Registration Dossier
Registration Dossier
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EC number: 939-401-9 | CAS number: 1469983-41-2
Endpoint summary
Administrative data
Description of key information
Skin sensitisation (OECDTG406): not sensitizing
Key value for chemical safety assessment
Skin sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
Basoplast 20 konz. K was tested for its sensitizing effect on the skin of the guinea pig in the Maximization Test based on the method of Magnusson and Kligman. The test substance concentrations for the main test were selected based on a study with a comparable test substance performed by a consulting institute resp. on the results of a pretest. The intradermal induction was performed with a 1 % test substance preparation in olive oil Ph.Eur./DAB or 1 % test substance preparation in Freund's adjuvant / 0.9% aqueous NaCI-solution (1: 1) and the epicutaneous induction with a 75% test substance preparation in olive oil Ph.Eur./DAB. For the challenge a 75% test substance preparation in olive oil Ph.Eur./DAB was chosen.
The study was initiated with 2 control groups and 1 test group. 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 or intense erythema and swelling at the injection sites of the test substance preparation 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 or intense erythema and swelling in all test group animals. After the challenge application moderate and confluent erythema was observed in 2 test
group animals at the test substance application sites. One of these animais also showed discrete or patchy erythema after application of the vehicle. Furthermore olive oil Ph.Eur.IDAB caused discrete or patchy erythema in 1 control group 2 animal.
The number of animais with skin findings after the challenge is summarized in the following table:
Challenge
Test substance 75%
in olive oil Ph.Eur./DAB
Vehicle control: olive oh Ph.Eur./DAB
24h
48h
Total
24h
48h
total
Control group 1
0/5
0/5
0/5
0/5
0/5
0/5
Control group 2*
No application of test substance
1/5
0/5
1/5
Test group
2/10
2/10
2/10
1/10
1/10
1/10
x/y: number of positive reactions/number of animals tested (reading at 24 h and/or 48 h after the removal of the patch)
* control group 2 that had been intended for a potential 2nd challenge was not treated with the test substance, since a 2nd challenge was not necessary on the basis of the unambiguous results of the 1st challenge.
It was concluded that Basopast 20 konz. K does not have a sensitizing effect on the skin of the guinea pig in the Maximization Test under the test conditions chosen.
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
Based on the available study results, the substance does not have to be classified and has no obligatory labelling requirement for skin sensitisation according to Regulation (EC) No 1272/2008 and its amendments.
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.
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