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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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 irritation: corrosive (OECD 404, GLP)
Eye irritation: corrosive (worst case classification, based on the data of a skin irritation study)

Key value for chemical safety assessment

Skin irritation / corrosion

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (corrosive)

Eye irritation

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Additional information

Skin irritation

One reliable animal study described in Vaeth (2004) (OECD 404; GLP compliant) is considered to be reliable without restrictions. The substance was determined to be corrosive to the skin.

An in vitro study described by Vaeth (2003) (draft proposal of OECD 431 and ZEBET SOP, non-GLP complaint) is submitted as supportive information. The results of the in vitro study will be used for the hazard evaluation for the following reasons: (i) the in vitro study has limitations and (ii) in vivo results are considered to be more convincing than in vitro data due to the direct assessment.

Eye irritation

One reliable animal study described by Kim (2009) (comparable to OECD 405; GLP complaint) is considered to be reliable without restrictions. However, the study was conducted with a 5 % solution of the test substance SymWhite 377 and for this reason can only be used as supportive information.

Further testing for eye irritation is waived based on the following reasons:

(i) A test according to EC method B.5 (eye-irritation) was not performed, since the substance was corrosive to the skin in undiluted form (EC method B.4). It is stated here that substances with known corrosive effects to the skin; should be considered to be corrosive to the eyes as well. Hence and due to animal welfare the in-vivo eye irritation study was not performed and severe damage to the eyes is assumed based on the outcome of the skin irritation study (section 8.2.1 column 2 of REACH Annex VIII).


(ii) In accordance with section 8.2 column 2 of REACH Annex VII, the in-vitro eye irritation study does not need to be conducted as the available information indicates that the criteria are met for classification as corrosive to the skin.

Effects on skin irritation/corrosion: corrosive

Effects on eye irritation: corrosive

Effect level: empty Endpoint conclusion: Adverse effect observed

Justification for classification or non-classification

Skin irritation

Reference Vaeth (2004) is considered as the key study for in vivo skin irritation and will be used for classification. The overall irritation result is as follows: The study showed that if the undiluted substance was applied to one female rabbit for duration of one hour, the test item was not visible anymore and seemed to be diffused into the skin. The skin was white and appeared cauterised. At the 14 day observation necrotic tissue with a healing full thickness destruction of the skin was observed.

The classification criteria according to regulation (EC) 1272/2008 as corrosive to skin are met since the animal showed destruction of the skin. SymWhite 377 will be classified as skin corrosive category 1B (H314).

Eye irritation

Based on the discussion on eye irritation not performed with SymWhite 377 (see discussion above) the substance should be classified as leading to serious damage to the eyes (Category 1; H318).

Respiratory irritation

The classification as respiratory irritant is normally covered under the endpoint specific target organ toxicity- single exposure and repeated exposure. For substances and mixtures classified as skin corrosive, the additional labelling EUH071: Corrosive to the respiratory tract should be used in case no acute inhalation test data are available or the substance maybe inhaled. This is the case for SymWhite® 377.

Nevertheless, MPPD modelling shows that only minimal amounts (~0.3%) of the substance are able to penetrate to the deep lung tissue, whereas the overwhelming bulk (99.7%) of inhaled material is cleared rapidly to the GI tract (by swallowing), where oral bioavailability will determine its uptake.