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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

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Diss Factsheets

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:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: scientifically acceptable and well documented

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1981
Report date:
1981

Materials and methods

Principles of method if other than guideline:
5 male and 5 female rats received a single oral application per gavage of 1.0, 2.0, 3.1, 4.0, 4.5 and 5.0 g/kg bw of the test substance. Post-exposure period was 14 days.
GLP compliance:
not specified
Test type:
standard acute method

Test material

Constituent 1
Chemical structure
Reference substance name:
2-tert-butyl-p-cresol
EC Number:
219-314-6
EC Name:
2-tert-butyl-p-cresol
Cas Number:
2409-55-4
Molecular formula:
C11H16O
IUPAC Name:
2-tert-butyl-4-methylphenol
Details on test material:
no data

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals or test system and environmental conditions:
male and female Wistar rats, (strain TNO 74), average weight 173 g. At the start of the study the male rats were about 9 weeks and the female rats were about 14 weeks old

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
other: lutrol
Details on oral exposure:
substance was formulated in lutrol at room temperature and applicated per gavage with a constant application volume of 20 ml/kg bw
Doses:
1.0, 2.0, 3.1, 4.0, 4.5 and 5.0 g/kg bw
No. of animals per sex per dose:
5 male + 5 female rats
Control animals:
not specified
Details on study design:
animals were inspected several times on day of the application of the test substance. During the post observation period of 14 days animals were inspected twice daily and beginning, nature and intensity of clinical signs recorded and dead animals removed if applicable
Statistics:
according Fink and Hund (1965), Arzneimittelforschung 15, 624

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
3 100 mg/kg bw
Mortality:
male rats: dose 1.0 g/kg bw, mortality 0/5; dose 2.0 g/kg bw, mortality 1/5; dose 3.1 g/kg bw, mortality 3/5; dose 4.0/kg bw, mortality 1/5; dose 4.5 g/kg bw, mortality 4/5; dose 5.0 ml/kg bw, mortality 5/5;
female rats: dose 1.0 g/kg bw, mortality 0/5; dose 2.0 g/kg bw, mortality 2/5; dose 3.1 g/kg bw, mortality 0/5; dose 4.0/kg bw, mortality 5/5; dose 4.5 g/kg bw, mortality 4/5; dose 5.0 ml/kg bw, mortality 5/5;
Clinical signs:
other: with toxic doses: reduction of general condition, prone position, sedation/anaesthesia, diarrhoea, increased diuresis, weight loss
Gross pathology:
perforation of the stomach, stomach adhered with spleen, liver, diaphragm, mucous membrane of stomach was covered with a white sanious covering, very small kidney, kidney adhered with adipose tissue
Other findings:
no further data

Any other information on results incl. tables

no data

Applicant's summary and conclusion

Executive summary:

method: 5 male and 5 female rats received a single oral application per gavage of 1.0, 2.0, 3.1, 4.0, 4.5 and 5.0 g/kg bw of the test substance. Post-exposure period was 14 days.

result: LD50 = 3100 mg/kg bw (male + female rats)

reference: Loeser (Bayer AG), 1981