Regulation (EC) No 1907/2006 of the European Parliament and of the CouncilDangos y teitl llawn

Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals Agency, amending Directive 1999/45/EC and repealing Council Regulation (EEC) No 793/93 and Commission Regulation (EC) No 1488/94 as well as Council Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC (Text with EEA relevance)

COLUMN 1 STANDARD INFORMATION REQUIRED COLUMN 2 SPECIFIC RULES FOR ADAPTATION FROM COLUMN 1
8.1. Skin irritation or skin corrosion

The assessment of this endpoint shall comprise the following consecutive steps:

(1)

an assessment of the available human and animal data,

(2)

an assessment of the acid or alkaline reserve,

(3)

in vitro study for skin corrosion,

(4)

in vitro study for skin irritation.

8.1. Steps 3 and 4 do not need to be conducted if:

  • the available information indicates that the criteria are met for classification as corrosive to the skin or irritating to eyes, or

  • the substance is flammable in air at room temperature, or

  • the substance is classified as very toxic in contact with skin, or

  • an acute toxicity study by the dermal route does not indicate skin irritation up to the limit dose level ( 2 000 mg/kg body weight).

8.2. Eye irritation

The assessment of this endpoint shall comprise the following consecutive steps:

(1)

an assessment of the available human and animal data,

(2)

an assessment of the acid or alkaline reserve,

(3)

in vitro study for eye irritation.

8.2. Step 3 does not need to be conducted if:

  • the available information indicates that the criteria are met for classification as corrosive to the skin or irritating to eyes, or

  • the substance is flammable in air at room temperature;

8.3. Skin sensitisation

The assessment of this endpoint shall comprise the following consecutive steps:

(1)

an assessment of the available human, animal and alternative data,

(2)

In vivo testing.

8.3. Step 2 does not need to be conducted if:

  • the available information indicates that the substance should be classified for skin sensitisation or corrosivity, or

  • the substance is a strong acid (pH ≤ 2,0 ) or base (pH ≥ 11,5 ), or

  • the substance is flammable in air at room temperature.

The Murine Local Lymph Node Assay (LLNA) is the first-choice method for in vivo testing. Only in exceptional circumstances should another test be used. Justification for the use of another test shall be provided.

8.4. Mutagenicity
8.4. Further mutagenicity studies shall be considered in case of a positive result.
8.4.1. In vitro gene mutation study in bacteria
8.5. Acute toxicity
8.5. The study/ies do(es) not generally need to be conducted if:

  • the substance is classified as corrosive to the skin.

8.5.1. By oral route
The study need not be conducted if a study on acute toxicity by the inhalation route (8.5.2) is available.]
(1)

[X1This Annex shall apply to producers of articles that are required to register in accordance with Article 7 and to other downstream users that are required to carry out tests under this Regulation adapted as necessary.]

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