MP99

Acute Toxicity: oral

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

Reference

Reference 1

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 2

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

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

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

Test material information

Constituent 1

Reference substance name:

o-cresol

EC Number:

202-423-8

EC Name:

o-cresol

Cas Number:

95-48-7

Molecular formula:

C7H8O

IUPAC Name:

2-methyl-phenol

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:

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)