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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

In a well conducted in vivo rabbit skin irritation study (OECD 404, GLP) where three rabbits had the test substance administered to their shaved flank under semi occlusive conditions for a period of 4 hours, clear irritative phenomena were observed during the first 24 hours. However the intensity decreased throughout the remaining observation period and was no longer present by day 6. The study authors concluded that Isostearyl Alcohol is irritating to skin under the conditions of the test. However, the individual scores reported do not support classification either under CLP Regulation (1272/2008) or the Dangerous Substances Directive (67/548/EEC)

In a well conducted study (OECD 404, GLP), the administration of Isostearyl Alcohol in a semi occlusive manner to the shaved skin of three albino rabbits for a period of four hours, resulted in a primary irritation index of 3.7 (moderately irritating). All effects were reversible after 14 days. Under the CLP Regulation (1272/2008) this would give rise to a classification of Category 2: Irritant. (Daamen 1990)

In a well conducted in vivo rabbit skin irritation study (OECD 404, GLP) where three rabbits had the test substance (Alcool Isostearylique) administered to their shaved flank under semi occlusive conditions for a period of 4 hours, clear erythema persisted for the duration of the observation period, until day 6 where all signs of irritation had completely disappeared. Under the conditions of the study the test substance would be classified as irritating to skin R38 (67/548/EEC). However it would NOT be classified according to CLP Regulation (1272/2008). (Saboureau 1989b)

Whilst it is likely that there may have been some compositional variation between the tested substances, insufficient information is available to make a definitive interpretation of relevance to the currently marketed product. Taking a conservative interpretation, it is therefore concluded that the substance fulfils the criteria for skin irritation (Category 2) under CLP 1272/2008.

In a well conducted in vivo eye irritation study using Isostearyl alcohol (OECD 405, GLP) minor transient irritation was observed after one hour. No other treatment related ocular effects were subsequently recorded. On the basis of these findings, Isostearyl alcohol is not classifed as irritating to eyes.


Justification for selection of skin irritation / corrosion endpoint:
PLACE HOLDER TO REVIEW

Justification for selection of eye irritation endpoint:
Good quality Rel.1 study conducted in accordance with OECD 405.

Justification for classification or non-classification

Skin irritation: Fulfils the criteria for skin irritation (Category 2) under CLP 1272/2008.

Eye irritation: Does not fulfil the criteria for eye irritation under CLP 1272/2008 and is therefore not classified.