Registration Dossier

Administrative data

Endpoint:
skin sensitisation
Remarks:
in vivo
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key 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:
A collection of guinea pig sensitization test results - grouped by chemical class
Author:
Rao KS et al.
Year:
1981
Bibliographic source:
Drug. Chem. Toxicol. 4, 331-351
Reference Type:
secondary source
Title:
Unnamed
Year:
2000
Reference Type:
secondary source
Title:
SIDS Initial Assessment Report - 2-Methylbut-3-yn-ol
Author:
Rao KS et al.
Year:
2002
Bibliographic source:
OECD SIDS

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
Method: in compliance with Maguire H. C.: J. Soc. Cosmet. Chem. 24, 151, 1973
GLP compliance:
not specified
Type of study:
other: modified Split adjuvant test

Test material

Reference
Name:
Unnamed
Type:
Constituent

In vivo test system

Test animals

Species:
guinea pig
Strain:
Hartley
Sex:
male
Details on test animals and environmental conditions:
TEST ANIMALS
- Weight at study initiation: ca. 300 g
- Diet (e.g. ad libitum): ad libitum, urina guinea pig chow supplemented with green vegetables
- Water (e.g. ad libitum): ad libitum

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
epicutaneous, open
Vehicle:
no data
Concentration / amount:
no data given
Challengeopen allclose all
Route:
epicutaneous, open
Vehicle:
no data
Concentration / amount:
no data given
No. of animals per dose:
10
Details on study design:
RANGE FINDING TESTS: yes
- test substance was applied to clipped flank; if irritation was observed dilutions were prepared
- The highest concentration which did not cause primary irritation was used for the guinea pig sensitization test


MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 4
- Test groups: 10 animals
- Site: clipped and depilated back of animals
- Frequency of applications: 4 times in 10 days
- Concentrations: no data
- Additions: at the time of the third application, 0 .2 ml of Freund's Adjuvant was injected intradermally at one point adjacent to the insult site


B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) after induction: 2 weeks
- Control: solvent control on other flank of the same animal; 10 animal for positive control
- Site: clipped flank
- Concentration: 100%
- Evaluation (hr after challenge): 24, 48 h


Evaluation:
- A moderate erythema and/or edema in two or more guinea pigs was considered sufficient to classify the test material as a potential human skin sensitizer .
Challenge controls:
- solvent
Positive control substance(s):
yes
Remarks:
Epoxy Resin

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
24
Group:
test group
Dose level:
100%
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 100%. No with. + reactions: 0.0. Total no. in groups: 10.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
test group
Dose level:
100%
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 100%. No with. + reactions: 0.0. Total no. in groups: 10.0.

Applicant's summary and conclusion

Interpretation of results:
not sensitising
Remarks:
Migrated information