Registration Dossier
Registration Dossier
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EC number: 309-886-6 | CAS number: 101316-84-1 A tar obtained from low temperature carbonization and low temperature gasification of brown coal. Composed primarily of aliphatic, naphthenic and cyclic aromatic hydrocarbons, heteroaromatic hydrocarbons and cyclic phenols.
Endpoint summary
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).Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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