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Diss Factsheets
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EC number: 814-835-0 | CAS number: 1310672-91-3
- 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
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Endpoint summary
Administrative data
Description of key information
In order to assess the potential to induce skin sensitisation of CD08467, available data from CD08679 (source substance) was used in read-across approach. The source substance was tested negative in an in vivo local lymph node assay conducted in accordance with OECD test guideline 429. Based on this result, the target substance CD08467 is not considered to be a skin sensitiser. This result is supported by a mouse ear swelling test conducted with the target substance. In this study, CD08467 does not present any sensitising properties.
Key value for chemical safety assessment
Skin sensitisation
Link to relevant study records
- Endpoint:
- skin sensitisation: in vivo (LLNA)
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Justification for type of information:
- For justification of read-across please refer to the read-across statement in IUCLID section 13.
- Reason / purpose for cross-reference:
- read-across source
- Positive control results:
- The positive-control substance exceeded (5.69) the stimulation index of 3 confirming the reliability of the test system. See Table 3 in box "Any other information on results incl. tables".
- Key result
- Parameter:
- SI
- Remarks:
- mean of 8 animals
- Value:
- 0.51
- Variability:
- SD = 0.34
- Test group / Remarks:
- 2.5% test item
- Key result
- Parameter:
- SI
- Remarks:
- mean of 8 animals
- Value:
- 0.57
- Variability:
- SD = 0.41
- Test group / Remarks:
- 5% test item
- Key result
- Parameter:
- SI
- Remarks:
- mean of 8 animals
- Value:
- 0.52
- Variability:
- SD = 0.47
- Test group / Remarks:
- 10% test item
- Cellular proliferation data / Observations:
- DETAILS ON STIMULATION INDEX CALCULATION
For groups 2 to 6, an individual Stimulation Index (SI) was calculated for each animal, as the ratio between the individual DPM of treated animals versus the mean DPM of the vehicle control group (group 1). Then for each of the groups 2 to 6, a mean SI was calculated.
Stimulation Index (mean) of 0.51, 0.57 and 0.52 was calculated in response to CD08479 2.5%, 5% and 10% formulated in gel, respectively.
Stimulation Index (mean) of 0.25 was calculated for the placebo group (group 2), statistically significant when compared to group 1 (negative control group) following Dunnett’s test.
Stimulation Index (mean) of 5.69 was calculated for the positive control group (HCA 25%), statistically significant when compared to group 1 (negative control group) following Dunnett’s test, which demonstrated the performance and the reliability of the assay (SI ≥ 3).
CLINICAL OBSERVATIONS:
No abnormal clinical signs were observed in any treated-groups during the in-life part of this study.
CUTANEOUS REACTIONS:
No cutaneous reaction (erythema or edema) was observed in groups 1 to 5.
In group 6, treated with positive control HCA at 25%, discrete erythema was observed on Days 1 to 3 in 5/8 females, on Days 2 and 3 in 2/8 females and discrete to slight erythema was observed on Days 1 to 3 in 1/8 female. On Day 6, these reactions were no longer visible.
EAR SWELLING MEASUREMENT:
There was no increase of ear thickness observed between Day 1 (before treatment) and Day 6 (before intravenous injection of 3[H] MT) for any group
BODY WEIGHTS
No effect on the body weight was observed in any treated-group. - Interpretation of results:
- GHS criteria not met
- Conclusions:
- In conclusion, under the conditions of this study, the test item CD08479 formulated in gel is not considered to be a skin sensitiser
- Executive summary:
In a dermal sensitization study conducted according to OECD 429 with the test item CD08479 formulated in gel and dissolved in AOO (4:1 (v/v) acetone/olive oil, young adult female CBA/JRj mice (8 per dose group) were treated CD08479 2.5%, 5% and 10% gel or Hexyl Cinnamic Aldehyde (HCA, 25% in AOO; positive control) at a constant dosing volume of 25μL on the dorsum of each ear, for three consecutive days. Simulation index along with other parameters including morbidity and mortality, clinical signs, cutaneous reactions, ear swelling and body weight were evaluated. During the study, no mortality or abnormal effects were observed on the female mice. However, discrete to slight erythema were observed on Days 1 to 3 for animals of positive control group (HCA). Stimulation Index of 0.51, 0.57 and 0.52 was calculated in response to CD08479 2.5%, 5% and 10% formulated in gel, respectively.
Based on these results, the test item did not show any potential for skin sensitization up to the concentration of 10% and thus is categorized as a non-skin sensitizer under UN GHS Criteria.
This information is used in a read-across approach in the assessment of the target substance.
For justification of read-across please refer to the attached read-across statement (see IUCLID section 13).
Reference
Chemical analyses
Analytical controls of CD08479 2.5%, 5% and 10% formulated in gel indicated that homogeneity and target concentrations were attained, within target ranges (100.00 ±10%; analytical method for active ingredient assay Reference RDS.03.ATP.03616.R01), and that the pharmaceutical dosage forms were stable for at least 3 weeks, covering the study duration.
Table 3: Results on Simulation Index
|
Concentration of test item in applied formulation (%) |
Positive control HCA |
|||
Placebo |
2.5 |
5 |
10 |
25% |
|
Group number |
2 |
3 |
4 |
5 |
6 |
N=number of date available |
7 |
8 |
6 |
7 |
6 |
LLNA Concentration series (%) |
NA |
25 |
50 |
100 |
NA |
SI (Mean) |
0.25 |
0.51* |
0.57 |
0.52 |
5.69* |
Standard deviation |
0.08 |
0.34 |
0.41 |
0.47 |
5.10 |
*: statistically significant when compared to vehicle group (5% significant level).
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
In order to assess the potential to induce skin sensitisation of CD08467, available data from CD08679 (source substance) was used in read-across approach. For read-across justification see IUCLID section 13. The source substance was tested negative in an in vivo local lymph node assay conducted in accordance with OECD test guideline 429. Based on this result, the target substance CD08467 is not considered to be a skin sensitiser. This result is supported by a mouse ear swelling test conducted with the target substance. In this study, CD08467 does not present any sensitising properties.
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
Based on available data, CD08467 does not warrant classification for skin sensitisation.
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
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