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Toxicological information

Acute Toxicity: oral

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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: No information about strain used, GLP

Data source

Reference
Reference Type:
publication
Title:
Bio-Fax-data sheet: p-cresol
Author:
Industrial. Bio-Test Laboratory Inc.
Year:
1969
Bibliographic source:
Industrial Bio-Test Laboratory Inc, Northbrook, Ill/USA, data sheet no. 5-5/69

Materials and methods

Principles of method if other than guideline:
5 rats/dose group, observed for symptoms for up to 14 d, 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:
p-cresol: M.P.: 36°C; B.P.: 202°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:
unchanged (no vehicle)
Details on oral exposure:
no flurther data
Doses:
100, 147, 215, 316 mg/kg bw
No. of animals per sex per dose:
5 male rat/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:
207 mg/kg bw
95% CL:
>= 172 - <= 250
Remarks on result:
other: hypoactivity, tremor, lacrimation, dyspnea, hemorrhagic rhinitis, conculsion, prostration
Mortality:
mortality occurred within 4 hours post dosing
100 mg/kg bw: 0/5; 147 mg/kg bw: 0/5; 215 mg/kg bw: 3/5; 316 mg/kg bw: 5/5
Clinical signs:
onset in all animals within the first 4 hours post dosing: hypoactivity, tremors, lacrimation, dyspnea, hemorrhagic rhinitis, convulsions, prostration, recovery occurred in all survivors
Body weight:
initial mean body weight ranged between 187-220 g terminal mean body of the survivor-groups: 227-229 g (no further data)
Gross pathology:
Necropsy of the rats that died revealed gastrointestinal inflammation and haemorrhage and hyperaemia of the lungs, liver and kidney.  
Survivors showed only gastrointestinal tract inflammation.
Other findings:
no further data

Any other information on results incl. tables

Doses and mortality:
100 mg/kg bw: 0/5; 147 mg/kg bw: 0/5; 215 mg/kg bw: 3/5; 316 mg/kg bw: 5/5
Signs of intoxication: hypoactivity, tremors, lacrimation, dyspnea, hemorrhagic rhinitis, convulsions, prostration, death
Necropsy of the rats that died revealed gastrointestinal inflammation and haemorrhage and hyperaemia of the lungs, liver and kidney.  
Survivors showed only gastrointestinal tract inflammation.

Applicant's summary and conclusion

Executive summary:

Following single oral doses to rats the LD50 was determined 207 mg/kg bw. The observed signs of intoxication included hypoactivity, tremors, lacrimation, dyspnea, hemorrhagic rhinitis, convulsions and prostration.