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Registration Dossier
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EC number: 231-826-1 | CAS number: 7757-93-9
Endpoint summary
Administrative data
Description of key information
There is no available data for calcium hydrogenorthophosphate. Reliable data are available for the read across substances pentacalcium hydroxide tris(orthophosphate) (CAS 12167 -74 -7).
Skin sensitistaion (RA-A 12167 -74 -7, OECD 406, RL1): not sensitisting
Key value for chemical safety assessment
Skin sensitisation
Link to relevant study records
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Justification for type of information:
- refer to analogue justification provided in IUCLID section 13
- Reason / purpose for cross-reference:
- read-across source
- Positive control results:
- Hexyl cinnamic acid (at challenge concentration of 55% in vaseline) induced skin sensitisation reactions in 90% of the treated animals.
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- induction (intradermal): 0%; induction (epicutaneoues): 0%, challenge 100%
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Clinical observations:
- no visible clinical symptoms over the period of observation
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- induction (intradermal): 0%; induction (epicutaneoues): 0%, challenge 100%
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Clinical observations:
- no visible clinical symptoms over the period of observation
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 100%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- no visible clinical symptoms over the period of observation
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 100%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- no visible clinical symptoms over the period of observation
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- positive control
- Dose level:
- 55%
- No. with + reactions:
- 9
- Total no. in group:
- 10
- Remarks on result:
- positive indication of skin sensitisation
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- positive control
- Dose level:
- 55%
- No. with + reactions:
- 9
- Total no. in group:
- 10
- Remarks on result:
- positive indication of skin sensitisation
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test material did not induce any skin reactions in intradermally and topically induced guinea pigs after challenge treatment. Therefore, the material does not fulfill the criteria for classification according to Regulation (EC) No 1272/2008 (CLP) and the Globally Harmonized System of Classification and Labelling of Chemicals (GHS), and is thus considered to be not skin sensitizing.
- Executive summary:
No skin senistisation properties are considered from the source study by Gruemmer, 2014 (GPMT). As explained in the justification for type of information, the differences in molecular structure between the target and the source are unlikely to lead to differences in the skin sensitisation potential.
Reference
Animal weights
Table 3: Individual animal weights (g) at start / test end (test group)
Animal |
Test start |
Test end |
Body weight change |
1 |
305.3 |
387.4 |
82.1 |
2 |
313.5 |
379.8 |
66.3 |
3 |
318.7 |
414.7 |
96.0 |
4 |
309.3 |
388.8 |
79.5 |
5 |
301.2 |
399.9 |
98.7 |
6 |
315.7 |
385.2 |
69.5 |
7 |
304.1 |
399.4 |
95.3 |
8 |
321.0 |
422.8 |
101.8 |
9 |
309.8 |
375.7 |
65.9 |
10 |
309.3 |
411.5 |
102.2 |
Individual weight of control group
Table 4: Individual animal weights (g) at test start and at test end (control group)
Animal |
Test start |
Test end |
Body weight change |
K1 |
309.4 |
383.0 |
73.6 |
K2 |
300.9 |
376.1 |
75.2 |
K3 |
324.0 |
396.1 |
72.1 |
K4 |
327.1 |
408.5 |
81.4 |
K5 |
326.4 |
398.7 |
72.3 |
Table 5: Skin reactions of test animals after treatment with the test material
Animal |
Numerical grading after |
|
24 h |
48 h |
|
1 |
0 |
0 |
2 |
0 |
0 |
3 |
0 |
0 |
4 |
0 |
0 |
5 |
0 |
0 |
6 |
0 |
0 |
7 |
0 |
0 |
8 |
0 |
0 |
9 |
0 |
0 |
10 |
0 |
0 |
Table 6: Skin reactions of control animals after treatment with the test material
Animal |
Numerical grading after |
|
24h |
48h |
|
K1 |
0 |
0 |
K2 |
0 |
0 |
K3 |
0 |
0 |
K4 |
0 |
0 |
K5 |
0 |
0 |
Table 7: Skin reactions of animals after challenge treatment with HCA 55 % in vaseline
Animal |
Numerical grading after |
|
24 h |
48 h |
|
1 |
1 |
1 |
2 |
0 |
0 |
3 |
1-2 |
1-2 |
4 |
1 |
1 |
5 |
1-2 |
2 |
6 |
1 |
1 |
7 |
1-2 |
1-2 |
8 |
0-1 |
1 |
9 |
1-2 |
1 |
10 |
1 |
1 |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
No studies are available with calcium hydrogenorthophosphate (CAS 7757- 93 -9). Reliable data are available for pentacalcium hydroxide tris(orthophosphate) (CAS 12167 -74 -7).
This study is considered relevant since the calcium phosphate compounds are structural similar. These two substance dissociate into Ca2+ cations and orthophosphate anion and it is assumed that they will undergo the same pathway once entered the body.
The difference between the two compounds will not have an impact on any sensitisation potential and therefore the negative GPMT test with pentacalcium hydroxide tris(orthophosphate) can reliably be read across to calcium hydrogenorthophosphate.
Pentacalcium hydroxide tris(orthophosphate) (CAS 12167 -74 -7)
A GPMT study according to OECD 406 was performed to assess the skin sensitisation potential of pentacalcium hydroxide tris(orthophosphate) in female Dunklin-Hartley guinea pigs following an intradermal induction with 0.5% of the test substance and an occlusive epicutaneous induction with 100% and an occlusive epicutaneous challenge with 100% test substance. These concentrations were the highest concentrations which caused mild to moderate skin irritation. 10 animals were used in the test group and 5 in the negative control group. At challenge, 0/10 positive responses were noted in the test group after 24 h or 48 h and 0/5 positive response was noted in the control group following treatment with 100% pentacalcium hydroxide tris(orthophosphate) after 24 h or 48 h. Thus, the test material was considered to be a non-sensitiser under the conditions of the test.
In conclusion, since pentacalcium hydroxide tris(orthophosphate) is a reliable read across substance and did not show skin sensitising potential, calcium hydrogenorthophosphate is also considered to be not sensitising.
Further in vivo testing is deemed to be scientifically unjustified.
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
Classification is not proposed on the basis of read-across from analogue substance pentacalcium hydroxide tris(orthophosphate).
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