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EC number: 433-180-8 | CAS number: -
- 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:
- 1999-02-02 02 to 1999-02- 09
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: The study was conducted in compliance with EEC-Guideline B4 and OECD Guidelines for testing chemicals 404 according to the good laboratory practice regulations annex of paragraph 19a, section 1 of the chemical law of July, 25, 1994.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 999
- Report date:
- 1999
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
- Details on test material:
- -Name of test material (as cited in study report): Reaktiv-Orange DYPR934
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
rabbit
New Zealand White
- Origin: Charles River Deutschland GmbH
88353 Kißlegg
- Age at study initiation: 3 healthy young adult rabbits were used
- Weight at study initiation: 2.0-2.4 kg
- Housing: In fully air-conditioned rooms in separate cages arranged in a battery.
- Food: ssniff® K-H (V2333) ad libitum and hay (approx. 15 g daily)
- Water (e.g. ad libitum): Water from automatic water dispensers, ad libitum
- Acclimation period: 1 week under study conditions
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 °C (± 3 °C)
- Relative humidity: 50 ± 20 %
- Air changes (per hr): at least 10 X
- Photoperiod (hrs dark / hrs light): 12 hours daily
-Animals Identification: numbered ear tags
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- other: Deionized water
- Controls:
- no
- Amount / concentration applied:
- 500 mg
- Duration of treatment / exposure:
- 4 h
- Observation period:
- Examinations of the skin took place after 30 - 50 minutes as well as 24, 48 and 72 hours after removal of the patches.
Because of persistent irritations 72 hours after removal of the patches, additional readings were performed after7 days. - Number of animals:
- 3
- Details on study design:
- TEST PROCEDURE AND TEST SITE
About 24 hours before start of study the hair 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 (500 mg) Reaktiv-Orange DYPR 934 pasted with 0.5 ml deionized water.
The substance was administered over the whole surface of a 2.5 x 2.5 cm cellulose patch on a piece of surgical plaster (specially produced by Beiersdorf Aktiengesellschaft). The plaster was fixed to the prepared skin area and then covered with a semi-occlusive bandage.
EXPOSURE PERIOD AND REMOVAL OF TEST SUBSTANCE
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.
SCORING SYSTEM:
Draize scale
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Remarks:
- (Erythema and eschar formation)
- Basis:
- animal: 61
- Time point:
- other: overall at 24, 48 and 72 h
- Score:
- 1.66
- Irritation parameter:
- erythema score
- Remarks:
- (Erythema and eschar formation)
- Basis:
- animal: 62
- Time point:
- other: overall at 24, 48 and 72 h
- Score:
- 0.66
- Irritation parameter:
- erythema score
- Remarks:
- (Erythema and eschar formation)
- Basis:
- animal: 63
- Time point:
- other: overall at 24, 48 and 72 h
- Score:
- 1.33
- Irritation parameter:
- erythema score
- Remarks:
- Erythema and eschar formation
- Basis:
- mean
- Remarks:
- All animals
- Time point:
- other: overall at 24, 48 and 72 h
- Score:
- 1.22
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- erythema score
- Remarks on result:
- other: Max. duration: 48 d; Max. value at end of observation period: 0 (related to all animals)
- Irritation parameter:
- edema score
- Basis:
- animal: 61
- Time point:
- other: overall at 24, 48 and 72 h
- Score:
- 0.66
- Irritation parameter:
- edema score
- Basis:
- animal: 62
- Time point:
- other: overall at 24, 48 and 72 h
- Score:
- 0
- Irritation parameter:
- edema score
- Basis:
- animal: 63
- Time point:
- other: overall at 24, 48 and 72 h
- Score:
- 1
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- All animals
- Time point:
- other: overall at 24, 48 and 72 h
- Score:
- 0.55
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- edema score
- Remarks on result:
- other: Max. duration: 0 d; Max. value at end of observation period: 0 (related to all animals)
- Irritant / corrosive response data:
- Reversibility of any observed effect: Changes fully reversible within 7 days
- Other effects:
- 30 - 60 minutes up to 3 days after removal of the plaster the animals showed very slight up to well-defined erythema and oedema. Additionally, the skin surface was dry-rough and orange discolored. 7 days after administration all signs of irritation were reversible.
Erythema, eschar formation and oedema were evaluated numerically according to the score of DRAIZE.
All other changes of the skin were recorded.
Any other information on results incl. tables
Table II: Generalised Results By Animal- Animals against parameters-Multiple Times Activity –skin irritation Results Study : 990015 – Reaktiv-Orange DYPR 934-Skin Irritation Test in Rabbits |
||||||||
Group Sex |
Animal Number |
Day Number |
Time slot |
Body weight (g) |
Treated Flank |
Duration Treatm. |
Erythema |
Edema |
1f |
61 |
1 |
Treatment 30-60 min. after decontamination |
2350 |
Left |
4 hours |
3 |
2 |
|
2 |
24 hours. after decontamination |
2 |
1 |
||||
|
3 |
48 hours after decontamination |
2 |
1 |
||||
|
4 |
72 hours after decontamination |
1 |
0 |
||||
|
8 |
7 days after decontamination |
0 |
0 |
||||
|
62 |
1 |
Treatment 30-60 min. after decontamination |
2050 |
Left |
4 hours |
2 |
1 |
|
2 |
24 hours. after decontamination |
|
2 |
0 |
|||
|
3 |
48 hours after decontamination |
|
0 |
0 |
|||
|
4 |
72 hours after decontamination |
|
0 |
0 |
|||
|
8 |
7 days after decontamination |
|
0 |
0 |
|||
|
63 |
1 |
Treatment 30-60 min. after decontamination |
2240 |
Left |
4 hours |
2 |
2 |
|
2 |
24 hours. after decontamination |
|
|
1 |
2 |
||
|
3 |
48 hours after decontamination |
|
|
2 |
1 |
||
|
4 |
72 hours after decontamination |
|
|
1 |
0 |
||
|
8 |
7 days after decontamination |
|
|
0 |
0 |
Table III: Clinical observations-clinical signs by Animal Study : 990015 – Reaktiv-Orange DYPR 934-Skin Irritation Test in Rabbits |
|||||||
Day numbers relative to Start Date |
|||||||
Group Sex 1f |
Animal number |
Clinical sign |
1 30-60 min After decontamination |
2 24 hours after decontamination |
3 48 hours after decontamination |
4 72 hours after decontamination |
8 7 days after decontamination |
|
61 |
No Abnormalities Detected |
- |
- |
- |
- |
X |
|
Skin discolored-small area |
o |
o |
o |
o |
- |
|
|
Skin surface dry and rough |
- |
X |
X |
X |
- |
|
|
62 |
No Abnormalities Detected |
- |
- |
X |
X |
X |
|
Skin discolored-small area |
o |
- |
- |
- |
- |
|
|
Skin surface dry and rough |
- |
X |
- |
- |
- |
|
|
63 |
No Abnormalities Detected |
- |
- |
- |
- |
X |
|
Skin discolored-small area |
o |
o |
o |
o |
- |
|
|
Skin surface dry and rough |
- |
X |
X |
X |
- |
|
-= result to left has an associated comment or marker X= present o=orange Nominal Dose: Group I = 0.5 g (moistened) |
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Conclusion:
Based on the results of this study Reaktiv-Orange DYPR 934 is slightly irritating to skin - Executive summary:
In a 4 hours skin irritation / corrosion study, 500 mg of Reaktiv-Orange DYPR 934 was applied in the intake skin of 3 healthy young adult New Zealand white Rabbits under semi occlusive conditions.
The aim of this study was to obtain information on the irritant effect of Reaktiv-Orange DYPR 934 on the skin after a single dermal administration (as a basic of the classification and labeling).
30-60 minutes up to 3 days after removal of the plaster the animals showed very slight up to well-defined erythema and oedema.
The skin surface was dryrough and orange discolored.
Testing of Reaktiv-Orange DYPR 934 for primary dermal irritation showed that the substance would be classified as slightly irritating to the skin.
Results Synopsis
Test Substance
Test animals
ENVIRONMENTAL CONDITIONS
Control
Results
Conclusion (based on the test conditions)
Reaktiv-Orange DYPR 934
New Zealand albino rabbit
- Temperature (°C): 20°C (± 3°C)
- Relative humidity: 50 ± 20%
- Air changes (per hr): at least 10 X
- Photoperiod (hrs dark / hrs light): 12 hours daily
Patch (the substance was administered over the whole surface of 2.5 X2.5 cm cellulose patch on a piece of surgical plaster)
30-60 minutes up to 3 days after removal of the plaster the animals showed very slight up to well-defined erythema and oedema.
-Skin surface was dryrough and orange discolored.
Reaktiv-Orange DYPR 934 is slightly 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.
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