Registration Dossier

Toxicological information

Acute Toxicity: dermal

Currently viewing:

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
migrated information: read-across based on grouping of substances (category approach)
Adequacy of study:
supporting study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Acceptable publication which meets basic scientific principles

Data source

Referenceopen allclose all

Reference Type:
publication
Title:
Range-Finding Toxicity Data: List VI
Author:
Smyth Jr. HF et al.
Year:
1962
Bibliographic source:
Am. Ind. Hyg. Ass. J., 23, 95-107
Reference Type:
secondary source
Title:
No information
Author:
RIFM
Year:
2008
Bibliographic source:
RIFM database

Materials and methods

Principles of method if other than guideline:
modified acc. to Draize, J.H. et al., J. Pharmacol. Exp. Therap. 82, 377 (1944)
GLP compliance:
no
Test type:
standard acute method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): 2-Methylbutanol

Test animals

Species:
rabbit
Strain:
New Zealand White
Sex:
male
Details on test animals 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
- Area of exposure: trunk
- Type of wrap if used: impervious plastic film


REMOVAL OF TEST SUBSTANCE
- Washing (if done): no data
- Time after start of exposure: 24 h
Duration of exposure:
24 h
Doses:
no data
No. of animals per sex per dose:
4
Control animals:
not specified
Details on study design:
- Duration of observation period following administration: 14 days
Statistics:
LD50 value and its fiducial range are estimated by the method of Thompson (1947) using the Tables of Weil (1952)

Results and discussion

Effect levelsopen allclose all
Sex:
male
Dose descriptor:
LD50
Effect level:
3.54 mL/kg bw
Based on:
test mat.
Sex:
male
Dose descriptor:
LD50
Effect level:
ca. 2 860 mg/kg bw
Based on:
test mat.
Remarks on result:
other: density = 0.808 g/cm3

Applicant's summary and conclusion

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