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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

Reference
Name:
Unnamed
Type:
Constituent
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 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:
All animals showed signs of intoxication including hypoactivity, tremor, convulsions, salivation, dyspnea, prostration within 4 hours post dosing
Body weight:
rat dosed 68 mg/kg bw: initial body weight: 195 g // terminal body weight: 219 g ; no further terminal body weights given
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)