Registration Dossier

Administrative data

Description of key information

The irritating potential of the test substance (calcium-salt) was not determined. Information on skin and eye irritation are derived from experimental data of structural analogues (barium- and calcium salts). To evaluate the irritation potential of the test article, skin or eyes of rabbits were treated with the test substanceand reactions were observed and scored up to 72h. Application onto skin provoked slight erythema which resolved within 72h. In contact with eyes, slight reactions at conjunctiva and cornea were observed. All reactions were reversible within 72h and are below the threshold of significance. The test substance is considered to be as non-irritating to skin or eyes.

Key value for chemical safety assessment

Skin irritation / corrosion

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Eye irritation

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Read across justification

The potential to cause irritation at skin or eyes was not assessed with the test item but with structural analogues. All of the substances are salts and share high similarity in structure. Moreover, all substances are minimal soluble in water. Therefore, it is acceptable to derive information on skin and eye irritation from experimental data of analogue substances. A detailed read across justification is given in Annex I of the CSR.

 

Procedure and observations

Read across to CAS 12286 -66 -7

In the course of the skin irritation study (Ciba, 1972), six (three per sex) English silver Strain rabbits were exposed for 24 hours to 0.5 g of the substance. Effects were scored 24 and 72 hours after removal of the wrap.The test article did not induce any effects on intact or abraded rabbit’s skin.

Read across to CAS 12286 -66 -7

Another skin irritation study was performed similar to OECD guideline 404 (Synthesia 1993). Application of the substance onto skin did not provoke any effects and is therefore not considered to be irritating. 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 5280-70-6

In this study (Ciba, 1980), primary skin irritation properties of the test material were investigated by topical application of 0.5 g of the test article in PEG onto shaved intact and abraded flank skin of each of three male and three female Californian rabbits. The scoring of skin reactions was performed 24 and 72 hours after removal of the dressing. Under the conditions of this experiment, the test substance induced slight erythema when applied onto abraded rabbit skin. All reaction resolved within 72h.

Read across to CAS 12286 -66 -7 

A study according to OECD 405 was performed to evaluate the eye irritation potential of the test article (Ciba, 1972b). Six English Silver Strain rabbits (three per sex) were exposed to 0.1 g of the test article. The treated eyes were rinsed at three of six animals 30 sec after application. Scoring of irritation effects was performed 1, 2, 3, 4 and 7 days after test article application. The test article did not cause any reaction to washed or unwashed eyes.

Read across to CAS 12286 -66 -7

A supporting eye irritation test in rabbits was performed according OECD guideline 405 (Synthesia 1993). The test material was instilled into the conjunctival sac of a rabbit eye (three animals each). Effects on cornea, iris and conjunctiva were scored 1, 24, 48 and 72h after treatment. Swelling and redness were observed after 1h and 24h. All symptoms resolved within 72h. 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 5280 -70 -6

The eye irritation potential of the analogue substance was investigated by instillation of 0.1 mg into one eye of each of three male and three female Californian rabbits (Ciba, 1980a). The treated eyes were rinsed at three of six animals 30 sec after application. Scoring of irritation effects was performed 1, 24, 48 and 72 hours after test article application. The substance induced slight reactions at conjunctiva (redness, chemosis and discharge) and cornea (opacity). All effects were reversible within 72h. Washed eyes tended to show a less severe reaction.

 

Discussion

Application of the test substance or the analogue onto skin induced slight erythema. Administration into the conjunctival sac of the rabbit eye induced slight redness and opacity. All reactions were reversible within 72h and are below the threshold of significance.

Therefore, the test substance is considered to be as non-irritating to skin or eyes.

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 as irritating for skin or eyes 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 irritation under Regulation (EC) No. 1272/2008,

as amended for the second time in Directive (EC 286/2011).