Registration Dossier

Administrative data

Description of key information

Not irritating to the eyes according to CLP criteria

Not irritating to the skin according to CLP criteria

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

For both end points, skin and eye irritation many study are existing, that are consistent and assess the substance as non irritating for skin and eyes

Justification for selection of skin irritation / corrosion endpoint:

The BASF (2004) study is performed in GLP but substance purity is low  23.7 %, therefore the study has been presented in Weight of Evidence with the Kemira (1986) study, described with less details, non GLP, but performed on a more pure composition (72 %). All presented studies agree on the classification as not irritating to the skin

Justification for selection of eye irritation endpoint:

The BASF (2004) study is performed in GLP but substance purity is low  23.7 %, therefore the study has been presented in Weight of Evidence with the Kemira (1986) study, described with less details, non GLP, but performed on a more pure composition (72 %). All presented studies agree on the classification as not irritating to the eye

Justification for classification or non-classification

Skin irritation has to be considered if following EU test B4, a mean value of≥2,3 -≤4,0 for erythema/eschar or for oedema in at least 2 of 3 tested animals from gradings at 24, 48 and 72 hours after patch removal or, if reactions are delayed, from grades on 3 consecutive days after the onset of skin reactions; or Inflammation that persists to the end of the observation period normally 14 days in at least 2 animals, particularly taking into account alopecia (limited area), hyperkeratosis, hyperplasia, and scaling; or (3) In some cases where there is pronounced variability of response among animals, with very definite positive effects related to chemical exposure in a single animal but less than the criteria above

Based on provided data no classification for skin irritation is warranted under Regulation 1272/2008

Substances are classified as eye irritant if they have the potential to induce reversible eye irritation according to the following criteria: if, when applied to the eye of an animal, a substance produces:

— at least in 2 of 3 tested animals, a positive response of:

— corneal opacity≥1 and/or

— iritis≥1, and/or

— conjunctival redness≥2 and/or

— conjunctival oedema (chemosis)≥2

— calculated as the mean scores following grading at 24, 48 and 72 hours after installation of the test material, and which fully reverses within an observation period of 21 days

Based on provided data no classification for eye irritation/corrosion is warranted under Regulation 1272/2008