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Diss Factsheets

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
Not reported.
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Reliability has been presented as 2 because similar to OECD Guideline protocol has been followed but not GLP.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1973
Report date:
1973

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
yes
Remarks:
no details on test material (purity not indicated), no details on test animals and environmental conditions.
GLP compliance:
no
Test type:
standard acute method
Limit test:
yes

Test material

1
Chemical structure
Reference substance name:
2-heptylcyclopentanone
EC Number:
205-273-1
EC Name:
2-heptylcyclopentanone
Cas Number:
137-03-1
Molecular formula:
C12H22O
IUPAC Name:
2-heptylcyclopentanone
Test material form:
liquid

Test animals

Species:
rabbit
Strain:
not specified
Sex:
not specified
Details on test animals or test system and environmental conditions:
TEST ANIMALS
No details.

ENVIRONMENTAL CONDITIONS
No details.

Administration / exposure

Type of coverage:
not specified
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
No data.
Duration of exposure:
No data.
Doses:
5000 mg/kg bw
No. of animals per sex per dose:
6
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: No data
- Necropsy of survivors performed: No data

Results and discussion

Effect levels
Key result
Sex:
not specified
Dose descriptor:
LD50
Effect level:
5 000 mg/kg bw
Based on:
test mat.
Mortality:
One animal died on day 3 and two animals died on day 4.
Clinical signs:
The animals who died on day 3 and 4 showed ataxia at 24 hours followed by prostration and death. The surviving animals showed progressive drying and cracking, developing into shedding of skin and continuing up to end of the 14 days.
Body weight:
No data.
Gross pathology:
No data.

Applicant's summary and conclusion

Interpretation of results:
other: Not acute harmful.
Remarks:
According to Regulation (EC) No. 1272/2008 and its mendments.
Conclusions:
An LD50 of 5000 mg/kg bw was obtained in the acute dermal toxicity study with rabbits. Based on the results, the substance is acutely toxic at 5000 mg/kg bw according to GHS.
Executive summary:

In an acute dermal toxicity study performed equivalent to OECD 402 guideline, one group of 6 rabbits were dermally exposed to 5000 mg/ kg bw of Fleuramone. The rabbits were observed for signs of toxicity and clinical signs for a period of 14 days. One animal died on day 3 and two animals died on day 4. The animals that died on day 3 and 4 showed ataxia at 24 hours followed by prostration and death. The surviving animals showed progressive drying and cracking, developing into shedding of skin and continuing up to end of the 14 days. Based on the results, an LD50 of 5000 mg/kg bw was obtained in the acute dermal toxicity study with rabbits. Based on the results, the substance is acutely toxic at 5000 mg/kg bw.

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