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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 306-523-3 | CAS number: 97281-24-8
- 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 irritation (OECD 404), rabbit: not irritating
Eye irritation (OECD 405), rabbit: not irritating
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 04 Mar - 10 Mar 1988
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: GLP - Guideline study with acceptable restrictions (analytical purity is not reported, occlusive dressing, residual test substance was not removed)
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- adopted in 1983
- Deviations:
- yes
- Remarks:
- Analytical purity is not reported, occlusive dressing, residual test substance was not removed.
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- other: Chbb: HM
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Fa. Thomae, Biberach, Germany
- Weight at study initiation: 2.5 kg
- Housing: individual
- Diet: Zucht- / Haltungsdiät
- Water: tap water, ad libitum
- Acclimation period: at least 7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-21
- Humidity (%): 45-50
- Photoperiod (hrs dark / hrs light): 12 / 12 - Type of coverage:
- occlusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: untreated sites of the same animal served as control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL - Duration of treatment / exposure:
- 4 h
- Observation period:
- 3 days
Reading time points: 1, 24, 48 and 72 h - Number of animals:
- 4 males
- Details on study design:
- TEST SITE
- Area of exposure: back
- Type of wrap if used: the treated skin was covered with a linen patch (2.5 cm x 2.5 cm). This was then covered with a large plastic foil, which was held in place with tape. Finally, by mean of a bond a secure fixation was achieved.
SCORING SYSTEM: Draize scoring system - Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- out of all 4 animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility: not applicable
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- out of all 4 animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility: not applicable
- Irritant / corrosive response data:
- No skin irritations were observed.
- Other effects:
- No further effects were observed.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- CLP: not classified
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Eye irritation
Link to relevant study records
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 01 Jul - 08 Jul 1988
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: GLP - Guideline study with acceptable restrictions (analytical purity not reported)
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- adopted in 1984
- Deviations:
- yes
- Remarks:
- analytical purity not reported; single application without washing.
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- other: Chbb: HM
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Thomae, Biberach, Germany
- Weight at study initiation: 2.7 kg
- Housing: individual housing
- Diet: Altromin-Haltungsdiät, ad libitum
- Water: tap water, ad libitum
- Acclimation period: at least 7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-21
- Humidity (%): 45-55
- Photoperiod (hrs dark / hrs light): 12 / 12 - Vehicle:
- unchanged (no vehicle)
- Controls:
- other: the untreated eye served as control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL - Duration of treatment / exposure:
- Single application without washing
- Observation period (in vivo):
- 3 days
Reading time points: 1, 6, 24, 48, and 72 h - Number of animals or in vitro replicates:
- 4 males
- Details on study design:
- SCORING SYSTEM: Draize scoring system
TOOL USED TO ASSESS SCORE: fluorescein
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- mean out of all 4 animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility: not applicable
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- mean out of all 4 animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: reversibility: not applicable
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Remarks:
- mean out of all 4 animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Reversibility:
- other: reversibility: not applicable
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- mean out of all 4 animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility: not applicable
- Irritant / corrosive response data:
- Slight conjuctival reactions were observed between 1-6 hours after treatment. They consisted in redness (4/4 animals within the first hour after treatment, 3/4 within 6 hours after treatment) and exudation (4/4 animals within the first hour after treatment). However, these reactions were fully reversible within 24 hours after treatment.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- CLP: not classified
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
In summary, two reliable studies assessing the skin and eye irritation potential of Fatty acids, C8-10 (even numbered), diesters with neopentyl glycol and di- and triesters with trimethylolpropane (CAS 97281-24-8) are available.
Skin irritation
CAS 97281-24-8
In a key skin irritation study performed equivalent or similar to OECD guideline 404 and in compliance with GLP four male Chbb: HM rabbits were exposed to 0.5 mL of the neat test material for 4 hours applied onto the shaved skin via occlusive dressing (BASF, 1988b). Skin reactions were evaluated 1, 24, 48 and 72 hours post-application. The dermal application of the test substance did not result in erythema or edema in any of the animals tested at any observation time point. No further local effects and no signs of systemic toxicity were observed in the animals during the test period and no mortality occurred.
Eye irritation
CAS 97281-24-8
A key eye irritation study performed equivalent or similar to OECD guideline 405 and in compliance with GLP with Fatty acids, C8-10 (even numbered), diesters with neopentyl glycol and di- and triesters with trimethylolpropane (CAS 97281-24-8) is available (BASF, 1988c). For the assessment of the eye irritation properties 0.1 mL of the test substance was instilled in the eye of four male Chbb: HM rabbits. The eyes were examined and the changes were graded according to the Draize scoring system 1, 6, 24, 48 and 72 hours post-application. Slight conjunctival reactions (grade 1) were observed between 1-6 hours after treatment consisting of redness (4/4 animals within the first hour after treatment, 3/4 within 6 hours after treatment) and exudation (4/4 animals within the first hour after treatment). However, these reactions were fully reversible within 24 hours after treatment. Neither corneal nor iridal effects were observed in the animals during the study period.
Conclusion for skin and eye irritation
In conclusion, two reliable skin and eye irritation studies are available for the target substance indicating that Fatty acids, C8-10 (even numbered), diesters with neopentyl glycol and di- and triesters with trimethylolpropane (CAS 97281-24-8) is not considered to be skin irritant or an eye irritant.
Justification for classification or non-classification
The available data on skin and eye irritation do not meet the classification criteria according to Regulation (EC) No. 1272/2008, and are therefore 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.