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EC number: 305-729-0 | CAS number: 95009-01-1
- 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
![](https://chesar.echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
Endpoint summary
Administrative data
Description of key information
The sensitization rate of Everlan SL65 was 0% and Everlan SL65 did not caused any skin sensitization in guinea pigs (OECD TG406).
Key value for chemical safety assessment
Skin sensitisation
Link to relevant study records
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- Jan 20, 2016 - Dec 07, 2016
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Version / remarks:
- OECD 406:1992
- Deviations:
- no
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- The guinea pig maximization test (GPMT) is already available for the registration outside of EU. Therefore, LLNA is not conducted.
- Species:
- guinea pig
- Strain:
- Hartley
- Sex:
- male
- Details on test animals and environmental conditions:
- - Source: WEI XIN HANG
- Weight at study initiation: 332.5-449.5g
- Housing: Every five animals were housed in a stainless steel wire mesh cage
- Acclimation period: 7 days
- Temperature (°C): 21 ± 2 °C
- Humidity (%): 55 ± 15%
- Photoperiod: 12-hrs dark / 12-hrs light - Route:
- intradermal and epicutaneous
- Vehicle:
- physiological saline
- Concentration / amount:
- 0.1mlLand 0.5mL 4% of Everlan SL65 for intradermal and epicutaneous, respectively
- Day(s)/duration:
- Day1 and Day7 for intradermal and epicutaneous, respectively
- Adequacy of induction:
- non-irritant substance, but skin pre-treated with 10% SDS
- Route:
- epicutaneous, occlusive
- Vehicle:
- physiological saline
- Concentration / amount:
- 0.5 mL 4% of Everlan SL65
- Day(s)/duration:
- Day23
- Adequacy of challenge:
- highest non-irritant concentration
- No. of animals per dose:
- For control group: five
For test group: ten - Positive control substance(s):
- yes
- Remarks:
- α-Hexylcinnamaldehyde (HCA)
- Positive control results:
- The latest results showed that positive control animals had shown skin reactions of 1-2 and the sensitization rate of α-Hexylcinnamaldehyde (HCA) was 100%.
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 4%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 0%
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- positive control
- Dose level:
- 4%
- No. with + reactions:
- 5
- Total no. in group:
- 5
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- According to OECD 406 test method and “Scoring system of Kligman”, the sensitization rate of Everlan SL65 was 0% and Everlan SL65 caused no notable sensitisation potential in guinea pigs. Therefore, Everlan SL65 did not meet a category for classification based on GHS criteria.
- Executive summary:
This test using the procedures outlined in the SuperLab Study Plan for M62-151100103002EN which is based on the SOP for the OECD 406 (SOPP-339) and OECD 406 (OECD, 1992). The results of this OECD 406 test for Everlan SL65 show that test reliability criteria was met.
A 4% Everlan SL65 was used for intradermal injection and occlusively patched to ten test guinea pigs to induce sensitization.The normal saline was used for similar injection and occlusively patched to five control guinea pigs. Following a recovery period, animals received a challenge patch with 4% Everlan SL65. The skin sensitization reactions were scored at approximately 24 and 48 hours after patch removal. At the end of study, body weight increase was observed in all animals. During 48 hours after challenge exposure, 0% treated animals showed sensitization to the Everlan SL65. Under the conditions of this study, Everlan SL65 did not caused any sensitization in guinea pigs.
Reference
Table 1. The body weight of the guinea pigs
Group |
Sex |
Animal ID. |
Animal Weight (g) |
Weight Change (g) |
|
Day 1 |
Day 26 |
||||
Control group |
Male |
11 |
417.9 |
506.4 |
+ 88.5 |
12 |
449.5 |
538.8 |
+ 89.3 |
||
13 |
389.3 |
492.8 |
+ 103.5 |
||
14 |
332.5 |
433.2 |
+ 100.7 |
||
15 |
448.6 |
545.2 |
+ 96.6 |
||
Test group |
Male |
16 |
406.8 |
504.0 |
+ 97.2 |
17 |
428.6 |
517.8 |
+ 89.2 |
||
18 |
426.8 |
515.6 |
+ 88.8 |
||
19 |
346.9 |
444.2 |
+ 97.3 |
||
20 |
389.6 |
475.2 |
+ 85.6 |
||
21 |
395.6 |
488.6 |
+ 93.0 |
||
22 |
368.5 |
458.6 |
+ 90.1 |
||
23 |
428.6 |
512.0 |
+ 83.4 |
||
24 |
435.4 |
520.0 |
+ 84.6 |
||
25 |
348.9 |
436.4 |
+ 87.5 |
Table 2. Individual skin reaction of guinea pigs
Group |
Sex |
Animal ID. |
Grade of skin reaction1 |
Percent of Animals Sensitized |
Sensitizing Capacity2 |
|
24 ± 1 hrs |
48 ± 1 hrs |
|||||
Control group |
Male |
11 |
0 |
0 |
0% |
Weak |
12 |
0 |
0 |
||||
13 |
0 |
0 |
||||
14 |
0 |
0 |
||||
15 |
0 |
0 |
||||
Test group |
Male |
16 |
0 |
0 |
0% |
Weak |
17 |
0 |
0 |
||||
18 |
0 |
0 |
||||
19 |
0 |
0 |
||||
20 |
0 |
0 |
||||
21 |
0 |
0 |
||||
22 |
0 |
0 |
||||
23 |
0 |
0 |
||||
24 |
0 |
0 |
||||
25 |
0 |
0 |
1 The skin reaction was grading according to “Magnusson and Kligman scale”.
2 The sensitizing capacity of the test article was classified according to the “Scoring system of Kligman”.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
A 4% Everlan SL65 was used for intradermal injection and occlusively patched, to ten test guinea pigs to induce sensitization. The normal saline was used for similar injection and occlusively patched to five control guinea pigs. Following a recovery period, animals received a challenge patch with 4% Everlan SL65. The skin sensitization reactions were scored at approximately 24 and 48 hours after patch removal. At the end of study, body weight increase was observed in all animals. During 48 hours after challenge exposure, 0% treated animals showed sensitization to the Everlan SL65. Under the conditions of this study, Everlan SL65 did not caused any sensitization in guinea pigs.
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
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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