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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Toxicological information

Acute Toxicity: dermal

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Administrative data

Endpoint:
acute toxicity: dermal
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: 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:
Method: other: 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

Constituent 1
Chemical structure
Reference substance name:
p-cresol
EC Number:
203-398-6
EC Name:
p-cresol
Cas Number:
106-44-5
Molecular formula:
C7H8O
IUPAC Name:
4-methyl-phenol
Details on test material:
IUCLID4 Test substance: other TS: 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 or test system 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
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

Freetext:
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 sclinical 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.