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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, statistical evaluation not given

Data source

Reference
Reference Type:
publication
Title:
Bio fax data sheet: m-cresol
Author:
Industrial Bio-test Laboratory Inc.
Year:
1969
Bibliographic source:
Industrial Bio-test Laboratory Inc, Northbrook, Ill/USA, Data sheet no 3-5/69

Materials and methods

Principles of method if other than guideline:
Method: other: 5 rabbits/dose, 4 doses, exposure time not mentioned, up to 14 days post exposure observation time
GLP compliance:
not specified
Test type:
standard acute method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
IUCLID4 Test substance: m-cresol, M.P.: 11-12 C; B.P.: 202.8 C

Test animals

Species:
rabbit
Strain:
not specified
Sex:
not specified
Details on test animals and environmental conditions:
TEST ANIMALS
- Weight at study initiation: 2.29 -2.67 kg

Administration / exposure

Type of coverage:
not specified
Vehicle:
other: none
Details on dermal exposure:
no further data
Duration of exposure:
no data
Doses:
1000, 1470, 2150, 3160 mg/kg bw
No. of animals per sex per dose:
5
Control animals:
not specified
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing:
- Necropsy of survivors and decedents performed: yes
- Other examinations performed: clinical signs,
Statistics:
yes, method not given

Results and discussion

Effect levels
Sex:
not specified
Dose descriptor:
LD50
Effect level:
2 050 mg/kg bw
95% CL:
>= 1 590 - <= 2 650
Remarks on result:
other: Clinical signs included hypoactivity, salivation, tremors and convulsions; the treated skin showed severe erythema and burns.
Mortality:
see section "remarks on results"
Clinical signs:
see section " remarks on results including tables and figures"
Body weight:
terminal body weight: no data
Gross pathology:
see sedtion " remarks on results including tables and figures"
Other findings:
no data

Any other information on results incl. tables

RS-Freetext:
Dosage onset of symp. mortality mortality
mg/kg 4-12 hrs 12-24 hrs day3 cumulative

1000 0/5
1470 0/5
2150 S 4/5 4/5
3160 S 4/5 4/5

S = signs of intoxication from 4 hrs up to 12 hrs p.a.:
lacrimation, salivation,
hypersensitivity, convulsion, hypoactivity:
dermal
irritation: severely burned, severe edema

gross necropsy-survivors: no significant findings
gross necropsy-decedents: hyperemia of lungs and kidneys

Applicant's summary and conclusion

Executive summary:

Dermal application of testsubstance to the skin of rabbits and an exposure observation time for 14 days yielded a LD50 of 2050 mg/kg bw and severe irritational effects