Calcium bis[3-nitro-4-[[2-oxo-1-[(phenylamino)carbonyl]propyl]azo]benzenesulphonate]

Endpoint summary

Description of key information

Information on acute oral and dermal toxicity is partially derived from structural analogues (barium- and calcium-salts). Four studies were performed to evaluate acute oral and dermal  toxicity of the test substance to the rat (according or similar to OECD 401, 402). The test substance did not induce any mortalities, abnormalities or clinical signs when applicated oral or dermal. The LD50 for oral and dermal toxicity is considered to be > 10.000 mg/kg bw and > 2000 mg/kg bw, respectively.

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

10 000 mg/kg bw

Acute toxicity: via inhalation route

Endpoint conclusion

Endpoint conclusion:

no study available

Acute toxicity: via dermal route

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

2 000 mg/kg bw

Additional information

Read across justification

The acute oral toxicity of the test substance was not determined. Thus, it is acceptable to derive information on acute toxicity from structural analogues since all of the substances are salts and share high similarity in structure. Moreover, all analogue substances are minimal soluble in water. A detailed read across justification is given in Annex I of the CSR.

Procedure and observations

Read across to CAS 12286 -66 -7

To evaluate the acute oral toxicity, single doses of 5000 and 10.000 mg/kg bw of the test article were administrated to groups of male and female rats by oral gavage (Ciba 1972a). Following dosing, the animals were observed for 8d. There were no deaths as a result of treatment with the test article. Clinical signs of toxicity or changes in body weight gain were not observed during the observation period. Gross necropsy was without any findings.

In the course of a second study according OECD guideline 401, a single dose of 15.85 g/kg bw of the test item dissolved in olive oil was administrated orally to rats (Synthesia 1993). All animals survived until scheduled necropsy. Any symptoms or clinical signs did not occur. However, analytical data and purity of the test material were not confirmed by the provider. Thus, this study is regarded as not reliable.

Read across to CAS 5270 -80 -6

In a limit test similar to OECD guideline 401 a single dose of 5000 mg/kg bw of barium-salt analogue dissolved in carboxymethyl-cellulose was administrated to rats by gavage (Civa 1980). The post observation period was 14d and animals were daily checked for clinical signs and mortalities. All animals survived until scheduled necropsy, body weights were uneffected by the substance and signs of toxicity were also not observed. Pathology was without any findings.

The substance was tested for acute dermal toxicity using Wistar rats. Two groups of animals (5 males and 5 females) received a single dose of 2000 mg/kg bw. The test material was applied onto shaved dorsal skin for 24 hours. The test animals were observed 14 days after exposure of the test substance, afterwards they were sacrificed, and the necropsy for macroscopic examination of the organs was performed. The test item did not cause mortalities. Clinical signs or macroscopic changes were not observed.

Read across to 12286 -66 -7

Dermal toxicity of the test item was evaluated on a group of 6 male rats which were treated with the test article at 5000 mg/kg for 24h by dermal application (Synthesia 1993). The substance was suspended in water and administrated onto greased (ethanol:acetone 1:1) skin. Animals were examined for clinical signs and viability 0.5, 3, 12, 24 and 72h after treatment. All animals were necropsied and examined macroscopically. No deaths occurred during the study period. Neither clinical signs of systemic toxicity nor local effects of the test article on the skin at the application site were observed during the observation period. However, analytical data and purity of the test material were not confirmed by the provider. Thus, this study is regarded as not reliable.

Discussion

Oral application of the test substance and a structural analogue did not induce any signs of toxicity. None of the animals died, viability and bodyweight gain were unaffected by the test article. Also dermal application did not induce any symptoms or mortalities. Thus, the substance is not considered to be toxic after single oral or dermal application.

Justification for classification or non-classification

Dangerous Substance Directive (67/548/EEC)

The available studies are considered reliable and suitable for classification purposes under 67/548/EEC. As a result the substance is not considered to be classified for acute toxicity under Directive 67/548/EEC, as amended for the 28th time in Directive 2001/59/EC.

 

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. As a result the substance is not considered to be classified for acute toxicity under Regulation (EC) No. 1272/2008, as amended for the second time in Directive (EC 286/2011).