Registration Dossier

Toxicological information

Skin irritation / corrosion

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Administrative data

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

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1982
Report Date:
1982

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
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

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
gas under pressure: refrigerated liquefied gas
Details on test material:
- Name of test material (as cited in study report): Aromox c/12-w
- Analytical purity: 36% in water

Test animals

Species:
rabbit
Strain:
New Zealand White

Test system

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.

Results and discussion

Any other information on results incl. tables

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

Applicant's summary and conclusion

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.