Manganese, 3-hydroxy-4-[(1-sulfo-2-naphthalenyl)azo]-2-naphthalenecarboxylic acid complex

Endpoint summary

Description of key information

A study on skin sensitization was not performed for the test item. Reliable experimental data from two analogue substances are available. These substance did not show a skin sensitising potential in the Local Lymph Node Assay (according to OECD TG 429 and GLP).

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records

Reference

Endpoint:

skin sensitisation: in vivo (LLNA)

Type of information:

read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Justification for type of information:

Please, see the attached justification.

Reason / purpose for cross-reference:

read-across source

Reason / purpose for cross-reference:

read-across: supporting information

Parameter:

SI

Value:

1.45

Test group / Remarks:

5%

Remarks on result:

other: CAS 6417-83-0

Parameter:

SI

Value:

1.51

Test group / Remarks:

10%

Remarks on result:

other: CAS 6417-83-0

Parameter:

SI

Value:

1.7

Test group / Remarks:

20%

Remarks on result:

other: CAS 6417-83-0

Interpretation of results:

GHS criteria not met

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not sensitising)

Additional information:

A study on skin sensitization was not performed for the test item. Reliable experimental data for an analogue approach are available. Please, see the attached read-across justification in section 7.4.1 or 13.

 

CAS 6417-83-0:

To assess the skin sensitizing potential of the test substance, a Local Lymph Node Assay (LLNA) was conducted in mice (CBA/CaOlaHsd) according to OECD TG 429 and GLP. Test item suspensions at different concentrations (5, 10 and 20 % w/w) were prepared using DMSO as a vehicle. The animals did not show any signs of systemic toxicity during the course of the study and no cases of mortality were observed. However, a possible erythema of the ear skin could not be determined due to the inherent color of the test item. On day 6, all animals treated with 10% and two animals treated with 20% test item concentration showed scabby ear skin. A statistically significant increase in ear weights was observed in the mid and the high dose group in comparison to the vehicle control group (p<0.05). Furthermore, for BALB/c mice, a cut-off value of 1.1 for the ear weight index was reported for a positive response regarding ear skin irritation. The high dose group slightly exceeded this threshold (index of 1.16). However, this was considered to be not biologically relevant, as the observed increase did not exceed the threshold value of 25% for excessive local skin irritation mentioned in OECD guideline 429. Nevertheless, the increased ear weights in the high dose group indicated a slight irritant property of the test item.

The determined Stimulation Indices (S.I.) of 1.45, 1.51 and 1.70 were at concentrations of 5, 10, and 20%, respectively. A statistically significant or biologically relevant increase in DPM values, lymph node weights and lymph node cell counts was not observed in any treated group in comparison to the vehicle control group. Furthermore, the cut-off value of 1.55 for a positive response regarding the lymph node cell count index reported for BALB/c mice was not exceeded in any dose group. Thus, the test item was not a skin sensitiser under the test conditions of this study.

 

CAS 7023-61-2:

A Local Lymph Node Assay (LLNA) was performed according to OECD TG 429 and GLP to assess the skin sensitizing potential of the test substance. A commercial product of adequately high content of the test substance was administered to CBA mice at doses of 6.25, 12.5, and 25 % in acetone/olive oil. Higher concentrations could not be achieved due to insolubility in this and other vehicles. Irritating properties could not be scored due to the staining properties of the red pigment. This did not affect the outcome, as there was no increase in stimulation index. Therefore, the test substance was considered to be non-sensitizing to skin under the experimetal conditions of this study.

Respiratory sensitisation

Endpoint conclusion

Endpoint conclusion:

no study available

Justification for classification or non-classification

Classification, Labelling, and Packaging Regulation (EC) No. 1272/2008

The available experimental test data are reliable and suitable for classification purposes under Regulation 1272/2008. No dose dependent increase in the stimulation index was observed in the LLNA (OECD 429). No EC3 could be established. Therefore, the substance does not require classification as a skin sensitizer under Regulation (EC) No. 1272/2008, as amended for the fourteenth time in Regulation (EC) No. 2020/217.