Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 203-756-1 | CAS number: 110-31-6
- 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
Skin sensitisation (OECD 429): not sensitising, based on read-across from Amides, C16-C18 (even), N,N’-ethylenebis
Key value for chemical safety assessment
Skin sensitisation
Link to relevant study records
- Endpoint:
- skin sensitisation: in vivo (LLNA)
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- 14 – 29 April 2010
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- GLP - Guideline study, tested with the source substance N,N’-Ethylenebis(stearamide). According to the ECHA guidance document “Practical guide 6: How to report read-across and categories (March 2010)”, the reliability was changed from RL1 to RL2 to reflect the fact that this study was conducted on a read-across substance.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- Deviations:
- no
- GLP compliance:
- yes
- Type of study:
- mouse local lymph node assay (LLNA)
- Species:
- mouse
- Strain:
- CBA
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Janvier, Le Genest-Saint-Isle, France
- Age at study initiation: young adult, approx. 9 weeks old
- Weight at study initiation: 21-25 g
- Housing: individual housing in labelled Macrolon cages (MI type; height 12.5 cm) containing sterilised sawdust as bedding material (Litalabo, S.P.P.S., Argenteuil, France). Paper (Enviro-dri, Wm. Lillico & Son (Wonham Mill Ltd), Surrey, United Kingdom) was supplied as cage-enrichment. The paper was removed on Day 1 prior to dosing and was supplied again after scoring of the ears on Day 3.
- Diet: pelleted rodent diet (SM R/M-Z from SSNIFF® Spezialdiäten GmbH, Soest, Germany), ad libitum
- Water: tap water, ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 ± 3 (actual range: 18.9-23.2)
- Humidity (%): 40-70 (actual range: 37-84)
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: 14 April 2010 To: 29 April 2010 - Vehicle:
- acetone/olive oil (4:1 v/v)
- Concentration:
- 10, 25 or 50% w/w
- No. of animals per dose:
- 5
- Details on study design:
- RANGE FINDING TESTS:
Concentrations of 25% and 50% were tested in order to determine the highest test substance concentration to be used in the study, which should be well tolerated systemically and may give moderate irritation.
- Irritation: slight irritation (erythema and edema score of 1 of max. 4) was noted with 50% test substance
MAIN STUDY
ANIMAL ASSIGNMENT AND TREATMENT
- Name of test method: Local Lymph Node Assay (LLNA)
- Criteria used to consider a positive response: if the results indicate a SI ≥ 3, the test substance may be regarded as a skin sensitiser, based on the test guideline and recommendations done by ICCVAM. The results were evaluated according to the Globally Harmonized System of Classification and Labeling of Chemicals (GHS) of the United Nations (2007) and the Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labeling and packaging of substances and mixtures. Consideration was given to the EC3 value (the estimated test substance concentration that will give a SI = 3).
TREATMENT PREPARATION AND ADMINISTRATION: in the main study, three experimental groups of five female CBA/J mice were treated with test substance concentrations of 10, 25 or 50% w/w on three consecutive days, by open application on the ears. Five vehicle control animals were similarly treated, but with vehicle alone (Acetone/Olive oil (4:1 v/v)). Three days after the last exposure, all animals were injected with 3H-methyl thymidine and after five hours the draining (auricular) lymph nodes were excised and pooled for each animal. After precipitating the DNA of the lymph node cells, radioactivity measurements were performed. - Positive control substance(s):
- hexyl cinnamic aldehyde (CAS No 101-86-0)
- Statistics:
- Mean DPM values and standard errors per group were calculated.
- Positive control results:
- The SI values calculated for the positive control substance at concentrations of 5, 10 and 25% were 1.7, 2.7 and 8.8, respectively. Based on the results, it was concluded that the Local Lymph Node Assay in the mouse as supplied by Janvier performed at NOTOX is an appropriate model for testing for contact hypersensitivity.
- Key result
- Parameter:
- SI
- Value:
- 1
- Test group / Remarks:
- vehicle control
- Key result
- Parameter:
- SI
- Value:
- 1.2
- Test group / Remarks:
- 10%
- Key result
- Parameter:
- SI
- Value:
- 1.3
- Test group / Remarks:
- 25%
- Key result
- Parameter:
- SI
- Value:
- 0.9
- Test group / Remarks:
- 50%
- Parameter:
- other: disintegrations per minute (DPM)
- Remarks on result:
- other: Mean DPM/animal values for the experimental groups treated with the test substance at concentrations of 10, 25 and 50% were 210, 235 and 163 DPM, respectively. The mean DPM/animal value for the vehicle control group was 176 DPM.
- Interpretation of results:
- other: CLP criteria not met, no classification required according to Regulation (EC) No 1272/2008
- Conclusions:
- CLP: not classified
Reference
Table 1: Individual and mean DPM and SI values (n = 5 animals per group)
Group |
concentration [% w/w] |
animal |
DPM |
SI |
1 |
0 |
1 |
256 |
1.45620023 |
2 |
300 |
1.70648464 |
||
3 |
137 |
0.77929465 |
||
4 |
65 |
0.36973834 |
||
5 |
121 |
0.68828214 |
||
mean |
175.8 |
1 |
||
SEM |
44 |
0.4 |
||
2 |
10 |
1 |
245 |
1.39362912 |
2 |
262 |
1.49032992 |
||
3 |
215 |
1.22298066 |
||
4 |
54 |
0.30716724 |
||
5 |
273 |
1.55290102 |
||
mean |
209.8 |
1.19340159 |
||
SEM |
40 |
0.4 |
||
3 |
25 |
1 |
211 |
1.20022753 |
2 |
132 |
0.75085324 |
||
3 |
137 |
0.77929465 |
||
4 |
413 |
2.34926052 |
||
5 |
280 |
1.592719 |
||
mean |
234.6 |
1.33447099 |
||
SEM |
52 |
0.4 |
||
4 |
50 |
1 |
147 |
0.83617747 |
2 |
219 |
1.24573379 |
||
3 |
118 |
0.67121729 |
||
4 |
178 |
1.01251422 |
||
5 |
153 |
0.87030717 |
||
mean |
163 |
0.92718999 |
||
SEM |
17 |
0.3 |
DPM: Disintegrations Per Minute
SI: Stimulation Index
SEM: Standard Error of Mean
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
There is no data available on the skin sensitisation potential of Amides, C16 and C18-C20 (even numbered, unsaturated), N,N’-ethylenebis. In order to fulfil the standard information requirements set out in Annex VII, 8.3, in accordance with Annex XI, 1.5, of Regulation (EC) No 1907/2006, read-across from a structurally related substance is conducted.
A detailed justification for the grouping of chemicals and read-across is provided in the Sections 7.1 and 13.
There exists one reliable study on the skin sensitisation potential of the structurally related substance Amides, C16-C18 (even), N,N'-ethylenebis. Therefore, read-across based on the analogue approach is performed to cover this endpoint.
A Local Lymph Node Assay was performed in mice with the test substance at concentrations of 10, 25 and 50% in acetone/olive oil (4:1 v/v) according to OECD guideline 429 and in compliance with GLP (Stitzinger, 2010). The animals (5 per group) were epidermally treated (25 µL/ear) with the respective concentrations of the test substance or vehicle alone for 3 consecutive days, and skin irritation was assessed on Day 3. The slight erythema observed on the ears of animals treated with 50% of test substance was considered not to have a toxicologically significant effect on the activity of the lymph nodes. On Day 6, auricular lymph nodes were excised, and their relative size and the incorporated radioactivity of the injected ³H-methyl thymidine were assessed.The mean disintegration per minute (DPM) values for the single cell suspensions of each animal were 210, 235 and 163 at concentrations of 10, 25 and 50% (w/v) of the test substance in acetone/olive oil (4:1 v/v), respectively. No significant changes compared to the control value (group DPM = 176) were observed after treatment with the test substance. The stimulation indices were 1.2, 1.3 and 0.9 for concentrations of 10, 25 and 50%, respectively. Since there were no SI values greater than 3 when tested up to 50%, the test substance was considered not to be a skin sensitiser. The established EC3 value exceeds a concentration of 50%.
Based on the results of the available study on the skin sensitisation potential of the structural analogue Amides, C16-C18 (even), N,N'-ethylenebis, it may be concluded that Amides, C16 and C18-C20 (even numbered, unsaturated), N,N’-ethylenebis is not skin-sensitising, either.
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
- Additional information:
Study not required according to Annex VII-X of Regulation (EC) No 1907/2006.
Justification for classification or non-classification
The available data on skin sensitisation of a substance structurally related to Amides, C16 and C18-C20 (even numbered, unsaturated), N,N’-ethylenebis according to Regulation (EC) No 1907/2006, Annex XI, 1.5 do not meet the criteria for classification according to Regulation (EC) No 1272/2008; therefore, Amides, C16 and C18-C20 (even numbered, unsaturated), N,N’-ethylenebis is not expected to exert a skin sensitisation potential, either, and the data are thus conclusive but not sufficient for 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.