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EC number: 939-056-4 | CAS number: 1469982-95-3
- 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:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP Guideline Study
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:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- GLP compliance:
- yes
- Type of study:
- mouse local lymph node assay (LLNA)
Test material
- Reference substance name:
- 1-{[4,5-dihydroxy-3-(hydroxymethyl)-2-oxoimidazolidin-1-yl]methyl}-4,5-dihydroxy-3-(hydroxymethyl)imidazolidin-2-one; 2-(2-hydroxyethoxy)ethan-1-ol; 4,5-dihydroxy-1,3-bis({[2-(2-hydroxyethoxy)ethoxy]methyl})imidazolidin-2-one
- EC Number:
- 939-056-4
- Cas Number:
- 1469982-95-3
- Molecular formula:
- UVCB substance
- IUPAC Name:
- 1-{[4,5-dihydroxy-3-(hydroxymethyl)-2-oxoimidazolidin-1-yl]methyl}-4,5-dihydroxy-3-(hydroxymethyl)imidazolidin-2-one; 2-(2-hydroxyethoxy)ethan-1-ol; 4,5-dihydroxy-1,3-bis({[2-(2-hydroxyethoxy)ethoxy]methyl})imidazolidin-2-one
- Details on test material:
- - Name of test material (as cited in study report): Fixapret PC, vor Magnesiumchlorid-Zugabe
- Physical state: liquid
- Analytical purity: Reaction product of urea, formaldehyde, glyoxal and diethylene glycol, content: 62.1 % in water
- Impurities (identity and concentrations): 37.9 % water (solvent)
- Lot/batch No.: 153
- Stability under test conditions: The stability of the test item under storage conditions over the study period was guaranteed by the sponsor,
and the sponsor holds this responsibility.
- Storage condition of test material: Room temperature; avoid temperatures < 5°C >30°C
Constituent 1
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- CBA
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Harlan Laboratories B.V.
- Age at study initiation: pretest: 9-10 weeks, main study: 8-9 weeks
- Weight at study initiation: 18,3 - 23,1 g
- Housing: 5 animals per cage
- Diet: ad libitum:
- Water: ad libitum:
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +- 2
- Humidity (%): 44 – 68%
- Photoperiod (hrs dark / hrs light): 12/12
Study design: in vivo (LLNA)
- Vehicle:
- dimethylformamide
- Concentration:
- 25, 50 and 100 %
- No. of animals per dose:
- 5
- Details on study design:
- RANGE FINDING TESTS:
- Compound solubility: up to 100 % (undiluted)
- Irritation: none
MAIN STUDY
ANIMAL ASSIGNMENT AND TREATMENT
- Name of test method: OECD 429
- Criteria used to consider a positive response: 3-fold or greater increase in incorporation of 3HTdR compared with concurrent controls, as indicated by the Stimulation Index (S.I.). - Positive control substance(s):
- hexyl cinnamic aldehyde (CAS No 101-86-0)
- Statistics:
- The mean values and standard deviations were calculated in the body weight tables, for
the ear weights, the lymph node weights and lymph node cell count, and for the DPM
values (group mean DPM ± standard deviation).
A statistical analysis was conducted on the DPM values, the ear weights, the lymph node
weights and the lymph node cell count to assess whether the difference was statistically
significant between test item groups and negative control group. For all statistical
calculations SigmaStat for Windows (Version 2.0) was used. A One-Way-Analysis-of-
Variance was used as statistical method. In case of significant results of the One-Way-
ANOVA, multiple comparisons were performed with the Dunnett test. Statistical
significance was set at the five per cent level (p < 0.05).
However, both biological and statistical significance were considered together.
Results and discussion
- Positive control results:
- The periodic positve control gave the expected results.
In vivo (LLNA)
Resultsopen allclose all
- Parameter:
- SI
- Remarks on result:
- other: Vehicle: 1 25 %: 0.57 50 %: 0.74 100 %: 0.89
- Parameter:
- other: disintegrations per minute (DPM)
- Remarks on result:
- other: Vehicle: 757 DMP (mean) 25 %: 432.2 DMP (mean) 50 %: 562 DMP (mean) 100 %: 671.8 DMP (mean)
Any other information on results incl. tables
In this study the test item Fixapret PC, vor Magnesiumchlorid-Zugabe was assessed for its
skin sensitising potential using the Local Lymph Node Assay (LLNA) in mice. Test item
solution at different concentrations was prepared in the vehicle N,N-dimethylformamide.
The local lymph node assay is recommended by international test guidelines (e.g. OECD)
as an animal test for predicting skin sensitization in humans and provides a rational basis
for risk assessment. The basic principle underlying the LLNA is that sensitisers induce a
primary proliferation of lymphocytes in the lymph node draining the application site. The
ratio of proliferation in test item treated groups compared to that in vehicle controls is
termed the Stimulation Index (S.I.). Radioactive labelling is used to measure cell
proliferation.
For this purpose a local lymph node assay was performed using test item concentrations of
25, 50% (w/w), and 100% (undiluted test item).
The animals did not show any signs of systemic toxicity or local skin irritation during the
course of the study and no cases of mortality were observed. A statistically significant or
biologically relevant increase in ear weights was not observed in any treated group in
comparison to the vehicle control group. Furthermore, the cutoff-value for a positive
response regarding the ear weight index of 1.1 reported for BALB/c mice (see Ref. 9) was
not exceeded in any dose group.
A test item is regarded as a sensitiser in the LLNA if exposure to one or more test item
concentration results in a 3-fold or greater increase in incorporation of 3HTdR compared
with concurrent controls, as indicated by the Stimulation Index (S.I.). The estimated test
item concentration required to produce a S.I. of 3 is referred to as the EC3 value.
In this study Stimulation Indices (S.I.) of 0.57, 0.74, and 0.89 were determined with the test
item at concentrations of 25, 50% (w/w) and 100% in N,N-dimethylformamide, respectively.
An EC3 value could not be calculated, since none of the tested concentrations induced a
S.I. greater than the threshold value of 3.
A statistically significant relevant increase in DPM value was observed in the low dose
group in comparison to the control group. However, this was not considered as biologically
relevant as the S.I. determined for this concentration did not exceed the threshold value of
3 mentioned by the OECD guideline 429. A statistically significant or biologically relevant
increase in lymph node weight and -cell count was not observed in any of the tested dose
groups. Furthermore, the the cutoff-value for a positive response regarding the lymph node
cell count index of 1.55 reported for BALB/c mice (see Ref. 8) was not exceeded in any
group.
The test item Fixapret PC, vor Magnesiumchlorid-Zugabe was thus not a skin sensitiser
under the test conditions of this study.
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
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