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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
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Comparable to guideline study with acceptable restrictions (occlusive exposure) study prior to GLP; peer reviewed study (EU RAR)

Data source

Referenceopen allclose all

Reference Type:
publication
Title:
Range finding toxicity data - List V -
Author:
Smyth H.F., Carpenter C.P., Weil C.S., Pozzani U.C
Year:
1954
Bibliographic source:
Arch. ind. hyg. occupat. med. 10, 61-68.
Reference Type:
secondary source
Title:
EU Risk Assessment Report, CAS No. 71-23-8: Propan-1-ol, Vol. 82
Author:
not applicable
Year:
2008
Bibliographic source:
ECB
Reference Type:
study report
Title:
Unnamed
Year:
1953
Report date:
1953

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
yes
Remarks:
(occlusive treatment, only 4 males/dose)
Principles of method if other than guideline:
Draize, J.H. et al., J. Pharmacol. Exp. Therap., 82, 377, (1944)

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/kg 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.
GLP compliance:
no
Test type:
standard acute method

Test material

Constituent 1
Chemical structure
Reference substance name:
Propan-1-ol
EC Number:
200-746-9
EC Name:
Propan-1-ol
Cas Number:
71-23-8
Molecular formula:
C3H8O
IUPAC Name:
propan-1-ol
Specific details on test material used for the study:
Analytical purity: no data

Test animals

Species:
rabbit
Strain:
other: New Zealand giant albino rabbits
Sex:
male
Details on test animals or test system and environmental conditions:
- Weight at study initiation: 2.5-3.5 kg

Administration / exposure

Type of coverage:
occlusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST SITE
- Area of exposure: 1/10 of body surface
- % coverage: no data
- Type of wrap if used: no data

REMOVAL OF TEST SUBSTANCE
- Washing (if done): no data

TEST MATERIAL
- Amount(s) applied: maximal 20 ml/kg bw
- Concentration (if solution): undiluted



Duration of exposure:
24 h
Doses:
no data
No. of animals per sex per dose:
4 male animals
Control animals:
not specified

Results and discussion

Effect levels
Sex:
male
Dose descriptor:
LD50
Effect level:
4 032 mg/kg bw
95% CL:
2 720 - 5 968
Remarks on result:
other: Conversion with density: 0.8 g/ml (original data given in publication: 5.04 ml/kg bw with 95 % confidence limits of 3.4-7.46)
Mortality:
no data
Clinical signs:
other: no data
Gross pathology:
no data

Applicant's summary and conclusion