Registration Dossier

Administrative data

Description of key information

An in vitro skin irritation study (EpiSkinTM) and an in vivo eye irritation study (OECD 405) were performed with barium dichloride dihydrate, which indicated that the test substance is not irritating to the skin but irritating to the eyes.

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)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Additional information

Skin irritation:
Reference Verbaan (2010) is considered as the key studies for in vitro skin irritation and will be used for classification. The overall irritation result is as follows:

Relative viability: mean after 15 min incubation 80% (max. score: 88%); evaluated by MTT reduction.

 

Eye irritation:

Reference Stitzinger (2010) is considered as the key study for eye irritation and will be used for classification. The overall irritation results are as follows:

Corneal opacity, iritis, chemosis and conjunctivae, 24, 48 and 72h after application: max score=3; effects were reversible within 21 days


Justification for selection of skin irritation / corrosion endpoint:
GLP guideline study of 2010

Justification for selection of eye irritation endpoint:
GLP guideline study of 2010

Effects on eye irritation: irritating

Justification for classification or non-classification

Skin irritation:

Reference Verbaan (2010) is considered as the key studies for in vitro skin irritation and will be used for classification. The overall irritation result is as follows:

Relative viability: mean after 15 min incubation 80% (max. score: 88%); evaluated by MTT reduction.

 

The classification criteria according to regulation (EC) 1272/2008 as irritating to skin are not met since the mean rel. viability is >50% of the control, hence no classification required. The in vitro study according to the draft EC method B.46 (EpiSkinTM) was validated and considered of being a reliable and relevant stand-alone test for predicting rabbit skin irritation, and for being used as a replacement of in vivo method OECD 404 for the purposes of distinguishing between R38 skin irritating and non-skin irritating test substances (ECVAM, 27.04.2007).

 

 

Eye irritation:

Reference Stitzinger (2010) is considered as the key study for eye irritation and will be used for classification. The overall irritation results are as follows:

Corneal opacity, iritis, chemosis and conjunctivae, 24, 48 and 72h after application: max score=3; effects were reversible within 21 days

The classification criteria according to regulation (EC) 1272/2008 as irritating to eyes are met since the mean score after 24, 48 and 72h was > 2 for chemosis and conjunctivae, hence classification and labelling as “skin irrit. 2” H319 is required.

 

Respiratory irritation:

The classification as respiratory irritant is covered under the endpoint specific target organ toxicity- single exposure and repeated exposure. Please refer to the endpoint summaries on acute toxicity (endpoint 7.2) and repeated dose toxicity (endpoint 7.5) for further information.