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EC number: 419-710-0 | CAS number: 42774-15-2 NYLOSTAB S-EED; NYSEED
- 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:
- 1996
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline conform GLP study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 996
- Report date:
- 1996
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.6 (Skin Sensitisation)
- Deviations:
- no
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- Study on skin sensitization already performed under Directive 67/548/EC, before REACH entered into force.
Test material
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Hartley
- Sex:
- male/female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Charles River France (Cleon, France)
- Age at study initiation: 6 weeks
- Weight at study initiation: 250 - 550 g
- Housing: in groups according to EEC/86/609 in stainless stell mesh cages
- Diet (e.g. ad libitum): pelleted complete guinea pig diet, ad libitum
- Water (e.g. ad libitum): softened and filtered mains drinking water, ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19+/-3°C
- Humidity (%): >/= 45%
- Air changes (per hr): >/= 22
- Photoperiod (hrs dark / hrs light): 12/12
Study design: in vivo (non-LLNA)
Induction
- Route:
- intradermal and epicutaneous
- Vehicle:
- other: absolute ethanol
- Concentration / amount:
- Induction:
- intradermal: 10% (w/w)
- topical: 60% (w/w)
Challenge:
- topical: 60% (w/w)
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: absolute ethanol
- Concentration / amount:
- Induction:
- intradermal: 10% (w/w)
- topical: 60% (w/w)
Challenge:
- topical: 60% (w/w)
- No. of animals per dose:
- Number of animals in test group: 20
Number of animals in negative control group: 10 - Details on study design:
- Control: 5 males, 5 females
Treatment group: 10 males, 10 females
- Intradermal induction
Administration area: 2x4 cm on the clipped dorsal shoulder region
Time of injection: day 1
Three pairs of intradermal injections were performed to the retroscapsular region left and right of the spine, in an approx. 2x4 cm area
1. Freund's complete adjuvant at 50% (v/v) in an isotonic injectable aolution
2. test article in a 10% (w/w) solution in absolute ethanol
3. mixture 50/50 (v/v): test article in a 20% (w/w) suspensin in absolute ehtanol + Freuns's complete adjuvant at 50% (v/v) in an isotonic injectable solution, i.e. a final 10% concentration of the test item.
Injection of the test item in a 10% solution provoked a moderate irritation with burnt appearance to the injection sites during the preliminary study.
- Topical application (48 h exposure)
Application area: clipped and shaved area, corresponding to that used for intradermal injections
Time of administration: day 9
0.5 mL test item in a 60% (w/w) paste in absolute ethanol
The test item was applied under an occlusive dressing composed of filter paper 2x4 cm maintained in contact with the skin with a waterproof and hypo-allergenic tape.Fixing of this tape was reinforced with a 4 cm wide linen adhesive tape applied on a hydrophilic gauze pad covering the whole clipped surface to avoid possible irritation by the adhesive tape.
As this application only provoked a weak irritation during the preliminary study, a skin painting was performed during the main study on day 8, with 0.5 mL of sodium lauryl sulphate at 10% (w/w) in Codex paraffin to create irritation.
- Control group
The intradermal injections and the topical occlusive application for 48 h were carried out under the same conditions as in the treated group, absolute ethanol replacing the test item.
- Rest period: day 11 to 22 - Challenge controls:
- - Challenge application
day 22
Application area: a 2x2 cm area on the left flank of each animal, close-clipped and shaved
The topical occlusive application for 24 h was performed in the treated group and the control group with the test item in a 60% (w/w) paste in absolute ethanol and at the dose level of 0.5 mL. The vehicle was also applied during challenge.
The cutaneous macroscoppic examinations were performed 24 and 48 h after removel of the occlusive dressing to the challenge applications sites, according to the Magnusson & Kligman scale.
Histopathological examination of the skin was performed for one animal of the treated group which showed doubtful macroscopic reaction at 24 h. - Positive control substance(s):
- yes
- Remarks:
- DCNB (1-Chlor-2,4-Dinitrobenzol)
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- positive control
- Dose level:
- 0
- No. with + reactions:
- 0
- Total no. in group:
- 0
- Remarks on result:
- not measured/tested
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- positive control
- Dose level:
- 0
- No. with + reactions:
- 0
- Total no. in group:
- 0
- Remarks on result:
- not measured/tested
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 60 %
- No. with + reactions:
- 1
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 60 %. No with. + reactions: 1.0. Total no. in groups: 20.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 60 %
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 60 %. No with. + reactions: 0.0. Total no. in groups: 20.0.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 60 %
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 60 %. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 60 %
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 60 %. No with. + reactions: 0.0. Total no. in groups: 10.0.
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- From the results obtained under the experimental conditions employed the test item is regared as not sensitising.
- Executive summary:
Testing for sensitising properties of N,N’-Bis(2,2,6,6-tetramethyl-4-piperidinyl)isophthalamide was performed in male and female guinea pigs according to the Magnusson & Kligman test (PPMT). Intradermal induction was performed using 10 % N,N’-Bis(2,2,6,6-tetramethyl-4-piperidinyl)isophthalamide, topical induction with 60% substance in paste. The challenge was carried out with 60% N,N’-Bis(2,2,6,6-tetramethyl-4-piperidinyl)isophthalamide (epidermal) 12 days after the last induction application.
The test item induced allergic reactions in only one out of twenty animals.
N,N’-Bis(2,2,6,6-tetramethyl-4-piperidinyl)isophthalamide is regarded as not sensitising.
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