Registration Dossier

Administrative data

Description of key information

Only very slight skin irritation was seen in a rabbit skin irritation study performed with CTF; a negative EpiSkin assay is available for DMP.  An in vivo eye irritation study with CTF indicates that this component is an eye irritant; no additional testing is proposed for animal welfare reasons and it is assumed that Polyol TD is an eye irritant and will therefore be classified as such.

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:
adverse effect observed (irritating)

Additional information

Skin irritation / corrosion

In a rabbit study with CTF (Dyring Jacobsen, 2010), very slight erythema was seen on one rabbit which persisted for the duration of the observation period (24 -72 hours); no signs of erythema or oedema were seen in any of the other three rabbits. It was concluded that CTF should not be classified as irritating to skin under the CLP Regulation. A negative response (87.91% viability) is reported in an EpiSkin assay performed with DMP (Blackstock, 2010).

The available information therefore demonstrates that the components CTF, DMP and TMP (by read-across from DMP) are not skin irritants and it can be concluded that the Reaction mass of 2-ethylpropane-1,3-diol(DMP) and 5-ethyl-1,3-dioxane-5-methanol(CTF) and propylidynetrimethanol(TMP) is not a skin irritant.

Eye irritation

The eye irritant potential of CTF was determined in a GLP study conducted according to OECD 405, with rabbits (Dyring Jacobsen, 2010). Slight to moderate reactions were seen at 24, 48, and 72 hours, slight reactions were observed at 7 days, and no reactions were seen at 14 days. It was concluded that CTF is irritating to eyes (CLP Category 2) based on the results of this study. As CTF is classified as an eye irritant, further testing with the Reaction mass of 2-ethylpropane-1,3-diol(DMP) and 5-ethyl-1,3-dioxane-5-methanol(CTF) and propylidynetrimethanol(TMP) or its components is not proposed for reasons of animal welfare and it is assumed that the substance will also be an eye irritant.


Effects on eye irritation: irritating

Justification for classification or non-classification

Skin irritation/corrosion:

The results of a rabbit study performed with the component CTF and an EpiSkin study performed with DMP show evidence that there is no need to classify The Reaction mass of 2-ethylpropane-1,3-diol(DMP) and 5-ethyl-1,3-dioxane-5-methanol(CTF) and propylidynetrimethanol(TMP) as a skin irritant according to the Directive 67/548/EEC or Regulation 1272/2008/EC.

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Eye irriation:

Based on the results of a rabbit study performed with the component CTF there is a need to classify The Reaction mass of 2-ethylpropane-1,3-diol(DMP) and 5-ethyl-1,3-dioxane-5-methanol(CTF) and propylidynetrimethanol(TMP) as irritating to eyes according to the Directive 67/548/EEC and as causing serious eye irritation according to the Regulation 1272/2008/EC.