Registration Dossier

Administrative data

Endpoint:
relative self-ignition temperature (solids)
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
other:
Justification for type of information:
JUSTIFICATION FOR DATA WAIVING

In accordance with section 1.1 of REACh Annex XI, the study does NOT need to be conducted if equivalent data is available.
Based on ECHA endpoint specific guidance on information requirements (R.7a, v5.0, December 2016, §R.7.1.12), the UN Test N.4 is preferable to generate the information for this endpoint.
Please refer to Flammability (self-heating) under 4.13.
Cross-referenceopen allclose all
Reason / purpose for cross-reference:
data waiving: supporting information
Reference

Based on information on the consituents of the test substance (calcium fluoride, calcium carbonate and calcium sulphate) and information on the test substance it self, we can concluded that the test substante is not classified regarding flammable hazard regarding flammability according to GHS criteria (flammable solid, not a self-heating, pyrophoricity; flammable if contact with water)

Flammability:
not classified

No experimental study is available on the registered reaction mass.

However, data is available for the three constituents, and considered sufficient for hazard assessment.

Calcium fluoride is considered as non-flammable from literature. Calcium sulfate is recommended for low hazard to fire in construction products. For calcium carbonate, a fully reliable experimental study shows no ignition if contact with a flame. No reaction is expected between the salts to form new species. Therefore the reaction mass is not anticipated to be a flammable solid.

In addition, based on high melting point for calcium fluoride and sulfate, and on fully reliable experimental study, negative, on carbonate, no self-heating is anticipated for the reaction mass either.

Based on experience, no pyrophoric properties, or release of flammable gas if contact with water, are anticipated with the registered reaction mass, therefore these studies were deemed unnecessary.

Reason / purpose for cross-reference:
data waiving: supporting information
Reference
Endpoint:
self-heating substances / mixtures
Data waiving:
other justification
Justification for data waiving:
other:
Justification for type of information:
JUSTIFICATION FOR DATA WAIVING
In accordance with column 2 of REACh Annex VII 7.12, the study does NOT need to be conducted if preliminary results exclude self-heating of the substance up to 400 °C.
As presented under IU Section 4.13 (flammable solids), the substance is non-flammable. Moreover, a melting point of 1403°C is presented under IU section 4.2. So it looks unlikely that the substance would undergo self-heating.
Therefore no additional information is required.
Reason / purpose for cross-reference:
data waiving: supporting information
Reference
Endpoint:
self-heating substances / mixtures
Data waiving:
other justification
Justification for data waiving:
other:
Justification for type of information:
JUSTIFICATION FOR DATA WAIVING
In accordance with column 2 of REACh Annex VII 7.12, the study does NOT need to be conducted if preliminary results exclude self-heating of the substance up to 400 °C.
As presented under IU Section 4.13 (flammable solids), the substance is non-flammable (Class A ‘No contribution to fire’ material, according to construction products legislation). Moreover, a melting point of 1460°C is presented under IU section 4.2. So it looks unlikely that the substance would undergo self-heating.
Therefore no additional information is required.
Reason / purpose for cross-reference:
data waiving: supporting information
Reference
Endpoint:
self-heating substances / mixtures
Type of information:
experimental study
Adequacy of study:
weight of evidence
Study period:
12 May 2010 to 02 June 2010
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
UN Manual of Tests and Criteria: Test N.4 (Test method for self-heating substances)
Version / remarks:
UN Recommendations on the Transport of Dangerous Goods, Manual of Tests and Criteria, 4th revised edition, 2003
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Specific details on test material used for the study:
The nano form of calcium carbonate was tested because this form was anticipated to represent the worst case due to the smaller size of the particles and therefore the greater surface area exposed to heat.
Test procedure:
100 mm sample cube at 140°C
Result:
negative outcome (no effect observed)

There were no signs of self-ignition or self heating over the duration of the test.

Interpretation of results:
not classified based on GHS criteria
Conclusions:
Not classified as self-heating, based on CLP criteria.
Executive summary:

A negative result was obtained in the UN N4 test with calcium carbonate (nano).

Data source

Materials and methods

Results and discussion

Applicant's summary and conclusion