Registration Dossier

Toxicological information

Acute Toxicity: oral

Currently viewing:

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
other: Only result reported in this compilation. No detailed documentation of test procedure and no raw data given.

Data source

Referenceopen allclose all

Reference Type:
publication
Title:
Range-finding toxicity data: List IV
Author:
Smyth HF, Carpenter CP, Weil CS
Year:
1951
Bibliographic source:
Arch Ind Hyg Occup Med 4: 119-122
Reference Type:
publication
Title:
The place of the range finding test in the industrial toxicology laboratory
Author:
Smyth HF, Carpenter CP
Year:
1944
Bibliographic source:
J Indus Hyg Toxicol 26,8: 269-274

Materials and methods

Test guideline
Qualifier:
no guideline available
Principles of method if other than guideline:
Six animals were given a single dose. After one week another 6 animals were given some other dose until two doses were found, differing by a factor of ten, where in one dose all animals died and in the other only some or no animals died. Post exposure period was 14 days. (see Smyth & Carpenter 1944)
GLP compliance:
no
Test type:
standard acute method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Cumene
- Analytical purity: Not stated
- Impurities (identity and concentrations): Not stated
- Lot/batch No.: Not given

Test animals

Species:
rat
Strain:
Wistar
Sex:
male

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Doses:
Initial dose judged by previous experience (10, 1, 0.1 etc. gm/kg). Six animals were given a single dose. After one week another 6 animals were given some other dose until two doses were found, differing by a factor of ten, where in one dose all animals died and in the other only some or no animals died.
No. of animals per sex per dose:
6
Control animals:
not specified

Results and discussion

Effect levels
Sex:
male
Dose descriptor:
approximate LD50
Effect level:
2 910 mg/kg bw
95% CL:
2 550 - 3 320

Applicant's summary and conclusion

Interpretation of results:
sligthly toxic
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The LD50 for male albino Wistar rats was determined to be 2910 mg/kg after a single exposure and 14d post exposure observation.