Registration Dossier
Registration Dossier
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EC number: 438-600-3 | CAS number: 110675-26-8
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: GLP Guideline study. According to ECHA guidance, a study with a read-across substance can have no reliability of higher than 2. The study itself is valid without restriction.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 986
- Report date:
- 1986
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Details on test material:
- - Batch #: Vers. 31-33
- Purity: pilot sample
- Storage: room temperature
- Physical state: liquid
- Expiry date: September 1991
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Kleintierfarm Madoerin AG, CH-4414 Fuellinsdorf
- Age at study initiation: 12-14 weeks
- Sex: male
- Weight at study initiation: 2070-2110 g (within ± 20% of mean value)
- Housing: individually in metal cages
- Diet: ad libitum; standard rabbit pellet - Nafag No. 814, Gossau, Switzerland
- Water: ad libitum (The quality of the drinking water was according to the specifications of the "Schweizerisches Lebensmittelbuch" (Edition 1972))
- Acclimation period: 5 days
- Rationale for choice: The albino rabbit is the recommended species for skin irritation/corrosion studies
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 3
- Humidity (%): 30-70
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: contra-lateral flank covered with gauze patch
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied: 0.5 ml - Duration of treatment / exposure:
- 4 hours
- Observation period:
- The skin reactions were evaluated 1, 24, 48, and 72 hours and 7 days after removing the gauze patches.
- Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: An area of approx. 6 cm2 was shaved on both flanks of the animals approximately 24 hours before treatment.
- % coverage: A gauze patch (20 cm2)
- Type of wrap if used: The patches were loosely covered with an aluminium foil (36 cm2 and held in place by an adhesive tape (Isoplast, Isoplast AG, CH-5200 Brugg)
SCORING SYSTEM: according to the OECD scoring system
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- other: Score after 1 hour was = 0
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no skin irritation was observed
- Remarks on result:
- other: Score after 1 hour was = 0
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- other: Score after 1 hour was = 0
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no edema was observed
- Remarks on result:
- other: Score after 1 hour was = 0
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no edema was observed
- Remarks on result:
- other: Score after 1 hour was = 0
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no edema was observed
- Remarks on result:
- other: Score after 1 hour was = 0
- Irritant / corrosive response data:
- Slight scaling at the application area was observed in all animals on day 7. On the control flanks, no skin irritation effects were observed in any animal.
- Other effects:
- A slight loss of weight was observed in one animal on day 3 (2090 g versus 2110 g at start of test)
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information
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