Registration Dossier

Toxicological information

Acute Toxicity: oral

Currently viewing:

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

Referenceopen allclose all

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

Constituent 1
Chemical structure
Reference substance name:
o-toluidine
EC Number:
202-429-0
EC Name:
o-toluidine
Cas Number:
95-53-4
Molecular formula:
C7H9N
IUPAC Name:
o-toluidine
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:
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

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.)