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EC number: 905-983-8 | 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
Endpoint summary
Administrative data
Description of key information
The LD50 (rat. oral) is > 5000 mg/kg bw.
The LC50 (rat) is >5000 mg/m³.
Key value for chemical safety assessment
Acute toxicity: via oral route
Link to relevant study records
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: no guideline defined, but available information is sufficient for assessment
- Principles of method if other than guideline:
- Method according to Kärber G, Naunyn-Schmiedebergs Arch. exper. Pathol. Pharmakol. 162, 480 (1931).
Rats were given different doses by gavage of undiluted 'Reaction mass of benzyl 2-ethylhexyl adipate and bis(2-ethylhexyl) adipate and dibenzyl adipate' and observed for 7 days for clinical signs and mortality. - GLP compliance:
- no
- Test type:
- standard acute method
- Limit test:
- no
- Species:
- rat
- Strain:
- not specified
- Sex:
- not specified
- Details on test animals or test system and environmental conditions:
- TEST ANIMAL
- Weight at study initiation: 120-180 g
- Housing: single
- Diet ad libitum
- Water ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature (°C): >20 - Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Details on oral exposure:
- Rats wer given different doses by gavage of undiluted 'Reaction mass of benzyl 2-ethylhexyl adipate and bis(2-ethylhexyl) adipate and dibenzyl adipate' and observed for 7 days for clinical signs and mortality.
Method according to Kärber G, Naunyn-Schmiedebergs Arch. exper. Pathol. Pharmakol. 162, 480 (1931). - Doses:
- no details given
- No. of animals per sex per dose:
- 10
- Control animals:
- no
- Details on study design:
- Rats wer given different doses by gavage of undiluted 'Reaction mass of benzyl 2-ethylhexyl adipate and bis(2-ethylhexyl) adipate and dibenzyl adipate' and observed for 7 days for clinical signs and mortality.
Method according to Kärber G, Naunyn-Schmiedebergs Arch. exper. Pathol. Pharmakol. 162, 480 (1931). - Statistics:
- calculation according to Burn JH, Biologische Auswertungsmethoden p. 29, Berlin: Springer 1937
- Key result
- Sex:
- not specified
- Dose descriptor:
- LD50
- Effect level:
- 10.4 mL/kg bw
- Remarks on result:
- other: 10400 mg/kg bw
- Mortality:
- no details given
- Clinical signs:
- other: somnolenz, staggering gait, diarrhea, poor general condition
- Gross pathology:
- no data
- Interpretation of results:
- GHS criteria not met
- Executive summary:
10 rats per dose received different doses of undiluted 'Reaction mass of benzyl 2-ethylhexyl adipate and bis(2-ethylhexyl) adipate and dibenzyl adipate' by gavage and were observed for 7 days for mortality and clinical finings. Animals showed staggering gait, somnolenz, suffered from diarrhea and poor general condition. The LD50 is 10.4 ml/kg bw accounting for 10400 mg/kg bw (density = 1).
Reference
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 10 400 mg/kg bw
- Quality of whole database:
- The study provides relevant information to evaluate the acute oral toxicity and can be evaluated with Klimisch score 2.
Acute toxicity: via inhalation route
Link to relevant study records
- Endpoint:
- acute toxicity: inhalation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: guideline study and GLP
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 403 (Acute Inhalation Toxicity)
- GLP compliance:
- yes
- Test type:
- standard acute method
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Age at study initiation: 9-12 weeks
- Weight at study initiation: males: 293-322 g, females: 215-230 g
- Housing: singly
- Diet ad libitum except during exposure
- Water (e.g. ad libitum except during exposure)
- Acclimation period: 23 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-23
- Humidity (%): 46-56
- Air changes (per hr): 13
- Photoperiod (hrs dark / hrs light): 12/12 - Route of administration:
- inhalation
- Type of inhalation exposure:
- nose only
- Vehicle:
- air
- Details on inhalation exposure:
- The animals were exposed to the test atmosphere for 4 hours and 5 minutes. The exposure period was extended beyond 4 hours to allow the chamber to reach equilibrium. At the end of the exposure period the generation was terminated and the chamber was operated for a further 15 min with clean air. At the end of this period the animals were removed from the exposure tube. Prior to being returned to their cages excess test substance was removed from the fur of each animal.
Atmosphere generation:
The test atmosphere was generated using a 1/4 inch JCO atomizer.
Chamber concentration measurements
Particel size distribution measurements - Analytical verification of test atmosphere concentrations:
- yes
- Duration of exposure:
- ca. 4 h
- Concentrations:
- 5.08 mg/L = 5080 mg/m³
- No. of animals per sex per dose:
- 5 males and 5 females
- Control animals:
- not specified
- Details on study design:
- The animals were exposed to the test atmosphere for 4 hours and 5 minutes. The exposure period was extended beyond 4 hours to allow the chamber to reach equilibrium. At the end of the exposure period the generation was terminated and the chamber was operated for a further 15 min with clean air. at the end of this period the animals were removed from the exposure tube. Prior to being returned to their cages excess test substance was removed from the fur of each animal. The animals were observed for 14 days.
- Statistics:
- no data
- Key result
- Sex:
- male/female
- Dose descriptor:
- LC50
- Effect level:
- > 5 000 mg/m³ air
- Exp. duration:
- 4 h
- Remarks on result:
- other: all animals survived
- Mortality:
- No animal died.
- Clinical signs:
- other: Follwing exposure all animals exhibited irregular respiration but recovered from this sympton by day 3.
- Body weight:
- All animals lost body weight by day 1 but showed a continued weight gain thereafter through day 14.
- Gross pathology:
- No gross abnormalities were detected at the end of the 14 day observation period.
- Interpretation of results:
- GHS criteria not met
- Executive summary:
An acute inhalation toxicity test according to OECD TG 403 was conducted to determine the potential of 'Reaction mass of benzyl 2-ethylhexyl adipate and bis(2-ethylhexyl) adipate and dibenzyl adipate' to produce toxicity from a 4-hour exposure via inhalation (nose-only exposure) route.
The test atmosphere was generated using a 1/4 inch JCO atomizer. The gravimetric chamber concentration was 5080 mg/m³. The mass median aerodynamic diameter was estimated to be 1.72 µm. All animals survived the exposure to the test atmosphere. Following exposure all animals exhibited irregular respiration. However, the animals recovered from this symptom by day 3 and appeared active and healthy for the remainder of the 14-day observation period. Although all animals lost body weight by day 1, all animals showed a continued weight gain thereafter through day 14. No gross abnormalities were noted for any of the animals when necropsied at the conclusion of the 14-day observation period. Thus, the LC50 is > 5000 mg/m³.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- discriminating conc.
- Value:
- 5 000 mg/m³ air
- Quality of whole database:
- This GLP study is performed according to Guideline and is evaluated with Klimisch score 1.
Acute toxicity: via dermal route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
ORAL APPLICATION
10 rats per dose received different doses of undiluted 'Reaction mass of benzyl 2-ethylhexyl adipate and bis(2-ethylhexyl) adipate and dibenzyl adipate' by gavage and were observed for 7 days for mortality and clinical findings. Animals showed staggering gait, somnolenz, suffered from diarrhea and poor general condition. The LD50 is 10.4 ml/kg bw accounting for 10400 mg/kg bw (d = 1).
INHALATION EXPOSURE
An acute inhalation toxicity test according to OECD TG 403 was conducted to determine the potential of 'Reaction mass of benzyl 2-ethylhexyl adipate and bis(2-ethylhexyl) adipate and dibenzyl adipate' to produce toxicity from a 4-hour exposure via inhalation (nose-only exposure) route.
The test atmosphere was generated using a 1/4 inch JCO atomizer. The gravimetric chamber concentration was 5080 mg/m³. The mass median aerodynamic diameter was estimated to be 1.72 µm. All animals survived the exposure to the test atmosphere. Following exposure all animals exhibited irregular respiration. However, the animals recovered from this symptom by day 3 and appeared active and healthy for the remainder of the 14 -day observation period. Although all animals lost body weight by day 1, all animals showed a continued weight gain thereafter through day 14. No gross abnormalities were noted for any of the animals when necropsied at the conclusion of the 14 -day observation period. Thus, the LC50 is > 5000 mg/m³.
DERMAL APPLICATION
There is no acute toxicity study with 'Reaction mass of benzyl 2-ethylhexyl adipate and bis(2-ethylhexyl) adipate and dibenzyl adipate'available using the dermal route.
According to Regulation (EC) No. 1907/2006 ANNEX VIII column 2: In addition to the acute toxicity study using the oral route at least the acute toxicity for one other route should be provided. This recommendation is fulfilled because there is another study available with 'Reaction mass of benzyl 2-ethylhexyl adipate and bis(2-ethylhexyl) adipate and dibenzyl adipate' using the inhalation route.
This study is performed according to the respective guideline and is GLP compliant and evaluated with Klimisch score 1. Thus, there is no need to conduct an acute toxicity study with 'Reaction mass of benzyl 2-ethylhexyl adipate and bis(2-ethylhexyl) adipate and dibenzyl adipate' using the dermal route.
Justification for selection of acute toxicity – oral endpoint
The study provides sufficient information to evaluate the acute oral
toxicity and can be evaluated with Klimisch score 2.
Justification for selection of acute toxicity – inhalation endpoint
There is only one study available. This GLP study is performed
according to Guideline and is evaluated with Klimisch score 1.
Justification for selection of acute toxicity – dermal endpoint
There is no acute toxicity study with 'Reaction mass of benzyl
2-ethylhexyl adipate and bis(2-ethylhexyl) adipate and dibenzyl
adipate'available using the dermal route.
According to Regulation (EC) No. 1907/2006 ANNEX VIII column 2: In
addition to the acute toxicity study using the oral route at least the
acute toxicity for one other route should be provided. This
recommendation is fulfilled because there is another study available
with 'Reaction mass of benzyl 2-ethylhexyl adipate and bis(2-ethylhexyl)
adipate and dibenzyl adipate' using the inhalation route.
This study is performed according to the respective guideline and is GLP
compliant and evaluated with Klimisch score 1. Thus, there is no need to
conduct an acute toxicity study with 'Reaction mass of benzyl
2-ethylhexyl adipate and bis(2-ethylhexyl) adipate and dibenzyl adipate'
using the dermal route.
Justification for classification or non-classification
The LD50 (rat. oral) is > 5000 mg/kg bw.
The LC50 (rat) is >5000 mg/m³.
According to CLP classification criteria (Regulation (EC) No 1272/2008) a classification is therefore not justified.
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.
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