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Administrative data

Description of key information

Sensitization: not sensitizing (Modified Split Adjuvans Test, guinea pig)

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records
Reference
Endpoint:
skin sensitisation
Remarks:
in vivo
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
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
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
Route:
epicutaneous, open
Vehicle:
no data
Concentration / amount:
no data given
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
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.
Interpretation of results:
not sensitising
Remarks:
Migrated information
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:

To assess sensitization to skin, a Modified Split Adjuvant Test was taken into account (Rao, 1981). In this test, ten male Hartley Guinea pigs received four applications as induction to the clipped and depilated back of the animals. At the time of the third application, 0.2 ml of Freund's Adjuvant was injected intradermal at one point adjacent to the insult site. After a two week rest period, the animals received an application of pure 2-methylbut-3-yn-2-ol and reactions were evaluated 24 and 48 hours thereafter. As result, no sensitizing reactions could be observed.

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

Classification is not warranted according to the criteria of Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008.