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Diss Factsheets
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EC number: 931-335-9 | CAS number: 90622-74-5
- 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://chesar.echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
Endpoint summary
Administrative data
Description of key information
Key value for chemical safety assessment
Skin sensitisation
Link to relevant study records
- Endpoint:
- skin sensitisation: in vitro
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- an in vitro skin sensitisation study does not need to be conducted because adequate data from an in vivo skin sensitisation study are available
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- read-across based on grouping of substances (category approach)
- Adequacy of study:
- key study
- Study period:
- Not reported
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
- Justification for type of information:
- Refer to section 13 of IUCLID for details on the category justification.
- Reason / purpose for cross-reference:
- read-across source
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- not specified
- Principles of method if other than guideline:
- The method employed in this study for the detection of delayed contact hypersensitivity was the guinea-pig maximization test described by Magnusson B and Kligman AM (1970) in "Allergic Contact Dermatitis in the Guinea-Pig: Identification of contact allergens", published by C. C. Thomas, Springfield, Illinois, U.S.A.
- GLP compliance:
- not specified
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- LLNA was not available and adopted as an OECD guideline at the time of the current study.
- Species:
- guinea pig
- Strain:
- Pirbright-Hartley
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Average weight at study initiation: 440 g - Route:
- intradermal
- Vehicle:
- other: Propylene glycol
- Concentration / amount:
- Induction: Intradermal injection - Site 1) 0.1 mL Freund's adjuvant; site 2) 0.1 mL of a 5% solution of test substance in propylene glycol; site 3) 0.1 mL of a 1:1 mix of Freund's adjuvant and 5% test substance solution
Challenge: After 1 week, 5% test substance in vaseline (occlusive patch for 48 h); after 14 days 25% test substance in vaseline (open application) - Route:
- epicutaneous, occlusive
- Vehicle:
- other: Propylene glycol
- Concentration / amount:
- Induction: Intradermal injection - Site 1) 0.1 mL Freund's adjuvant; site 2) 0.1 mL of a 5% solution of test substance in propylene glycol; site 3) 0.1 mL of a 1:1 mix of Freund's adjuvant and 5% test substance solution
Challenge: After 1 week, 5% test substance in vaseline (occlusive patch for 48 h); after 14 days 25% test substance in vaseline (open application) - No. of animals per dose:
- 20
- Details on study design:
- MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 1
- Test groups: 20
- Control group: 20
- Site: both sites of the spinal cord at the level of the shoulder blades
B. CHALLENGE EXPOSURE
- No. of exposures: once, one week after induction, then again 14 days later (re-challenge)
- Exposure period: after one week; exposure over the injection sites via occlusive patch for 48 h; after 14 days: open application on right flank
- Evaluation (h after challenge): Animals observed after induction and challenge, up until 72 h after re-challenge (at 14 days) - Challenge controls:
- Identical to test group.
- Positive control substance(s):
- yes
- Positive control results:
- Intracutaneous application of Freund's adjuvant caused strong skin reddening, skin swelling and later necrosis and scarring
- Key result
- Reading:
- other: After removal of the occlusive patch
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 5% test substance in vaseline
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- No specific skin reactions
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- rechallenge
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 25% test substance in vaseline
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- None
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- rechallenge
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 0% test substance
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- None
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- positive control
- Remarks on result:
- not measured/tested
- Remarks:
- No details were provided
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the study conditions, read across substance did not produce any evidence of delayed contact hypersensitivity and was therefore considered non-sensitising.
- Executive summary:
A study was conducted to evaluate the skin sensitisation potential of the read across substance, C8-18 and C18-unsatd. DEA, according to OECD Guideline 406 using guinea pig maximisation test. The procedure consisted of two parts: induction and challenge exposures. For induction, three sets of intradermal injections were given (0.1mL Freund's adjuvant; 0.1 mL of a 5% solution of read across substance in propylene glycol, and 0.1 mL of a 1:1 mix of Freund's adjuvant and 5% read across substance. One week after the injections, a 5% test solution was placed on the skin over the injection sites via an occlusive patch and left for 48 h. This was followed by a re-challenge: 14 days after the cutaneous exposure, 25% read across substance in vaseline was placed on the skin of the right flank (open application). Under the study conditions, read across substance did not produce any evidence of delayed contact hypersensitivity and was therefore considered non-sensitising (Potokar, 1982).
Referenceopen allclose all
For detailed results tables kindly refer to the attached background materials section of the IUCLID.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
A study was conducted to evaluate the skin sensitisation potential of the read across substance, C8-18 and C18-unsatd. DEA, according to OECD Guideline 406 using guinea pig maximisation assay. The procedure consisted of two parts: induction and challenge exposures. For induction, three sets of intradermal injections were given (0.1mL Freund's adjuvant; 0.1 mL of a 5% solution of test substance in propylene glycol, and 0.1 mL of a 1:1 mix of Freund's adjuvant and 5% test substance. One week after the injections, a 5% test solution was placed on the skin over the injection sites via an occlusive patch and left for 48 h. This was followed by a re-challenge: 14 days after the cutaneous exposure, 25% test substance in vaseline was placed on the skin of the right flank (open application). Under the study conditions, test substance did not produce any evidence of delayed contact hypersensitivity and was therefore considered non-sensitising (Potokar, 1982).
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
The read across substance C8-18 and C18-unsatd. DEA was negative in in vivo skin sensitisation testing, therefore no classification is required for this endpoint according to CLP (EC 1272/2008) criteria.
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.
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