Registration Dossier
Registration Dossier
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EC number: 618-281-9 | CAS number: 895520-71-5
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From 1 December 2003 to 3 February 2004
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 004
- Report date:
- 2004
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- Adopted : 24th April 2002
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2500 (Acute Dermal Irritation)
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- 618-281-9
- EC Number:
- 618-281-9
- Cas Number:
- 895520-71-5
- Molecular formula:
- C28 H29 N5 O5
- IUPAC Name:
- 618-281-9
- Test material form:
- solid: particulate/powder
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: E-699-2003
- Expiration date of the lot/batch: 1 July 2004
- Purity test date: 27 and 28 October 2003
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: white to light beige powder stored at approximately 20°C in a fume cupboard
- Stability under test conditions: is guaranteed for 4 hours in dionized water by the sponsor (dated 04 December 2003) (Information from analysis of the same batch already used in Acute Toxicity oral Test)
- Solubility and stability of the test substance in the solvent/vehicle: is guaranteed for 4 hours in dionized water by the sponsor (dated 04 December 2003) (Information from analysis of the same batch already used in Acute Toxicity oral Test)
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Remarks:
- Crl:KBL(NZW)BR(N.Zeal.White)
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Deutschland
- Age at study initiation: no information
- Weight at study initiation: 2.0-2.5 kg
- Housing: in fully air-conditionned rooms in separate cages arranged in a battery
- Diet (e.g. ad libitum): ssniff K-H, ad libitum and hay (15g daily)
- Water (e.g. ad libitum):tap water in plastic bottles ad libitum
- Acclimation period: 1 week under study conditions
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20±3 deg C
- Humidity (%): 50±20%
- Air changes (per hr): no specified
- Photoperiod (hrs dark / hrs light): 12h/12h
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- water
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- 500 mg per patch
- Duration of treatment / exposure:
- 4 hours
- Observation period:
- Examinations of the skin took place after 30-60 minutes as well as 24, 48, 72 hours after removal of the patches
- Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: dorsal region of the body
- % coverage: 6cm2
- Type of wrap if used: cellulose patch
REMOVAL OF TEST SUBSTANCE
- Washing (if done): warm tap water
- Time after start of exposure:4 hours
OBSERVATION TIME POINTS
(indicate if minutes, hours or days)
30 minutes, 60 minutes, 24 hours, 48 hours and 72 hours
SCORING SYSTEM:
- Method of calculation:score of the DRAIZE
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- not specified
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- 3 animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- 3 animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- No signs of irritations were observed during the study. All scores are equal to zero.
Applicant's summary and conclusion
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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