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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Skin corrosion / irritation:
No reliable study is available for the skin irritation endpoint. Based on the reliable data for the eye irritation tests, no additional skin irritation should be performed and a waiver based on expert judgement is added to this dossier.
Gabriel (1974) performed an in vivo skin and in vivo eye irritation test in New Zealand White rabbits. Skin and eye irritation was observed in this old study that had some deficiencies. A new in vitro and in vivo eye irritation test has been performed with this substance. The latter tests didn't reveal eye irritation. As the eye is generally more vulnerable for irritation/corrosion, it is considered unnecessary to perform a new in vivo skin irritation test and it is considered that the substance should not be classified for irritation to the skin.
Eye corrosion / irritation:
Two K1 studies are available for this endpoint (one in vitro and one in vivo study). The in vivo test is selected as key study as in vivo studies are more reliable than in vitro studies. Based on the outcome of the study, the substance do not need to be classified for eye irritation.

Key value for chemical safety assessment

Skin irritation / corrosion

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

Eye irritation

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

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Skin irritation / corrosion:

No study need to be performed for this endpoint. Therefore following waiver statement is added to the dossier based on the data of the reliable eye irritation tests and expert judgement:

Gabriel (1974) performed an in vivo skin and in vivo eye irritation test in New Zealand White rabbits (K3 study). Skin and eye irritation was observed in this old study that had some deficiencies. A new in vitro and in vivo eye irritation test has been performed with this substance. The latter tests didn't reveal eye irritation. As the eye is generally more vulnerable for irritation/corrosion, it is considered unnecessary to perform a new in vivo skin irritation test and it is considered that the substance should not be classified for irritation to the skin.

Eye irritation:

An in vivo study was performed in New Zealand White rabbits (Stitzinger, 2013). Based on the results of this test, reaction product of oleic acid, N1-(9Z)-9-octadecen-1-yl-1,3-propanediamine and paraformaldehyde does not have to be classified and has no obligatory labelling requirements for eye irritation according to the Globally Harmonized System of Classification and Labelling of Chemicals (GHS) of the United Nations (2011) and Regulation (EC) No 1272/2008 of the European Parliament and the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures including all amendments.

In addition, a reliable in vitro study was performed with corneas of bovine eyes from young cattle (Verspeek-Rip, 2013). The purpose of this study was to determine the eye irritation potential of the test material after a treatment period of 10 minutes. The Reaction Product of Oleic acid, N1-(9Z)-9-octadecen-1 -yl-1,3 -propanediamine and paraformaldehyde is not severe irritant or corrosive in the bovine corneal opacity and permeability test under the experimental conditions of this test.

A non reliable K3 study (Gabriel, 1974) observed conjunctival redness and chemosis but no final conclusion could be made related to classification based on the available data and criteria of the CLP Regulation. In addition, observations were stopped 7 days after the exposure period. No conclusion could be made on overall reversibility of effects and therefore, an in vitro and in vivo eye irritation test were performed which revealed no eye irritation (Verspeek-Rip, 2013; Stitzinger, 2013, respectively).


Justification for selection of skin irritation / corrosion endpoint:
Study waived

Justification for selection of eye irritation endpoint:
In vivo test is more reliable than an in vitro test

Justification for classification or non-classification

Based on the available data and according to DSD/CLP criteria, the substance should not be classified for skin irritation / corrosion nor eye irritation / corrosion.