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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 701-338-8 | CAS number: -
- 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
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- September 2015- November 2015
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Justification for type of information:
- Guideline study under GLP
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 016
- Report date:
- 2016
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- 3-[(2E)-octadec-2-en-1-yl]dihydrofuran-2,5-dione
- Cas Number:
- 1628163-42-7
- Molecular formula:
- C22H38O3
- IUPAC Name:
- 3-[(2E)-octadec-2-en-1-yl]dihydrofuran-2,5-dione
- Reference substance name:
- 3-[(2Z)-octadec-2-en-1-yl]dihydrofuran-2,5-dione
- Molecular formula:
- C22H38O3
- IUPAC Name:
- 3-[(2Z)-octadec-2-en-1-yl]dihydrofuran-2,5-dione
- Reference substance name:
- 3-(octadecenyl)dihydrofuran-2,5-dione excluding 3-(2-octadecen-1-yl)dihydrofuran-2,5-dione
- Molecular formula:
- C22H38O3
- IUPAC Name:
- 3-(octadecenyl)dihydrofuran-2,5-dione excluding 3-(2-octadecen-1-yl)dihydrofuran-2,5-dione
- Reference substance name:
- Hexadecenylsuccinic anhydride
- EC Number:
- 250-911-4
- EC Name:
- Hexadecenylsuccinic anhydride
- Molecular formula:
- C20H34O3
- IUPAC Name:
- 3-(hexadecenyl)dihydrofuran-2,5-dione
- Reference substance name:
- 3-icosenylsuccinic anhydride
- EC Number:
- 258-603-1
- EC Name:
- 3-icosenylsuccinic anhydride
- Molecular formula:
- C24H42O3
- IUPAC Name:
- 3-icosenyldihydrofuran-2,5-dione
- Reference substance name:
- Side products from the reaction of octadec-1-ene and maleic anhydride
- Molecular formula:
- Not applicable - UVCB component
- IUPAC Name:
- Side products from the reaction of octadec-1-ene and maleic anhydride
- Reference substance name:
- C16-20 (even numbered) alkenes (branched and linear)
- Molecular formula:
- C16H32, C18H36, C20H40
- IUPAC Name:
- C16-20 (even numbered) alkenes (branched and linear)
- Reference substance name:
- Maleic anhydride
- EC Number:
- 203-571-6
- EC Name:
- Maleic anhydride
- Cas Number:
- 108-31-6
- Molecular formula:
- C4H2O3
- IUPAC Name:
- furan-2,5-dione
- Test material form:
- solid
- Details on test material:
- off-white solid, amber liquid at 80 °C. Expected to be stable for duration of testing; Expiration date: not applicable.
Constituent 1
Constituent 2
Constituent 3
Constituent 4
Constituent 5
Constituent 6
Constituent 7
Constituent 8
- Specific details on test material used for the study:
- As a result of increasingly rigorous criteria being applied to the analysis of commercial material used in physical property/toxicity testing, the identity of the material has been modified to reveal a more accurate and precise depiction of the commercial substance. This enhancement is reflected in changes in chemical identifiers such as EC and/or CAS numbers from those noted in earlier versions of data records or in study reports.
Test animals
- Species:
- rabbit
- Strain:
- other: New Zealand albino
- Details on test animals or test system and environmental conditions:
- Housing: The animals were singly housed in suspended stainless steel caging,which conforms to the size recommendations in the most recent Guide for the Care and Use of Laboratory Animals (Natl. Res. Council, 2011). Enrichment (e.g., toy) was placed in each cage. Litter paper was placed beneath the cage and was changed at least three times per week.
Animal Room Temperature and Relative Humidity Ranges: 19-23ºC and 40-60%, respectively
Animal Room Air Changes/Hour: 12.
Photoperiod: 12-hour light/dark cycle
Acclimation Period: 21 or 28 days
Food: EnvigoTeklad Global High Fiber Rabbit Diet®#2031. A designated amount of the diet (approximately 150 grams/day) and a Premium Timothy Cube (TM) (Ontario Dehy Inc.) were available to each rabbit.
Water: Filtered tap water was supplied adlibitum.
Cage: Each cage was identified with a cage card indicating at least the study number and identification and sex of the animal.
Animal: A number was allocated to each rabbit on receipt and a stainless steel ear tag bearing this number was attached to the animal. This number, together with a sequential animal number assigned to study 41878, constituted unique identification.
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- other: 75 % w/w mixture in mineral oil
- Controls:
- no
- Amount / concentration applied:
- Five-tenths of a gram of the test substance (0.67g of the prepared test mixture) was placed on a 1-inch x 1-inch, 4-ply gauze pad and applied to one 6-cm2 intact dose site on each animal. The pad and entire trunk of each animal were then wrapped with semi-occlusive 3-inch Micropore tape to avoid dislocation of the pad. Elizabethan collars were placed on each rabbit and they were returned to their designated cages.
- Duration of treatment / exposure:
- After 4 hours of exposure to the test substance, the pads and collars were removed and the test sites were gently cleansed with a 3% soap solution followed by tap water and a clean paper towel to remove any residual test substance.
- Observation period:
- Individual dose sites were scored according to the Draize scoring system at approximately 30-60 minutes, 24, 48, and 72 hours and 7, 10 and 14 days after patch removal
- Number of animals:
- 3 female rabbits were used. They were nulliparous and non-pregnant.
- Details on study design:
- On the day before application, a group of animals was prepared by clipping the dorsal area and the trunk. On the day of dosing, but prior to application, the animals were examined for health and the skin checked for any abnormalities. Three healthy, naive animals (not previously tested) without pre-existing skin irritation were selected for test.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- primary dermal irritation index (PDII)
- Basis:
- mean
- Time point:
- 24 h
- Score:
- 3.7
- Max. score:
- 8
- Reversibility:
- fully reversible within: 14 days
- Remarks:
- reversible
- Remarks on result:
- probability of moderate irritation
- Irritation parameter:
- primary dermal irritation index (PDII)
- Basis:
- mean
- Time point:
- 48 h
- Score:
- 3
- Max. score:
- 8
- Reversibility:
- fully reversible within: 14 days
- Remarks:
- reversible
- Remarks on result:
- probability of moderate irritation
- Irritation parameter:
- primary dermal irritation index (PDII)
- Basis:
- mean
- Time point:
- 72 h
- Score:
- 3
- Max. score:
- 8
- Reversibility:
- fully reversible within: 14 days
- Remarks:
- reversible
- Remarks on result:
- probability of moderate irritation
- Irritation parameter:
- primary dermal irritation index (PDII)
- Basis:
- mean
- Time point:
- 7 d
- Score:
- 1
- Max. score:
- 8
- Reversibility:
- fully reversible within: 14 days
- Remarks:
- reversible
- Remarks on result:
- probability of mild irritation
- Irritation parameter:
- primary dermal irritation index (PDII)
- Basis:
- mean
- Time point:
- 10 d
- Score:
- 0.3
- Max. score:
- 8
- Reversibility:
- fully reversible within: 14 days
- Remarks:
- reversible
- Remarks on result:
- probability of weak irritation
- Irritation parameter:
- primary dermal irritation index (PDII)
- Basis:
- mean
- Time point:
- 14 d
- Score:
- 0
- Max. score:
- 8
- Reversibility:
- fully reversible within: 14 days
- Remarks:
- reversible
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- The Primary Dermal Irritation Index (PDII) calculated for this test substance was 3.2.
- Other effects:
- Over the first 48 hours after patch removal, all three treated sites exhibited well-defined to moderate to severe erythema and very slight to slight edema. The overall incidence and severity of irritation decreased gradually with time. Desquamation was noted at all three dose sites on Days 7 and 10. All animals were free of dermal irritation by Day 14 (study termination).
Any other information on results incl. tables
Animal No. |
Sex |
Time After Patch Removal |
||||||
30-60 mins |
24 hrs |
48 hrs |
72 hrs |
Day 7 |
Day 10 |
Day 14 |
||
3501 |
F |
2/1 |
2/2 |
2/0 |
2/0 |
1/0 |
0/0 |
0/0 |
3502 |
F |
2/1 |
2/2 |
3/2 |
3/2 |
2/0 |
1/0 |
0/0 |
3503 |
F |
2/1 |
2/1 |
2/0 |
2/0 |
0/0 |
0/0 |
0/0 |
Total |
6/3 |
6/5 |
7/2 |
7/2 |
3/0 |
1/0 |
0/0 |
|
Mean |
2.0/1.0 |
2.0/1.7 |
2.3/0.7 |
2.3/0.7 |
1.0/0.0 |
0.3/0.0 |
0/0 |
Summed values used for evaluation of irritation:
|
Time After Patch Removal |
||||||
30-60 min |
24 hrs |
48 hrs |
72 hrs |
Day 7 |
Day 10 |
Day 14 |
|
Erythema |
2.0 |
2.0 |
2.3 |
2.3 |
1.0 |
0.3 |
0.0 |
Edema |
1.0 |
1.7 |
0.7 |
0.7 |
0.0 |
0.0 |
0.0 |
Total (PDI2) |
3.0 |
3.7 |
3.0 |
3.0 |
1.0 |
0.3 |
0.0 |
The average value was calculated to be 3.2.
Applicant's summary and conclusion
- Interpretation of results:
- Category 2 (irritant) based on GHS criteria
- Remarks:
- Migrated information: Irritation scores are > 2.3 and < 5 for 2 of 3 animals at 24, 48 and 72 hours after application.
- Conclusions:
- n-ODSA EC 701-338-8 is moderately irritating to skin according to the Draize scale. The substance is classified as a skin irritant, Category 2.
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.