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Toxicological information

Skin sensitisation

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Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2009
Report date:
2009

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
GLP compliance:
yes
Type of study:
Buehler test
Justification for non-LLNA method:
A non-LLNA test is available that was performed prior to the current data requirements, stipulated in Regulation (EC) No 1907/2006. In accordance with the same Regulation, the data was included to avoid unnecessary testing.

Test material

Constituent 1
Chemical structure
Reference substance name:
-
EC Number:
484-470-6
EC Name:
-
Cas Number:
623-40-5
Molecular formula:
C5H11NO
IUPAC Name:
N-pentan-2-ylidenehydroxylamine

In vivo test system

Test animals

Species:
guinea pig
Strain:
Hartley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Elm Hill Breeding Labs, Chelmsford, MA
- Weight at study initiation: 292-352 gms
- Housing:
- Diet: ad libitum
- Water:ad libitum
- Acclimation for at least 5 days

ENVIRONMENTAL CONDITIONS
- Photoperiod (hrs dark / hrs light): 12 hrs

IN-LIFE DATES: From: 01/04/2009 To: 08/05/09

Study design: in vivo (non-LLNA)

Induction
Route:
epicutaneous, occlusive
Vehicle:
corn oil
Concentration / amount:
100%
Challenge
Route:
epicutaneous, occlusive
Vehicle:
corn oil
Concentration / amount:
25%
No. of animals per dose:
10 M/10 F
Details on study design:
RANGE FINDING TESTS: non irritating dose = 25%

MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 3
- Frequency of applications: once a week
- Duration: 3 weeks
- Concentrations: 100%


B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: 2 weeks following last induction
- Concentrations: 25%
- Evaluation (hr after challenge): 24 and 48 hours

Positive control substance(s):
yes
Remarks:
HCA

Results and discussion

Positive control results:
Testing with 85% hexylcinnamaldehyde are confirmed in the laboratory every 6 months. Data from the study conducted in summer 2009 included with results as expected.

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
25%
No. with + reactions:
0
Total no. in group:
10
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
25%
No. with + reactions:
0
Total no. in group:
10
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
25%
No. with + reactions:
1
Total no. in group:
20
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
25%
No. with + reactions:
0
Total no. in group:
20
Group:
positive control
Remarks on result:
positive indication of skin sensitisation

Applicant's summary and conclusion

Interpretation of results:
other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No 1272/2008
Conclusions:
2-PO (MPKO) is not a skin sensitizer under conditions of this study.