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8.: TOXICOLOGICAL INFORMATION


COLUMN 1

STANDARD INFORMATION REQUIRED

COLUMN 2

SPECIFIC RULES FOR ADAPTATION FROM COLUMN 1

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8.1.  Skin corrosion/irritation

8.1.  The study/ies do(es) not need to be conducted if:

— the substance is a strong acid (pH ≤ 2,0) or base (pH ≥ 11,5) and the available information indicates that it should be classified as skin corrosion (Category 1), or

— the substance is spontaneously flammable in air or in contact with water or moisture at room temperature, or

— the substance is classified as acute toxicity by the dermal route (Category 1), 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).

If results from one of the two studies under point 8.1.1 or 8.1.2 already allow a conclusive decision on the classification of a substance or on the absence of skin irritation potential, the second study need not be conducted.

8.1.1.  Skin corrosion, in vitro

 

8.1.2.  Skin irritation, in vitro

 

8.2.  Serious eye damage/eye irritation

8.2.  The study/ies do(es) not need to be conducted if:

— the substance is classified as skin corrosion, leading to classification as serious eye damage (Category 1), or

— the substance is classified as skin irritation and the available information indicates that it should be classified as eye irritation (Category 2), or

— the substance is a strong acid (pH ≤ 2,0) or base (pH ≥ 11,5) and the available information indicates that it should be classified as serious eye damage (Category 1), or

— the substance is spontaneously flammable in air or in contact with water or moisture at room temperature.

8.2.1.  Serious eye damage/eye irritation, in vitro

8.2.1.  If results from a first in vitro study do not allow a conclusive decision on the classification of a substance or on the absence of eye irritation potential, (an)other in vitro study/ies) for this endpoint shall be considered.

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8.3.  Skin sensitisation

Information allowing:

— a conclusion whether the substance is a skin sensitiser and whether it can be presumed to have the potential to produce significant sensitisation in humans (Cat. 1A), and

— risk assessment, where required.

The study(ies) under point 8.3.1 and 8.3.2 do not need to be conducted if:

— the substance is classified as skin corrosion (Category 1), or

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

— the substance is spontaneously flammable in air or in contact with water or moisture at room temperature.

8.3.1.  Skin sensitisation, in vitro/in chemico

Information from in vitro/in chemico test method(s) recognised according to Article 13(3), addressing each of the following key events of skin sensitisation:

(a)  molecular interaction with skin proteins;

(b)  inflammatory response in keratinocytes;

(c)  activation of dendritic cells.

The(se) test(s) do not need to be conducted if:

— an in vivo study according to point 8.3.2 is available, or

— the available in vitro/in chemico test methods are not applicable for the substance or are not adequate for classification and risk assessment according to point 8.3.

If information from test method(s) addressing one or two of the key events in column 1 already allows classification and risk assessment according to point 8.3, studies addressing the other key event(s) need not be conducted.

8.3.2.  Skin sensitisation, in vivo

An in vivo study shall be conducted only if in vitro/in chemico test methods described under point 8.3.1 are not applicable, or the results obtained from those studies are not adequate for classification and risk assessment according to point 8.3.

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 in vivo test shall be provided.

In vivo skin sensitisation studies that were carried out or initiated before 10 May 2017, and that meet the requirements set out in Article 13(3), first subparagraph, and Article 13(4) shall be considered appropriate to address this standard information requirement.

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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.