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Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
other information
Study period:
Sep to Oct 2000
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: well reported Guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2001
Report date:
2001

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
yes
Remarks:
3 instead of 5 animals/sex used according to acute-toxic-class-method (OECD 423)
Test type:
standard acute method
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
5-Cyano-11 alpha-hydroxy-3,5'-dioxo-4 beta,5',6,7 beta-tetrahydrocyclopenta[4,5,6,7]-5 beta,17 alpha-pregnane-21,17-carbolactone
EC Number:
606-280-6
Cas Number:
192704-54-4
Molecular formula:
C24 H29 N O5
IUPAC Name:
5-Cyano-11 alpha-hydroxy-3,5'-dioxo-4 beta,5',6,7 beta-tetrahydrocyclopenta[4,5,6,7]-5 beta,17 alpha-pregnane-21,17-carbolactone
Details on test material:
- Name of test material (as cited in study report): ZK 233744
- Batch No: 1366

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female

Administration / exposure

Type of coverage:
semiocclusive
Vehicle:
paraffin oil
Duration of exposure:
24 hours
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
3
Control animals:
no

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.

Any other information on results incl. tables

No mortalities occurred. No compound-related clinical findings or findings at necropsy were observed. One male animal showed a body weight loss in week 1 and showed a reduced body weight gain throughout the study period, when compared to the 90% range of historical reference data used in the study performing laboratory. All other animals showed no effect on body weight, therefore, the significance of the finding remains unclear.

Moreover, no compound-related local findings were observed. The mean values of findings at the time-points 24, 48 and 72 h after administration were 0 for swelling, reddening and scab formation.

Applicant's summary and conclusion

Executive summary:

The single dermal administration of the test substance (ZK 233744) to male and female rats at a dose of 2000 mg/kg was tolerated without any mortality, clinical signs or findings at necropsy. The body weight of one male decreased in week 1 and this male showed a reduced body weight gain throughout the whole study period, when compared to the 90% range of historical reference data used in the study performing laboratory. As all other animals did not show any effect on the body weight, the significance of the finding remains unclear.

The acute dermal toxicity of Diketon in rats is therefore above 2000 mg/kg body weight.

Moreover, no compound-related local findings were observed. The mean values of findings at the time-points 24, 48 and 72 h after administration were 0 for swelling, reddening and scab formation.

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