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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 947-954-2 | 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
![](https://chesar.echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
Endpoint summary
Administrative data
Description of key information
Read-across: The acute oral median lethal dose (LD50) of the test item in the female Wistar strain rat was approximately 2500 mg/kg bodyweight.
Globally Harmonised Classification System - Category 5, >2000 - 5000 mg/kg bodyweight.
Acute inhalation and dermal studies were waived as the substance is deemed corrosive to skin.
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:
- 30 June 2011 and 26 July 2011
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study conducted to GLP and in compliance with agreed protocols, with no or minor deviations f rom standard test guidelines and/or minor methodological deficiencies, which do not effect the quality of the relevant results.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.1100 (Acute Oral Toxicity)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: Japanese MAFF, 2000
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- acute toxic class method
- Limit test:
- no
- Specific details on test material used for the study:
- Reaction mass of bis(2-ethylhexyl) hydrogen phosphate and 2-ethylhexyl dihydrogen phosphate :
- Species:
- rat
- Strain:
- Wistar
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Female Wistar (RccHan#:WIST) strain rats were supplied by Harlan Laboratories UK Ltd., Oxon, UK.
- Age at study initiation: Eight to twelve weeks of age
- Weight at study initiation: 158 - 183 g
- Fasting period before study: Overnight fast immediately before dosing and for approximately three to four hours after dosing
- Housing: The animals were housed in groups of three in suspended solid floor polypropylene cages furnished with woodflakes.
- Diet (e.g. ad libitum): Food (2014C Teklad Global Rodent diet supplied by Harlan Laboratories UK Ltd., Oxon, UK) was allowed throughout the study.
- Water (e.g. ad libitum): Free access to mains drinking water was allowed throughout the study.
- Acclimation period: At least five days.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): Set to achieve limits of 19 to 25°C
- Humidity (%): Set to achieve limits of 30 to 70%
- Air changes (per hr): At least fifteen changes per hour
- Photoperiod (hrs dark / hrs light): lighting was controlled by a time switch to give twelve hours continuous light (06:00 to 18:00) and twelve hours darkness. - Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on oral exposure:
- VEHICLE- Concentration in vehicle: 30 mg/ml or 200 mg/mlMAXIMUM DOSE VOLUME APPLIED:
10 ml/kgDOSAGE PREPARATION: The test item was freshly prepared, as required, as a solution at the appropriate concentration in distilled water. The test item was formulated within two hours of being applied to the test system. It is assumed that the formulation was stable for this duration.
CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: Using available information on the toxicity of the test item, 300 mg/kg was chosen as the starting dose. - Doses:
- 300 mg/kg and 2000 mg/kg
- No. of animals per sex per dose:
- 3 females at 300 mg/kg. 6 females at 2000 mg/kg
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: The animals were observed for deaths or overt signs of toxicity ½, 1, 2 and 4 hours after dosing and subsequently once daily for up to fourteen days. Individual bodyweights were recorded prior to dosing and seven and fourteen days after treatment or at death.
- Necropsy of survivors performed: yes; At the end of the observation period the surviving animals were killed by cervical dislocation. All animals were subjected to gross pathological examination. This consisted of an external examination and opening of the abdominal and thoracic cavities for examination of major organs. The appearance of any macroscopic abnormalities was recorded. No tissues were retained. - Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- 2 500 mg/kg bw
- Based on:
- test mat.
- Mortality:
- Individual mortality data are given in Table 1.One animal treated at a dose level of 2000 mg/kg was found dead two days after dosing.
- Clinical signs:
- Individual clinical observations are given in Table 2 and Table 3.Signs of systemic toxicity noted in one animal treated at a dose level of 2000 mg/kg were increased salivation, red/brown staining around the snout and noisy respiration. There were no other signs of systemic toxicity noted.
- Body weight:
- Individual bodyweights and weekly bodyweight changes are given in Table 4 and Table 5.The surviving animals showed expected gains in bodyweight over the study period.
- Gross pathology:
- Individual necropsy findings are given in Table 6 and Table 7.Abnormalities noted at necropsy of the animal that died during the study were patchy pallor of the liver, dark spleen, dark kidneys and haemorrhage of the gastric mucosa. No other abnormalities were noted at necropsy of animals that were killed at the end of the study.
- Interpretation of results:
- other: not classified Migrated informationCriteria used for interpretation of results: EU
- Conclusions:
- The acute oral median lethal dose (LD50) of the test item in the female Wistar strain rat was approximately 2500 mg/kg bodyweight (Globally Harmonised Classification System - Category 5, >2000 - 5000 mg/kg bodyweight).
- Executive summary:
Introduction.
The study was performed to assess the acute oral toxicity of the test item following a single oral administration in the Wistar strain rat. The method was designed to be compatible with the following:
- OECD Guidelines for the Testing of Chemicals No. 423 “Acute Oral Toxicity – Acute Toxic Class Method” (adopted 17 December 2001)
- Method B1 tris Acute Toxicity (Oral) of CommissionRegulation (EC) No. 440/2008
Method.
A group of three fasted females was treated with the test item at a dose level of 300 mg/kg bodyweight. Based on the results from this dose level further groups of fasted females were treated at a dose level 2000 mg/kg bodyweight. Dosing was performed sequentially.
The test item was administered orally as a solution in distilled water. Clinical signs and bodyweight development were monitored during the study. All animals were subjected to gross necropsy.
Mortality.
One animal treated at a dose level of 2000 mg/kg was found dead two days after dosing.
Clinical Observations.
Signs of systemic toxicity noted in one animal treated at a dose level of 2000 mg/kg were increased salivation, red/brown staining around the snout and noisy respiration. There were no other signs of systemic toxicity noted.
Bodyweight.
The surviving animals showed expected gains in bodyweight over the study period.
Necropsy.
Abnormalities noted at necropsy of the animal that died during the study were patchy pallor of the liver, dark spleen, dark kidneys and haemorrhage of the gastric mucosa. No other abnormalities were noted at necropsy of animals that were killed at the end of the study.
Conclusion.
The acute oral median lethal dose (LD50) of the test item in the female Wistar strain rat was approximately 2500 mg/kg bodyweight (Globally Harmonised Classification System ‑ Category 5, >2000 ‑ 5000 mg/kg bodyweight).
- Endpoint:
- acute toxicity: oral
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Justification for type of information:
- 1. HYPOTHESIS FOR THE ANALOGUE APPROACH
The read-across hypothesis proposed is that the organism is not exposed to common compounds but rather, because of structural similarity, that different compounds have similar toxicological and fate properties. In this case the ECHA Read-Across Assessment Framework (RAAF) Scenario 2 is used.
2. SOURCE AND TARGET CHEMICAL(S) (INCLUDING INFORMATION ON PURITY AND IMPURITIES)
Source(Prime): Phosphoric acid, 2-ethylhexyl ester [EC 235-741-0; CAS 12645-31-7]
Source (Supporting): Phosphoric acid, mono and bis-linear butyl esters, potassium salts [EC 947-719-4]
Target: Phosphoric Acid, C8-12 (even-numbered) linear Alkyl Esters [EC not yet assigned; CAS not assigned]
3. ANALOGUE APPROACH JUSTIFICATION
The acute oral toxicity of the Source substances is very low with an LD50 value of greater than 2500 mg/kg bw. Structural and chemical similarities in the Source and Target molecules suggests that these molecules are likely to be of very low oral systemic toxicity. The predicted acute oral toxicity of the Target would likely be an LD50 of greater than 2000 mg/kg bw.
4. DATA MATRIX
Please refer to attached justification. - Reason / purpose for cross-reference:
- read-across source
- Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- 2 500 mg/kg bw
- Based on:
- test mat.
Referenceopen allclose all
Table 1: Mortality Data
Dose Level mg/kg |
Sex |
Number of Animals Treated |
Deaths During Day of Dosing |
Deaths During Period After Dosing |
Deaths |
||||||||||
½ |
1 |
2 |
4 |
1 |
2 |
3 |
4 |
5 |
6 |
7 |
8-14 |
||||
300 |
Female |
3 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0/3 |
2000 |
Female |
3 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0/3 |
Female |
3 |
0 |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
1/3 |
Table 2: Individual Clinical Observations - 300 mg/kg
Dose Level mg/kg |
Animal Number and Sex |
Effects Noted After Dosing |
Effects Noted During Period After Dosing |
||||||||||||||||
½ |
1 |
2 |
4 |
1 |
2 |
3 |
4 |
5 |
6 |
7 |
8 |
9 |
10 |
11 |
12 |
13 |
14 |
||
300 |
1-0 Female |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1-1 Female |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
1-2 Female |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0= No signs of systemic toxicity
Table 3: Individual Clinical Observations - 2000 mg/kg
Dose Level mg/kg |
Animal Number and Sex |
Effects Noted After Dosing |
Effects Noted During Period After Dosing |
||||||||||||||||
½ |
1 |
2 |
4 |
1 |
2 |
3 |
4 |
5 |
6 |
7 |
8 |
9 |
10 |
11 |
12 |
13 |
14 |
||
2000 |
2-0 Female |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
2-1 Female |
SSs |
SSs |
S |
Rn |
Rn |
Rn |
Rn |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
2-2 Female |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
3-0 Female |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
3-1 Female |
0 |
0 |
0 |
0 |
0 |
X |
|
|
|
|
|
|
|
|
|
|
|
|
|
3-2 Female |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0= No signs of systemic toxicity
Rn = Noisy respiration
S = Increased salivation
Ss = Red/brown staining around the snout
X = Animal dead
Table 4: Individual Bodyweights and Weekly Bodyweight Changes - 300 mg/kg
Dose Level mg/kg |
Animal Number |
Bodyweight (g) at Day |
Bodyweight Gain (g) During Week |
|||
0 |
7 |
14 |
1 |
2 |
||
300 |
1-0 Female |
177 |
203 |
210 |
26 |
7 |
1-1 Female |
158 |
173 |
180 |
15 |
7 |
|
1-2 Female |
183 |
210 |
220 |
27 |
10 |
Table 5: Individual Bodyweights and Weekly Bodyweight Changes - 2000 mg/kg
Dose Level mg/kg |
Animal Number |
Bodyweight (g) at Day |
Bodyweight (g) at Death |
Bodyweight Gain (g) During Week |
|||
0 |
7 |
14 |
1 |
2 |
|||
2000 |
2-0 Female |
177 |
182 |
193 |
|
5 |
11 |
2-1 Female |
171 |
174 |
189 |
|
3 |
15 |
|
2-2 Female |
169 |
177 |
191 |
|
8 |
14 |
|
3-0 Female |
162 |
177 |
183 |
|
15 |
6 |
|
3-1 Female |
158 |
- |
- |
150 |
- |
- |
|
3-2 Female |
168 |
174 |
180 |
|
6 |
6 |
Table 6: Individual Necropsy Findings - 300 mg/kg
Dose Level mg/kg |
Animal Number and Sex |
Time of Death |
Macroscopic Observations |
300 |
1-0 Female |
Killed Day 14 |
No abnormalities detected |
1-1 Female |
Killed Day 14 |
No abnormalities detected |
|
1-2 Female |
Killed Day 14 |
No abnormalities detected |
Table 7: Individual Necropsy Findings - 2000 mg/kg
Dose Level mg/kg |
Animal Number and Sex |
Time of Death |
Macroscopic Observations |
2000 |
2-0 Female |
Killed Day 14 |
No abnormalities detected |
2-1 Female |
Killed Day 14 |
No abnormalities detected |
|
2-2 Female |
Killed Day 14 |
No abnormalities detected |
|
3-0 Female |
Killed Day 14 |
No abnormalities detected |
|
3-1 Female |
Found Dead Day 2 |
Liver: patchy pallor Spleen: dark Kidneys: dark Gastric mucosa: haemorrhagic |
|
3-2 Female |
Killed Day 14 |
No abnormalities detected |
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 2 500 mg/kg bw
- Quality of whole database:
- Adequate
Acute toxicity: via inhalation route
Link to relevant study records
- Endpoint:
- acute toxicity: inhalation
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- the study does not need to be conducted because the substance is classified as corrosive to the skin
Reference
Endpoint conclusion
- Endpoint conclusion:
- no study available
Acute toxicity: via dermal route
Link to relevant study records
- Endpoint:
- acute toxicity: dermal
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- the study does not need to be conducted because the substance is classified as corrosive to the skin
Reference
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Justification for classification or non-classification
The acute oral median lethal dose (LD50) of the test item in the female Wistar strain rat was approximately 2500 mg/kg bodyweight. Globally Harmonised Classification System - Category 5, >2000 - 5000 mg/kg bodyweight.
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.
![ECHA](/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/echa_logo.png)