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EC number: 500-281-4 | CAS number: 98362-33-5
- 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
2,3-Epoxypropyl neodecanoate, oligomeric reaction products with toluene-4-sulfonic acid is of low oral and inhalation toxicity with an oral LD50 (rat) of > 10000 mg/kg bw (OECD 401, Hüls AG, 1985) and an inhalation LC50 of > 1900 mg/ m3 (OECD 403, Seibersdorf 2011)
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
- Study period:
- 1985-11-23 to 1985-12-07
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Version / remarks:
- 1981
- Deviations:
- no
- GLP compliance:
- no
- Test type:
- standard acute method
- Limit test:
- yes
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- - Strain: Wistar (Bor: WISW (SPF TNO))
- Source: Winkelmann, Borchen (Germany)
- Weight at study initiation: females 153 g, males 206 g (mean)
- Fastening before administration: 16 hours
Environmental conditions: - Feed: R 10 complete feed for rats (Ssniff, Soest; Germany)
- Water: tap water ad libitum
- Room temperature: 20°C (+/- 1°C)
- Humidity: 60% (+/- 5%)
- Air change: 15 times per hour
- Illumination: 12 hour light/dark rhythm - Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Details on oral exposure:
- The test item was administered undiluted. Rats were fasted for 16 hours and then received a single oral dose by gavage: Volume 9.488 mL/kg bw.
- Doses:
- - Doses: 10000 mg/kg body weight, volume: 9.488 mL/kg bw
- No. of animals per sex per dose:
- 5 males, 5 females
- Control animals:
- no
- Details on study design:
- - Post dose observation period: 14 days
EXAMINATIONS:
- body weight: before and on days 1, 7, 14 after treatment
- clinical signs: up to 6 hours after treatment, then daily
- gross pathology at the end of investigation - Statistics:
- not necessarry
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 10 000 mg/kg bw
- Mortality:
- no mortality
- Clinical signs:
- other: After 1-2 hours some animals had ruffled fur ans one animal diuresis, after 4 hours ruffled fur was observed in 9 animals and diuresis in 10 animals, and later some of them showed staggering gait, slight ataxia and sedation, diarrhoe and a squatting posi
- Gross pathology:
- Dissection at the end of the experiment revealed hyperaemia of the gastric mucosa in 5 animals and additionally in one animal partial hyperaemia of the small intestinal mucosa
- Other findings:
- no further information
- Conclusions:
- Under the conditions of this study, the acute toxicity of the test item in male and female rats is greater than 10000 mg/kg body weight.
- Executive summary:
In a determination of the acute oral toxicity in a limit test of 2,3-Epoxypropyl neodecanoate, oligomeric reaction products with toluene-4-sulfonic acid
5 male and 5 female rats received a single oral dose by gavage of 10000 mg/kg body weight. After 1-2 hours some animals had ruffled fur and one animal diuresis, after 4 hours ruffled fur was observed in 9 animals and diuresis in 10 animals, and later some of them showed staggering gait, slight ataxia and sedation, diarrhoe and a squatting position.While after 24 hours diuresis was still observed in 9 animals, all of them were free from the symptoms of poisoning after 48 hours. The increase of body weight was unaffected by the treatment. Dissection at the end of the experiment revealed hyperaemia of the gastric mucosa in 5 animals and additionally in one animal partial hyperaemia of the small intestinal mucosa
Under the conditions of this study, the acute toxicity of 2,3-Epoxypropyl neodecanoate, oligomeric reaction products with toluene-4-sulfonic acid in male and female rats is greater than 10000 mg/kg body weight.
Reference
no further remarks
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 10 000 mg/kg bw
- Quality of whole database:
- The study is valid without restriction (Klimisch code 1)
Acute toxicity: via inhalation route
Link to relevant study records
- Endpoint:
- acute toxicity: inhalation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2011-10-07 to 2011-10-25
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 403 (Acute Inhalation Toxicity)
- Version / remarks:
- 2009
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.2 (Acute Toxicity (Inhalation))
- Version / remarks:
- 2008
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.1300 (Acute inhalation toxicity)
- Version / remarks:
- 1998
- GLP compliance:
- no
- Remarks:
- (Lab. closed before GLP-Konformation)
- Test type:
- standard acute method
- Limit test:
- yes
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ORGANISMS:
- Strain: Rattus norvegicus) / CD / Crl: CD(SD)
- Source: Charles River Laboratories, 97633 Sulzfeld, Germany
- Age: 8 to 9 weeks at time of administration
- Weight at study initiation: males: 317.4 g, females: 244.9 g
- Number of animals: 5 males and 5 females
- Housing: single caging
- Diet: ad libitum, ssniff R/M-H V 1534
- Water: ad libitum, tab water
- Acclimatisation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): mean 20.8 °C
- Humidity (%): mean 41.7 %
- Photoperiod (hrs dark / hrs light): 12 hours darkness, 12 hours artifical light
- Air exchange: about 12/h - Route of administration:
- inhalation: aerosol
- Type of inhalation exposure:
- nose only
- Vehicle:
- air
- Details on inhalation exposure:
- GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Type of exposure: nose-only, using a Head Nose Only Exposure Unit from TSE-Systems GmbH, Bad Homburg, Germany
- Method of holding animals in test chamber (volume 24 l): In ten openings of the chamber, the inhalation tubes with the animals were situated.
- Type or preparation of particles: For aerosol generation am aerosol nozzle was used. Test substance – ethanol mixtures (1+9) were dosed with a
syringe pump and sprayed by an nozzle. The desired aerosol concentrations were obtained by controlling the feed rate of the syringe pump. The
nozzle was placed into a separator which was fixed on the upper centre of the inhalation chamber. Larger droplets sediment within the separator
and smaller ones followed the air stream to the outer chamber and reached the animals
- Method of particle size distribution: The size of the aerosol particles was analysed twice during the exposure with a cascade impactor
(Berner-Impaktor Type LPI4/0,06/2 from Hauke KG, Gmunden, Austria). It contains nine steps with cut-off- diameters from 0.06 µm to 16 µm.
The cut-off diameters were obtained from the manufacturer. 5.65 litres/minute of the test substance - air mixture were passed through the
impactor and the amount which sediment in the individual steps was determined gravimetrically. The site of collection was the same as for the
analysis.
The calculated mass median aerodynamic diameter (MMAD) of the test substance aerosol was 2.0 and 1.96 µm.
- Temperature, humidity: T: 19.3 to 19.7°C, H: 47.5 % to 47.9 %
TEST ATMOSPHERE
- Concentrations: 1.9 mg/l, the maximal obtainable aerosol concentrations were only about 1.9 mg/L and therefore below the limit concentration of 5 mg/L.
- Flow (L/min): 5.65 litres/minute of the test substance - air mixture were passed through the impactor
- Air flow: 17.2 L/min - Analytical verification of test atmosphere concentrations:
- yes
- Remarks:
- The concentration of the aerosol was detected 7 times during the exposure period
- Duration of exposure:
- 4 h
- Concentrations:
- The mean actual aerosol concentration was 1.9 mg/L.
- No. of animals per sex per dose:
- 5
- Control animals:
- no
- Details on study design:
- EXAMINATIONS:
- Post dose observation period: 14 days
- body weights: before, 1, 7 and 14 days after treatment
- behavior/clinical signs/mortality: 1, 2, 3, 4, 5, and 6 hours after start of exposure and then at least once a day for a total of 14 days
- Necropsy: Surviving animals were killed by CO2-asphyxia (80 % CO2 and 20 % air) and subjected to a necropsy including a gross pathological
examination. - Statistics:
- not necessary
- Preliminary study:
- Before starting the test, the following experiments were made to obtain more information about the test substance:
- It was tried to produce an aerosol with an actual concentration of about 5 mg respirable test substance per litre.
- Two animals were exposed to an aerosol of the test substance to get first information about its possible toxicity. - Sex:
- male/female
- Dose descriptor:
- LC50
- Effect level:
- > 1.9 mg/L air
- Exp. duration:
- 4 h
- Mortality:
- All animals survived till the end of the study.
- Clinical signs:
- other: No abnormal observations were seen in any animal during the 14 days observation period.
- Body weight:
- The body weight and weight gain was inconspicuous in all animals. The body weight loss the first days after the expose which was seen in most
animals is caused by the restraining in the inhalation tube and not necessarily test substance related. No adverse effect of the test substance can
be derived from the body weight data. - Gross pathology:
- Nothing abnormal was seen in any of the animals.
- Other findings:
- no other findings
- Conclusions:
- The LC50, per inhalation, four hours exposure, of Copolymer of neodecanoic acid oxiranylmethyl ester and 4 -methylbenzenesulfonic acid for male and female rats is therefore greater than 1.9 mg/L air which is the highest technically feasible aerosol concentration.
- Executive summary:
It was the aim of this study to reveal acute toxic effects of
2,3-Epoxypropyl neodecanoate, oligomeric reaction products with toluene-4-sulfonic acid
after a single administration per inhalation as a liquid aerosol.
2,3-Epoxypropyl neodecanoate, oligomeric reaction products with toluene-4-sulfonic acid
was administered as aerosol with a mass median aerodynamic diameter of 2.0µm per inhalation to Sprague Dawley rats. The test substance was applied for 4 hours in a nose-only inhalation device. The actual concentration of the aerosol was1.9mg per litre air which is under the limit concentration for this kind of tests. Five male and fivefemale animals were exposed. The inhalation exposure of rats to
2,3-Epoxypropyl neodecanoate, oligomeric reaction products with toluene-4-sulfonic acid
at the maximal technically feasible concentration of 1.9 mg/L did not produce signs of toxicity. All animals survived and no adverse effects were observed during the 14-day observation period.
The LC50, per inhalation, four hours exposure, of
2,3-Epoxypropyl neodecanoate, oligomeric reaction products with toluene-4-sulfonic acid
for male and female rats is therefore greater than 1.9 mg/L air which is the highest technically feasible aerosol concentration.
Reference
no further remarks
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LC50
- Value:
- 1 900 mg/m³ air
- Quality of whole database:
- The study is valid without restriction (Klimisch code 1)
Acute toxicity: via dermal route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
2,3-Epoxypropyl neodecanoate, oligomeric reaction products with toluene-4-sulfonic acid is of low oral and inhalation toxicity with an oral LD50 (rat) of > 10000 mg/kg bw (OECD 401, Hüls AG, 1985) and an inhalation LC50 of > 1900 mg/ m3 (OECD 403, Seibersdorf 2011).
Justification for selection of acute toxicity – dermal endpoint
According to REACH Annex VIII (Column 2 of section 8.5.3) acute
dermal study not needed because inhalation is considered to be the
relevant route of exposure during use.
Justification for classification or non-classification
According to the criteria of EC Directive 67/548/EEC and EC Regulation 1272/2008 and subsequent regulations on classification, labelling and packaging of substances and mixtures and based on the results of the studies
2,3-Epoxypropyl neodecanoate, oligomeric reaction products with toluene-4-sulfonic acid is not classified.
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