Registration Dossier

Administrative data

Description of key information

The registration substance at 36% in water was investigated for skin and eye irritation properties according/equivalent to OECD 404 and OECD 405 respectively. The registration substance induced severe irritating/corrosive effects. 

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records
Reference
Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Scientifically well performed study
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Principles of method if other than guideline:
The procedure employed was used to classify the test item according to the recommendations given in the Transport of Dangerous Goods, Special Recommendations Relating to Class 8 United Nations Handbook, 1977.
GLP compliance:
not specified
Species:
rabbit
Strain:
New Zealand White
Type of coverage:
other: occluded with "sleek" plaster
Preparation of test site:
clipped
Vehicle:
unchanged (no vehicle)
Remarks:
the test material corresponds to 36% registration substance in water
Controls:
not required
Amount / concentration applied:
0.5 ml of test material (36% regstration substance in water) on skin area of 2.5 x2.5 cm
Duration of treatment / exposure:
Preliminary investigation: 3, 30, 60 and 4 hours
Conformatory investigation: 4 hours
Observation period:
up to 72 hours
Number of animals:
One for the preliminary, three for the conformatory intestigations.

Preliminary investigations (Table 1):

Well-defined erythema with very slight or slight oedema developed at the 60 minutes and 4 hours exposure sites at the 24 hours reading.

By the 48 hours reading, the dermal reactions had ameliorated to very slight erythema and oedema at the 60 minutes exposure site but had progressed to severe necrotic lesions with slight oedema at the 4 hours exposure site. The necrotic lesions persisted at the 72 hours reading.

No dermal reactions were recorded at the 3 and 30 minutes exposure sites.

Confirmatory study (Table 2)

Very slight or well-defined erythema with or without very slight or slight oedema was seen at both sites of all three rabbits at the 24 hours reading. These dermal reactions were also recorded at three sites at the 48 hours reading and six sites at the 72 hours reading.

No evidence of skin necrosis was seen in any animal.

 

                Table 1: Preliminary investigation
 Exposure Time  Reaction  Time after removal of patch         
     0 hour  24 hours  48 hours  72 hours
 3 min  erythema  0  0
  oedema  0  0 0 0
 30 min erythema   0  0  0  0
  oedema   0  0  0
 60 min  erythema  0  2  1
   oedema  0
 4 hours  erythema  0  2
   oedema  0  2

               Table 2: Confirmatory study             
 Rabbit  Reaction Time after removal of patch                      
        0 hour       24 hours   48 hours   72 hours    
     Site 1  Site 2  Site 1  Site 2  Site 1  Site 2  Site 1  Site 2
 A  erythema  0  0  2  2  2
   oedema  0  0  2  2  2  2  2
 B  erythema  0  0 1  1  0  1
   oedema  0  0  0  0  0  0
 C  erythema  0  0  1  1  0  1  1  1
   oedema  0  0  0  0  0
Interpretation of results:
corrosive
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The skin irritation property of the registration substance formulation (36% in water) was tested equivalent to OECD 404. After 4 hours exposure, the treated animals exhibited either necrosis or effects that was not fully reversible within 72hours of observation period. It is justified to assign R 34 for the registration substance according to 67/548/EEC(DSD), or Cat 1C according to GHS.
Executive summary:

The skin irritation property of the registration substance formulation (36% in water) was tested equivalent to OECD 404. After 4 hours exposure, the treated animals exhibited either necrosis or effects that was not fully reversible within 72 hours of observation period. After up to 1 hour exposure, no or only reversible irritating effects were observed. It is justified to assign R 34 for the registration substance according to 67/548/EEC(DSD), or Skin Corr. Cat 1C according to GHS.

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (corrosive)

Eye irritation

Link to relevant study records
Reference
Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1965
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Scientifically well-performed study
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
GLP compliance:
not specified
Species:
rabbit
Strain:
other: reported as "male albino rabbit"
Vehicle:
unchanged (no vehicle)
Remarks:
the test material corresponds to 36% registration substance in water
Controls:
not required
Amount / concentration applied:
0.1 ml
Observation period (in vivo):
up to seven days
Number of animals or in vitro replicates:
6
Irritation parameter:
maximum mean total score (MMTS)
Basis:
mean
Time point:
other: 24h
Score:
8.3
Max. score:
12
Irritation parameter:
maximum mean total score (MMTS)
Basis:
mean
Time point:
other: 48h
Score:
11.8
Max. score:
29
Irritation parameter:
maximum mean total score (MMTS)
Basis:
mean
Time point:
other: 72h
Score:
22
Max. score:
41
Irritation parameter:
maximum mean total score (MMTS)
Basis:
mean
Time point:
other: 96h
Score:
32.8
Max. score:
61
Irritation parameter:
maximum mean total score (MMTS)
Basis:
mean
Time point:
other: 168h
Score:
41.2
Max. score:
86

Rabbit eye irritation scores: Rabbit no. 1           
                  Hours after treatment [h]
   1  24  48  72  96  168
 Cornea  0  0  0  5  5  0
 Iris  0  0  0  5  5  5
 Conjuctivae  6  8  8  6  4  4
 Total  6  8  8  16  14  9

Rabbit eye irritation scores: Rabbit no. 2          
                  Hours after treatment [h]
   1  24  48  72  96  168
 Cornea  0  0  0  5  20  45
 Iris  0  0  0  5  5  5
 Conjuctivae  8  8  14 14  12  16
 Total  8  8 14  24  37  66

Rabbit eye irritation scores: Rabbit no. 3           
                  Hours after treatment [h]
   1  24  48  72  96  168
 Cornea  0  0  0  0  0  0
 Iris  0  0  0  5  5  5
 Conjuctivae  6  8 6  8  6  6
 Total  6  8  6  13  11  11

Rabbit eye irritation scores: Rabbit no. 4           
                  Hours after treatment [h]
   1  24  48  72  96  168
 Cornea  0  0  10  20  40 60
 Iris  0  0  5  5  5  10
 Conjuctivae  6  12  14  16  16  16
 Total  6  12  29  41 61 86

Rabbit eye irritation scores: Rabbit no. 5          
                  Hours after treatment [h]
   1  24  48  72  96  168
 Cornea  0  0  0  5  20  30
 Iris  0  0  0  5  5  5
 Conjuctivae  6  8  8  10  12  14
 Total  6  8  8  20  37  49

Rabbit eye irritation scores: Rabbit no. 6           
                  Hours after treatment [h]
   1  24  48  72  96  168
 Cornea  0  0  0  5  20  10
 Iris  0  0  0  5  5  5
 Conjuctivae  6  6  6  8  12  14
 Total  6  6  6  18  37  29
Interpretation of results:
corrosive
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The registration substance at 36% was investigated for its eye irritation property equivalent to OECD 405. Scores of uo to 86 (MMTS) were obtained and there was no indication of recovery within the observation period of 168 hours.
Executive summary:

The registration substance at 36% was investigated for its eye irritation property equivalent to OECD 405. Scores of uo to 86 (MMTS) were obtained and there was no indication of recovery within the observation period of 168 hours.

It is justified to assign R 41 for the registration substance according to 67/548/EEC(DSD), or Eye Dam.1 according to GHS.

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Additional information

Skin irritation:

The skin irritation property of the registration substance formulation (36% in water) was tested equivalent to OECD 404. After 4 hours exposure, the treated animals exhibited either necrosis or effects that was not fully reversible within 72 hours of observation period. After up to 1 hour exposure, no or only reversible irritating effects were observed. It is justified to assign R 34 for the registration substance according to 67/548/EEC(DSD), or Skin Corr. Cat 1C according to GHS.

Eye irritation:

The registration substance at 36% was investigated for its eye irritation property (method applied was equivalent to OECD 405). Scores of uo to 86 (MMTS) were obtained and there was no indication of recovery within the observation period of 168 hours.

It is justified to assign R 41 for the registration substance according to 67/548/EEC(DSD), or Eye Dam.1 according to GHS.


Justification for selection of skin irritation / corrosion endpoint:
Scientifically well-performed study

Justification for selection of eye irritation endpoint:
Scientifically well-performed study

Effects on skin irritation/corrosion: corrosive

Effects on eye irritation: corrosive

Justification for classification or non-classification

Based on the obtained experimental results, it is justified to assign R34 and R41 according to 67/548/EEC (DSD), or Skin Corr. Cat 1C and Eye Dam. 1 according to GHS.