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Description of key information

A skin sensitizing study was performed in year 1994 according to OECD 406 and GLP. No positive skin reactions were observed in any of the control-or test group animals following challenge administration.

One animal in the test group showed a slight erythema after 48h. The test item was not sensitizing in guinea pigs.

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
Study period:
1994
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Version / remarks:
1992
Deviations:
no
GLP compliance:
yes
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
Existing study
Species:
guinea pig
Strain:
Dunkin-Hartley
Sex:
male
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Møllegaard Breeding Centre Deutschland GmbH, D-16352 Schönwalde
- Age at study initiation:7-8 weeks
- Weight at study initiation:285-377 g
- Housing: co-housing 2-3 animals
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 5 d


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21+/-3
- Humidity (%): 55+/-15
- Air changes (per hr):10
- Photoperiod (hrs dark / hrs light):12/12
Route:
intradermal
Vehicle:
water
Concentration / amount:
0.5%
Day(s)/duration:
0
Route:
epicutaneous, semiocclusive
Vehicle:
water
Concentration / amount:
50%
Day(s)/duration:
7-9
No.:
#1
Route:
epicutaneous, semiocclusive
Vehicle:
water
Concentration / amount:
50%
Day(s)/duration:
21-22
No. of animals per dose:
20 in test group, 10 in control group
Positive control substance(s):
no
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
50%
No. with + reactions:
0
Total no. in group:
20
Remarks on result:
no indication of skin sensitisation
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
50%
No. with + reactions:
1
Total no. in group:
20
Clinical observations:
one animal showed a slight erythema
Remarks on result:
no indication of skin sensitisation
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
not indicated
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
no indication of skin sensitisation
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
positive control
Dose level:
not indicated
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
no indication of skin sensitisation
Remarks:
positive control not used

No positive skin reactions were observed in any of the control- or test group animals following challenge administration. One animal in the test group showed a slight erythema after 48h.

Interpretation of results:
GHS criteria not met
Conclusions:
In a study according to OECD 406 in guinea pigs, MMPP was not sensitizing.
Executive summary:

The study was performed in year 1994 according to OECD 406 and GLP. No positive skin reactions were observed in any of the control-or test group animals following challenge administration.

One animal in the test group showed a slight erythema after 48h. The test item was not sensitizing in guinea pigs.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

Based on the available data no classification is necessary.

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