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EC number: 271-663-3 | CAS number: 68603-55-4
- 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
Key value for chemical safety assessment
Acute toxicity: via oral route
Link to relevant study records
- Endpoint:
- acute toxicity: oral
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- November 13, 1981 - December 2, 1981
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Justification for type of information:
- Refer to the section 13 of IUCLID dataset for details on the read across justification. The acute oral toxicity study with the read across substance is considered sufficient to fulfil the information requirements as further explained in the provided endpoint summary
- Reason / purpose for cross-reference:
- read-across source
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- yes
- Species:
- rat
- Strain:
- other: Tif: RAIf (SPF), F3-crosses of RII 1/Tif x RII 2/Tif
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: CIBA-GEIGY Ltd., Tierfarm, CH-4332 Sisseln
- Age at study initiation: 7 to 8 weeks
- Weight at study initiation: 163 - 190 g
- Fasting period before study: over night, prior to dosing
- Housing: groups of 5 in macrolon cages type 3 with standardized soft wood bedding
- Diet: rat food, Nafag No. 890
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 3
- Humidity (%): 55 +/- 15
- Air changes (per hr): approx. 15
- Photoperiod (hrs dark / hrs light): 12/12 - Route of administration:
- oral: gavage
- Vehicle:
- polyethylene glycol
- Details on oral exposure:
- MAXIMUM DOSE VOLUME APPLIED: 10 ml/kg bw
- Doses:
- 5000 mg/kg bw
- No. of animals per sex per dose:
- 5
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days or until all symptoms have disappeared, whichever lasts longer
- Frequency of observations: daily
- Frequency of weighing: on days 1, 7, 14 and at death
- Necropsy of survivors performed: yes - Statistics:
- For the body weights, the group means and their standard deviation were calculated.
The LD50 including the 95 % confidence limit were computed by the logit method. - Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 5 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- 1 female animal died 2 days post application.
- Clinical signs:
- other: Dyspnoea, ruffled fur and curved body position were observed directly after application and lasted up to day 7 post application. For several hours or days, respectivley, sedation and diarrhoea was also observed. All clinical signs were reversible within t
- Gross pathology:
- No compound related gross organ changes were observed.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Upon an acute oral administration and a 14 day post-treatment observation period, an LD50 of > 5000 mg/kg bw was determined in the rat.
- Executive summary:
A study was conducted to determine the acute oral toxicity of the read-across substance amines, C11-14-branched alkyl, monohexyl and dihexyl phosphates according to OECD Guideline 401, under GLP conditions. Groups of 5 rats per sex were administered the test substance at an oral gavage dose of 5000 mg/kg bw and observed for 14 days post dose for mortality, clinical signs, and body weight. Following observation period, the treated animals were sacrificed to observe gross pathological signs in the internal organs. No mortality was observed througout the study. Under the study conditions, the acute oral LD50 of the substance was determined to be greater than 5000 mg/kg bw (Sarasin, 1981).
Reference
Dose (mg/kg bw) |
Day 1 |
Day 7 |
Day 14 |
|
Males |
||
5000 |
182 (5.8) |
206 (9.3) |
250 (15.7) |
|
Females |
||
5000 |
171 (5.2) |
178 (6.9) |
202 ( 5.5) |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 5 000 mg/kg bw
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
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- test procedure in accordance with generally accepted scientific standards and described in sufficient detail
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- GLP compliance:
- not specified
- Test type:
- fixed dose procedure
- Limit test:
- yes
- Species:
- rat
- Strain:
- other: Tif:RAIf(SPF), F3-crosses of RII 1/Tif X RII 2/Tif
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- Source of animals: CIBA-GEIGY LTD. Tierfarm, 4334 Sisseln, Switzerland
Initiral body weight range: 177-239 g
Initial age: 7-8 weeks
Husbandry: The animals were kept under conventional laboratory conditions. They were caged individually in Macrolon cages type 2 with standardized soft wood bedding (Societe Parisienne des
sciures, Pantin). The animal room was air conditionned: temperature 22+3C, relative humidity 55±15%, 12 hours light/day, approximately 15 air changes/h.
Food: NAFAG No. 890, NAFAG AG, Gossau, SG (Switzerland),and water were provided ad libitum. - Type of coverage:
- semiocclusive
- Vehicle:
- unchanged (no vehicle)
- Duration of exposure:
- 24 h
- Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 5
- Control animals:
- yes, concurrent no treatment
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the study conditions, the acute dermal LD50 of the substance was determined to be greater than 2000 mg/kg bw.
- Executive summary:
A study was conducted to determine the acute dermal toxicity of the substance according to OECD Guideline 402, under GLP conditions. Groups of 5 rats per sex were administered the test substance at a topical dose of 2000 mg/kg bw on the shaved skin of the back with a semiocclusive bandage. The exposure was for 24 h following which the test substance was washed with water and the treated animals were observed for 14 days post dose for mortality, clinical signs, and body weight. Following observation period, the treated animals were sacrificed to observe gross pathological signs in the internal organs. No mortality was observed througout the study. Under the study conditions, the acute dermal LD50 of the substance was determined to be greater than 2000 mg/kg bw (Kobel, 1984).
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 2 000 mg/kg bw
Additional information
A study was conducted to determine the acute oral toxicity of the read-across substance amines, C11-14-branched alkyl, monohexyl and dihexyl phosphates according to OECD Guideline 401, under GLP conditions. Groups of 5 rats per sex were administered the test substance at an oral gavage dose of 5000 mg/kg bw and observed for 14 days post dose for mortality, clinical signs, and body weight. Following observation period, the treated animals were sacrificed to observe gross pathological signs in the internal organs. No mortality was observed througout the study. Under the study conditions, the acute oral LD50 of the substance was determined to be greater than 5000 mg/kg bw (Sarasin, 1981).
A study was conducted to determine the acute dermal toxicity of the read-across substance amines, C11-14-branched alkyl, monohexyl and dihexyl phosphates according to OECD Guideline 402, under GLP conditions. Groups of 5 rats per sex were administered the test substance at a topical dose of 2000 mg/kg bw on the shaved skin of the back with a semiocclusive bandage. The exposure was for 24 h following which the test substance was washed with water and the treated animals were observed for 14 days post dose for mortality, clinical signs, and body weight. Following observation period, the treated animals were sacrificed to observe gross pathological signs in the internal organs. No mortality was observed througout the study. Under the study conditions, the acute dermal LD50 of the substance was determined to be greater than 2000 mg/kg bw (Kobel, 1984).
Justification for classification or non-classification
Based on the results of the read across studies through oral and dermal routes, the substance does not warrant any classification according to EU CLP (1272/2008/EC) criteria.
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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