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Toxicological information

Acute Toxicity: oral

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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Reproduced from SIAR 6-tert-Butyl-m-cresol, 08.08.2002

Data source

Reference
Reference Type:
publication
Title:
Unnamed
Year:
1999

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Principles of method if other than guideline:
5 male and 5 female rats received a single oral application per gavage of 0, 130, 320, 800 or 2000 g/kg bw of the test substance. Post-exposure period was 14 days.
GLP compliance:
yes
Test type:
standard acute method

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
produced by Sumitomo Chemical Co., Ltd. Purity 99.23 %

Test animals

Species:
rat
Strain:
Crj: CD(SD)
Sex:
male/female

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
corn oil
Doses:
0, 130, 320, 800, 2000 mg/kg bw
No. of animals per sex per dose:
5 males and 5 females
Control animals:
yes

Results and discussion

Effect levelsopen allclose all
Sex:
female
Dose descriptor:
LD50
Effect level:
>= 130 - <= 320 mg/kg bw
Sex:
male
Dose descriptor:
LD50
Effect level:
>= 320 - <= 800 mg/kg bw
Mortality:
male rats: dose 0 mg/kg bw, mortality 0/5; dose 130 mg/kg bw, mortality 0/5; dose 320 mg/kg bw, mortality 0/5; dose 800/kg bw, mortality 4/5; dose 2000 mg/kg bw, mortality 3/5
female rats: dose 0 mg/kg bw, mortality 0/5; dose 130 mg/kg bw, mortality 0/5; dose 320/kg bw, mortality 3/5; dose 800 mg/kg bw, mortality 4/5; dose 2000 mg/kg bw, mortality 4/5
Clinical signs:
hypoactivity, a prone or lateral position and soiled fur in 800 mg/kg or in males and 130 mg/kg or more in females. Bradypnea and Cheyne-Strokes' respiration in moribund animals of both sexes. Hypothermia, clonic convulsion, ataxic gait and vocalisation in females
Body weight:
decrease in body weight was noted in males receiving 320 mg/kg or more and with 800 mg/kg and more in females
Gross pathology:
pathological lesions were observed in the digestive organ and kidneys
Other findings:
no data

Any other information on results incl. tables

Cumulative Daily Mortality 

Male
Dose(mg/kg) Cum. Mortal. Time of death
0 0/5
130 0/5
320 0/5
800 4/5 d1:1an, d2:3an
2000 3/5 d2:2an, d3:1an
Female
Dose(mg/kg) Cum. Mortal. Time of death
0 0/5
130 0/5
320 3/5 d2:3an
800 4/5 d1:1an, d2:3an
2000 4/5 d2:4an
Cum. Mortal.; Cumulative Mortality; No. of animals which dead/ No. of animals used an; animal, d; day

Applicant's summary and conclusion

Interpretation of results:
harmful
Remarks:
Migrated information
Executive summary:

method: 5 male and 5 female rats received a single oral application per gavage of 0, 130, 320, 800 or 2000 g/kg bw of the test substance. Post-exposure period was 14 days.

result: LD50 = 130 -320 mg/kg bw (rat, female), LD50 = 320 -800 mg/kg bw (rat, male)

reference: MHW, Japan (1999)