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EC number: 253-455-4 | CAS number: 37310-83-1
- 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
ORAL EXPOSURE:
The test item Reaction product of oleylalcohol with polyphosphoric acid did not induce mortality following a single oral administration to female rats at a dose of 2000 mg/kg bw. There were no toxic clinical signs or any other test item related effects. Body weights and body weight gain were not influenced by the test item during the study. Autopsy revealed no treatment related pathological changes.
RESPIRATORY EXPOSURE:
According to REACH Regulation (EC) No 1907/2006, Annex VIII, 8.5 data for a maximum of two routes of exposure need to be provided. Testing for acute toxicity via the inhalation route was not required as data on acute oral and acute dermal toxicity were available. In addition, the vapour pressure of the high viscous liquid is expected to be very low.
DERMAL EXPOSURE:
In this acute dermal toxicity study with the test item Reaction product of oleylalcohol with polyphosphoric acid, the obtained acute dermal LD50 value was higher than 2000 mg/kg bw in male and female Crl:(WI)BR rats.
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:
- 2013-03-19 to 2013-04-04
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: according to GLP, OECD and EC guidelines
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Version / remarks:
- adopted 17th December 2001
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
- Version / remarks:
- (Official Journal L 142, 31/05/2008)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.1100 (Acute Oral Toxicity)
- Version / remarks:
- adopted December 2002
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- acute toxic class method
- Limit test:
- yes
- Species:
- rat
- Strain:
- Wistar
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Species / Strain: Rat, Crl(WI)Br
- Source: Toxi-Coop Zrt. 1103 Budapest, Cserkesz u. 90.
- Age at study initiation: Young adult rats, 8 weeks old in group 1 and 2
- Body weight range at starting (first step): 181-194 g
- Body weight range at starting (second step): 187-198 g
- Fasting period before study: food but not water was withheld overnight
- Housing: 3 animals/sex/cage
- Diet: ad libitum (ssniff® SM R/M-Z+H complete diet)
- Water: ad libitum
- Acclimatisation time: 5 days in first step and 6 days in second step
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3 °C
- Humidity (%): 30 - 70 %
- Air changes (per hr): 10-15 air exchanges/hour by central air-condition system.
- Photoperiod: Artificial light, from 6 a.m. to 6 p.m. - Route of administration:
- oral: gavage
- Vehicle:
- other: Helianthi annui oleum raffinatum
- Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 3 animals/group
- Control animals:
- no
- Details on study design:
- Testing Procedure
A single oral administration - followed by a fourteen-day observation period - was performed by gavage. The day before treatment the animals were fasted. The food but not water was withheld overnight. Animals were weighed before the application and the food was given back 3 hours after the treatment.
Dose Level
Starting dose was selected on the basis of the available information about the test item.
The acute toxic class method was carried out involving a stepwise procedure with the use of 2000 mg/kg bw as the starting dose in three female rats. No animal died in the first step at 2000 mg/kg bw dose level. Therefore, treatment with 2000 mg/kg bw was repeated with further three female rats. Again, no animal died in the second step, thus, no further testing was required. The stopping criteria of Annex 2d of OECD Guideline No. 423 (presented in Appendix 7) were met.
A single administration was performed by oral route and was followed by a
14-day observation period.
Observations
Mortality
Inspection for signs of morbidity and mortality were made twice daily at the beginning and end of the working day.
Clinical Observations
Animals were observed individually after dosing once during the first 30 minutes, then 1 h, 2 h, 3 h, 4 h after the treatment and once per day for 14 days thereafter. Individual observations were performed on the skin and fur, eyes and mucous membranes and also respiratory, circulatory, autonomic and central nervous system, somatomotor activity and behaviour pattern.
Particular attention was directed to observation of tremors, convulsions,
salivation, diarrhoea, lethargy, sleep and coma.
Body weight
The body weight were recorded on day 0 (shortly before the treatment), on day 7 and on day 15 on all animals with a precision of 1 g.
Pathology
All animals were subjected to gross pathology. All animals were exsanguinated under isoflurane anaesthesia. After examination of the external appearance the cranial, thoracic and abdominal cavities were opened and the appearance of the tissues and organs were observed. All gross pathological changes were recorded for each animal on the post mortem record sheets. - Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- The test item Reaction product of oleylalcohol with polyphosphoric acid did not induce mortality following a single oral administration to female rats at a dose of 2000 mg/kg bw. All female rats survived the performed treatment until the end of the 14-day observation period.
- Clinical signs:
- other: No treatment related symptoms were observed throughout the treatment day and 14-day post-treatment period at any groups of the female animals.
- Gross pathology:
- All animals treated with 2000 mg/kg bw dose of test item survived until the
scheduled necropsy on Day 15.
No pathological changes were found related to the effect of the test item during the macroscopic examination of animals. - Other findings:
- none
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The test item Reaction product of oleylalcohol with polyphosphoric acid did not induce mortality following a single oral administration to female rats at a dose of 2000 mg/kg bw. There were no toxic clinical signs or any other test item related effects. Body weights and body weight gain were not influenced by the test item during the study. Autopsy revealed no treatment related pathological changes.
- Executive summary:
The method used is not intended to allow for the calculation of a precise LD50value. However, for this acute oral toxicity study with the test item Reaction product of oleylalcohol with polyphosphoric acid in rats the determined LD50is greater than 2000 mg/kg bw (LD50≥ 2000 mg/kg bw).
The test item was ranked into classes of the current EU Regulation on classification, labelling and packaging (CLP) (EC) No 1272/2008 as below:
Table 2:
Dose
(mg/kg bw)Mortality (dead/treated)
LD50
(mg/kg bw)CLP
2000
0/6
above 2000
not classified
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 2 000 mg/kg bw
- Quality of whole database:
- GLP and guideline compliant study with test item.
Acute toxicity: via inhalation route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Acute toxicity: via dermal route
Link to relevant study records
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2013-03-19 to 2013-04-03
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: CLP and Guideline compliant study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Version / remarks:
- , adopted 24th February 1987
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.3 (Acute Toxicity (Dermal))
- Version / remarks:
- , 31.05.2008
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.1200 (Acute Dermal Toxicity)
- Version / remarks:
- , adopted August, 1998
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Limit test:
- yes
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Toxi-Coop Zrt. 1103 Budapest, Cserkesz u. 90.
- Age at study initiation: Young adult rats, females were nulliparous and non-pregnant
- Weight at study initiation: Male 230-248 g, Female 233-263 g
- Fasting period before study: food but not water was withheld overnight
- Housing during acclimasation: 3 animals/sex/cage and during the study: animals were housed individually
- Diet: ad libitum (ssniff® SM R/M-Z+H complete diet )
- Water: ad libitum
- Acclimation period: 5 days (males), 47 days (females)
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3 °C
- Humidity (%): 30 - 70 %
- Air changes (per hr): 10-15 air exchanges/hour by central air-condition system.
- Photoperiod: Artificial light, from 6 a.m. to 6 p.m. - Type of coverage:
- semiocclusive
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- TEST SITE
- Area of exposure: approximately 10 % of the total body surface
- The vial with the test item was opened shortly before being moistened and applied.
- Type of wrap if used: sterile gauze pad below a semi-occlusive plastic wrap
REMOVAL OF TEST SUBSTANCE
- residual test item was removed, using helianthi oleum raffinatum as an appropriate solvent
- Time after start of exposure: 24 hours
TEST MATERIAL
- Amount applied: Limit test: 2000 mg/kg bw - Duration of exposure:
- single administration for 24 hours
- Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 5 males and 5 females
- Control animals:
- not required
- Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: the body weight of all animals were recorded on day 0 (shortly before the treatment), on day 7 and on day 15 (with a precision of 1 g)
- Necropsy of survivors performed: yes
- Other examinations performed: Animals were observed individually 1 h and 5 h after dosing, and once each day for 14 days thereafter. Observations included the skin and fur, eyes and mucous membranes, and also respiratory, circulatory, autonomic and central nervous system, and somatomotor activity and behaviour pattern. Particular attention was directed to observation of tremors, convulsions, salivation, diarrhoea, lethargy, sleep and coma.
All animals were subjected to gross pathology. All animals were exsanguinated under isoflurane anaesthesia on day 15. After examination of the external appearance the cranial, thoracic and abdominal cavities were opened and the appearance of the tissues and organs were observed. All gross pathological changes were recorded for each animal on the post mortem record sheets. - Statistics:
- not applicable
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- no mortality occured
- Clinical signs:
- other: General symptoms No behavioural changes or systemic toxic signs were noted during the study. Dermal irritation symptoms as erythema (redness), oedema and other signs were observed on the treatment site. The very slight (score 1) redness, well defined (sc
- Gross pathology:
- All animals survived until the scheduled necropsy on Day 15.
Slight hydrometra was observed in one female and moderate hydrometra was found in two females. Hydrometra was an indication for the sexual cycle of female animals and is a frequent observation in experimental rats with no toxicological meaning.
No macroscopic alterations due to the systemic toxic effects of the test item were found. - Other findings:
- none
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- In this acute dermal toxicity study with the test item Reaction product of oleylalcohol with polyphosphoric acid, the obtained acute dermal LD50 value was higher than 2000 mg/kg bw in male and female Crl:(WI)BR rats.
- Executive summary:
A limit test was carried out. A single group of male and female animals (n=5 animals/sex) was exposed to Reaction product of oleylalcohol with polyphosphoric acid at 2000 mg/kg bw by dermal route. The test item was applied in its original form and left in contact with the skin for 24 hours, followed by a 14-day observation period.
The results of the study were summarised as follows:
No mortality occurred during the study.
Dose
2000 mg/kg bw
Male
5
Mortality
0/5
Female
5
Mortality
0/5
Neither male nor female animals treated at 2000 mg/kg bw showed behavioural changes and no systemic toxic signs were noted during the study.
The test item caused dermal irritation symptoms as slight to severe erythema, slight oedema and other signs as wounds, crusting and desquamation between Day 1 and Day 14 in males and between Day 1 and Day 11 in females.
Very slight body weight variations were observed in two females during first week and also in one out of the two females during second week.
The body weight development was undisturbed in all male animals.
No macroscopic alterations of organs and tissues referred to the systemic toxic effect of the test item were seen during the necropsy.
In this acute dermal toxicity study with the test item Reaction product of oleylalcohol with polyphosphoric acid, the obtained acute dermal LD50 value was higher than 2000 mg/kg bw in male and female Crl:(WI)BRrats.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 2 000 mg/kg bw
- Quality of whole database:
- GLP and guideline compliant study with test item.
Additional information
Oral:
The method used is not intended to allow for the calculation of a precise LD50value. However, for this acute oral toxicity study with the test item Reaction product of oleylalcohol with polyphosphoric acid in rats the determined LD50is higher than 2000 mg/kg bw (LD50≥ 2000 mg/kg bw). According to the current EU Regulation on classification, labelling and packaging (CLP) (EC) No 1272/2008 no classification for the test item
Reaction product of oleylalcohol with polyphosphoric acid.
Inhalation:
According to REACH Regulation (EC) No 1907/2006, Annex VIII, 8.5 data for a maximum of two routes of exposure need to be provided. Testing for acute toxicity via the inhalation route was not required as data on acute oral and acute dermal toxicity were available. In addition, the vapour pressure of the high viscous liquid is expected to be very low.
Dermal:
A limit test was carried out. A single group of male and female animals (n=5 animals/sex) was exposed to Reaction product of oleylalcohol with polyphosphoric acid at 2000 mg/kg bw by dermal route. The test item was applied in its original form and left in contact with the skin for 24 hours, followed by a 14-day observation period.
Neither male nor female animals treated at 2000 mg/kg bw showed behavioural changes and no systemic toxic signs were noted during the study.
No macroscopic alterations of organs and tissues referred to the systemic toxic effect of the test item were seen during the necropsy.
In this acute dermal toxicity study with the test item Reaction product of oleylalcohol with polyphosphoric acid, the obtained acute dermal LD50 value was higher than 2000 mg/kg bw in male and female Crl:(WI)BRrats.
Justification for selection of acute toxicity – oral endpoint
Most reliable study
Justification for selection of acute toxicity – dermal endpoint
Most reliable study
Justification for classification or non-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.
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