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Diss Factsheets
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EC number: 412-720-6 | CAS number: 156653-67-7
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 06 April 1993 to 09 April 1993
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study condcuted to EU & OECD test guidance in compliance with GLP.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 993
- Report date:
- 1993
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Version / remarks:
- 84/449/EEC
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Details on test material:
- See below
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Chemisch Pharmazeutische
- Age at study initiation: 3 - 5 months
- Weight at study initiation: 2.8 - 3.0 kg
- Housing: in fully air conditioned rooms, seperate cages (arranged in a battery)
- Diet (e.g. ad libitum): Alromin 2123 maintenance diet, ad libitum and hay (approx 15g daily)
- Water (e.g. ad libitum): deionised, chlorinated water from automatic water dispenser, ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 (±3C)
- Humidity (%): 55 (±20%)
- Photoperiod (hrs dark / hrs light): 12 hours lighting per day
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- physiological saline
- Controls:
- no
- Amount / concentration applied:
- 500 mg over 2.5 cm2 patch
- Duration of treatment / exposure:
- 4 h
- Observation period:
- 72 hours
- Number of animals:
- 3
- Details on study design:
- About 24 hours before the start of the study the hair in the dorsal region of the body of 3 rabbits was removed with an electric clipper over an area of about 25 cm2. Only animals with intact skin were used.
Each animal was treated with 0.5 g Reaktiv-Gelb F-66 923 FW pasted with 0.70 ml isotonic saline. The substance was applied over the whole surface of a 2.5 x 2,5 cm cellulose patch on a piece of surgical plaster (specially produced by Beiers-dorf AG, Hamburg). The plaster was fixed to the prepared skin area and then covered with a semi-occlusive bandage.
The exposure period was 4 hours. After the exposure period all remnants of the test substance were carefully removed from the skin with warm tap water.
Examinations of the skin took place after 30 - 60 minutes, and 24, 48 and 72 hours after removal of the patches.
Erythema, eschar formation and oedema were evaluated numerically according to the technique of DRAIZE . All other changes of the skin were recorded.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- animal#1
- Time point:
- other: overall 24, 48, 72h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- animal#2
- Time point:
- other: overall 24, 48, 72h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- animal#3
- Time point:
- other: overall 24, 48, 72h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- animal #1
- Time point:
- other: overall 24, 48, 72h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- animal#2
- Time point:
- other: overall 24, 48, 72h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- animal#3
- Time point:
- other: overall 24, 48, 72h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritant / corrosive response data:
- The animals showed no irritations throughout the study.
- Other effects:
- From 30 minutes up to 72 hours after removal of the patches the skin surface of the animals was small, light yellow discoloured by the test compound.
Any other information on results incl. tables
DRAIZE SKIN TEST RESULTS
Animal number |
ERYTHEMA |
OEDEMA |
||||||||
Time after decontamination |
MEAN SCORE |
Time after decontamination |
MEAN SCORE |
|||||||
30-60 MIN |
1 DAY |
2 DAYS |
3 DAYS |
30-60 MIN |
1 DAY |
2 DAYS |
3DAYS |
|||
90 |
0 |
0 |
0 |
0 |
0.0 |
0 |
0 |
0 |
0 |
0.0 |
91 |
0 |
0 |
0 |
0 |
0.0 |
0 |
0 |
0 |
0 |
0.0 |
92 |
0 |
0 |
0 |
0 |
0.0 |
0 |
0 |
0 |
0 |
0.0 |
|
OVERALL MEAN : 0.0 |
OVERALL MEAN : 0.0 |
The means have been calculated using the day 1, 2 & 3 values.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Based on the results of this study Reaktiv-Gelb F-66 923 FW is not irritating to skin
- Executive summary:
Testing for primary dermal irritation provides information on the irritant effect of the test substance on the skin following a single dermal application and serves as a basis for classification and labelling.
The present study was conducted in compliance with EEC Directive B.4. 'Acute toxicity Skin Irritation' of the Directive 84/449/EEC and OECD Guidelines for Testing of Chemicals, 404 "Acute Dermal Irritation/Corrosion" and in compliance with GLP.
The animals showed no irritations throughout the study.
From 30 minutes up to72 hours after removal of the patches the skin surface of the animals was small, light yellow discoloured by the test compound.
Testing of Reaktiv-Gelb F-66 923FW for primary dermal irritation in the rabbit showed, that the substance is not irritating to skin.
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.
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