Registration Dossier
Registration Dossier
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EC number: 947-121-3 | CAS number: -
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- other: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
- Remarks:
- Source study has reliability 2. The use of a read across approach is considered as acceptable, since target and read across substance differ only in the degree of salification, i.e. monosodium vs. disodium salt.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 985
- Report date:
- 1985
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- GLP compliance:
- no
Test material
- Reference substance name:
- Similar Substance 01
- IUPAC Name:
- Similar Substance 01
- Test material form:
- solid: particulate/powder
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Body weight: 2.2 - 2.3 kg
- Housing: individually
- Diet: ad libitum
- Water: ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature: 19 - 25 °C
- Humidity: 40 - 60 %
- Photoperiod: 12 h dark / 12 h light
Test system
- Type of coverage:
- not specified
- Preparation of test site:
- shaved
- Vehicle:
- water
- Controls:
- no
- Amount / concentration applied:
- 0.5 g
- Duration of treatment / exposure:
- 4 h
- Observation period:
- 7 d
- Number of animals:
- 3 males
- Details on study design:
- TEST SITE
- Area of exposure: 2.5 × 2.5 cm
- Type of wrap if used: gauze fixed by elastic, air-permeable adhesive bandage
REMOVAL OF TEST SUBSTANCE
- Washing: yes
- Time after start of exposure: 4 h
OBSERVATION TIME POINTS
1, 24, 48, 72 h up to 7 d
SCORING SYSTEM:
Erythema - redness / scabbing
0 no redness
1 slight, barely perceptible redness
2 well noticeable redness
3 moderate to severe redness
4 deep redness to slight scabbing (changes to id the depth of the skin)
Oedema - swelling
0 no swelling
1 very slight, barely perceptible swelling
2 slight swelling (margins well defined)
3 moderate swelling (meander approx. 1 mm raised)
4 severe swelling (margins greater than 1 mm raised, extension via exposure site)
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- no indication of irritation
Applicant's summary and conclusion
- Interpretation of results:
- other: not classified according to the CLP Regulation (EC 1272/2008)
- Conclusions:
- Not irritant to rabbit skin.
- Executive summary:
Method
Test substance was applied on skin of 3 male rabbits according to OECD guideline 404. Test substance was removed by rinsing with water 4 hours after application. Observations for erythema and oedema were done at 1, 24, 48 and 72 h up to 7 days after substance removal.
Results
No signs of irritation in terms of erythema and oedema were noted.
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