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Diss Factsheets

Administrative data

Description of key information

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records
Reference
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:
other: OECD guideline study conducted under GLP
Qualifier:
according to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
GLP compliance:
yes
Type of study:
Buehler test
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
Route:
epicutaneous, occlusive
Vehicle:
corn oil
Concentration / amount:
induction - 100%, challenge 25%
Route:
epicutaneous, occlusive
Vehicle:
corn oil
Concentration / amount:
induction - 100%, challenge 25%
No. of animals per dose:
10 M/10F
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
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.
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
25%
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 25%. No with. + reactions: 0.0. Total no. in groups: 10.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
25%
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 25%. No with. + reactions: 0.0. Total no. in groups: 10.0.
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
25%
No. with + reactions:
1
Total no. in group:
20
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 25%. No with. + reactions: 1.0. Total no. in groups: 20.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
25%
No. with + reactions:
0
Total no. in group:
20
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 25%. No with. + reactions: 0.0. Total no. in groups: 20.0.
Interpretation of results:
not sensitising
Remarks:
Migrated information
Conclusions:
MPKO is not a skin sensitizer under conditions of this study. OS1600 is not expected to be a skin sensitizer
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:

Skin sensitization studies on several oximes and oxime silanes have been conducted. MEKO was shown to be a skin sensitizer in guinea pig studies. Methylisobutyl ketoxime (MIBKO) was not a skin sensitizer in guinea pigs. MEKO-containing oxime silanes have produced skin sensitization reactions in guinea pigs similar to MEKO itself. Oxime silanes containing MIBKO did not produce skin sensitization in guinea pigs. These data indicate the skin sensitization potential of the oxime silanes are due to the oxime and not the silicone containing moieties. Due to the differences in skin sensitization potential between MEKO and MIBKO, the skin sensitization potential of MPKO was evaluated. Originally, we conducted a local lymph node assay (LLNA) as this is the preferred methodology. In this study, we used MEKO as the positive control. Neither MPKO nor MEKO were positive in the LLNA. Since MEKO was also negative in the LLNA, we conducted another skin sensitization study on MPKO using a guinea pig method which produced skin sensitization reactions with MEKO. MPKO was not a skin sensitizer in guinea pigs. Currently, we do not know why MEKO was negative in the LLNA. However, the LLNA methodology evaluated the induction phase but not the elucidation phase of skin sensitization. The LLNA does not appear to be an appropriate method to evaluate the skin sensitization potential of oximes. Due to the rapid hydrolysis of OS2600 to MPKO and the similarities in response between other oximes and their associated oxime silanes, it is appropriate to use the MPKO data to evaluate the skin sensitization potential of OS2600.     


Migrated from Short description of key information:
Not a skin sensitizer in the guinea pig (Beuhler) or LLNA studies

Justification for classification or non-classification

MPKO, the hydrolysis product of OS-2600, was not a skin sensitizer in animal models. Classification is not necessary.