Registration Dossier
Registration Dossier
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 279-013-0 | CAS number: 78948-87-5
Skin sensitisation
Administrative data
- 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
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 994
- Report date:
- 1994
Materials and methods
Test guideline
- 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
Test material
- Reference substance name:
- Dihydrogen bis[monoperoxyphthalato(2-)-O1,OO1]magnesate(2-)
- EC Number:
- 279-013-0
- EC Name:
- Dihydrogen bis[monoperoxyphthalato(2-)-O1,OO1]magnesate(2-)
- Cas Number:
- 78948-87-5
- Molecular formula:
- C16H8MgO10.2H
- IUPAC Name:
- Dihydrogen bis[monoperoxyphthalato(2-)-O1,OO1]magnesate(2-)
Constituent 1
In vivo test system
Test animals
- 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
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- 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
Challenge
- 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
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- 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
Any other information on results incl. tables
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.
Applicant's summary and conclusion
- 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.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
