Registration Dossier

Administrative data

Description of key information

The in vivo tests of Skin irritation and Eye irritation were performed according to the following methods: 
1/ EU Method B.4 - Acute Toxicity: Dermal Irritation/Corrosion, Council Regulation (EC) No.440/2008, published in O.J. L 142, 2008.
2/ EU Method B.5 - Acute Toxicity: Eye Irritation/Corrosion, Council Regulation (EC) No.440/2008, published in O.J. L 142, 2008.
The in vitro tests of Skin irritation, Skin Corrosion and Eye irritation were performed according to the following methods:
1/ EU Method B.46 - In vitro skin irritation: Reconstructed human epidermis model test and Standard Operating Procedure for EpiDermTM published by ZEBET.
2/ EU Method B.40 - Skin corrosion (in vitro), Council Regulation (EC) No.440/2008. Published in O.J. L 142, 2008
3/ Method according to MatTek Ocular Irritation Protocol: Neat Method (MTT ET-50), Rev. 1/1/01 (1): in vitro eye irritation in human corneal model EpiOcularTM.
4/ OECD Test Guideline No. 437, Bovine Corneal Opacity and Permeability Test Method for Identifying Ocular Corrosives and Severe Irritants, Adopted 7th September 2009.
The tests were performed according to GLP (except last test - Bovine Corneal Opacity and Permeability).

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:

On the ground of impossibility (due the chemical character of test item) to perform in vitro tests (in vitro skin corrosion and in vitro skin irritation - see in vitro endpoints in section 7.3.1), the in vivo test on rabbits was performed.

In vivo test "Acute Toxicity: Dermal Corrosion/Irritation" on rabbits no evidence of corrosive effects or symptoms of irritation were observed on skin.

 

Eye irritation:

On the ground of impossibility (due the chemical character of test item) to perform in vitro test (in vitro eye irritation in human corneal model EpiOcularTM irritation - see in vitro endpoint in section 7.3.2), the in vitro test was performed: "Bovine Corneal Opacity and Pemeability Test Method for Identifying Ocular Corrosives and Severe Irritants". No corrosive and no severe irritating properties were not found.

In vivo test "Acute Toxicity: Eye Corrosion/Irritation" on one rabbit it was observed that the test item caused severe irritation of rabbit eye.


Effects on eye irritation: irritating

Justification for classification or non-classification

The test item - Tar, brown-coal, low-temp., did not irritate the skin of the rabbits (Vik L., 2010a) and significantly irritated the eye of the rabbit (Vik L., 2010b).

The substance was not defined as a corrosive or severe irritant to eyes, based on In Vitro Irritancy Score (Roznovska Z., 2010a).

The substance is classified as Eye Irrit. 2; H319 Causes serious eye irritation - according to Regulation (EC) No 1272/2008 criteria (Xi; R36 Irritating to eyes - according to DSD criteria).