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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
Acute Toxicity: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 15 April 1993 to 29 April 1993
- 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:
- 1 993
- Report date:
- 1993
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.3 (Acute Toxicity (Dermal))
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Details on test material:
- See below
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- Test species: Winstar rat
Strain: Hoe:WISKf(SPF71)
Source: HOECHST AG, Kastengrund, SPF breeding colony
Body Weight at start of study: males: x = 280g (=100%)
s = ± 4g
x min = 204g (-1.9%)
x max = 213g (+2.4%)
n = 5
females: x = 190g (=100%)
s = ± 6g
x min = 184g (-3.2%)
x max = 200g (+5.3%)
n = 5
Age at start of study: males: approx. 7 weeks
females: approx. 8 weeks
Randomisation: Randomisation schemes 6358/92 and 639/93
Animal maintenance: In fully air-conditioned rooms in Makrolon cages (Type 3) on soft wood granulate one animal per cage
Room temperature: 22 ± 3⁰C
Relative humidity: 55 ± 20%
Lighting time: 12 hours daily
Acclimatisation: not necessary (breeding at identical conditions)
Food: Altromin 1324 rat diet (Altromin GmbH. Lage/Lippe), ad libitum
Water: Tap water in plastic bottles, ad libitum
Animal identification: cage numbering
Administration / exposure
- Type of coverage:
- occlusive
- Vehicle:
- physiological saline
- Details on dermal exposure:
- 0.5 g Reaktiv-Gelb F-66 923 FW was moistened with 0.7 ml isotonic saline.
Before dermal treatment the fur was mechanically removed from the dorsal skin of the animals over an area of approximatly 30 cm2.
The appropriate amount of the test substance was moistened on an aluminium foil (6x8 cm) and distributed as uniformly as possible. Together with the foil the test substance was applied to the shaved and intact dorsal skin. The foil was held in place with an elastic plaster bandage fixed around the animal's body (Fixomull, and Elastoplast, 8 cm in width, both manufactured by Beiersdorf).
At the end of the dermal exposure period of 24 hours the bandage was removed and the treated skin area washed with warm water in order to remove any unabsorbed remnants of the test substance. - Duration of exposure:
- 24 h
- Doses:
- 2000 mg/kg body weight
- No. of animals per sex per dose:
- Five male and five female rats received the pasted test compound
- Control animals:
- no
- Details on study design:
- The observation period after the dermal application lasted for 14 days. Symptoms and lethality were recorded twice every day (in the morning and in the afternoon), on weekends and holidays only once. Animals found dead were dissected as soon as possible and examined for macroscopically visible changes. During the observation period the animals were weighed weekly. At the end of the observation period surviving animals were killed by carbon dioxide asphyxiation, dissected and examined for macroscopically visible changes.
- Statistics:
- No data
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:
- One male animal was found dead at day 5 of the study.
- Clinical signs:
- other: No symptoms were observed after application 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:
- From the first day p.a. up to the end of the study the skin surface of the animals was discoloured yellow.
Dark disolouration of the liver, plethora of the lung, blood in the urinary bladder and clear liquid in the abdominal cavity was observed at necropsy in the animal found dead.
Any other information on results incl. tables
CLINICAL OBSERVATIONS TIME TO RESPONSE PRINT
[ABSOLUTE TIME AFTER START DATE]
GROUP: 1
DOSE LEVEL: 2000 DOSE UNIT: MG/KG SEX: BOTH
Day Number |
1 |
2 |
3 |
4 |
5 |
6 |
7 |
8 |
9 |
10 |
11 |
12 |
13 |
14 |
No. of Animals Dosed |
10 |
10 |
10 |
10 |
10 |
10 |
10 |
10 |
10 |
10 |
10 |
10 |
10 |
10 |
No. of Animals Survived |
10 |
10 |
10 |
10 |
9 |
9 |
9 |
9 |
9 |
9 |
9 |
9 |
9 |
0 |
No Abnormalities Detected |
10 |
10 |
10 |
10 |
9 |
9 |
9 |
9 |
9 |
9 |
9 |
9 |
9 |
9 |
Skin Discolouration Large:Text |
- |
10 |
10 |
10 |
9 |
3 |
3 |
3 |
3 |
3 |
3 |
3 |
3 |
3 |
Skin Discolouration Small: Text |
- |
- |
- |
- |
- |
6 |
6 |
6 |
6 |
6 |
6 |
6 |
6 |
6 |
Found Dead |
- |
- |
- |
- |
1 |
- |
- |
- |
- |
- |
- |
- |
- |
- |
Killed at End of Study |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
9 |
Dissection: No. Macroscopic Findings |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
9 |
Text: Skin discoloured yellow
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- LD50 > 2000mg/kw body weight
- Executive summary:
Testing for acute dermal toxicity provides information on health risks resulting from acute dermal exposure and serves as a basis for classification and labelling. It permits the selection of optimum dose levels for repeated dermal toxicity testing and gives the first indications on the percutaneous resorptive properties of a substance. The Wistar rat has proved to be a suitable species for acute dermal toxicity testing with many different substances.
The present study was conducted in compliance with OECD Guidelines for Testing of Chemicals, 402 "Acute Dermal Toxivity", OECD 1987 updated guideline and EEC Guideline B.3, Acute Dermal Toxoicty in Council Directive 84/449/EEC. This study was conducted in compliance with the Principles of Good Labotarory Practice (GLP).
Acute dermal toxicity testing of Reaktiv-Gelb F-66 923 FW in the Wistar rat yielded a median lethal dose above 2000 mg/kg b.w. in both male and female animals.
No clinical signs were observed after application of 2000 mg/kg body weight.
From the first day p.a. up to the end of the study the skin surface of the animals was discoloured yellow.
One male animal was found dead on day 5 of the study. Development of body weight was not impaired.
Dark disolouration of the liver, plethora of the lung, blood in the urinary bladder and clear liquid in the abdominal cavity was observed at necropsy in the animal found dead.
The animals killed at the end of the observation period showed no macroscopically visible changes.
The substance is not considered to be harmful by dermal 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.
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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