Registration Dossier

Diss Factsheets

Administrative data

Description of key information

No components are classified for skin sensitisation, hence this endpoint is "Not Classified".Please refer to Section 13 “Evaluation of Toxicity Endpoints” in addition for further information.

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records
Reference
Endpoint:
skin sensitisation, other
Type of information:
calculation (if not (Q)SAR)
Adequacy of study:
key study
Study period:
January 2020
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
accepted calculation method
Justification for type of information:
K2 is assigned as results are based on calculation of effects based on components.
CLP classification is available for the individual components of the substance via REACH Annex VI harmonised classifications, REACH Registration dossiers or notifications to the CLP inventory. As such, it is deemed inappropriate to conduct additional testing on the reaction mass subject to this registration when the results may be predicted on the basis of the components themselves. Skin Sensitisation is assessed in this manner. Please refer to Section 13 “Evaluation of Toxicity Endpoints” in addition for further information.
Qualifier:
no guideline followed
Principles of method if other than guideline:
(EC) No 1907/2006 Regulation on classification, labelling and packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/2006 and its amendments

Calculation of ATEMix utilising (EC) No 1907/2006 Regulation on classification, labelling and packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/2006 and its amendments. The highest concentration in the composition range for each substance was utilised for the purposes of the assessment.
GLP compliance:
no
Justification for non-LLNA method:
CLP classification is available for the individual components of the substance via REACH Annex VI harmonised classifications, REACH Registration dossiers or notifications to the CLP inventory. As such, it is deemed inappropriate to conduct additional testing on the reaction mass subject to this registration when the results may be predicted on the basis of the components themselves. Skin Sensitisation is assessed in this manner. Please refer to Section 13 “Evaluation of Toxicity Endpoints” in addition for further information.
Species:
other: Not applicable - Calculation method
Strain:
other: Not applicable - Calculation method
Sex:
not specified
Details on test animals and environmental conditions:
Not applicable - Calculation method
Positive control results:
Not applicable - Calculation method
Key result
Run / experiment:
other: Not applicable - Calculation method
Parameter:
other: Calculation of skin sensitisation potential
Vehicle controls validity:
not applicable
Negative controls validity:
not applicable
Positive controls validity:
not applicable
Remarks on result:
no indication of skin sensitisation
Remarks:
On the basis of calculation. See below
Cellular proliferation data / Observations:
Not applicable - Calculation method

No components are classified for skin sensitisation, hence this endpoint is "Not Classified". Please refer to Section 13 “Evaluation of Toxicity Endpoints” in addition for further information.

Interpretation of results:
GHS criteria not met
Conclusions:
No components are classified for skin sensitisation, hence this endpoint is "Not Classified". Please refer to Section 13 “Evaluation of Toxicity Endpoints” in addition for further information.
Executive summary:

No components are classified for skin sensitisation, hence this endpoint is "Not Classified".Please refer to Section 13 “Evaluation of Toxicity Endpoints” in addition for further information.

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

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

No components are classified for skin sensitisation, hence this endpoint is "Not Classified".Please refer to Section 13 “Evaluation of Toxicity Endpoints” in addition for further information. Further more, corrosive effects are proposed to take precedence in the unlikely event of exposure.

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