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, v6.0, July 2017, §R.7.1.12), the UN Test N.4 is preferable to generate the information for this endpoint. Please refer to Flammability (self-heating temperature) under 4.13.
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Reason / purpose:
data waiving: supporting information
Reference
Endpoint:
self-heating substances / mixtures
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Justification for type of information:
The test substance is aluminium sulphate basic, of formula Al2 (OH)0.18 (SO4)2.91, and not pure aluminium sulphate Al2 (SO4)3; however, according to the notifier, limited basicity may occur in the technical substance. Therefore, the chemical similarity (only 0.9% OH) is considered sufficient for supporting data on the hydrated form, the reference substance for the REACh registration dossier being the anhydrous form.
Reason / purpose:
read-across source
Key result
Test procedure:
100 mm sample cube at 140°C
Max. temp. reached:
140
Induction time (h):
24
Result:
negative outcome (no effect observed)
Interpretation of results:
not classified based on GHS criteria
Conclusions:
The substance is NOT classified as self-heating, based on CLP criteria.
Executive summary:

From analogue, no exothermic reaction is anticipated in UN N4 test conditions.

Reason / purpose:
data waiving: supporting information
Reference
Endpoint:
self-heating substances / mixtures
Type of information:
experimental study
Adequacy of study:
key study
Study period:
09 March 2010- 04 June 2010
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Remarks:
This study has been performed according to UN guideline and according to GLP princip les. Test substance is adequately characterised. Therefore full validation applies.
Qualifier:
according to
Guideline:
UN Manual of Tests and Criteria: Test N.4 (Test method for self-heating substances)
Version / remarks:
2003
Deviations:
no
GLP compliance:
yes (incl. certificate)
Key result
Test procedure:
100 mm sample cube at 140°C
Max. temp. reached:
140
Induction time (h):
24
Result:
negative outcome (no effect observed)

No exothermic reaction was observed. The test substance temperature did not exceed 200°C (i.e. a rise of more than 60°C above the oven temperature). Therefore this test was considered negative. No changes were observed in the appearance of the test substance.

Based on this, the test substance is ‘not a self-heating substance’.

Interpretation of results:
not classified based on GHS criteria
Conclusions:
The test substance is ‘not a self-heating substance’.
Executive summary:

The self-heating potential of aluminium sulphate basic hydrated was investigated according to UN N4 guideline. No exothermic reaction was observed. The test substance temperature did not exceed 200°C (i.e. a rise of more than 60°C above the oven temperature). Therefore this test was considered negative. No changes were observed in the appearance of the test substance.

The test is relevant for classification according to CLP criteria.

Data source

Materials and methods

Results and discussion

Applicant's summary and conclusion