Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1969, 1983
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: No individual animal data were indicated.

Data source

Referenceopen allclose all

Reference Type:
publication
Title:
Bio-Fax data sheet: o-cresol
Author:
Industrial Bio-Test Laboratories Inc.
Year:
1969
Bibliographic source:
Data sheet no 4-5/69, Industrial Bio-Test Laboratories Inc. Northbrook, Ill, USA
Reference Type:
review article or handbook
Title:
Toxizität von Desinfektionsmittelwirkstoffen
Author:
Harke HP
Year:
1983
Bibliographic source:
Hygiene + Medizin 8, 420-423
Reference Type:
publication
Title:
O-CRESOL CAS N°: 95-48-7
Year:
2005
Bibliographic source:
PPCS INCHEM; UNEP publication; OECD Screening information datat set (SIDs)

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
no
GLP compliance:
no
Test type:
standard acute method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rat
Strain:
not specified
Sex:
male

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
other: undiluted
Doses:
68, 100, 147, 215 mg/kg bw
No. of animals per sex per dose:
5 male rats/dose
Control animals:
no

Results and discussion

Effect levels
Sex:
male
Dose descriptor:
LD50
Effect level:
121 mg/kg bw
Remarks on result:
other: signs of intoxication included hypoactivity, tremor, convulsions, salivation, dyspnea, prostration within 4 hours post dosing
Mortality:
68 mg/kg bw: no deaths but signs of intoxication; recovery within 2 days
100 mg/kg bw: mortality: 2/5; survivors recovered within 4 days
147 mg/kg bw: mortality: 3/5; surviors recovered within 6 days
215 mg/kg bw: mortality: 5/5
Clinical signs:
All animals showed signs of intoxication including hypoactivity, tremor, convulsions, salivation, dyspnea, prostration within 4 hours post dosing
Body weight:
Initial body weight: 195 g // terminal body weight: 219 g
Gross pathology:
At autopsy, survivors showed no significant findings, decedents showed hemorrhage of gastrointestinal tract, hyperemia of liver , kidneys and lungs.
Other findings:
no further data

Applicant's summary and conclusion