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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 248-469-2 | CAS number: 27458-92-0
- 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
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 003
- Report date:
- 2003
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- adopted April 24, 2002
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Version / remarks:
- adopted Dec. 29, 1992
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2500 (Acute Dermal Irritation)
- Version / remarks:
- August 1998
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: Japan IVIAFF Testing Guideline of 12 Nosan No. 8147
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Reference substance 001
- EC Number:
- 607-896-8
- Details on test material:
- - Name of test material (as cited in study report): Tridecanol H
- Physical state: Liquid / colorless - clear
- pH-value: about 5 - 6
- Analytical purity: >99 w%
- Lot/batch No.: EVD 55712
- Test substance No.: 03/0197-1
- Stability: The stability under storage conditions was confirmed by reanalysis.
- Storage condition of test material: Room temperature, exclusion of oxygen (storage under nitrogen)
- Homogeneity: The test substance was homogeneous by visual inspection.
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Centre Lago S.A., 01540 Vonnas, France
- Age at study initiation: About 7 - 8 months
- Weight at study initiation: 3.89 - 4.18 kg
- Housing: Single housing
- Diet: Kliba-Labordiaet, Provimi Kliba SA, Kaiseraugst, Switzerland (about 130 g/animal per day )
- Water: Tap water ad libitum
- Acclimation period: At least 5 days before the beginning of the study.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 24
- Humidity (%): 30 - 70
- Air changes (per hr):
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- undiluted
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 ml
- Concentration (if solution):
VEHICLE
- Amount(s) applied (volume or weight with unit):
- Concentration (if solution):
- Lot/batch no. (if required):
- Purity: - Duration of treatment / exposure:
- 4 hour(s)
- Observation period:
- 14 days
- Number of animals:
- 3 (2 female and 1 male animal)
- Details on study design:
- TEST SITE
- Area of exposure:flank (the test patch (2.5 cm x 2.5 cm) was moistened with a dose of 0.5 ml of the undiluted liquid test substance)
- % coverage:
- Type of wrap if used: The test substance was covered with a test patch (Idealbinde, Pfaelzische Verbandstoff-Fabrik, Kaiserslautern) and Fixomull stretch (adhesive fleece), Beiersdorf AG
REMOVAL OF TEST SUBSTANCE
- Washing (if done): The test substance was removed at the end of the exposure period with Lutrol E 400 (Polyethylenglycol) and Lutrol/water (1 : 1)
- Time after start of exposure: 4 h
SCORING SYSTEM: according to Draize / OECD 404
EVALUATION OF RESULTS:
For evaluation, the calculation of the mean values of erythema and edema for readings 24, 48 and 72 hours were quoted. Additionally, the reversibility of the observed findings was taken into account. The evaluation is based on the criteria of Annex VI of the Commission Directive 67/548/EEC that were in place on the date of report signature.
ILLUMINATION USED FOR READING: Daylight tubes "Lumilux" (L 58W/860 PLUS ECO 25X1, Osram, Germany)
CHECK FOR DEAD OR MORIBUND ANIMALS: Twice each workday (beginning and end) and once on Saturdays, Sundays and on public holidays.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- (animal 1-3)
- Time point:
- other: 24 - 48 - 72 h
- Score:
- 3
- Max. score:
- 4
- Reversibility:
- not fully reversible within:
- Remarks:
- (within the observation period of 14 days)
- Remarks on result:
- other: Scaling at the end of the observation period in 3 animals (see table below for details).
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- (animal 1-3)
- Time point:
- other: 24 - 48 - 72 h
- Score:
- 0.3
- Max. score:
- 4
- Reversibility:
- fully reversible
- Remarks:
- in 2 animals after 24 h, in 1 animal after 14 days
- Remarks on result:
- other: Scaling at the end of the observation period in 3 animals (see table below for details).
- Irritant / corrosive response data:
- Moderate erythema (grade 2), observed in all animals immediately and 1 hour after removal of the patch, increased to marked (grade 3) after 24 hours and persisted up to 72 hours in all animals and up to day 7 in one animal. Marked erythema decreased to moderate in two animals on day 7 and to slight (grade 1) in all animals after 14 days (study termination). Slight or moderate edema (grade 1 or 2) was noted in all animals immediately and 1 hour after removal of the patch. Slight edema persisted in 1 animal up to day 7. Additionally erythema and edema were partly extended beyond the area of exposure.
Moreover scaling, partly extending beyond the area of exposure, severe scaling as well as petechiae, both extending beyond the area of exposure and thickening of the skin in the region of the application area were noted during the observation period.
The cutaneous reactions (such as slight erythema) were not reversible in all animals within study termination on day 14.
Any other information on results incl. tables
Exposition: | 4 h (semiocclusive) | |||
Animal | Reading | Erythema | Edema | Comments |
1 | 0 h | 2 | 1 | Erythema/Edema extending beyond the area of exposure |
2 | 0 h | 2 | 1 | Erythema/Edema extending beyond the area of exposure |
3 | 0 h | 2 | 1 | Erythema/Edema extending beyond the area of exposure |
1 | 1 h | 2 | 1 | Erythema/Edema extending beyond the area of exposure |
2 | 1 h | 2 | 2 | Erythema/Edema extending beyond the area of exposure |
3 | 1 h | 2 | 1 | Erythema/Edema extending beyond the area of exposure |
1 | 24 h | 3 | 0 | Erythema extending beyond the area of exposure |
2 | 24 h | 3 | 1 | Erythema/Edema extending beyond the area of exposure |
3 | 24 h | 3 | 0 | Erythema extending beyond the area of exposure |
1 | 48 h | 3 | 0 | Erythema extending beyond the area of exposure |
2 | 48 h | 3 | 1 | Erythema/Edema extending beyond the area of exposure |
3 | 48 h | 3 | 0 | Erythema extending beyond the area of exposure |
1 | 72 h | 3 | 0 | Erythema extending beyond the area of exposure |
2 | 72 h | 3 | 1 | Erythema/Edema/Petechiae extending beyond the area of exposure |
3 | 72 h | 3 | 0 | Erythema extending beyond the area of exposure |
1 | 7 days | 2 | 0 | Scaling |
2 | 7 days | 3 | 1 | Erythema/Edema/Severe Scaling extending beyond the area of exposure |
3 | 7 days | 2 | 0 | Erythema/Scaling extending beyond the area of exposure |
1 | 14 days | 1 | 0 | Scaling |
2 | 14 days | 1 | 0 | Erythema/Scaling extending beyond the area of exposure, Thickening of the skin in the region of the application area |
3 | 14 days | 1 | 0 | Erythema/Scaling extending beyond the area of exposure |
mean (animal 1) | 24 - 72 h | 3 | 0 | |
mean (animal 2) | 24 - 72 h | 3 | 1 | |
mean (animal 3) | 24 - 72 h | 3 | 0 | |
mean (animal 1-3) | 24 - 72 h | 3.00 | 0.33 |
Applicant's summary and conclusion
- Interpretation of results:
- Category 2 (irritant) based on GHS criteria
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.