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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 203-845-5 | CAS number: 111-20-6
- 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:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 979
- Report date:
- 1979
Materials and methods
- Principles of method if other than guideline:
- Skin sensitisation in guinea pigs, intradermal injection of test substance for induction (seven doses) and challenge.
- GLP compliance:
- no
- Remarks:
- pre-GLP
- Type of study:
- intracutaneous test
- Justification for non-LLNA method:
- In accordance with Annex VII of EC legislation 1907/2006 in-vivo testing studies apart from murine local lymph node assay (LLNA) meet the regulatory requirements if they were carried out or initiated before 11 October 2016. The described experimental test was performed by an intradermal application during induction and challenge. This reported study is much more sensitising than the epidermal application according to OECD guideline 406 (GPMT method or Buehler test method) and meet the requirements set out in Article 13(3), first subparagraph, and Article 13(4).
Test material
- Reference substance name:
- Sebacic acid
- EC Number:
- 203-845-5
- EC Name:
- Sebacic acid
- Cas Number:
- 111-20-6
- Molecular formula:
- C10H18O4
- IUPAC Name:
- sebacic acid
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Hartley
- Sex:
- male
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Sweetwater Farms
Study design: in vivo (non-LLNA)
Induction
- Route:
- intradermal
- Vehicle:
- peanut oil
- Concentration / amount:
- 0.1 %
- Day(s)/duration:
- 7 days, each at an interval of 48 h
Challenge
- Route:
- intradermal
- Vehicle:
- peanut oil
- Concentration / amount:
- 0.1 %
- Day(s)/duration:
- one injection
- No. of animals per dose:
- 20
- Details on study design:
- Twenty male albino guinea pigs were used to test the sensitizing potential of the materials. The sensitization test was started on a Monday when the guinea pigs were weighed and closely clipped on the scapular areas. The material (0.05 ml of a 0.1% dilution in peanut oil) was injected intradermally into the upper right scapular area of each pig. A similar injection of peanut oil alone into the upper left scapular area served as a control site. Readings were made 24 and 48 hours later. Doses of 0.1 ml of the same dilutions (freshly prepared) were injected into the clipped dorsal lumbo-sacral areas of the guinea pigs on the following Wednesday, Friday, Monday, etc., until seven doses were administered. Care was taken to insure that the repeated doses were not injected into the same site. The guinea pigs were rested for three weeks (incubation period), weighed and given a challenge dose of 0.05 ml of the 0.1% dilution of the test material into the lower right scapular area. A control injection of the vehicle alone was also administered into the lower left scapular area at this time. The reactions were read after 24 and 48 hours.
The grading system is designed so that the intensity of the skin reaction is represented by a proportionate numerical value and also that any reaction elicited by the vehicle (control substance) is subtracted from the reaction elicited by the test material and vehicle combined. The product of the width and length of the wheal (in mm) is multiplied by the following reaction scores to determine a final grade:
0 = needle puncture ("np")- no wheal
1 = very faint pink ("vfp") - no value for this reaction
2 = faint pink ("fp")
3 = pink P
4 = red ("r")
5 = bright red ("R")
6 = edema - <1 mm in height ( "e")
7 = edema - >1 mm in height ("E")
*8 = necrosis - <1 sq. mm ("n")
*9 = necrosis - >1 sq. mm ("N")
*The product of the width and length of the necrotic area multiplied by 8 or 9 is added to the numerical value of the foregoing reactions that are present and calculated in the same manner.
As a characterization of the sensitizing response which may be expected from exposure to the test material, the final grade was compared with the following categories (Final Grade --> Sensitizing Response): 0-25 --> None; 26-99 --> Mild; 100-200 --> Moderate; >200 --> Severe.
The sensitizing potential of the test material is estimated from the number of animals giving a response with a final grade of at least 25. The scale for this estimation is shown below (Number Sensitized (N=20) --> Sensitizing Potential): 1-3 --> Slight; 4-10 --> Moderate; 11-20 --> Severe.
Results and discussion
In vivo (non-LLNA)
Results
- Reading:
- other: overall result
- Group:
- test chemical
- Dose level:
- 0.05 ml of a 0.1% dilution in peanut oil
- No. with + reactions:
- 3
- Total no. in group:
- 20
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test substance caused a mild sensitization response (final grades per animal: 26 -99) and was categorized as a substance with "slight" sensitization potential. According to the applied scoring system, this refers to 1 - 3 animals out of 20 with mild, but positive reactions (final grade per animal >= 25).
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.