Registration Dossier

Administrative data

Endpoint:
flash point of flammable liquids
Data waiving:
study technically not feasible
Justification for data waiving:
the study does not need to be conducted because the substance is inorganic
the study does not need to be conducted because the flash point is only relevant to liquids and low melting point solids
Justification for type of information:
JUSTIFICATION FOR DATA WAIVING

In accordance with column 2 of REACh Annex VII 7.9, the study does not need to be conducted if the substance is inorganic.
As presented under Section 1, the substance is a Reaction mass of three inorganic calcium salts (fluoride, sulfate, and carbonate, the last being also considered as inorganic, though it contains carbon).

Moreover, Flash Point testing is only applicable to substances which are liquids, or evolve to liquids within the classification range, i.e. up to 60°C considering CLP criteria. As presented under Sections 4.1 and 4.2, the substance,is a solid with melting expected in the range 825 - 1460°C, after moisture vaporisation followed by deocmposition of one consituent.

Please refer to Flammability under 4.13 for relevant data for classification purpose of a solid.
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:
flammable solids
Type of information:
not specified
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
data from handbook or collection of data
Remarks:
Authoritative source, peer reviewed.
Principles of method if other than guideline:
No details.
GLP compliance:
not specified

Calcium fluoride is not combustible. (ICSC)

Fluorides are non-flammable compounds. (INRS toxicolological sheet on alkali and alkaline-earth fluorides)

).

Interpretation of results:
not classified based on GHS criteria
Executive summary:

Calcium fluoride is not expected to be a flammable solid, from reliable literature data.

Reason / purpose for cross-reference:
data waiving: supporting information
Reference
Endpoint:
flammable solids
Data waiving:
study waived due to provisions of other regulation
Justification for data waiving:
other:
Justification for type of information:
JUSTIFICATION FOR DATA WAIVING
Calcium sulfate (gypsum) is listed in Annex of Commission Decision 96/603/EC as a Class A (‘No contribution to fire’) material. According to Article 1 of the Decision, the materials, and products made from them, that are listed in the Annex of the Decision, shall, on account of their low level of combustibility and subject to the conditions also set out in the Annex, be classified in Classes A (‘No contribution to fire’) as provided for in tables 1 and 2 of the Annex to Decision 94/611/EC on construction products. As such, flammability testing is deemed unnecessary for calcium sulfate.
Reason / purpose for cross-reference:
data waiving: supporting information
Reference
Endpoint:
flammable solids
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
Remarks:
GLP guideline study
Qualifier:
according to guideline
Guideline:
UN Manual of Tests and Criteria: Test N.1 (Test method for readily combustible solids)
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:
burning rate test: preliminary screening test
Remarks on result:
substance does not ignite and propagate combustion either by burning with flame or smouldering along 200 mm of the powder train within the 2 minutes test period

The result of the preliminary screening test obviated the need to perform the main test.

Interpretation of results:
not classified based on GHS criteria
Conclusions:
Not classified as a flammable solid, based on CLP criteria.
Executive summary:

Calcium carbonate (nano) failed to ignite in the UN N1 preliminary screening test.

Data source

Materials and methods

Results and discussion

Applicant's summary and conclusion