Registration Dossier
Registration Dossier
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EC number: 617-745-8 | CAS number: 856976-65-3
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: Guideline study, no GLP study, please refer to section 13 for justification of read-across.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 988
- Report date:
- 1988
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- no
Test material
- Reference substance name:
- 82448-02-0
- EC Number:
- 617-334-3
- Cas Number:
- 82448-02-0
- IUPAC Name:
- 82448-02-0
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- Vienna White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Gaukler, 6050 Offenbach a/M, FRG
- Weight at study initiation: Males: 2.14 kg, 2.45 kg
- Housing: Cage made of stainless steel with wire mesh walk floors, floor area: 40 cm x 51 cm.
- Diet: Kliba 341, 4MM, Firma Klingentalmuehle AG, CH 4303 Kaiseraugst, Switzerland, about 130 G per animal per day.
- Water: about 250 mL Tap water per animal per day
- Acclimation period: At least 8 days before the beginning of the study; Same housing conditions as during the study.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-24 °C
- Humidity (%): 30-70 %
- Photoperiod (hrs dark / hrs light): 12 H/ 12 H
Test system
- Type of coverage:
- open
- Preparation of test site:
- clipped
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied: 0.5 mL of the undiluted and heated test substance to the test patch - Duration of treatment / exposure:
- Exposure period: 4 h
- Observation period:
- 72 h
- Number of animals:
- 2 males
1 female - Details on study design:
- TEST SITE
- Area of exposure: Upper third of the back or flanks, 2.5 cm x 2.5 cm
- Form of application: Unchanged
REMOVAL OF TEST SUBSTANCE
- Washing: With Lutrol and Lutro/water
- Time after start of exposure: At the end of the exposure
SCORING SYSTEM:
0=None
1 = very Slight
2 = Well defined
3 = Moderate to severe
4 = Severe to very severe
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- animal 1
- Time point:
- other: 24, 48, 72 h
- Score:
- 0.7
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- animal 2
- Time point:
- other: 24, 48, 72 h
- Score:
- 0.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- animal 3
- Time point:
- other: 24, 48, 72 h
- Score:
- 0.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- all animals
- Time point:
- other: 24, 48, 72 h
- Score:
- 0
- Max. score:
- 4
- Irritant / corrosive response data:
- The test item is not irritating according to the EU criteria.
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
