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Diss Factsheets

Toxicological information

Acute Toxicity: dermal

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Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1954
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Scientifically acceptable range finding test.

Data source

Referenceopen allclose all

Reference Type:
publication
Title:
Range-Finding Toxicit Data List V
Author:
Smyth HF, Carpenter CP, Weil CS & Pozzani UC
Year:
1954
Bibliographic source:
Arch. Ind. Hyg Occup. Med. 10: 61–68
Reference Type:
publication
Title:
Range-Finding Toxicity Data List VI
Author:
Smyth HF, Carpenter CP, Weil CS, Pozzani UC, Striegel JA
Year:
1962
Bibliographic source:
Am. Ind. Hyg. Assoc. J. , 23. 95-107, 1962

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Principles of method if other than guideline:
Method: according to Draize, J.H. et al.: J. Pharmacol. & Exper. Therap. 82, 377
GLP compliance:
no
Remarks:
prior to GLP
Test type:
standard acute method
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Pentan-3-one
EC Number:
202-490-3
EC Name:
Pentan-3-one
Cas Number:
96-22-0
Molecular formula:
C5H10O
IUPAC Name:
pentan-3-one
Details on test material:
- Name of test material: Pentanone-3

Test animals

Species:
rabbit
Strain:
other: New Zealand giant albino
Sex:
male
Details on test animals or test system and environmental conditions:
- weight of animals: 2.5-3.0 kg

Administration / exposure

Type of coverage:
occlusive
Vehicle:
not specified
Details on dermal exposure:
no data
Duration of exposure:
24 h
Doses:
no data
No. of animals per sex per dose:
4
Control animals:
no
Details on study design:
Penetration of rabbit skin is estimated by a technique essentially the one-day cuff method of Draize and associates using groups of four male New Zealand giant albino rabbits weighing 2.5 to 3.5 kg. The fur is closely clipped over the entire trunk, and the dose, retained beneath an impervious plastic film, contacts about 1/10 of the body surface . Dosages greater than 20 mL per kilogram of body, weight cannot be retained in contact with the skin . After 24 hours' contact the film is removed, and mortality is considered complete after 14 additional days.

Results and discussion

Effect levels
Sex:
male
Dose descriptor:
LD50
Effect level:
16 200 mg/kg bw
Remarks on result:
other: LD50 obtained graphically
Mortality:
only LD 50 value of 20 ml/kg bw (corr. to 16200 mg/kg bw) reported
Clinical signs:
other: no data
Gross pathology:
no data
Other findings:
no data

Applicant's summary and conclusion

Executive summary:

In this acute dermal toxicity study (Smyth et al., 1954) groups of four male giant albino rabbits were dermally exposed to Diethyl ketone occlusively for 24 hours to an area of 1/10 of the body surface. Animals then were observed for 14 days. A LD50 value of 20 mL/kg bw was identified graphically which corresponds to 16.2 g/kg bw. This study is classified as acceptable key study.