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EC number: 939-368-0 | CAS number: -
- 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 (LLNA)
- Type of information:
- other: DSH-30-3-0260-2018
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 012
- Report date:
- 2012
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.6 (Skin Sensitisation)
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- mouse local lymph node assay (LLNA)
Test material
- Reference substance name:
- Reaction product of naphthalene, propan-2-ol, sulfonated and neutralized by caustic soda
- EC Number:
- 939-368-0
- Cas Number:
- 1322-93-6
- Molecular formula:
- Not applicable (a generic molecular formula can not be provided for this specific UVCB substance)
- IUPAC Name:
- Reaction product of naphthalene, propan-2-ol, sulfonated and neutralized by caustic soda
Constituent 1
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- CBA
- Sex:
- female
Study design: in vivo (LLNA)
- Vehicle:
- propylene glycol
- Concentration:
- 0, 5, 10 and 25% (w/v) in propylene glycol
- No. of animals per dose:
- 4
Results and discussion
- Positive control results:
- The threshold positive value of 3 for the SI was reached in the positive control group (SI = 13.90).
In vivo (LLNA)
Results
- Parameter:
- SI
- Value:
- >= 0.92
- Variability:
- 0.92 at 5% 1.14 at 10% 3.14 at 25%
Applicant's summary and conclusion
- Conclusions:
- In this study the stimulation indices (S.I.) of 0.92, 1.14 and 3.14 were determined with the test item at
concentrations of 5, 10 and 25% in propylene glycol.
As a significant lymphoproliferation (SI > 3) was noted at the concentration of 25%, the EC3 value
was determined (23.95%).
Based on the positive SI value observed at the concentration of 25%, the test material may be c
onsidered as a skin sensitiser. However, irritation was also observed at this concentration and is
known to be potentially involved in false positive lymphoproliferation responses.
Therefore, the test item may not be a skin sensitizer for the following reasons: an increase in ear
thickness was above the limit of 25% in two out of four mice (Nos. 14 and 15); the SI cut-off of 3 was
only just exceeded (SI = 3.14). Therefore it is highly likely that this weak lymphoproliferation was the
consequence of the local irritation clearly observed in 2/4 animals of this group.
Based on the results of this study, it was not possible to definitively reject the impact of irritation on
the stimulation index observed at the highest concentration, therefore it was not possible to clearly c
onclude on the potential of reaction product of naphthalene, propan-2-ol, sulfonated and neutralized
by caustic soda to induce delayed contact hypersensitivity. - Executive summary:
In order to study a possible contact allergenic potential of reaction product of naphthalene, propan-2-ol,
sulfonated and neutralized by caustic soda, a local lymph node assay (LLNA) was performed according
to the OECD Guideline 429 and under GLP regulations.
For this purpose, three groups of four female mice received the test item by topical route to the dorsal
surface of both ears on days 1, 2 and 3 at concentrations of 5, 10 or 25% (maximum technically
applicable concentration) under a dose‑volume of 25 µL. One negative control group of four females
received the vehicle (Propylene Glycol) under the same experimental conditions. Additionally, one
positive control group of 4 females received the positive control,α‑hexylcinnamaldehyde (HCA), at 25%
in a mixture acetone/olive oil (4/1; v/v) under the same experimental conditions.
From day 1 to day 3 then on day 6, the thickness of the left ear of each animal was measured, except in
animals of the positive control group and the local reactions were recorded. Each animal was observed
at least once a day for mortality and clinical signs. Body weight was recorded on days 1 and 6. After 2
days of resting, on day 6, the animals received a single intravenous injection of tritiated methyl thymidine
(3H-TdR). Approximately 5 hours later, the animals were sacrificed and the auricular lymph nodes were
excised. The proliferation of lymphocytes in the lymph node draining the application site was measured
by incorporation of3H-TdR. The results were expressed as disintegrations per minute (dpm) per group
and as dpm/node. The obtained values were used to calculate Stimulation Indices (SI). A test item is
regarded as a sensitizer in the LLNA if the exposure to one or more test concentrations resulted in 3-
fold or greater increase in incorporation of 3HTdR compared with concurrent controls, as indicated by
the stimulation index (S.I.).
No unscheduled deaths occurred and no clinical signs were observed in any animals throughout the
study. On day 6, erythema and dryness of ear skin were noted in all females treated at 25%. Erythema
was also observed in 1/4 females treated at 10%. An increase in ear thickness of 31% was observed
in females treated at 25%.
In this study the stimulation indices (S.I.) of 0.92, 1.14 and 3.14 were determined with the test item at
concentrations of 5, 10 and 25% in propylene glycol.
As a significant lymphoproliferation (SI > 3) was noted at the concentration of 25%, the EC3 value was
determined (23.95%).
Based on the positive SI value observed at the concentration of 25%, the test material may be considered
as a skin sensitiser. However, irritation was also observed at this concentration and is known to be
potentially involved in false positive lymphoproliferation responses.
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Skin sens. V1 2012 CitoxLab
Therefore, the test item may not be a skin sensitizer for the following reasons: an increase in ear
thickness was above the limit of 25% in two out of four mice (Nos. 14 and 15); the SI cut-off of 3 was
only just exceeded (SI = 3.14). Therefore it is highly likely that this weak lymphoproliferation was the
consequence of the local irritation clearly observed in 2/4 animals of this group.
Based on the results of this study, it was not possible to definitively reject the impact of irritation on the
stimulation index observed at the highest concentration, therefore it was not possible to clearly conclude
on the potential of reaction product of naphthalene, propan-2-ol, sulfonated and neutralized by caustic
soda to induce delayed contact hypersensitivity.
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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