Registration Dossier

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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Description of key information

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records
Reference
Endpoint:
skin sensitisation
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Authorative secondary source with dose decriptor provided only. Original study report was not available.
Principles of method if other than guideline:
Secondary literature source no data about the method was available.
GLP compliance:
not specified
Species:
guinea pig

Positive in the modified Maguire method

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (sensitising)
Additional information:

The US-EPA RED (2005) document reports that the test item was tested positive for dermal sensitization using a "modified Maguire method". No information on the testing procedure was provided. This result was used as key value to reflect the worst case scenario.


Migrated from Short description of key information:
The information obtained from the available authorative secondary source indicated that the test item was tested positive for dermal sensitization using a "modified Maquire method" (US-EPA RED (2005). Although no information on the testing procedure was provided, this result was used as key value to reflect the worst case scenario.

Justification for selection of skin sensitisation endpoint:
Sole reference available.

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

The classification derived from the available result differs from the harmonised classification.

According to self classification:

Dangerous Substance Directive (67/548/EEC)

The available study is used for classification purposes under Directive 67/548/EEC. As a result the substance is considered to be classified as R43 (May cause sensitisation by skin contact) with regard to skin sensitisation under Directive 67/548/EEC, as amended for the 31st time in Directive 2009/2/EG.  

Classification, Labelling, and Packaging Regulation (EC) No 1272/2008

The available experimental data is used for classification purposes under Regulation (EC) No 1272/2008. As a result the substance is considered to be classified as skin sensitiser cat. 1 (H317) under Regulation (EC) No 1272/2008, as amended for the sixth time in Regulation (EC) No 605/2014.

According to harmonised classification:

Dangerous Substance Directive (67/548/EEC)

According to the harmonised Annex I classification the substance is not considered to be classified for skin an respiratory sensitisation under Directive 67/548/EEC, as amended for the 31st time in Directive 2009/2/EG.  

Classification, Labelling, and Packaging Regulation (EC) No 1272/2008

According to the harmonised Annex VI classification the substance is not considered to be classified for skin and respiratory sensitisation under Regulation (EC) No 1272/2008, as amended for the sixth time in Regulation (EC) No 605/2014.