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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
Endpoint summary
Administrative data
Description of key information
The study was performed in 1981 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.
Key value for chemical safety assessment
Skin sensitisation
Link to relevant study records
- 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.
- 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
- Specific details on test material used for the study:
- - Lot-no.: Lot C11
- Storage: no data - 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 - 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
- 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
- Positive control results:
- no positive control tested
- 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
- 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.
Reference
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.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
Justification for selection of skin sensitisation endpoint: non GLP-study following OECD-guideline; Klimisch 2
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
- Additional information:
There is no indication for respiratory irritation/sensitization from handling and use.
Justification for classification or non-classification
Based on the data available the substance is not classified or labeled according to Directive 67/548/EEC (DSD) or Regulation 1272/2008/EC (CLP).
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