Calcium tetraborate

Endpoint summary

Description of key information

Based on the available in vivo test data for analogous substances which indicate an absence of skin sensitising effect, an absence of evidence from widespread consumer and occupational use of inorganic borates and very low dermal penetration, it can be concluded that all calcium borates are unlikely to cause sensitisation by skin contact.

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records

Reference

Endpoint:

skin sensitisation, other

Remarks:

weight of evidence

Type of information:

read-across based on grouping of substances (category approach)

Adequacy of study:

weight of evidence

Justification for type of information:

A literature review of available data which is considered relevant to calcium metaborate was conducted to ascertain the potential for skin sensitisation effects.

At physiological pH, the substances dissociate and release boric acid and calcium ions as a result of relevant transformation pathways. The literature review looked at a range of borate substances and reported no signs of skin sensitisation. Data collected in the weight of evidence report also noted that it is unlikely that the calcium cation would cause sensitisation by skin contact. As calcium tetraborate will dissociate to the same common compounds, then the weight of evidence report can also be used to cover the sensitisation endpoint for the REACH registration of calcium tetraborate.

Remarks on result:

other: Weight of evidence approach

Remarks:

This is a weight of evidence which is based on different types of data which are considered relevant to the assessment of the likelihood of skin sensitising effects to occur by exposure to calcium metaborate.

Remarks on result:

other: weight of evidence

Remarks:

This is a weight of evidence which is based on different types of data which are considered relevant to the assessment of the likelihood of skin sensitising effects to occur by exposure to calcium metaborate

Interpretation of results:

GHS criteria not met

Conclusions:

Based on the available in vivo test data for analogous substances which indicate an absence of skin sensitising effect, an absence of evidence from widespread consumer and occupational use of inorganic borates and very low dermal penetration, it can be concluded that all calcium borates are unlikely to cause sensitisation by skin contact.

Executive summary:

A literature review of available data which is considered relevant to calcium metaborate was conducted to ascertain the potential for skin sensitisation effects. At physiological pH, the calcium borates dissociate and release boric acid and calcium ions as a result of relevant transformation pathways. The literature review looked at a range of borate substances which reported no signs of skin sensitisation.  Data collected in the weight of evidence report also noted that it is unlikely that the calcium cation would cause sensitisation by skin contact. As calcium tetraborate will dissociate to the same common compounds as calcium metaborate, then the weight of evidence report can also be used to cover the sensitisation endpoint for the REACH registration of calcium . Classification as a skin sensitiser is therefore not required.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not sensitising)

Justification for classification or non-classification

Based on the available in vivo test data for analogous substances which indicate an absence of skin sensitising effect, an absence of evidence from widespread consumer and occupational use of inorganic borates and very low dermal penetration, it can be concluded that all calcium borates are unlikely to cause sensitisation by skin contact.