416-730-1

Endpoint summary

Description of key information

Three studies were performed to evaluate acute oral, inhalative and dermal  toxicity of the test substance and an analogue substance to the rat (according EU guideline B.1 and B.3 and OECD 403). The test substance did not induce any mortalities, abnormalities or clinical signs when applicated oral or dermal. A yellow discoloration of faeces and skin after administration was recorded. These observations are substance induced effects and are not treated as toxicological symptoms. Also single administration via respiratory system did not cause health effects or mortalities. The LD50 for oral and dermal toxicity is considered to be 2000 mg/kg bw, LC50 is > 5.5 mg/l air.

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion

Dose descriptor:

LD50

Value:

2 000 mg/kg bw

Acute toxicity: via dermal route

Endpoint conclusion

Dose descriptor:

LD50

Value:

2 000 mg/kg bw

Additional information

Read across justification

The substance was not assessed for its potential to induce mortalitiy or health effects after single inhalative administration. It is acceptable to derive data on acute inhalative toxicity from a structural analogue since both complexes are calcium salts with similar structure and comparable toxicity profile (detailed justification CSR, Annex I).

Procedure and methods

Two studies were performed to evaluate acute toxicity of the test substance to the rat. In the first study, a group of ten fasted rats (five males and five females) was given a single dose by gavage of the test substance, formulated in distilled water, at a dose level of 2.0 g/kg bodyweight. All animals were killed and examined macroscopically on Day 15, the end of the observation period.

There were no mortalities. Clinical signs of reaction to treatment were limited to piloerection, recovery was complete by Day 2. However, a yellow discolouration of the faeces was evident for all animals on Day 2 only. All rats achieved the anticipated bodyweight gains throughout the study. No abnormalities were recorded at the macroscopic examination on Day 15.

In a second study, a group of ten rats (five males and five females) was given a single dermal application of the test substance, at a maximum practical concentration of 71.43% w/v in distilled water, and at a dose level of 2.0 g/kg bodyweight. All animals were killed and examined macroscopically on Day 15, the end of the observation period. There were no deaths and no signs of systemic reaction to treatment. Sites of application of the test material showed no irritation or other dermal changes. However, a residual yellow staining was evident in a number of animals during the clearing in all instances by Day 15. A slightly low bodyweight gain was recorded for one male and one female on Day 8 and in three males on Day 15. All other rats achieved the anticipated bodyweight gains throughout the study. No abnormalities were recorded at the macroscopic examination on Day 15.

To evaluate the acute inhalative toxicity, male and female rats (10/sex/dose) were exposed for 4h to a dust aerosol (5.5 mg/l air, 1.500 l/h, nose only) of the analogue substance. Following dosing, the animals were observed for 14d. Examination of clinical signs and viability were performed daily, weighing on day 1, 3, 7 and 13 after treatment. 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.

Discussion

The test substance did not induce any mortalities, abnormalities or clinical signs when applied oral or dermal. A yellow discoloration of faeces and skin after administration was recorded. These observations are substance induced effects and are not treated as toxicological symptoms.

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 30th time in Directive 2008/58/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).