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EC number: 304-059-6 | CAS number: 94233-27-9
- 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
Key value for chemical safety assessment
Effects on fertility
Effect on fertility: via oral route
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- NOAEL
- 50 mg/kg bw/day
- Study duration:
- chronic
- Species:
- rat
Effect on fertility: via inhalation route
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- NOAEC
- 417 mg/m³
- Study duration:
- subchronic
- Species:
- rat
Effect on fertility: via dermal route
- Endpoint conclusion:
- no study available
Effects on developmental toxicity
Description of key information
Effects on Developmental toxicity
2-ethylhexanol
In an inhalation study by Nelson (1989, 1990) no maternal toxicity or developmental toxicity was noted in a rat inhalation study that was conducted similar to OECD TG 414; the study is valid though less animals (n = 15) than suggested by the test guideline. The rats were exposed during days 0 -19 of gestation to 2 -EH at 850 mg/m³, the maximum achievable concentration without aerosol formation.
Pentane-2,4-dione
(Union Carbide Corp. Bushy Run Research Center)
Based on a significantly reduced body weight gain in the 400 ppm exposure group the
NOAEL/LOAEL derived for maternal toxicity is 200 and 400 ppm (= 834 / 1,668 mg/m3 = 288.2 / 576.4mg/kg bw/d assuming a respiratory minute volume of 0.24 l/min and an average weight of 250 g/rat), respectively. The NOAEL for developmental toxicity is 50 ppm (= 209 mg/m3 = 72.2mg/kg bw/d), respectively, which is based on reduced fetal weights in male fetuses at 200 and in male and female fetuses at 400 ppm and a consistent pattern of reduced fetal ossification at 400 ppm. [cited from UNEP SIDS 2001].
Based on overall findings, the inhalation NOACE was 400 ppm (d) (read from pentane-2,4-dione).
Link to relevant study records
- Endpoint:
- developmental toxicity
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study
- Justification for type of information:
- 2-ethylhexanol is the main hydrolysis of the target substance, properties of which are used for read-across.
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 414 (Prenatal Developmental Toxicity Study)
- Deviations:
- yes
- Remarks:
- low number of animals: 15 females instead of 25
- Principles of method if other than guideline:
- low number of animals: 15 females instead of 25
- GLP compliance:
- not specified
- Limit test:
- yes
- Species:
- rat
- Strain:
- Sprague-Dawley
- Route of administration:
- inhalation
- Type of inhalation exposure (if applicable):
- whole body
- Vehicle:
- air
- Details on exposure:
- Exposure apparatus: 0.5 m³ whole body exposure chamber (hinners-type)
Method of holding animals in test chamber: animals were caged - Analytical verification of doses or concentrations:
- yes
- Duration of treatment / exposure:
- gestation day 1 - 19
- Frequency of treatment:
- daily, 7 hr/day
- Duration of test:
- 19 days
- Dose / conc.:
- 850 mg/m³ air (analytical)
- No. of animals per sex per dose:
- 15 females
- Control animals:
- yes, concurrent vehicle
- Details on study design:
- Dose selection rationale: the highest achievable concentration was used (850 mg/m³) which could be generated as a vapor while maintaining the chamber temperature <26°C. As no maternal toxicity was noted, there was no need to test lower concentrations.
- Clinical signs:
- no effects observed
- Number of abortions:
- no effects observed
- Key result
- Dose descriptor:
- NOAEC
- Effect level:
- ca. 850 mg/m³ air
- Based on:
- test mat.
- Basis for effect level:
- other: maternal toxicity
- Key result
- Dose descriptor:
- NOAEC
- Effect level:
- ca. 850 mg/m³ air
- Based on:
- test mat.
- Basis for effect level:
- other: developmental toxicity
- Key result
- Abnormalities:
- no effects observed
- Fetal body weight changes:
- no effects observed
- Key result
- Dose descriptor:
- NOAEC
- Effect level:
- ca. 850 mg/m³ air
- Based on:
- test mat.
- Sex:
- not specified
- Basis for effect level:
- other: teratogenicity
- Abnormalities:
- no effects observed
- Key result
- Developmental effects observed:
- no
- Conclusions:
- No signs of maternal and fetal toxicity were noted in this inhalation study, where the maximum vapour concentration was used which does not lead to formation of aerosol.
- Executive summary:
As the target substance hydrolyses rapidly (half-life < 30 minutes) the intrinsic properties are related to hydrolysis products of the target substance. This information is used as a supporting evidence on the toxicity of the target substance in CSA.
- Endpoint:
- developmental toxicity
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study
- Justification for type of information:
- pentane-2,4-dione is the main hydrolysis of the target substance, properties of which are used for read-across.
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 414 (Prenatal Developmental Toxicity Study)
- Deviations:
- no
- GLP compliance:
- yes
- Limit test:
- no
- Species:
- rat
- Strain:
- Fischer 344
- Route of administration:
- inhalation
- Type of inhalation exposure (if applicable):
- whole body
- Vehicle:
- unchanged (no vehicle)
- Analytical verification of doses or concentrations:
- yes
- Duration of treatment / exposure:
- gestational days (GD) 6-15
- Frequency of treatment:
- 6 h/day consecutive days
- Duration of test:
- 13 days (treatment), animals were sacrificed on GD 21
- Dose / conc.:
- 0 ppm (analytical)
- Dose / conc.:
- 50 ppm (analytical)
- Dose / conc.:
- 200 ppm (analytical)
- Dose / conc.:
- 400 ppm (analytical)
- No. of animals per sex per dose:
- 25 females
- Control animals:
- yes, concurrent vehicle
- Details on study design:
- Timed-pregnant Fischer F-344 rats (Harlan Fischer F-344/HarBR) were exposed to 2,4-pentanedione vapour by inhalation on gestational days (gd) 6 to 15 at exposure target concentrations of 0, 50, 200 and 400 ppm (0, 52.7, 202 and 398 ppm mean analytical concentrations, respectively) to evaluate the embryotoxic and fetotoxic (including teratogenic) potential of the TS administered during organogenesis.
The day a copulation plug was found was designated gestational day (gd) 0. Twenty-five plug-positive females were assigned to each experimental group. Clinicalobservations were recorded daily, and maternal body weights were taken on gd 0, 6, 9, 12, 15 and 18. At scheduled necropsy on gd 21 (CO2 asphyxiation), dams were evaluated for body weight, liver and thymus weights, gravid uterine weight, and status of implantation sites (i.e. resorptions, dead fetuses, live fetuses). Maternal brains were removed, fixed and examined histopathologically. Live fetuses were dissected from the uterus, counted, weighed and sexed and examined for external abnormalities. - Body weight and weight changes:
- effects observed, treatment-related
- Description (incidence and severity):
- reduced body weight gain
- Key result
- Dose descriptor:
- NOAEC
- Effect level:
- ca. 200 ppm (analytical)
- Based on:
- test mat.
- Basis for effect level:
- body weight and weight gain
- Key result
- Dose descriptor:
- LOAEC
- Effect level:
- ca. 400 ppm (analytical)
- Based on:
- test mat.
- Basis for effect level:
- body weight and weight gain
- Fetal body weight changes:
- effects observed, treatment-related
- Description (incidence and severity):
- reduced fetal weights
reduced fetal ossification in the 200 and 400 ppm group - Key result
- Dose descriptor:
- NOAEC
- Effect level:
- ca. 50 ppm (analytical)
- Based on:
- test mat.
- Basis for effect level:
- other: fetotoxicity
- Key result
- Dose descriptor:
- LOAEC
- Effect level:
- ca. 200 ppm (analytical)
- Based on:
- test mat.
- Basis for effect level:
- other: fetotoxicity
- Key result
- Dose descriptor:
- NOAEC
- Effect level:
- ca. 400 ppm (analytical)
- Based on:
- test mat.
- Basis for effect level:
- other: teratogenicity
- Key result
- Dose descriptor:
- NOAEC
- Effect level:
- ca. 400 ppm (analytical)
- Based on:
- test mat.
- Basis for effect level:
- other: embryotoxicity
- Key result
- Developmental effects observed:
- no
- Conclusions:
- Based on a significantly reduced body weight gain in the 400 ppm exposure group the NOAEC/LOAEC derived for maternal toxicity is 200 and 400 ppm, respectively. The NOAEC/LOAEC for developmental toxicity is 50 and 200 ppm, respectively, which is based on reduced fetal weights in male fetuses at 200 ppm and in male and female fetuses at 400 ppm and a consistent pattern of reduced fetal ossification at 400 ppm. The NOAEL for embryotoxicity and teratogenicity is 400 ppm (highest dose tested).
- Executive summary:
As the target substance hydrolyses rapidly (half-life < 30 minutes) the intrinsic properties are related to hydrolysis products of the target substance. This information is used as a supporting evidence on the toxicity of the target substance in CSA.
- Endpoint:
- developmental toxicity
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study
- Justification for type of information:
- pentane-2,4-dione is the main hydrolysis of the target substance, properties of which are used for read-across.
- Reason / purpose for cross-reference:
- read-across source
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 414 (Prenatal Developmental Toxicity Study)
- Deviations:
- no
- GLP compliance:
- yes
- Limit test:
- no
- Species:
- rat
- Strain:
- Fischer 344
- Route of administration:
- inhalation
- Type of inhalation exposure (if applicable):
- whole body
- Vehicle:
- unchanged (no vehicle)
- Analytical verification of doses or concentrations:
- yes
- Duration of treatment / exposure:
- gestational days (GD) 6-15
- Frequency of treatment:
- 6 h/day consecutive days
- Duration of test:
- 13 days (treatment), animals were sacrificed on GD 21
- Dose / conc.:
- 0 ppm (analytical)
- Dose / conc.:
- 50 ppm (analytical)
- Dose / conc.:
- 200 ppm (analytical)
- Dose / conc.:
- 400 ppm (analytical)
- No. of animals per sex per dose:
- 25 females
- Control animals:
- yes, concurrent vehicle
- Details on study design:
- Timed-pregnant Fischer F-344 rats (Harlan Fischer F-344/HarBR) were exposed to 2,4-pentanedione vapour by inhalation on gestational days (gd) 6 to 15 at exposure target concentrations of 0, 50, 200 and 400 ppm (0, 52.7, 202 and 398 ppm mean analytical concentrations, respectively) to evaluate the embryotoxic and fetotoxic (including teratogenic) potential of the TS administered during organogenesis.
The day a copulation plug was found was designated gestational day (gd) 0. Twenty-five plug-positive females were assigned to each experimental group. Clinicalobservations were recorded daily, and maternal body weights were taken on gd 0, 6, 9, 12, 15 and 18. At scheduled necropsy on gd 21 (CO2 asphyxiation), dams were evaluated for body weight, liver and thymus weights, gravid uterine weight, and status of implantation sites (i.e. resorptions, dead fetuses, live fetuses). Maternal brains were removed, fixed and examined histopathologically. Live fetuses were dissected from the uterus, counted, weighed and sexed and examined for external abnormalities. - Body weight and weight changes:
- effects observed, treatment-related
- Description (incidence and severity):
- reduced body weight gain
- Key result
- Dose descriptor:
- NOAEC
- Effect level:
- ca. 200 ppm (analytical)
- Based on:
- test mat.
- Basis for effect level:
- body weight and weight gain
- Key result
- Dose descriptor:
- LOAEC
- Effect level:
- ca. 400 ppm (analytical)
- Based on:
- test mat.
- Basis for effect level:
- body weight and weight gain
- Fetal body weight changes:
- effects observed, treatment-related
- Description (incidence and severity):
- reduced fetal weights
reduced fetal ossification in the 200 and 400 ppm group - Key result
- Dose descriptor:
- NOAEC
- Effect level:
- ca. 50 ppm (analytical)
- Based on:
- test mat.
- Basis for effect level:
- other: fetotoxicity
- Key result
- Dose descriptor:
- LOAEC
- Effect level:
- ca. 200 ppm (analytical)
- Based on:
- test mat.
- Basis for effect level:
- other: fetotoxicity
- Key result
- Dose descriptor:
- NOAEC
- Effect level:
- ca. 400 ppm (analytical)
- Based on:
- test mat.
- Basis for effect level:
- other: teratogenicity
- Key result
- Dose descriptor:
- NOAEC
- Effect level:
- ca. 400 ppm (analytical)
- Based on:
- test mat.
- Basis for effect level:
- other: embryotoxicity
- Key result
- Developmental effects observed:
- no
- Conclusions:
- Based on a significantly reduced body weight gain in the 400 ppm exposure group the NOAEC/LOAEC derived for maternal toxicity is 200 and 400 ppm, respectively. The NOAEC/LOAEC for developmental toxicity is 50 and 200 ppm, respectively, which is based on reduced fetal weights in male fetuses at 200 ppm and in male and female fetuses at 400 ppm and a consistent pattern of reduced fetal ossification at 400 ppm. The NOAEL for embryotoxicity and teratogenicity is 400 ppm (highest dose tested).
- Executive summary:
The study was conducted on pentane-2,4 -dione, the strucural analogue and also the hydrolysis product of the target substance. As the target substance is hydrolytically unstable, its intrinsic property lies in the the hydrolysis products. The result is used as weight of evidence approach in hazard assessment.
Referenceopen allclose all
Effect on developmental toxicity: via oral route
- Endpoint conclusion:
- no study available
Effect on developmental toxicity: via inhalation route
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- NOAEC
- 209 mg/m³
- Study duration:
- subchronic
- Species:
- rat
Justification for classification or non-classification
Based on the studies, there's no adverse effect on reproduction observed. Therefore, there is no need for classification as reproductive toxicity according to CLP Regulation.
Additional information
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.