o-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 necropsy and no histopathological examinations were performed)

Data source

Reference

Reference 1

Reference Type:

study report

Title:

Unnamed

Year:

1978

Report date:

1978

Reference 2

Reference Type:

publication

Title:

o-TOLUIDINE CAS No: 95-53-4 SIDS Initial Assessment Report.

Author:

OECD SIDS

Year:

2006

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. Females were not tested. Fasting of animals not reported. No necropsy and no histopathological examinations. Body weights not recoreded. Few informations on environmental conditions.

GLP compliance:

no

Remarks:

GLP 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:

o-toluidine

EC Number:

202-429-0

EC Name:

o-toluidine

Cas Number:

95-53-4

Molecular formula:

C7H9N

IUPAC Name:

2-methylaniline

Test material form:

other: liquid

Details on test material:

- Name of test material (as cited in study report): o-toluidine
- Analytical purity: no data
- Physical state: liquid

Test animals

Species:

rat

Strain:

other: Wistar-II

Sex:

male

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Winkelmann, Germany
- Age: 6 - 7 weeks
- Weight at study initiation: 160 -180 g
-Housing conditions. animals were housed in groups of 5 per cage

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

single oral application of different doses of undiluted substance to groups of male rats

Doses:

0.600 - 0.650 - 0.700 - 0.800 - 0.900 mL/kg bw, undiluted (corresponding to 600, 650, 700, 800, 900 mg/kg bw (density: 0.998 g/cm³)

No. of animals per sex per dose:

10

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Necropsy of survivors performed: no
- Other examinations performed: clinical signs

Statistics:

Calculation of the median lethal dose (LD50) according to Fink and Hund (Arzneim. Forsch. 15, 1965, 624)

Results and discussion

Effect levels

Sex:

male

Dose descriptor:

LD50

Effect level:

750 mg/kg bw

95% CL:

710 - 790

Mortality:

Dose [ml/kg bw]: 600 mg/kg: 0/10 650 mg/kg: 1/10 4d post application 700 mg/kg: 4/10 within 3-4 days post application 800 mg/kg: 6/10 within 2-4 days post application 900 mg/kg: 10/10 within 2-5 days post application

Clinical signs:

other: 600 mg/kg: reduced general condition at day 2; 650 mg/kg: reduced general condition, anesthesia day 1 up to day 14; 700 mg/kg: reduced general condition, anaesthesia, increased diurese - day 1 up to day 14; 800 mg/kg: reduced general

Any other information on results incl. tables

MORTALITY:
Dose [ml/kg bw]:
600 mg/kg: 0/10
650 mg/kg: 1/10 4d post application
700 mg/kg: 4/10 within 3-4 days post application
800 mg/kg: 6/10 within 2-4 days post application
900 mg/kg: 10/10 within 2-5 days post application

CLINICAL SIGNS:
600 mg/kg: reduced general condition at day 2
650 mg/kg: reduced general condition, anesthesia
           day 1 up to day 14
700 mg/kg: reduced general condition, anaesthesia,
           increased diurese - day 1 up to day 14
800 mg/kg: reduced general condition, anaesthesia,
           cyanosis, bloody eyes - day 1 up to day 14
900 mg/kg: reduced general condition, anaesthesia,
           cyanosis, bloody eyes - day 1 up to time of
           death

Applicant's summary and conclusion

Executive summary:

Löser E (1978)

In male Wistar rats (n = 10) dosed with 0.6, 0.65, 0.7, 0.8 or 0.9 ml/kg bw (app. 600, 650, 700, 800 or 900 mg/kg bw) undiluted o-toluidine, deaths occurred at dose levels of = 0.65 ml/kg bw within 2 - 5 days after application. In moribund animals anesthesia, increased diurese, cyanosis, bloody eyes were observed. No necropsy and no histopathological examinations were performed. From this study a LD50 value of 0.75 ml/kg bw (corresponding to 750 mg/kg bw) was derived. This study was conducted with a method similar to OECD guideline 401 with acceptable deviations (Analytical purity not reported. Females were not tested. Fasting of animals not reported. No necropsy and no histopathological examinations. Body weights not recoreded. Few informations on environmental conditions of the animals.)