Registration Dossier
Registration Dossier
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EC number: 279-013-0 | CAS number: 78948-87-5
Endpoint summary
Administrative data
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
- 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
- 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.
Reference
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.
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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