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EC number: 252-939-2 | CAS number: 36265-41-5
- 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
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- Endpoint:
- skin irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 29.06.2018 - 20.07.2018
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
- Version / remarks:
- 28 July 2015
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.46 (In Vitro Skin Irritation: Reconstructed Human Epidermis Model Test)
- Version / remarks:
- Jul-2012
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Irritation / corrosion parameter:
- % tissue viability
- Value:
- > 50
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of irritation
Reference
In the present study the skin irritant potential of Didodecyl 1,4-dihydro-2,6-dimethylpyridine-3,5-
dicarboxylate was analysed. The EpiDerm™-Standard Model (EPI-200™), a reconstituted threedimensional
human epidermis model, was used as a replacement for the Draize Skin Irritation Test
(OECD TG 404, [7]) to distinguish between UN GHS “Category 2” skin irritating test substances and
not categorized test substances (“No Category”) which may be considered as non-irritant. Hereby,
the test item was applied topically. Cytotoxicity is expressed as the reduction of mitochondrial
dehydrogenase activity measured by formazan production from MTT after a 60 min exposure and
42 h post-incubation period and compared to those of the concurrent negative controls.
The mixture of 25 mg test item per 1 mL MTT medium showed no reduction of MTT compared to the
solvent. The mixture did not turn blue/purple. Therefore, NSMTT equalled 0%.
The mixture of 25 mg of the test item per 300 μl aqua dest. showed no colouring detectable by
unaided eye-assessment. The mixture of 25 mg of the test item per 300 μl isopropanol showed
colouring detectable by unaided eye-assessment. Therefore, the absorption of the chemical in
isopropanol was measured in the range of 570 ± 30 nm. No absorption was measured in the
relevant range (see Figure 1). Therefore, NSC equalled 0%.
The test item showed no irritant effects. The mean relative tissue viability (% negative control) was
> 50% (109.8%) after 60 min treatment and 42 h post-incubation.
8.2. Conclusion
In this study under the given conditions the test item showed no irritant effects. The relative mean
tissue viability after 60 min of exposure and 42 h post-incubation was > 50%. The test item is
therefore classified as “non-irritant” in accordance with UN GHS “No Category”.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Eye irritation
Link to relevant study records
- Endpoint:
- eye irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2018 -2019
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 492 (Reconstructed Human Cornea-like Epithelium (RhCE) Test Method for Identifying Chemicals Not Requiring Classification and Labelling for Eye Irritation or Serious Eye Damage)
- Version / remarks:
- 25 Jun 2018
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: EURL ECVAM DB-ALM Method Summary No. 164: EpiOcular™ Eye Irritation Test
- Version / remarks:
- Summary, 22 July 2015
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: EpiOcular™ Eye Irritation Test (OCL-200-EIT) For the prediction of acute ocular irritation of chemicals For use with MatTek Corporation’s Reconstructed Human EpiOcular™ Model
- Version / remarks:
- 29 June 2015
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Details on test animals or tissues and environmental conditions:
- The EpiOcular™ tissues are provided as kits (e.g. OCL-200-EIT; MatTek), consisting of the following components relevant for this study:
1x sealed 24-well plate containing 24 inserts with EpiOcular™ tissues on agarose
1x bottle EpiOcularTM assay medium
1x bottle Ca2+/Mg2+-free DPBS buffer - Vehicle:
- water
- Controls:
- yes
- Irritation parameter:
- in vitro irritation score
- Value:
- 108
- Negative controls validity:
- valid
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- In this study under the given conditions the test item showed no irritant effects. The relative mean viability of the test item treated tissues was 108 %. The test item is therefore classified as “non-irritant” in accordance with UN GHS “No Category”.
- Executive summary:
In the present study the eye irritating potential of Didodecyl 1,4-dihydro-2,6-dimethylpyridine-3,5-dicarboxylate was analysed. Since irritant substances are cytotoxic to the corneal epithelium after a short time exposure the cytotoxic effects of the test item on EpiOcular, a reconstituted three-dimensional human corneal epithelium model, were determined. Hereby, the test item was applied topically. Cytotoxicity is expressed as the reduction of mitochondrial dehydrogenase activity measured by formazan production from MTT after a 6 h exposure period and 18 h post-treatment period and compared to those of the concurrent negative controls.
The mixture of 50 mg test item per 1 mL MTT medium showed no reduction of MTT as compared to the solvent. The mixture did not turn blue/purple. Therefore, NSMTT equalled 0%.
The mixture of 50 mg test item per 1 mL Aqua dest. and 2 mL isopropanol showed colouring as compared to the solvent. Since the mean relative tissue viability of the test item treated tissues (TM) was above the 60% threshold value coloured tissue controls were performed for quantitative correction of results.
NSCliving [%] = [ODTVT/ODNC] * 100 = 0.7%
Difference of NSCliving of the two duplicate tissues must be < 20%, otherwise not accepted.
NSC1 [%] = [ODTVT1 / ODNC] * 100 = 0.7%
NSC2 [%] = [ODTVT2 / ODNC] * 100 = 0.7%
NSC1 – NSC2 = ± 0.0%
NSCliving was ≤ 60% (0.7%) relative to the negative control of living epidermis and could therefore be used for determination of the NSC-corrected mean relative tissue viability (NSCCV) according to the following formula:
NSCCV [%] = viabilityTM [%] – NSCliving [%] = 108.7% - 0.7% = 108.0%
The test item showed no irritant effects. The mean relative tissue viability (% negative control) was > 60% (108.0%, NSCliving-corrected).
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Additional information
Justification for classification or non-classification
No classified on experimental data
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