Registration Dossier
Registration Dossier
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EC number: 233-796-5 | CAS number: 10361-80-5
Endpoint summary
Administrative data
Description of key information
No reliable data to cover the skin sensitisation endpoint is available for praseodymium trinitrate. This endpoint is covered with a read-across approach with praseodymium trichloride as source substance, for which a justification is added in section 13. In an in vivo skin sensitisation study in guinea pigs (Tarcai, 2017; GPMT, OECD 406, Klimisch 1), praseodymium trichloride demonstrated to not induce a skin sensitisation response in the guinea pig after intradermal, dermal and challenge exposures. Therefore, preasodymium trinitrate is also considered to be a non-sensitizer.
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
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
- Justification for type of information:
- Data from the related substance praseodymium trichloride is used to cover this endpoint. Justification for this approach is included in section 13.
- Reason / purpose for cross-reference:
- read-across source
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 10% (w/v) in saline
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- No signs of systemic or local toxicity observed in any of the animals. No mortality observed.
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 10% (w/v) in saline
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- No signs of systemic or local toxicity observed in any of the animals. No mortality observed.
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 10% (w/v) in saline
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Clinical observations:
- No signs of systemic or local toxicity observed in any of the animals. No mortality observed.
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 10% (w/v) in saline
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Clinical observations:
- No signs of systemic or local toxicity observed in any of the animals. No mortality observed.
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- positive control
- Dose level:
- 50% (w/v) 2-mercaptobenzothiazole in aqueous methylcellulose solution (concentration not reported)
- No. with + reactions:
- 10
- Total no. in group:
- 10
- Clinical observations:
- Discrete or moderate erythema (score 1 or 2) on the skin surface of previously sensitised guinea pigs.
- Remarks on result:
- positive indication of skin sensitisation
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- positive control
- Dose level:
- 50% (w/v) 2-mercaptobenzothiazole in aqueous methylcellulose solution (concentration not reported)
- No. with + reactions:
- 9
- Total no. in group:
- 10
- Clinical observations:
- Discrete or moderate erythema (score 1 or 2) on the skin surface of previously sensitised guinea pigs.
- Remarks on result:
- positive indication of skin sensitisation
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- No reliable skin sensitisation study is available for praseodymium trinitrate. Therefore, reliable data from the related substance praseodymium trichloride is used to cover this endpoint.
Challenge with this test item (praseodymium trichloride) evoked no positive responses in the test animals previously sensitised with the test item or in the control group. The net response value represented an incidence rate of 0% and the net score value of 0.00. In conclusion, under the conditions of the present assay, the test item praseodymium trichloride was shown to have no skin sensitisation potential and is consequently classified as a non-sensitiser, according to current EU-regulations. The same is assumed for Praseodymium trinitrate. - Endpoint:
- skin sensitisation: in vitro
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- an in vitro skin sensitisation study does not need to be conducted because adequate data from an in vivo skin sensitisation study are available
Referenceopen allclose all
Clinical observations/mortality/body weight
- No signs of systemic or local toxicity were observed in any of the animals.
- No mortality was observed during the study.
- There were no notable differences in body weight between the test animal group and the control group.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
No reliable data to cover the skin sensitisation endpoint is available for praseodymium trinitrate. This endpoint is covered with a read-across approach with praseodymium trichloride as source substance, for which a justification is added in section 13. In an in vivo skin sensitisation study in guinea pigs (Tarcai, 2017; GPMT, OECD 406, Klimisch 1), praseodymium trichloride demonstrated to not induce a skin sensitisation response in the guinea pig after intradermal, dermal and challenge exposures. No signs of systemic or local toxicity and no mortality were observed in this study. There were no notable differences in body weight between the test group and the control group. Therefore, preasodymium trinitrate is also considered to be a non-sensitizer.
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
The substance is considered not to be classified as skin sensitizer based on the results with the analogue substance praseodymium trichloride and according to the criteria laid down in the CLP Regulation.
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