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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 205-516-1 | CAS number: 141-97-9
- 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 sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- November 23 - December 3, 1981
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study
- Remarks:
- this study was performed in 1981, prior to implementation of domestic and international good laboratory practice standards. The study was conducted using standard procedures used in the performing laboratory at that time. However, there are some gaps in the study design itself, as there was no re-challenge as in the standard maximization test. Therefore, the study was assessed as Klimisch 2 study.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 981
- Report date:
- 1997
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Version / remarks:
- of 12 May 1981 (Footpad method)
- Deviations:
- no
- GLP compliance:
- no
- Type of study:
- Freund's complete adjuvant test
- Justification for non-LLNA method:
- this study was performed in 1981, prior to implementation of domestic and international good laboratory practice standards and before OECD guideline n0. 429 was available
Test material
- Test material form:
- other: non-viscous clear liquid
- Details on test material:
- - Physical state: liquid
- Stability under test conditions: stable
- Storage condition of test material: at room temperature in the dark
Constituent 1
- Specific details on test material used for the study:
- - Lot-no.: Lot C11
- Storage: no data
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- not specified
- Sex:
- male/female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: not known
- Weight at study initiation: 328-522 grams
- Housing: single housing
Study design: in vivo (non-LLNA)
Induction
- Route:
- intradermal
- Vehicle:
- other: 7:2:1 solution of acetone / dioxane / guinea pig fat
- Concentration / amount:
- Ten guinea pigs (Numbers 634-643) were injected in the footpad, with 0.05 mL of FCA (control group). Atthe same time, the remaining ten guinea pigs (Numbers 644-653) were injected in the same manner with 0.05 mL of a suspension of FCA containing 1% test substance (test group).
- Day(s)/duration:
- 7 days
- Adequacy of induction:
- highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
Challenge
- No.:
- #1
- Route:
- epicutaneous, open
- Vehicle:
- other: 7:2:1 solution of acetone / dioxane / guinea pig fat
- Concentration / amount:
- The animals were then challenged with 0.3 mL of a 0.1% solution of the test substance (the concentration was based on results of the irritation screen) in the vehicle.
- Day(s)/duration:
- 24 & 48 hours
- Adequacy of challenge:
- not specified
- No. of animals per dose:
- PRIMARY IRRITATION SCREENING:
- Five female guinea pigs
MAIN TEST:
- Induction & Challenge: Ten male guinea pigs each for control and test group - Details on study design:
- This dermal sensitization study was conducted using the footpad method.
PRIMARY IRRITATION SCREENING
In a primary irritation screening, five female guinea pigs previously exposed to Freund's complete adjuvant (FCA), were administered topical doses of a 1% solution of the test substance in a vehicle of acetone, dioxane, and guinea pig fat (7:2:1). Signs of initation included slight to moderate erythema at the 24- and 48-hour examinations for all guinea pigs. Therefore, a decision was made to use a concentration of 0.1% of the test substance in the vehicle for the challenge application of the sensitization study.
INDUCTION
For the induction phase, twenty male guinea pigs weighing 328-387 grams were assigned to one of two groups. Ten guinea pigs were injected in the footpad with 0.05 mL of FCA (control group). At the same time, the remaining ten guinea pigs were injected in the same manner with 0.05 mL of a suspension of FCA containing 1% test substance (test group).
CHALLENGE
Seven days later, the hair was removed from the backs of the twenty guinea pigs with an electric clipper. The animals were then challenged with 0.3 mLof a 0.1% solution of the test substance (the concentration was based on results of the irritation screen) in the vehicle. The guinea pigs were depilated24 hours after the challenge dose and the reaction to the topical challenge was scored. The next day (48 hours after challenge) the reaction was scored again. - Challenge controls:
- none
- Positive control substance(s):
- no
Results and discussion
- Positive control results:
- no positive control tested
In vivo (non-LLNA)
Resultsopen allclose all
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 0.1%
- No. with + reactions:
- 10
- Total no. in group:
- 10
- Clinical observations:
- None
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 0.1%
- No. with + reactions:
- 10
- Total no. in group:
- 10
- Clinical observations:
- None
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 0.1%
- No. with + reactions:
- 10
- Total no. in group:
- 10
- Clinical observations:
- None
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 0.1%
- No. with + reactions:
- 10
- Total no. in group:
- 10
- Clinical observations:
- None
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Group:
- positive control
- Remarks on result:
- not measured/tested
Any other information on results incl. tables
Following the challenge application, slight dermal responses were noted for all ten animals assigned to the control group and for all ten animals assigned to the test group. Since there was no difference in the dermal responses between the control group of animals and the test group of animals, the test substance was not considered to be a dermal sensitizer in guinea pigs.
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- When animals were challenged with a concentration of 0.1% test substance in the vehicle, no difference in the dermal responses were noted between the control animals and the test animals, based on the criteria cited in this study. The test substance was not considered to be a dermal sensitizer in guinea pigs.
- Executive summary:
The study was performed in 1981 as non-GLP according to OECD 406 using the footpad method. After intradermal induction with FCA (control group) and 1% test item in FCA, ten test animals and ten control animals were both challenged with 0.1% solution of EAA in the vehicle (solution of acetone, dioxane and GP-fat). No difference in the dermal responses were noted between the control animals and the test animals, based on the criteria cited in this study. The test substance was not considered to be a dermal sensitizer in guinea pigs. Based on results of this study, the test substance requires no label for sensitization by skin contact.
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.
Although ECHA is providing a lot of online material in your language, part of this page is only in English. More about ECHA’s multilingual practice.
Welcome to the ECHA website. This site is not fully supported in Internet Explorer 7 (and earlier versions). Please upgrade your Internet Explorer to a newer version.
the-echa-website-uses-cookies
find-out-more-on how-we-use-cookies