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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: individual animal not shown

Data source

Reference
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

Materials and methods

Principles of method if other than guideline:
Method: other: 5 rabbits/dose, exposure period not given, observation up to 14 days, 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:
rabbit
Strain:
not specified
Sex:
not specified
Details on test animals or test system and environmental conditions:
no further data

Administration / exposure

Type of coverage:
not specified
Vehicle:
other: undiluted
Details on dermal exposure:
no further data
Duration of exposure:
no data
Doses:
681, 1000, 1470, 2150 mg/kg bw
No. of animals per sex per dose:
5 rabbits/dose
Control animals:
not specified
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:
1 380 mg/kg bw
95% CL:
>= 841 - <= 2 260
Remarks on result:
other: clinical signs included hypoactivity salivation, tremors ; dermal irritation: severe erythema
Mortality:
681 mg/kg bw: 1/5
1000 mg/kg bw: 2/5
1470 mg/kg bw: 2/5
2150 mg/kg bw: 4/5
Clinical signs:
Hypoactivity salivation, tremors ; dermal irritation: severe erythema
Body weight:
initial bw 2.44 - 2.61 kg; terminal bw not given
Gross pathology:
gross autopsy: survivors: no significant findings; decedents: hyperemia of the liver and lungs
Other findings:
no further details

Any other information on results incl. tables

RS-Freetext:
Signs of intoxication:
hypoactivity, salivation, tremor, severe erythema

681 mg/kg bw: 1/5 rabbit died between day 8 and day 14, but showed no signs of intoxication
1000 mg/kg bw: clinical signs developed between 4-12 hours and 2/5 rabbits diedwithin the first 2 days
1470 mg/kg bw: clinical clinical signs developed between 4-12 hours, 1/5 rabbit died on day 2 and 1/5 between day 8 and day 14
2150 mg/kg bw: clinical signs developed between 0-4 hours, death of 4/5 rabbits occurred within 4 days.

Gross autopsy revealed in survivors no significant findings; decedents showed hyperemia of the liver and lungs

Applicant's summary and conclusion

Executive summary:

Single dermal application of undiluted o-cresol (681 -2150 mg/kg bw) to the skin of rabbits resulted in an LD50 value of 1380 mg/kg bw . Clinical signs displayed by the animals included hypoactivity, tremorm convulsion, salivation, dyspnea, prostration and additionally severe erythema.(Industrial Biotest Laboratories 1969)

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