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EC number: 432-080-1 | 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

Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 20 October 1998 to 03 November 1998
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study conducted to EU & OECD test guidance in compliance with GLP.
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:
- EU Method B.1 (Acute Toxicity (Oral))
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Details on test material:
- Name: Reaktiv-Orange DYPR 1410
Certificate of analysis: NB 208 of December 15, 1998
Content: 73 % (w/w) + 2 %
Appearance: orange powder
Solubility: approx. 350 g/l in water
Batch number: DYPR 1410
Date of production: August 17th 1993
Date of receiving: August 26, 1998
Date of expiry: August 2003
Storage conditions: darkness at approximately 5⁰C in a refrigerator
Stability and homogeneity in the vehicle: is guaranteed for 4 hours
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- Species: Sprague Dawley rat
Strain: HSD: Sprague Dawley SO
Origin: HARLAN WINKELMANN Gartenstr. 27, 33178 Borchen SPF breeding colony
Body weight at start of study: male animals: mean = 196g (=100%)
s = ±5.8g
min = 190g (-3.1%)
max = 205g (+4.6%)
n = 5
female animals: mean = 180g (=100%)
s = ±6.2g
min = 170g (-5.6%)
max = 187g (+3.9%)
n = 5
Age at the start of the study: 6 – 10 weeks
Randomization: Randomization schemes 93,0603 and 93,0702
Animal maintenance: in fully air-conditioned rooms in macrolon cages (type 4) on soft wood granulate in groups of 5 animals
Room temperature: 22 ± 3⁰C
Relative humidity: 50 + 20%
Lighting time: 12 hours daily
Acclimatization: at least seven days
Food: ssniff* R/M-H (V 1534), ad libitum
Withdrawal of food: from about 16 hours before to 3 - 4 hours after treatment
Water: tap water in plastic bottles, ad libitum
Animal identification: fur marking with KMnOj and cage numbering
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Remarks:
- deionised
- Details on oral exposure:
- Test groups
The animals received the compound as a 20 % solution in deionised water, the administration volume being 10 ml/kg body weight.
If no compound-related mortality is produced in this limit test according to the guidelines no full study has to be carried out
Preparation of the test compound
Reaktiv-Orange DYPR 1410 was dissolved in the stated concentration in deionised water and distributed homogeneously by means of a magnetic stirrer.
The stability and the homogeneity of the test substance in the vehicle was determined by analytical methods. - Doses:
- The acute oral toxicity of Reaktiv-Orange DYPR 1410 was tested only at a dose level of 2000 mg/kg body weight.
- No. of animals per sex per dose:
- Male 5
Female 5 - Control animals:
- no
- Details on study design:
- The prepared test substance was administered by gavage to fasted animals at the stated dosage. The observation period following treatment fasted for 14 days. Symptoms were recorded twice every day (in the morning and in the afternoon), on weekends and public holidays only once. During this time the animals were weighed weekly. At the end of the observation period the animals were killed by carbon dioxide asphyxiation, dissected and examined for macroscopically visible changes.
- Statistics:
- Not reported.
Results and discussion
- Preliminary study:
- Not applicable
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No deaths occurred during the whole study.
- Clinical signs:
- other: No symptoms were observed after administration of 2000 mg/kg body weight.
- Gross pathology:
- The animals killed at the end of the observation period showed no macroscopically visible changes.
- Other findings:
- Only reddish discolored feces were observed in some male and female animals after the administration of Reaktiv-Orange DYPR 1410, At day two of the study all clinical signs were reversible.
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Based on the results obtained in this study the median lethal dose value (LD50) of Reaktiv-Orange DYPR 1410 for the male and female rat is greater than 2000 mg/kg body weight.
- Executive summary:
A study to assess the acute toxic effects of the test item was conducted in compliance with EEC-Guideline B,1. "Acute Oral Toxicity" of the Directive 92/69/EEC and OECD Guidelines for Testing of Chemicals, 401 “Acute Oral Toxicity”. This study was conducted in compliance with the Principles of Good Laboratory Practice (GLP).
No lethality occurred after administration of 2000 mg/kg body weight. Only reddish discoloured faeces were observed in same male and female animals. At day two of the study all clinical signs were reversible. With exception of one female, which suffered a loss of weight between day 8 and day 15, the body weight of all surviving animals increased during the observation period. The animals killed at the end of the observation period showed no macroscopically visible changes.
Acute oral toxicity testing of Reaktiv-Orange DYPR 1410 in the rat yielded a median lethal dose (LD50) above 2000 mg/kg body weight in both male and female animals. The substance is not classified as acutely harmful by oral exposure.
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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