1 
 EN 
 
ANNEX   
 
Point 8.1. of Annex VII  shall be replaced by the following:   
"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  it is classified  as corrosive to skin (Cat. 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 acutely toxic by dermal route 
(Cat. 1) , or  
— an acute toxicity study by th e 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 studies under points 8.1.1 or 8.1.2 
already allow a conclusive decision on the classification of a 
substance, or on the absen ce 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 "  
 
Point 8.2. of Annex VII  shall be replaced by the following:   
"8.2. Serious eye damage/eye 
irritation  8.2. These study/ies do(es) not need to be conducted  if:  
- the substance is classified as corrosive to skin and the  
registrant classifies it  as causing serious eye damage (Cat. 1), 
or 
— the substance is a strong acid (pH ≤ 2,0) or base (pH ≥ 
11,5) and it is classifie d  as causing serious eye damage (Cat. 
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 " 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, other in vitro  studies for 
this endpoint shall be considered.  2 
  
Point 8.3. of Annex VII  shall be replaced by the following:   
"8.3. Skin sensitisation   This study does not need to be conducted if:  
 
—the substance is classified for skin corrosion, 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 
vivo. 
 This  study does not need to be conducted if:  
 
- sufficient information that is adequate for classification 
and/or risk assessment is available from non -animal 
approaches .  
 
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 sh all be provided. " 
 3 
   
 
Point 8.1. of Annex VIII  shall be replaced by the following:   
"8.1. Skin corrosion/ 
irritation  
 8.1. An in vivo  study for skin corrosion/irritation shall be 
considered only if the in vitro  studies under point 8.1.1. and 
8.1.2. in  Annex VII are not applicable, or the results of these 
studies are not adequate  for classification and /or risk 
assessment.  
 
The study does not need to be conducted  if:  
— the substance is a strong acid (pH ≤ 2,0) or base (pH ≥ 
11,5) and it is classified as corrosive to skin (Cat. 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  acutely toxic by dermal route 
(Cat. 1) , or  
— an acute toxicity study by the d ermal route does not 
indicate skin irritation up to the limit dose level (2 000 mg/kg 
body weight). " 
 
Point  8.2. of Annex VIII  shall be replaced by the following:   
"8.2.  Serious eye 
damage/eye irritation   
 8.2. An in vivo  study for eye corrosion/irritation shall be 
considered only if the in vitro  studies under point 8.2.1. in 
Annex VII are not applicable, or the results obtained from 
these  studies are not adequate for classification and /or risk 
assessment.  
 
The study does  not need to be conducted  if:  
— the substance is classified as  corrosive to the skin , 
resulting in a classification  as causing serious eye damage 
(Cat. 1), or  
— the substance is a strong acid (pH ≤ 2,0) or base (pH ≥ 
11,5) and classified  as causing serious eye damage (Cat. 1), 
or  
— the substance is spontaneously flammable in air or in 
contact with water or moisture at room temperature. " 
 
Point 8.5. of Annex VIII shall be replaced by the following:  
"8.5. Acute toxicity  
 8.5. The study/i es do(es) not generally need to be conducted if:  
 — the substance is classified as corrosive to the skin.  
 In addition to the oral route ( Annex VII, 8.5.1), for substances 4 
 other than gases, the information mentioned under 8.5.2 to 8.5.3 
shall be provided f or at least one other route. The choice for the 
second route will depend on the nature of the substance and the 
likely route of human exposure. If there is only one route of 
exposure, information for only that route need be provided.  
8.5.2. By inhalation  
 8.5.2. Testing by the inhalation route is appropriate if exposure of 
humans via inhalation is likely taking into account the vapour 
pressure of the substance and/or the possibility of exposure to 
aerosols, particles or droplets of an  inhalable size.  
8.5.3. By dermal route  
 8.5.3. Testing by the dermal route is appropriate if:  
(1) inhalation of the substance is unlikely; and  
(2) skin contact in production and/or use is likely; and  
(3) the physicochemical and toxicological propert ies suggest 
potential for a significant rate of absorption through the skin . 
Testing by the dermal route does not need to be conducted if:  
- the substance does not meet the criteria for classification as 
acutely toxic or STOT SE by the oral route and  
- no systemic effects have been observed in  in vivo  studies with 
dermal exposure (e.g. skin irritation, skin sensitisation) or ,  in the 
absence of an in vivo  study by the oral route , no systemic effects 
after dermal exposure are predicted  on the basis of non-testing 
approaches (e.g. read across, QSAR studies ). "