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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Toxicological information

Acute Toxicity: oral

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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
migrated information: read-across based on grouping of substances (category approach)
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: individual animal data not given

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

Materials and methods

Principles of method if other than guideline:
Method: other: 5 male rats/dose, observed for symptoms and mortality up to 10-14 days, afterwards gross autopsy
GLP compliance:
no
Test type:
standard acute method
Limit test:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
o-cresol
EC Number:
202-423-8
EC Name:
o-cresol
Cas Number:
95-48-7
Molecular formula:
C7H8O
IUPAC Name:
o-cresol
Details on test material:
IUCLID4 Test substance: other TS: o-cresol, no data on purity, MP. 30°C

Test animals

Species:
rat
Strain:
not specified
Sex:
male
Details on test animals or test system and environmental conditions:
no further data

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
other: undiluted
Details on oral exposure:
no further data
Doses:
68, 100, 147, 215 mg/kg bw
No. of animals per sex per dose:
5 male rats/dose
Control animals:
no
Details on study design:
no further details
Statistics:
yes, but method not mentioned

Results and discussion

Effect levels
Sex:
male
Dose descriptor:
LD50
Effect level:
121 mg/kg bw
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:
other: All animals showed signs of intoxication including hypoactivity, tremor, convulsions, salivation, dyspnea, prostration within 4 hours post dosing
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

Any other information on results incl. tables

RS-Freetext:
All animals showed signs of intoxication including hypoactivity, tremor,  
convulsion, salivation, dyspnea, prostration within 4 hours post dosing  
and from 100 mg onwards animals died.
mortality occurred within 4 hours post dosing;
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

At autopsy, survivors showed no significant findings, decedents showed  
hemorrhage of gastrointestinal tract, hyperemia of liver, kidney and lungs

Applicant's summary and conclusion

Executive summary:

To determine LD50 -value 5 male rats/dose received single oral doses of 68, 100, 147, 215 mg/kg bw by gavage and were observed for symptoms and mortality for up to 10 -14 days. Suvivors and decedents were examined afterwards by gross autopsy:

LD50 was determined 121 mg/kg bw (Industrial Bio-test Laboratories 1969)