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EC number: 429-320-2 | CAS number: 24748-23-0
- 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:
- supporting study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Well conducted GLP study. No certificate of analysis included in the report.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 997
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:
- -
- EC Number:
- 429-320-2
- EC Name:
- -
- Cas Number:
- 24748-23-0
- Molecular formula:
- C12H24O6
- IUPAC Name:
- 3,6,9-triethyl-3,6,9-trimethyl-1,2,4,5,7,8-hexaoxonane
- Reference substance name:
- Initiator D-129
- IUPAC Name:
- Initiator D-129
- Details on test material:
- Colourless liquid
Batch No.: KOW96170
44% in aliphatic hydrocarbons
Constituent 1
Constituent 2
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- Albino Rabbit, New Zealand White, (SPF-Quality)
Source: Broekman Institute, Someren, The Netherlands.
Air-conditioned room with approximately 15 air changes per hour and the
environment controlled with optimal conditions considered as being a temperature
of 21°C and a relative humidity of 50%. Fluctuations from these optimal
conditions were noted, but were considered not to have affected study integrity.
Lighting was 12 hours artificial fluorescent light and 12 hours dark per day.
Accommodation
Individually in labelled cages with perforated floors (Scanbur Denmark) and
equipped with an automatic drinking system (ITL, Bergen, The Netherlands).
Acclimatisation period was at least 5 days before start of treatment under
laboratory conditions.
Diet
Standard laboratory rabbit diet (LKK-20, pellet diameter 4mm, Hope Farms,
Woerden, The Netherlands) approx. 100 gram per day. Certificates of analysis
were examined and retained in the NOTDX archives.
In addition, hay (BMI, Helmond, The Netherlands) was provided once a week.
Water
Free access to tap-water diluted with decalcified water.
Certificates of quarterly analysis were examined and retained in the NDTDX
archives.
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- unchanged (no vehicle)
- Amount / concentration applied:
- 0.5 ml
- Duration of treatment / exposure:
- 4 hours
- Details on study design:
- Approximately 24 hours before treatment, the dorsal fur was clipped with
electric clippers, exposing an area of approximately 150 square centimeters
(10x15 cm').
A health inspection was performed prior to the commencement of treatment, to
ensure that the animals were in a good state of health. Special attention was
paid to the skin to be treated, which was intact and free from abnormalities.
On test day 1, 0.5 ml of the test substance was applied to the skin of one
flank, using a surgical gauze patch of 2x3 cm. The patch was mounted on
Micropore tape*. which was wrapped around the abdomen and secured with Coban
elastic bandage.
Four hours after the application, the dressing was removed and the remaining
test substance removed using a tissue moistened with tap-water and subsequently
a dry tissue.
Whenever considered necessary the treated skin areas were re-clipped at least 3
hours before the observations, to facilitate the scoring .
Results and discussion
In vivo
Results
- Irritation parameter:
- primary dermal irritation index (PDII)
- Basis:
- mean
- Time point:
- other: 24 and 72 hours
- Score:
- 3.7
- Max. score:
- 2.3
- Reversibility:
- fully reversible within: 14 days
- Irritant / corrosive response data:
- labelling requirements for dangerous substances and preparations (Guidelines in
Commission Directive 93/21/EEC, 27th April 1993), the test substance should be labelled as:
irritating to the skin (R 38).
Applicant's summary and conclusion
- Interpretation of results:
- irritating
- Remarks:
- Criteria used for interpretation of results: EU
- Conclusions:
- Based on these results and according to the EEC criteria For classification and
labelling requirements For dangerous substances and preparations (Guidelines in
Commission Directive 93/21/EEC, 27th April 1993), 0-129 should be labelled as:
irritating to the skin (R 38).
- - Executive summary:
The study was carried out in accordance with the OECD guideline No. 404, 'Acute Dermal Irritation/Corrosion' and the EEC Directive 92/69/EEC, B.4, 'Acute Toxicity - Skin irritation. Three rabbits were exposed to 0.5 m1 of the test substance, applied onto clipped skin for 4 hours using a semi-occlusive dressing. Observations were made 1, 24, 48 and 72 hours, 7 and 14 days after exposure. Exposure to the test substance resulted in well defined or moderate to severe erythema and slight oedema in the treated skin-areas of the three rabbits. Scaliness was observed in all animals 7 days after exposure. The skin irritation had resolved within 14 days after exposure in all animals. Sticky remnants of the test substance, which became dry remnants after day 1, were present in the treated skin-areas of all animals up to 72 hours after exposure. Dermal application of the test substance resulted in a primary irritation index of 3.7 (moderately irritating) when applied to the intact rabbit skin. Based on these results and according to the EEC criteria For classification and labelling requirements For dangerous substances and preparations (Guidelines in Commission Directive 93/21/EEC, 27th April 1993), the test substance should be labelled as: irritating to the skin (R 38).
The test substance would be classified as a category 2 irritant in accordance with the criteria for classification in accordance with Guidance to Regulation (EC) No 1272/2008 on classifica tion, labelling and packaging (CLP) of substances and mixtures Version 3.0 November 2012.
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