Registration Dossier

Administrative data

Description of key information

Skin corrosion (in-vitro, Epiderm): Not corrosive.
Skin irritation (in-vitro, Episkin): Not irritating.
Eye irritation (in-vivo): Not irritating.

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

Two in-vitro tests were conducted to assess the effect of exposure of Fe3P to the skin. An Epiderm study (Huntingdon Life Sciences, 2010, study number FGE0004) assessed the potential corrosivity of the test material, whereas an Episkin study (Huntingdon Life Sciences, 2011, study number FGE0018) was performed to assess potential skin irritancy. Both studies were conducted according to official OECD test guidelines and in compliance with GLP. The overall conclusion of the two studies was that Fe3P shows no evidence of skin irritation or skin corrosion. On the basis of these two studies, it was concluded that an in-vitro test was not necessary.

An in-vitro study (Bovine Corneal Opacity and Permeability, BCOP, Huntingdon Life Sciences, 2011, study number FGE0017) was conducted to asess the eye irritant potential of Fe3P. The BCOP test was negative (did not indicate any potential to cause eye irritation), but this result alone was not considered sufficient to reach a definitive conclusion on the eye irritant properties of Fe3P, and so an in-vivo test was conducted (Huntingdon Life Sciences, 2012, study number FGE0019). Both studies were conducted according to official test guidelines (OECD and / or EC) and in compliance with GLP. Mild conjunctival redness was seen in one rabbit (out of three) one hour after instillation, but this was fully resolved by the 24-hour observation timepoint, and all treated animals' eyes were considered overtly normal from the 24-hour timepoint onwards. It was concluded that Fe3P is not an eye irritant.


Justification for selection of skin irritation / corrosion endpoint:
Note that no single study has been selected, as the conclusion as "not corrosive and not irritating" is based on the results of two in-vitro tests (Episkin and Epiderm).

Justification for selection of eye irritation endpoint:
The in-vivo eye irritation test was selected as the Key study as in-vivo data is considered more reliable than in-vitro data.

Justification for classification or non-classification

Fe3P did not demonstrate any irritant properties in any of the skin or eye irritation studies conducted. On this basis it is concluded that Fe3P does not meet the criteria for classification as a skin or eye irritant neither under the Classification, Labelling and Packaging (CLP) Regulation, nor under the Dangerous Substances Directive.