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Toxicological information

Acute Toxicity: dermal

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Administrative data

Endpoint:
acute toxicity: dermal
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 and no information on 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 rabbits/dose, 4 doses, exposure time not mentioned, up to 14 d observation time, gross autopsy
GLP compliance:
no
Test type:
standard acute method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Test substance: p-cresol, purity not noted; M.P.: 36° C; B.P.: 202°C

Test animals

Species:
rabbit
Strain:
not specified
Sex:
not specified
Details on test animals and environmental conditions:
no further data

Administration / exposure

Vehicle:
other: none
Details on dermal exposure:
no further data
Duration of exposure:
no data
Doses:
215, 316, 464, 681 mg/kg bw
No. of animals per sex per dose:
5 rabbits per dose
Control animals:
no
Details on study design:
no further data
Statistics:
yes, but method not mentioned

Results and discussion

Effect levels
Sex:
not specified
Dose descriptor:
LD50
Effect level:
ca. 301 mg/kg bw
95% CL:
>= 213 - <= 426
Remarks on result:
other: tremor, salivation, sedation , severe subdermal hemorrhaging, severe erythema
Mortality:
: 215 mg/kg bw: 1/5; 316 mg/kg bw: 3/5; 464 mg/Kg bw: 4/5; 681 mg/kg bw: 5/5
Clinical signs:
signs of intoxication from 4-12 hrs post appl.: tremor, salivation sedation , recovery occurred within 3 days post application
Body weight:
initial mean body weight ranged from2.5-2.7 kg; mean terminal body weight of rabbists dosed with 215 mg/kg : 2.3 kg (no further data given)
Gross pathology:
gross autopsy: survivors: no significant findings; decedents: inflammation of kidneys
Other findings:
dermal irritation: severe subdermal hemorrhaging, severe erythema

Any other information on results incl. tables

doses and mortality:
215mg/kg bw: 1/5; 316 mg/kg bw: 3/5; 464 mg/Kg bw: 4/5; 681 mg/kg bw: 5/5
signs of intoxication from 4-12 hrs post appl.: tremor, salivation sedation, death
dermal irritation: severe subdermal hemorrhaging, severe erythema
gross autopsy: survivors: no significant findings; decedents: inflammation of kidneys

Applicant's summary and conclusion

Executive summary:

To determine LD-50 value, rabbits received dermal application of 215 -681 mg/kg bw undiluted p-cresol and were observed for clinical signs of toxicity and mortality for up to 14 days: LD50 was determined 301 mg/kg bw. As signs of intoxication tremor, salivation, sedation was noted ; the treated skin showed severe erythema and severe subdermal hemorrhaging.