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EC number: 403-590-1 | CAS number: 104815-18-1
- 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
Skin sensitisation (in vivo; GPMT); Not sensitising (OECD 406)
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:
- other: SNIF
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- All information in this endpoint has been provided by the ECHA using the 12-year rule, this is data not owned by the registrant. The reliability is assumed to be at level 2. Therefore the following reliability statement can be used: Study conducted in accordance with generally accepted scientific principles, possibly with incorect reporting or methodological deficiencies, which do not affect the quality of the relevant results.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- GLP compliance:
- not specified
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- All information in this endpoint has been provided by the ECHA using the 12-year rule.
- Species:
- guinea pig
- Strain:
- other: Hartley/Dunkin
- Sex:
- female
- Route:
- intradermal
- Vehicle:
- other: liquid paraffin
- Concentration / amount:
- 1%
- Day(s)/duration:
- Day 0
- Adequacy of induction:
- other: no irritation noted
- Route:
- other: dermal
- Vehicle:
- other: liquid paraffin
- Concentration / amount:
- 50%
- Day(s)/duration:
- Day 7
- Adequacy of induction:
- other: no irritation noted
- No.:
- #1
- Route:
- other: not stated
- Vehicle:
- other: liquid paraffin
- Concentration / amount:
- 25%
- Day(s)/duration:
- 48 hrs
- Adequacy of challenge:
- not specified
- No.:
- #2
- Route:
- other: not stated
- Vehicle:
- other: liquid paraffin
- Concentration / amount:
- 50%
- Day(s)/duration:
- 48 hrs
- Adequacy of challenge:
- not specified
- No. of animals per dose:
- 20 test group
20 controls - Positive control substance(s):
- no
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 25%
- No. with + reactions:
- 4
- Total no. in group:
- 20
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 25%
- No. with + reactions:
- 2
- Total no. in group:
- 19
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 50%
- No. with + reactions:
- 5
- Total no. in group:
- 20
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 50%
- No. with + reactions:
- 4
- Total no. in group:
- 19
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- In an in vivo skin sensitisation (GPMT), the substance is not sensitising.
- Executive summary:
In a dermal sensitization study (OECD 406) with DL-N33 in paraffin oil, Hartley/Dunkin female guinea pigs were tested in a maximisation test. For induction, 1% DL-N33 in paraffin oil (intradermal injections) and 50% DL-N33 in paraffin oil (dermal) was used. For challenge, 25% and 50% DL-N33 in paraffin oil was used. The evaluation of skin reactions after challenge was carried out at 48 hrs.
In the preliminary study, dermal application at 10-50% w/w in liquid paraffin did not cause any skin reactions. One control animal died prior to challenge in the main study (death not treatment-related). In the main study at 25%, 4/20 test group animals and 2/19 control animals were positive. At 50%, 5/20 test group animals and 4/19 control animals were positive. At challenge, only slight erythema was seen in all animals that showed a skin reaction. The substance is not sensitising.
Referenceopen allclose all
Other observations:
In a preliminary study, dermal application at 10-50% w/w in liquid paraffin did not cause any skin reactions. At challenge only slight erythema was seen in all animals that showed a skin reaction; scores in test animals did not exceed those in controls. One control animal died prior to challenge (death not treatment-related).
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
There is no in vitro skin sensitisation data available. One in vivo skin sensitisation (GPMT) is available.
In a dermal sensitization study (OECD 406) with DL-N33 in paraffin oil, Hartley/Dunkin female guinea pigs were tested in a maximisation test. For induction, 1% DL-N33 in paraffin oil (intradermal injections) and 50% DL-N33 in paraffin oil (dermal) was used. For challenge, 25% and 50% DL-N33 in paraffin oil was used. The evaluation of skin reactions after challenge was carried out at 48 hrs. No positive control substance was used. In a preliminary study, dermal application at 10-50% w/w in liquid paraffin did not cause any skin reactions. One control animal died prior to challenge in the main study (death not treatment-related). In the main study at 25%, 4/20 test group animals and 2/19 control animals were positive. At 50%, 5/20 test group animals and 4/19 control animals were positive. At challenge, only slight erythema was seen in all animals that showed a skin reaction. The substance is not sensitising.
The data is acceptable to use in the human health risk assessment.
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
Based on the available information in the dossier, the substance DL-N33 (CAS No. 104815-18-1) does not need to be classified for skin sensitisation when the criteria outlined in Annex I of 1272/2008/EC and Annex I of 286/2011/EC are applied.
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.
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