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Toxicological information

Acute Toxicity: oral

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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

Referenceopen allclose all

Reference Type:
study report
Title:
Unnamed
Year:
1978
Report date:
1978
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

Constituent 1
Chemical structure
Reference substance name:
p-toluidine
EC Number:
203-403-1
EC Name:
p-toluidine
Cas Number:
106-49-0
Molecular formula:
C7H9N
IUPAC Name:
p-toluidine
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:
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 

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).