name:

Reaction mass of N-phenyl,N'-o-tolyl-phenylene diamine, N,N'-diphenyl-p-phenylene diamine and N,N'-di-o-tolyl-phenylene diamine

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

Rats purchased from Charles River, Massachusetts at 6-10 weeks of age. Animals were in ranges of 146 -165 grams in rangefinder, and 174-266 grams for limit test. Rats were housed individually @ 18 - 26 degrees C, 12 hr/ light/12 hr dark cycles at 40 - 70% humidity. Rats were fasted prior to dosing (time unspecified), and given diet (Wayne Teklad Lab Blox) and water ad libitum.

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

corn oil

Details on oral exposure:

The vehicle was corn oil administered as control & with test chemical at dosing volume of 10 ml/kg. Test chemical was suspended in corn oil with use of Polytron at concentrations of 50, 250 and 500 mg/ml to achieve delivered doses of 500, 2500 & 5000 mg/kg bw (single dose). The limit dose of 5000 mg/kg bw was prepared in the same manner.

No. of animals per sex per dose:

The rangefinder employed 1 male, 1 female rat for each of 3 doses. The limit test used 5 rats of each sex.

Control animals:

no

Details on study design:

Rats were observed daily for signs of gross behavior & mortality. Body weights were recorded on days 0, 7, and 14. Animals were subjected to necropsies following sacrifice on day 14.

Statistics:

None

Results and discussion

Preliminary study:

0/2 rats died within 72 hr at the 500, 2500 or 5000 mg/kg bw dose.

Effect levels

Effect levels 1

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Based on:

test mat.

Effect levels 2

Sex:

male

Dose descriptor:

LDLo

Effect level:

ca. 5 000 mg/kg bw

Based on:

test mat.

Mortality:

1 of 5 male rats died at the limit dose (5000 mg/kg bw) on Day 7 of the test while 0/5 females died.

Clinical signs:

other: Females exhibited no adverse signs during 14 day observation period. Males showed decreased activity & muscular tone (2/5), and diarrhea 3/5).

Gross pathology:

Pale color observed for kidneys, liver, and spleen in males; no adverse signs in females.

Applicant's summary and conclusion

Interpretation of results:

practically nontoxic

Remarks:

Migrated information Criteria used for interpretation of results: expert judgment

Conclusions:

Test chemical exhibits very low toxicity following single dose by oral gavage. LD50 >5000 mg/kg.

Executive summary:

An oral gavage test was conducted in rats. Following pilot study that showed no lethality up to dose of 5000 mg/kg bw, a limit test was conducted. Test chemical exhibits very low toxicity following single dose by oral gavage with LD50 >5000 mg/kg bw.