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EC number: 807-111-0 | CAS number: 1211441-98-3
- 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
Endpoint summary
Administrative data
Description of key information
LEE011-A4 did not cause any relevant changes in ear weight or LN weight up to a concentration of 25% in DAE433. LEE011-A4 did not exceed LN count threshold but showed statistical significance when compared to vehicle and showed a dose response. The substance is non-sensitizing.
Key value for chemical safety assessment
Skin sensitisation
Link to relevant study records
- Endpoint:
- skin sensitisation: in vivo (LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- Feb 2014 - July 2014
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.42 (Skin Sensitisation: Local Lymph Node Assay)
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2600 (Skin Sensitisation)
- GLP compliance:
- yes
- Type of study:
- mouse local lymph node assay (LLNA)
- Species:
- mouse
- Strain:
- Balb/c
- Sex:
- female
- Details on test animals and environmental conditions:
- Mouse, Balb/c strain, inbred, SPF-Quality. 30 females (nulliparous and non-pregnant), six females per group.
- Vehicle:
- other: DAE433
- Concentration:
- Correction of the purity/composition of the test substance is not applicable, since the test method requires a logical concentration range rather than specific dose levels to be dosed.
The accuracy of preparation was considered acceptable if the mean measured concentrations were 85-115% of the target concentration for suspensions. Homogeneity was demonstrated if the coefficient of variation was ≤ 10%. - No. of animals per dose:
- Pre-screen test
Four young adult animals were selected and two test item concentrations were tested, each on two animals. Concentrations of 10% and 25% were tested. Trial formulations showed that 25% was the highest concentration that could be prepared homogeneously to a visible acceptable level.
Main study
Three groups of six animals were treated with one test item concentration per group. The highest test item concentration was selected from the pre-screen test. One group of six animals was treated with vehicle and one group with the positive control item. - Details on study design:
- A pre-screen test was conducted in order to select the highest test item concentration to be used in the main study.
Three groups of six animals were treated with one test item concentration per group. The highest test item concentration was selected from the pre-screen test. One group of six animals was treated with vehicle and one group with the positive control item. - Positive control substance(s):
- other: 0.5% 1-Chloro-2,4-Dinitrobenzene (DNCB)
- Statistics:
- Calculations were performed in MS EXCEL and statistical analysis was performed with GraphPad Prism 4 (Kruskal-Wallis test, followed by the Mann Whitney test).
- Positive control results:
- The positive control item DNCB elicited a reaction pattern with increased LN hyperplasia, which was in congruence with the expected mode of action of a contact allergen.
- Key result
- Parameter:
- other: Ear weight index
- Value:
- ca. 1.03
- Test group / Remarks:
- 0.25% LEE011-A4
- Key result
- Parameter:
- other: Ear weight index
- Value:
- ca. 1.03
- Test group / Remarks:
- 2.5% LEE011-A4
- Key result
- Parameter:
- other: Ear weight index
- Value:
- ca. 1.04
- Test group / Remarks:
- 25% LEE011-A4
- Key result
- Parameter:
- other: local lymph node weight index
- Value:
- ca. 0.88
- Test group / Remarks:
- 0.25% LEE011-A4
- Key result
- Parameter:
- other: local lymph node weight index
- Value:
- ca. 1
- Test group / Remarks:
- 2.5% LEE011-A4
- Key result
- Parameter:
- other: local lymph node weight index
- Value:
- ca. 0.91
- Test group / Remarks:
- 25% LEE011-A4
- Key result
- Parameter:
- other: Cell count index
- Value:
- ca. 1.03
- Test group / Remarks:
- 0.25% LEE011-A4
- Key result
- Parameter:
- other: Cell count index
- Value:
- ca. 1.17
- Test group / Remarks:
- 2.5% LEE011-A4
- Key result
- Parameter:
- other: Cell count index
- Value:
- ca. 1.29
- Test group / Remarks:
- 25% LEE011-A4
- Key result
- Parameter:
- SI
- Test group / Remarks:
- 0.25% LEE011-A4
- Remarks on result:
- not measured/tested
- Key result
- Parameter:
- SI
- Test group / Remarks:
- 2.5% LEE011-A4
- Remarks on result:
- not measured/tested
- Key result
- Parameter:
- SI
- Test group / Remarks:
- 25% LEE011-A4
- Remarks on result:
- not measured/tested
- Interpretation of results:
- other: no sensitizing or irritating potential was ascribed to LEE011-A4
- Conclusions:
- In conclusion, no sensitizing or irritating potential was ascribed to LEE011-A4 in the murine LLNA TIER I.
Based on these results LEE011-A4 would not be regarded as a skin sensitizer according to the recommendations made in the test guidelines. It does not have to be classified and has no obligatory labelling requirement for sensitization by skin contact according to the Globally Harmonized System of Classification and Labelling of Chemicals (GHS) of the United Nations (2007) (including all amendments).
Reference
No irritation of the ears was noted after visual examination in the majority of animals. Yellow staining of test substance remnants on the dorsal surface of the ears of the animals treated at 25% did not hamper scoring for erythema.Visual examination of the nodes revealed that all nodes of the experimental animals were considered normal in size when compared to the vehicle control group. No macroscopic abnormalities of the surrounding areas were noted in any of the animals.
Body weights and body weight gain of experimental animals remained in the same range as controls over the study period. There were no clinical observations attributable to treatment with LEE011-A4.
The positive control item DNCB elicited a reaction pattern with increased LN hyperplasia, which was in congruence with the expected mode of action of a contact allergen.
LEE011-A4 did not cause any relevant changes in ear weight or LN weight up to a concentration of 25% in DAE433. LEE011-A4 did not exceed LN count threshold but showed statistical significance when compared to vehicle and showed a dose response.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
- Additional information:
In the 4-week toxicity study (dogs): Inflammatory changes in the lungs of dogs were considered secondary to aspiration of test-article and are indicative of the irritant potential of the formulated test-article in the respiratory tract.)
Justification for classification or non-classification
LEE011-A4 did not cause any relevant changes in ear weight or LN weight up to a concentration of 25% in DAE433. LEE011-A4 did not exceed LN count threshold but showed statistical significance when compared to vehicle and showed a dose response. The substance is non-sensitizing.
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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