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EC number: 928-726-1 | CAS number: 1179913-28-0
- 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
- Study period:
- From March 24, 2016 to April 15, 2016
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 016
- Report date:
- 2016
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- mouse local lymph node assay (LLNA)
Test material
- Reference substance name:
- Reaction product of oxiran-2-ylmethyl 2,2,3,5-tetramethylhexanoate with linseed oil fatty acids (including majorly linolenic acid, linoleic acid and oleic acid) (1:1)
- Molecular formula:
- Not applicable (UVCB constituent)
- IUPAC Name:
- Reaction product of oxiran-2-ylmethyl 2,2,3,5-tetramethylhexanoate with linseed oil fatty acids (including majorly linolenic acid, linoleic acid and oleic acid) (1:1)
- Reference substance name:
- Reaction product of 4,4'-Methylendiphenyldiglycidylether (BADGE) with linseed oil fatty acids (including majorly linolenic acid, linoleic acid and oleic acid) (1:2)
- Molecular formula:
- Not applicable (UVCB constituent)
- IUPAC Name:
- Reaction product of 4,4'-Methylendiphenyldiglycidylether (BADGE) with linseed oil fatty acids (including majorly linolenic acid, linoleic acid and oleic acid) (1:2)
- Reference substance name:
- Reaction product of 4,4'-Methylendiphenyldiglycidylether (BADGE) with linseed oil fatty acids (including majorly linolenic acid, linoleic acid and oleic acid) (1:1)
- Molecular formula:
- Not applicable (UVCB substance)
- IUPAC Name:
- Reaction product of 4,4'-Methylendiphenyldiglycidylether (BADGE) with linseed oil fatty acids (including majorly linolenic acid, linoleic acid and oleic acid) (1:1)
- Reference substance name:
- Reaction product of 4,4'-Methylendiphenyldiglycidylether (BADGE) with linseed oil fatty acids (including majorly linolenic acid, linoleic acid and oleic acid) (1:3)
- Molecular formula:
- Not applicable (UVCB substance)
- IUPAC Name:
- Reaction product of 4,4'-Methylendiphenyldiglycidylether (BADGE) with linseed oil fatty acids (including majorly linolenic acid, linoleic acid and oleic acid) (1:3)
- Reference substance name:
- High Mw components based on linseed oil fatty acids
- Molecular formula:
- Not applicable (UVCB substance)
- IUPAC Name:
- High Mw components based on linseed oil fatty acids
- Reference substance name:
- Sum of unassigned components
- Molecular formula:
- Not applicable (UVCB substance)
- IUPAC Name:
- Sum of unassigned components
- Test material form:
- liquid
- Details on test material:
- UVCB
Constituent 1
Constituent 2
Constituent 3
Constituent 4
Constituent 5
Constituent 6
- Specific details on test material used for the study:
- Batch no.: #210162718
Composition: reaction products of linseed-oil fatty acids, 4,4'Methylendiphenyldiglycidylether with neodecanoic fatty acid, oxiranylmethylester
Purity: 100 % as per definition of UVCB
Appearance: brown liquid
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- CBA/Ca
- Sex:
- female
- Details on test animals and environmental conditions:
- Source: AnLab Prague, Czech Republic
Age: at least 8 - 10 weeks old (non-pregnant and nulliparous)
Acclimation: 7 days
Room temperature: 22 ± 2°C, relative humidity: 55 ± 10 %
The light regimen was set to a 12-hour light / 12-hour dark cycle
Feed and water: Altromin and tap water, ad libitum
Study design: in vivo (LLNA)
- Vehicle:
- acetone/olive oil (4:1 v/v)
- Concentration:
- 100, 50 and 25% (25 µL to the dorsum of each ear)
The pre-screen test was performed using dose of 100 % (v/v). Based on the observations recorded in the preliminary test, the concentration of 100 % was selected as top dose for the main test. - No. of animals per dose:
- 5
- Details on study design:
- Main study
Day 1: each animal was identified and the body weight was recorded. To the dorsum of each ear 25µL of the appropriate dilution of the test substance, or the vehicle alone was applied.
Days 2 and 3: the application procedure carried out on day 1 was repeated.
Days 4 and 5: no treatment.
Day 6: The body weight of each animal was recorded. 250µL of phosphate-buffered saline (PBS) containing 2 µCi (7.4 x 104 Bq) of 125I-iododeoxyuridine and 10E-05M fluorodeoxyuridine was injected into all test and control mice via the tail vein. Five hours later, the animals were killed. The draining auricular lymph nodes from each ear were excised and pooled in PBS for each experimental group (pooled treatment group approach).
Cell suspension of lymph node cells from pooled treatment groups was prepared and the cellular proliferation was determined (incorporated radioactivity).
Erythema scores and ear thickness were recorded as well. - Positive control substance(s):
- hexyl cinnamic aldehyde (CAS No 101-86-0)
Results and discussion
In vivo (LLNA)
Resultsopen allclose all
- Key result
- Parameter:
- SI
- Value:
- ca. 2.24
- Test group / Remarks:
- at 25% concentration
- Remarks on result:
- other: SI <3
- Key result
- Parameter:
- SI
- Value:
- ca. 3.93
- Test group / Remarks:
- at 50% test concentration
- Remarks on result:
- other: SI >3
- Key result
- Parameter:
- SI
- Value:
- ca. 4.38
- Test group / Remarks:
- at 100% concentration
- Remarks on result:
- other: SI >3
- Key result
- Parameter:
- EC3
- Value:
- ca. 36.25
- Remarks on result:
- other: moderate skin sensitiser
- Cellular proliferation data / Observations:
- Lymph Node Proliferation:
In comparison with the control group, an increase of the pooled lymph node weights was recorded in all tested concentrations. This increase was dose dependent. The pooled lymph node weights of treated groups were 0.0371g for 25% concentration, 0.0400g for 50% concentration and 0.0574g for 100% concentration of tested substance. The lymph node weight of control group and positive control group were 0.0284g and 0.0663g, respectively. The DPM values for the three treated groups were 2228 (25%), 3899 (50%) and 4345 (100%), respectively. The SI values for the three treated groups were 2.24 (25%), 3.93 (50%) and 4.38 (100%), respectively. The calculated EC3 value was 36.25%. After application of the test substance at three concentrations (25%, 50% and 100%) animals did not show visible clinical symptoms or local irritation or systemic toxicity.
From the results of this study, the test substance was considered as a potential skin sensitizer in the murine local lymph node assay and should be classified as Skin Sensitizer Category 1B according to EC 1272/2008 on classification, labeling and packaging.
Any other information on results incl. tables
No marked changes of mean body weight were observed during the study.
Applicant's summary and conclusion
- Interpretation of results:
- other: category 1B - as per CLP criteria
- Conclusions:
- Under the study conditions, the test substance was considered as a skin sensitizer in the murine local lymph node assay.
- Executive summary:
A study was conducted to determine the skin sensitisation potential of the test substance according to OECD Guideline 429 (LLNA), in compliance with GLP.Three groups of 5 female CBA/J mice were treated at concentrations of 25, 50 and 100% w/w on three consecutive days by open application on the ears. Five control animals each were similarly treated, but with vehicle alone (acetone/olive oil, 4:1, v/v; negative control) and α-hexylcinnamaldehyde (positive control).Lymphocyte proliferation was measured using incorporation of radioactive 125I-iododeoxyuridine and 10E-05M fluorodeoxyuridine in the draining lymph nodes. The radioactive incorporation was expressed as disintegrations per minute (DPM)/pooled treatment group and compared with DPM values from the vehicle control group and expressed as the Stimulation Index (SI). Animals were also carefully observed once daily for any clinical symptoms, either of local irritation at the application site or of systemic toxicity. The body weight was recorded as well. In comparison with the control group, a dose dependent increase of the pooled lymph node weights was recorded in all tested concentrations. The pooled lymph node weights of treated groups were determined to be 0.0371g for 25% concentration, 0.0400g for 50% concentration and 0.0574g for 100% concentration of tested substance. The lymph node weight of control group and positive control group was 0.0284g and 0.0663g, respectively. The DPM values for the three treated groups were 2228 (25%), 3899 (50%) and 4345 (100%), respectively. The SI values for the three treated groups were 2.24 (25%), 3.93 (50%) and 4.38 (100%), respectively. The calculated EC3 value was 36.25%. The values for the negative and positive controls were in the expected ranges and the experiment was considered valid. The treated animals however did not show visible clinical symptoms or local irritation or systemic toxicity. The body weights and body weight gain of experimental animals remained in the same range as controls over the study period. Under the study conditions, the test substance was considered to be sensitizing to skin (Kochan, 2016).
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