Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 613-953-8 | CAS number: 66603-10-9
- 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:
- 1971
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- test procedure in accordance with generally accepted scientific standards and described in sufficient detail
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 971
- Report date:
- 1971
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- Before OECD guideline 404 was established, eye initiation was tested using an internal method (BASF test). However the method is comparable to OECD 405.
- Principles of method if other than guideline:
- - Principle of test: in vivo skin irritation / corrosion test
- Short description of test conditions: The skin of the back of the rabbit was exposed for 1, 5 and 15 minutes and 20 hours to a test patch (about 2.5 x 2.5 cm) impregnated with the test substance (patch test). Following the short exposure (time test), the treated areas of skin were first washed with undiluted Lutrol 9 and then with a 50 % strength aqueous solution of Lutrol, while the skin was untreated after exposure for 20 hours. On the rabbit ear, cotton carriers impregnated with 1-2 ml of test substance were fixed inside the external ear with gauze dressings for 20 hours. In each case, the findings were recorded on removal of the dressing and after 1, 3 and 8 days.
- Parameters analysed / observed: local irritant effect, signs of toxicity due to absorption - GLP compliance:
- no
- Remarks:
- GLP was not compulsory at the time the study was performed
Test material
- Reference substance name:
- Cyclohexylhydroxydiazene 1-oxide, potassium salt
- EC Number:
- 613-953-8
- Cas Number:
- 66603-10-9
- Molecular formula:
- C6H11KN2O2
- IUPAC Name:
- Cyclohexylhydroxydiazene 1-oxide, potassium salt
- Test material form:
- liquid
- Details on test material:
- Xyligen 30F is a 30% aqueous solution of K-HDO.
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- Vienna White
- Details on test animals or test system and environmental conditions:
- - Source: obtained commercially
- Sex: male / female
- Weight at study initiation: 2.75 kg (mean value)
- Diet: ad libitum
- Water: ad libitum
Test system
- Type of coverage:
- not specified
- Preparation of test site:
- not specified
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not specified
- Amount / concentration applied:
- The product was applied undiluted to the skin of the back and ears of the rabbit.
- Duration of treatment / exposure:
- 1, 5 and 15 minutes and 20 hours
- Observation period:
- 8 days
- Number of animals:
- 3 male / 1 female animal
- Details on study design:
- TEST SITE
- Area of exposure: 2.5 x 2.5 cm
REMOVAL OF TEST SUBSTANCE
- Washing (if done): First washed with undiluted Lutrol 9 and then with a 50 % strength aqueous solution of Lutrol
- Time after start of exposure: Dorsal skin: 1, 5, 15 min and 20 hours; rabbit ear: 20 hours
OBSERVATION TIME POINTS
(indicate if minutes, hours or days): 24 hours and 8 days
SCORING SYSTEM:
- BASF scoring system:
Explanation of signs:
0 = non-irritant
+ = slight
++ = severe
R = reddening
S = scaling
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- other: erythema and eschar formation on the back of the test animal
- Basis:
- mean
- Time point:
- 24 h
- Score:
- 4
- Reversibility:
- not reversible
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24 h
- Score:
- 2
- Reversibility:
- fully reversible
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24 h
- Score:
- 2
- Reversibility:
- fully reversible
- Irritant / corrosive response data:
- The undiluted product was non-irritant on exposure of the very sensitive dorsal skin for short periods (1, 5 and 15 minutes). On exposure for 20 hours, Xyligen 30 F led to moderately severe overlapping reddening, which was spotty in some cases, and to slight swelling; there was formation of coarse scars after 8 days. Only a slight reddening, which disappeared within 8 days, was observed in the 20-hour test on the skin of the ear.
- Other effects:
- No signs of toxicity due to absorption were observed.
Any other information on results incl. tables
The conditions of 20h exposure without washing after exposure are more severe compared to the conditions recommended by the OECD guideline (4h exposure, washing after exposure). However, without a more adequate test the reported results have to be used for hazard assessment as worst case situation. The average score for 24h, 48h and 72h cannot be calculated, since no results are documented for 48h and 72h. Therefore, the 24h score has to be used instead.
Applicant's summary and conclusion
- Conclusions:
- After translation to OECD scores the 24h average scores are: For the back for erythema and eschar formation 4 and not reversible and for edema 2 (reversible); for the ear the erythema formation score is 2 (reversible). Therefore 30% K-HDO is considered to be irritating to skin.
- Executive summary:
The primary irritant effect of Xyligen 30F on rabbit skin and mucosa has been tested. The undiluted product was non-irritant on exposure of the very sensitive dorsal skin for short periods (1, 5 and 15 minutes). On exposure for 20 hours, Xyligen 30F led to moderately severe overlapping reddening, which was spotty in some cases, and to slight swelling; there was formation of coarse scales after 8 days. Only a slight reddening, which disappeared within 8 days, was observed in the 20-hour test on the skin of the ear.
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.