Registration Dossier
Registration Dossier
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EC number: 807-821-0 | CAS number: -
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 15-18 October 2013
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Data have been generated according to current internationally recognised study guidelines and in accordance with GLP.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 014
- Report date:
- 2014
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- GLP compliance:
- yes (incl. QA statement)
Test material
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS- Source: S&K LAP Kft, Hungary- Age at study initiation: 14 weeks old- Weight at study initiation: 3256-3521g- Housing: Individual- Diet (e.g. ad libitum): ad libitum- Water (e.g. ad libitum): ad libitum- Acclimation period: 25 daysENVIRONMENTAL CONDITIONS- Temperature (°C): 18.4-22.1- Humidity (%): 32-70- Air changes (per hr): 15-20- Photoperiod (hrs dark / hrs light): 12 hours
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- 0.5g
- Duration of treatment / exposure:
- 4 hours
- Observation period:
- 60 minutes and 24, 48 and 72 hours after patch removal
- Number of animals:
- 3 males
Results and discussion
In vivo
Results
- Irritation parameter:
- primary dermal irritation index (PDII)
- Basis:
- mean
- Time point:
- other: 1, 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 0
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated informationCriteria used for interpretation of results: EU
- Conclusions:
- The substance was observed to not be dermally irritant following exposure to rabbit skin
- Executive summary:
The primary skin irritation has been assessed by application to the clipped and shaved skin of three male rabbits in accordance with the OECD 404 test guideline in compliance with GLP. Following 4 hour semi-occluded exposure, skin reactions were recorded 1, 24, 48 and 72 h after exposure and resulted in no skin reactions. The substance is therefore not irritant to skin.
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