p-toluidine

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Comparable to guideline study with acceptable restrictions: No gross and/or microscopic pathology

Data source

Reference

Reference 1

Reference Type:

study report

Title:

Unnamed

Year:

1978

Report date:

1978

Reference 2

Reference Type:

secondary source

Title:

p-Toluidine - CAS No: 106-49-0 - SIDS Initial Assessment Report.

Author:

OECD

Year:

2005

Bibliographic source:

UNEP Publications

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

yes

Remarks:

Analytical purity not reported. Animal environmental conditions not reported. Fasting period not reported. Individual weights are not reported. Microscopic and gross pathology examination not performed.

GLP compliance:

no

Remarks:

GLP compliance was not mandatory at the time of the study

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

p-toluidine

EC Number:

203-403-1

EC Name:

p-toluidine

Cas Number:

106-49-0

Molecular formula:

C7H9N

IUPAC Name:

4-methylaniline

Details on test material:

- Name of test material (as cited in study report): p-toluidine
- Analytical purity: no data

Test animals

Species:

rat

Strain:

Wistar

Sex:

male

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Winkelmann, Germany
- Weight at study initiation: 160-180 kg
- Housing: 5 animals per cage

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

other: Lutrol

Doses:

100, 500, 600, 650, 700, 900 mg/kg bw

No. of animals per sex per dose:

10

Control animals:

other: not applicable

Details on study design:

- Duration of observation period following administration: 14 days
- Other examinations performed: clinical signs

Statistics:

Calculation of LD50 value: Fink, Arzneim.-Forschg: 15, 624, 1965

Results and discussion

Effect levels

Sex:

male

Dose descriptor:

LD50

Effect level:

620 mg/kg bw

95% CL:

>= 560 - <= 670

Remarks on result:

other: rats

Mortality:

see table 1

Clinical signs:

other: Signs of intoxication: poor reflexes, increased excretion of urine, emaciation, bloody eye, narcosis, cyanosis

Any other information on results incl. tables

Table 1: Overview of mortalities, time points of death and signs of intoxication:

dose (mg/kgbw)	time o fdeaths	number of deaths	no of rats with signs of intoxication	no of rats used
100	no deaths	0	10	10
500	2 -3 days	2	10	10
600	3 hrs-5 days	4	10	10
650	2 -3 hrs	4	10	10
700	2 -3 days	9	10	10
900	3 hrs- 3 days	10	10	10

 

 

Applicant's summary and conclusion

Executive summary:

To determine LD50 values of p-toluidine, an acute oral toxicity test was performed according to a method similar to OECD 401 with deviations (analytical purity not reported. Housing and feeding conditions not reported. Individual weights not reported. Microscopic and gross pathology examination not performed). In the present study 10 male rats per dose received dosages ranging from 100 mg/kg bw up to 900 mg/kg bw dissolved in lutrol. Signs of intoxications were hypoactivity, increase of urinary excretion, emaciation, bloody eyes, cyanosis, anorexia and narcosis which led to dose related death during the 14 day post exposure observation period. The resulting LD50 value is 620mg/kg bw (95%CL: 560 -670 mg/kg bw).