Registration Dossier
Registration Dossier
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EC number: 480-240-4 | CAS number: 185257-07-2
Endpoint summary
Administrative data
Description of key information
Key value for chemical safety assessment
Skin sensitisation
Endpoint conclusion
- Additional information:
There is a reliable study available to assess the skin sensitising potential of the test substance.
MGDN (purity: 99.5 area-%) was tested for its sensitizing effect on the skin of the guinea pig in the Maximization Test according to GLP requirements and OECD guideline 406 (BASF AG 2006). The test-substance concentrations for the main test were selected based on the results of the pretests. The intradermal induction was performed with a 2.5% test-substance preparation in 1% aqueous CMC-solution or 2.5% test-substance preparation in Freund’s complete adjuvant / 0.9% aqueous NaCl-solution (1:1) and the epicutaneous induction with a 50% test-substance preparation in 1% aqueous CMC-solution. For the challenge, a 50% test substance
preparation in 1% aqueous CMC-solution was chosen.
The study was performed using 1 control group and 1 test group consisting of 5 and 10 female HsdPoc:DH guinea pigs, respectively.
The intradermal induction was performed on day 0 and the epicutaneous induction on day 7. A challenge was carried out 14 days after the epicutaneous induction.
The intradermal induction caused moderate and confluent to intense erythema and swelling at the injection sites of the test-substance preparations in all test group animals. After the epicutaneous induction, incrustation, partially open (caused by the intradermal induction) could be observed in addition to moderate and confluent erythema and swelling in all test group animals. No animals with skin findings were observed after the challenge.
Based on the results of this study, it was concluded that MGDN does not have a sensitizing effect on the skin of the guinea pig in the Maximization Test under the test conditions chosen.
Migrated from Short description of key information:
Guinea pig maximization test (GPMT): not sensitising (GLP, OECD 429; BASF AG 2006)
Respiratory sensitisation
Endpoint conclusion
- Additional information:
no data
Migrated from Short description of key information:
no data
Justification for classification or non-classification
Skin sensitisation
Based on the available study, there is no indication for a relevant skin sensitising potential of the test substance. Thus, no classification is warranted according to 67/548/EEC, EU-GHS and OECD-GHS, respectively.
Respiratory sensitisation
No data available
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