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EC number: 284-851-5 | CAS number: 84988-61-4
- 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 oral LD50 of the substance in the rat was approximately 2500 mg/kg. Acute dermal and acute inhalation studies were not conducted due to the corrisivity of the substance.
Key value for chemical safety assessment
Acute toxicity: via oral route
Link to relevant study records
- Endpoint:
- acute toxicity: oral
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- The study was performed between 30 June 2011 and 26 July 2011
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- Study conducted to GLP and in compliance with agreed protocols, with no or minor deviations from standard test guidelines and/or minor methodological deficiencies, which do not effect the quality of the relevant results. Reliability downgraded from Klimisch 1 to 2 since study being used for read-across.
- 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
- 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/ml
MAXIMUM DOSE VOLUME APPLIED: 10 ml/kg
DOSAGE 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. - 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:
- other: 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 ot
- 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:
- not classified
- Remarks:
- Migrated information Criteria 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).
Reference
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:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 2 500 mg/kg bw
- Quality of whole database:
- Sufficient to meet data requirements. The study is Klimisch 2 (due to read-across only).
Acute toxicity: via inhalation route
Endpoint conclusion
- Endpoint conclusion:
- no study available
- Quality of whole database:
- Study waived on the basis of the corrosivity of the substance. In addition it is not volatile so inhalation is not a significant route of exposure.
Acute toxicity: via dermal route
Endpoint conclusion
- Endpoint conclusion:
- no study available
- Quality of whole database:
- Study waived on the basis of the corrosivity of the substance.
Additional information
The acute toxicity assessment of isononyl phosphate is based on read-across data from the structurally related substance 2-ethylhexyl phosphate (CAS 12645-31-7).
Acute Oral Toxicity
In a reliable study the acute oral median lethal dose (LD50) of the test item in the female Wistar strain rat was approximately 2500 mg/kg bodyweight.
Acute Dermal/Inhalation Toxicity
Acute dermal and acute inhalation studies were not conducted as the substance is classified as corrosive. Effects would be dominated by local tissue damage. The low acute oral toxicity indicates a low systemic toxicity.
Justification for selection of acute toxicity – oral endpoint
Only one study available on the substance.
Justification for classification or non-classification
The substance does not meet the criteria for classification for acute toxicity via the oral route based on the result of an acute oral toxicity study conducted on a related substance, giving a LD50of approximately 2500 mg/kg.The substance is corrosive and therefore no acute dermal or inhalation toxicity studies were conducted.
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