Registration Dossier
Registration Dossier
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EC number: 944-884-4 | CAS number: -
Endpoint summary
Administrative data
Description of key information
non skin sensitiser
Key value for chemical safety assessment
Skin sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
The skin sensitisation of the substance was evaluated by considering data on a Similar Substance. Justification for Read Across is given in section 13 of IUCLID.
The skin sensitisation of Similar Substance was evaluated in the Guinea Pig Maximisation test according to the ISO 10993 -10. For this reason, 15 guinea pigs were used, 10 of which were treated with the test item and 5 were used as a control group and 3 for the range-finding test. During the preliminary test the concentration of the test sample to be used in the main test was determined. During the induction phase, guinea pigs (test and control group) were treated with 3 pairs of intradermal injections. After six days, a local application of SLS at 10 % vaseline was performed. Topical application with the test sample and sodium chloride was performed for the treated and control group respectively 7 days after the injections. 21 days after the beginning of the treatment, both treated and control animals were subjected to a challenge phase, during which the test sample and sodium chloride was applied on the right and left side of the back respectively. The bandages were left for 24 hours. After 48 and 72 hours after the challenge, the reactions of both treated and control animals were evaluated: a slight erythema was observed in 7/10 animals in the treated group and 4/5 animals in the control group. Due to the positive results obtained in the control group the animals were subjected to a re-challenge. No abnormalities were observed in treated and control animals.
The test material is considered as non sensitiser.
Supporting data from literature suggests that the substance is not a skin sensitiser. Hydroxyapatite is the main component of teeth and bones in mammals. Its safety for cosmetic use has been assessed in many studies and it is suggested that it does not present a particular health hazard per se. In general, engineered hydoxyapatite materials and their composites are intended for a variety of biomedical applications (bone substitute in intraosseous implantation, implant coating materials) due to their biocompatibility. No allergic skin reactions have been reported in clinical studies including those with specific investigation of potential allergenic effects (Kannan et al., 2004a,b; Li et al., 2008; Pankratov et al., 1994; Rajab et al., 2004; Suzina et al., 2004).
Kannan, T.P. et al., 2004a. Chromosome aberration test for hydroxyapatite in sheep. Med. J. Malaysia 59 (Suppl. B), 168–169.
Kannan, T.P. et al., 2004b. In vivo chromosome aberration test for hydroxyapetite in mice. Med. J. Malaysia 59 (Suppl. B), 115–116.
Li, H. et al., 2008. Preparation and biological safety evaluation of porous n-HA/PA66 composite. Sheng Wu Yi Xue Gong Cheng Xue Za Zhi 25, 1126–1129.
Pankratov, A.S. et al., 1994. The immunotropic and allergenic activity of hydroxyapatite with an ultrahigh degree of dispersion. Stomatologiia (Mosk)
Rajab, N.F. et al., 2004. DNA damage evaluation of hydroxyapatite on fibroblast cell L929 using the single cell gel electrophoresis assay. Med. J. Malaysia 59 (Suppl. B), 170–171. 73, 37–40.
Suzina, A.H. et al., 2004. Mutagenicity of CORAGRAF and REKAGRAF in the Ames test. Med. J. Malaysia 59 (Suppl. B), 105–106.
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
According to the Guidance on the application of the CLP criteria (Version 5.0 July 2017), when a GPMT test result is available, potency categorisation may be possible on the basis of the concentration of test material used for intradermal induction and the percentage of guinea pigs sensitised. It should be noted that the guinea pig tests should be conducted at highest induction dose causing mild (Buehler Assay) or mild-to-moderate (GPMT) skin irritation. As a consequence, it is unlikely that substances (except strong irritants) would be tested at low concentration. The intradermal induction was conducted at 100 % of test substance. During the challenge phase a slight erythema was observed in 7 out of 10 animals in the treated group. A re-challenge was performed due to the positive results obtained during the challenge phase in the control group (a slight erythema was observed in 4 out of 5 animals). During the re-challenge none of the animals presented any abnormalities. Based on the results and the classification criteria of Table 3.4.3 and 3.4.4 of Annex I: 3.4.2.2.3.2 of the CLP Regulation (EC) No.1272/2008 and therefore the substance isnot classified for skin sensitisation.
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