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Diss Factsheets

Toxicological information

Acute Toxicity: dermal

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Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
other: secondary literature, reproduced from SIAR 6-tert-Butyl-m-cresol, 08.08.2002

Data source

Reference
Reference Type:
secondary source
Title:
No information
Author:
Sumitomo Chemical (1976)
Year:
1976
Bibliographic source:
cited: OECD SIDS Initial Assessment Report, Boston 20-25th Oct. 2002

Materials and methods

Principles of method if other than guideline:
10 male/female mice per group received a dose of 500, 750, 1000, 1750, 2500 and 5000 mg/kg bw of 6-tert-butyl-m-cresol
GLP compliance:
no
Test type:
standard acute method

Test material

Constituent 1
Chemical structure
Reference substance name:
6-tert-butyl-m-cresol
EC Number:
201-842-3
EC Name:
6-tert-butyl-m-cresol
Cas Number:
88-60-8
Molecular formula:
C11H16O
IUPAC Name:
2-tert-butyl-5-methylphenol
Details on test material:
IUCLID4 Test substance: no data

Test animals

Species:
mouse
Strain:
not specified
Sex:
male/female
Details on test animals or test system and environmental conditions:
no data

Administration / exposure

Type of coverage:
not specified
Vehicle:
other: cotton oil
Details on dermal exposure:
no data
Duration of exposure:
no data
Doses:
500, 750, 1000, 1750, 2500, 5000 mg/kg
No. of animals per sex per dose:
10/group
Control animals:
not specified
Details on study design:
no data
Statistics:
no data

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
1 200 mg/kg bw
Mortality:
male rats: dose 500 mg/kg bw, mortality 0/10; dose 750 mg/kg bw, mortality 0/10; dose 1000 mg/kg bw, mortality 5/10; dose 1750 mg/kg bw, mortality 7/10; dose 2500 mg/kg bw, mortality 10/10; dose 5000 mg/kg bw, mortality 10/10
female rats: dose 500 mg/kg bw, mortality 0/10; dose 750 mg/kg bw, mortality 2/10; dose 1000 mg/kg bw, mortality 4/10; dose 1750 mg/kg bw, mortality 7/10; dose 2500 mg/kg bw, mortality 10/10; dose 5000 mg/kg bw, mortality 10/10
Clinical signs:
other: decrease of spontaneous activity, ataxia, hyperpnea, poor appetite, pilo-erection, edema in application site. Toxic signs were observed decrease of spontaneous activity and pilo-erection in 750 mg/kg or more, and ataxia, hyperpnea and poor appetite in 100
Gross pathology:
no remarkable change was found in macroscopic observation
Other findings:
no data

Any other information on results incl. tables

Cumulative Daily Mortality (Mouse Dermal)
Male
Dose(mg/kg)   Cum.Mortal.   Time of deat
500           0/10
750           0/10
1000          5/10          d1:5an
1750          7/10          d1:6an,
d2:1an
2500         10/10          d1:10an
5000         10/10          d1:10an

Female
Dose(mg/kg)   Cum.Mortal.   Time of deat
500           0/10
750           2/10          d1:2an
1000          4/10          d1:3an,
d6:1an
1750          7/10          d1:7an
2500         10/10          d1:10an
5000         10/10          d1:10an

Cum. Mortal.= Cumulative Mortality; No. of animals which died/ No. of  animals used
an= animal, d= da

Applicant's summary and conclusion

Executive summary:

method: 10 male/female mice per group received a dose of 500, 750, 1000, 1750, 2500 and 5000 mg/kg bw of 6-tert-butyl-m-cresol

result: LD50 = 1200 mg/kg bw (mouse, male + female)

reference: Sumitomo (1976)