Registration Dossier
Registration Dossier
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EC number: 615-497-5 | CAS number: 71809-65-9
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: The study has been conducted in compliance with GLP and according to the OECD guideline 404.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 003
- Report date:
- 2003
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- 32085-79-3
- EC Number:
- 608-700-3
- Cas Number:
- 32085-79-3
- IUPAC Name:
- 32085-79-3
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- Himalayan
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Age at study initiation: approx. 3 months
- Weight at study initiation: 2.3-2.5 kg
- Housing: individually
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 20 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 3°C
- Humidity (%): 55 +/- 15%
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- other: 4 g test item moistened with 1 ml water
- Controls:
- other: control site at the same animal
- Amount / concentration applied:
- 500 mg/patch and animal
- Duration of treatment / exposure:
- 4 hours
- Observation period:
- 60 min, 24, 48 and 72 hours
- Number of animals:
- 3
- Details on study design:
- Route of administration: dermal application to the shaved, intact dorsal skin
Area of exposure: approx. 6 cm2
Exposure period: 4 hours
Frequency of administration: single administration
Dose level: 500 mg/patch and animal (4 g test item were mixed with 1 mL aqua ad iniectabilia, 625 mg of this paste was applied per animal
(= 500 mg test item/animal))
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal: 1-3
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- animal: 1-3
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 4
- Irritant / corrosive response data:
- Under the present test conditions none of the three rabbits exposed for 4 hours to 500 mg Gly-Dane salt (W)/patch and animal
(semi-occlusive condition) showed any substance related Iesions 24, 48 and 72 hours after patch removaL
There were no systemic intolerance reactions.
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Under the conditions of this skin irritation study in the rabbit the test item is not irritant.
- Executive summary:
Under the conditions of this skin irritation study in the rabbit the test item is not irritant.
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