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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 309-831-6 | CAS number: 101227-08-1
- 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
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2005-02-15 - 2005-02-25
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline study, GLP-study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 005
- Report date:
- 2005
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Fatty acids, C16-18, 2-butyloctyl esters
- EC Number:
- 309-831-6
- EC Name:
- Fatty acids, C16-18, 2-butyloctyl esters
- Cas Number:
- 101227-08-1
- Molecular formula:
- C28H56O2 - C30H60O2
- IUPAC Name:
- Fatty acids, C16-18, 2-butyloctyl esters
- Test material form:
- other: liquid
- Details on test material:
- - Name of test material (as cited in study report): ISOFOL ESTER 1202
- Molecular formula (if other than submission substance): not mentioned
- Molecular weight (if other than submission substance): not mentioned
- Smiles notation (if other than submission substance): not mentioned
- InChl (if other than submission substance): not mentioned
- Substance type: Ester
- Physical state: liquid
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- other: Little Russian
- Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source:Charles River GmbH, 97633 Sulzfeld
- Age at study initiation: approx. 13 to 17 months
- Weight at study initiation: 2.4 - 2.6 kg b.w.
- Housing: The study took place in animal room No. 6 and 8 provided with filtered air. During a pre-period of at least one week and throughout the experiment the rabbits were caged individually in PPO cages (floor area: 2576 sq. cm) with perforated floor.
- Diet (e.g. ad libitum): A pelleted complete rabbit diet "Altromin 2123" from Altromin, 0-32791 Lage, Lippe, was available ad libitum. Analyses for major nutritive components and relevant possible contaminants are performed regularly on the diet.
- Water (e.g. ad libitum): The animals had free access to bottles with domestic quality drinking water acidified with hydrochloric acid to pH 2.5 in order to prevent microbial growth. Analyses for relevant possible contaminants are performed regularly.
- Acclimation period:
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17 - 23°C
- Humidity (%): 40 - 70%
- Air changes (per hr): 10 times/hour
- Photoperiod (hrs dark / hrs light): 12 / 12
IN-LIFE DATES: From: To: not mentioned
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: untreated area on the test animals
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL, test substance was applied to the 16-layer gauze patch (2.5 x 2.5 cm) and the test patch was secured to the animals skin with adhesive Gothaplast tape (2.5 cm) (semiocclusive) - Duration of treatment / exposure:
- 4 h
- Observation period:
- 72 h
- Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: rabbit back (2.5 cm x 2.5 cm)
- % coverage: no data
- Type of wrap if used: test patch: Gothaplast tape (2.5 cm and 5 cm wide)
REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes; with mild soap and lukewarm water
- Time after start of exposure: 3 min, 1 h, 4 h (3 different exposure times)
SCORING SYSTEM: according to table in OECD TG 404 (Draize system)
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 0, 1, 24, 48, and 72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: no effects observed
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 0, 1, 24, 48, and 72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: no effects observed
- Irritant / corrosive response data:
- no effects
- Other effects:
- no effects
Any other information on results incl. tables
Skin reactions following a single topical application of 0.5 mL of Isofol ester 1202 to rabbits (grading according to OECD TG 404)
None of the animals showed an edema reaction or erythema.
Animal | Skin reaction | 1 h afterpatch removal | 24 h afterpatch removal | 48 h afterpatch removal | 72 h after patch removal | Mean (24 -72 h) after patch removal |
1 |
Erythema | 0 | 0 | 0 | 0 | - |
Edema | 0 | 0 | 0 | 0 | - | |
2 | Erythema | 0 | 0 | 0 | 0 | - |
Edema | 0 | 0 | 0 | 0 | - | |
3 | Erythema | 0 | 0 | 0 | 0 | - |
Edema | 0 | 0 | 0 | 0 | - |
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Based on the results of the study described in this report and according to the directive of the EEC commission 2001/59/EC from August 6th, 2001 the test substance was not skin irritating and shall not be classified as skin irritating.
- Executive summary:
During an initial test using one female albino rabbit a sequential application (exposure time 3 min., 1 h. and 4 h.) of the test substance was carried out on one site of the right back area each. The skin was examined for signs of irritation straight after as well as 1 h., 24 h., 48 h. and 72 h. after the termination of exposure. Since the animal did not show signs of skin irritation and no full thickness destruction of the skin within the observation period of 72 hours it was decided to carry out a confirmatory test with two additional animals in order to allow a categorization of the test item based on the classification criteria.Two female albino rabbits were exposed to the test item at one skin site on the back during the confirmatory test. After 4-hour exposure time the test item was removed and the skin was examined 1 h., 24 h., 48 h. and 72 h after the termination of exposure. No skin reactions were observed in these animals, too. Under the experimental conditions described in this final report, the mean score for erythema was 0.0 and for oedema 0.0. Based on the results of the study described in this report and according to the directive of the EEC commission 2001/59/EC from August 6th, 2001 the test substance was not skin irritating and shall not be classified as skin irritating.
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.