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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 261-521-9 | CAS number: 58958-60-4
- 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
![](https://echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- 09 Mar - 30 Apr 1984
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Remarks:
- (no rationale for used concentrations given, limited etails on test substance purity)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 984
- Report date:
- 1984
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- yes
- Remarks:
- analytical purity of test substance not specified, no range finding for irritation, thus no explanation for used concentrations of 5% for intra- and epidermal induction, 25% for challenge
- Principles of method if other than guideline:
- Magnusson and Kligman method in guinea pigs
- GLP compliance:
- not specified
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- A non-LLNA test is available that was performed prior to the current data requirements, stipulated in Regulation (EC) No 1907/2006. In accordance with the same Regulation, the data was included to avoid unnecessary testing.
Test material
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Pirbright-Hartley
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Züchter Winkelmann, Borchen
- Weight at study initiation: test group mean: 382 g; control group mean: 337 g
- Housing: 5 per cage
- Diet: ad libitum
- Water: ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 23
- Humidity (%): 50 - 56
- Air changes (per hr): 11
- Photoperiod (hrs dark / hrs light): 12 / 12
Study design: in vivo (non-LLNA)
Induction
- Route:
- intradermal and epicutaneous
- Vehicle:
- other: Carboxymethylcellulose, Cremophor
- Concentration / amount:
- 5% for injection
5% for dermal induction
25% for dermal challenge
Challenge
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: Carboxymethylcellulose, Cremophor
- Concentration / amount:
- 5% for injection
5% for dermal induction
25% for dermal challenge
- No. of animals per dose:
- 15 for treatment, 19 as control
- Details on study design:
- RANGE FINDING TESTS: no data
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 2
- Exposure period: injection on day 1, epidermal application on day 7
- Test groups: 3 injections: 0.1 mL Freund's adjuvant, 0.1 mL 5% test substance in 2% Carboxymethylcellulose and 0.5% Cremophor, 0.1 mL Freund's adjuvant with test substance 1:1, concentration 5%; epidermal application: 5% in Vaseline
- Control group: the same than test group without test substance
- Site: two rows with 3 injections right and left of the scapular midline, dermal application on the injections sites
- Frequency of applications: 1
- Duration: single injections and 48 h dermal exposure under occlusive conditions
- Concentrations: 5%
B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: 14 days after dermal induction (day 22)
- Exposure period: 24 h
- Test groups: 0.1 mL 25% test substance in 2% Carboxymethylcellulose and 0.5% Cremophor
- Control group: 0.1 mL 2% Carboxymethylcellulose and 0.5% Cremophor
- Site: test substance on the right flank, vehicle on the left
- Concentrations: 25% and vehicle only
- Evaluation (hr after challenge): 48 and 72 h - Positive control substance(s):
- no
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 25%
- No. with + reactions:
- 0
- Total no. in group:
- 15
- Clinical observations:
- none
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 25%
- No. with + reactions:
- 0
- Total no. in group:
- 19
- Clinical observations:
- none
- Reading:
- 2nd reading
- Hours after challenge:
- 72
- Group:
- test chemical
- Dose level:
- 25%
- No. with + reactions:
- 0
- Total no. in group:
- 15
- Clinical observations:
- none
- Reading:
- 2nd reading
- Hours after challenge:
- 72
- Group:
- negative control
- Dose level:
- 25%
- No. with + reactions:
- 0
- Total no. in group:
- 19
- Clinical observations:
- none
- Group:
- positive control
- Remarks on result:
- not measured/tested
Any other information on results incl. tables
The test substance is not sensitising to the skin of guinea pigs, when used as 5% solution for induction and 25% solution for challenge.
Applicant's summary and conclusion
- Interpretation of results:
- other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No. 1272/2008
- Conclusions:
- CLP: not classified
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.
![ECHA](/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/echa_logo.png)
Embora a ECHA disponibilize muito material em linha na sua língua, uma parte desta página está disponível apenas em inglês. Mais informações sobreas práticas de multilinguismo da ECHA.
Bem-vindo ao sítio Web da ECHA O navegador Internet Explorer 7 (e versões anteriores) não é totalmente suportado por este sítio Web. Por favor atualize o seu Internet Explorer para uma versão mais recente.
Este sítio Web utiliza cookies a fim de garantir a melhor experiência possível nos nossos sítios Web.
Saiba mais sobre como utilizar cookies.