Registration Dossier

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: Acceptable publication which meets basic scientific principles
Cross-reference
Reason / purpose for cross-reference:
reference to same study

Data source

Reference
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

Materials and methods

Principles of method if other than guideline:
According to Draize et al. 1944. J. Pharmacol. Exper. Therap. 82, 377
GLP compliance:
no
Test type:
standard acute method
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Pentane-1,5-diol
EC Number:
203-854-4
EC Name:
Pentane-1,5-diol
Cas Number:
111-29-5
Molecular formula:
C5H12O2
IUPAC Name:
pentane-1,5-diol
Details on test material:
- Name of test material (as cited in study report): 1,5-pentanediol

Test animals

Species:
rabbit
Strain:
New Zealand White
Sex:
male
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- 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
- Type of wrap if used: impervious plastic film
- Site: fur was clipped

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 20 ml
- Concentration (if solution): 100%
- Constant volume or concentration used: yes
Duration of exposure:
24 h
Doses:
not specified
No. of animals per sex per dose:
4
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
Statistics:
calculation acc. to method of Thompson using the Tables of Weil.

Results and discussion

Effect levelsopen allclose all
Sex:
male
Dose descriptor:
LD50
Effect level:
> 20 mL/kg bw
Sex:
male
Dose descriptor:
LD50
Effect level:
> 19 800 mg/kg bw

Applicant's summary and conclusion

Interpretation of results:
practically nontoxic
Remarks:
Migrated information Criteria used for interpretation of results: EU