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Diss Factsheets
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EC number: 942-466-6 | 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://echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
Acute Toxicity: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- 1998-07-07 - 1998-12-30
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: well documented guideline study in compliance with GLP (conducted with a read-across substance)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 998
- Report date:
- 1998
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- The Department of Health of the Government of the United Kingdom
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Test material form:
- other: viscous liquid
- Details on test material:
- - Molecular formula (if other than submission substance): C28H62NO4P (for a representative structure: Phosphoric acid, di(C8)ester, compds with C12 amine)
- Molecular weight (if other than submission substance): 507.76
- Smiles notation (if other than submission substance): CCCCCCCCCCCCN.O=P(O)(OCCCCCCCC)OCCCCCCCC
- InChl (if other than submission substance): InChI=1/C12H27N/c1-2-3-4-5-6-7-8-9-10-11-12-13/h2-13H2,1H3
- Physical state: liquid
- Storage condition of test material: room temperature in the dark
- Other: Data relating to the identity, purity and stability of the test material are the responsibility of the Sponsor.
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River (UK) Ltd, Margate, Kent
- Age at study initiation: approximately eight to twelve weeks
- Weight at study initiation: 205 to 225 g (males); 201 to 234 g (females)
- Housing: housed individually in suspended polypropylene cages furnished with woodflakes during the 24-hour exposure period and in groups of five, by sex, for the remainder of the study
- Diet/Water (e.g. ad libitum): free access to mains drinking water and food (Rat and Mouse Expanded Diet No.1, Special Diets Services Limited, Witham, Essex, UK)
- Acclimation period: five days
- Others: The animals were selected at random and given a number unique within the study by indelible ink-marking on the tail and a number written on a cage card.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 to 22 °C
- Humidity (%): 50 to 62 %
- Air changes (per hr): approximately fifteen changes per hour
- Photoperiod (hrs dark / hrs light): twelve hours continuous light and twelve hours darkness
Administration / exposure
- Type of coverage:
- semiocclusive
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- TEST SITE
- % coverage: 10
- Type of wrap if used: veterinary clippers
REMOVAL OF TEST SUBSTANCE
- Washing (if done): bandage was carefully removed and the treated skin and surrounding hair wiped with cotton wool moistened with distilled water to remove any residual test material
- Time after start of exposure: 24 h
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2000 mg/kg
- Constant volume or concentration used: yes - Duration of exposure:
- 24 h
- Doses:
- 2000 mg/kg
- No. of animals per sex per dose:
- 5 males / 5 females
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Individual bodyweights were recorded prior to application of the test material on day 0 and on days 7 and days 14. The animals were observed for deaths or overt signs of toxicity 0.5, 1, 2 and 4 hours after dosing and subsequently once daily for fourteen days.
- Necropsy of survivors performed: yes - Statistics:
- not applied
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- There were no deaths.
- Clinical signs:
- No signs of systemic toxicity were noted during the study.
- Body weight:
- All animals showed an expected gain in bodyweight during the study.
- Gross pathology:
- No abnormalities were noted at necropsy.
- Other findings:
- Dermal reaction
Signs of skin irritation noted in males were restricted to one animal and included crust formation five to seven days after dosing. Signs of skin irritation noted in females included very slight or well-defined erythema and crust formation one to seven days after dosing.
Any other information on results incl. tables
No effects after dosing were notes (0.5, 1, 2, 3 and 4 hours after dosing). Considering individual dermal reactions, crust formation was reported for one male animals on day 5, 6 and 7 after dosing. Furthermore, crust formation was reported for five females on day 4, 5, 6 and 7 after dosing.
Table 1. Individual Bodyweights and weekly Bodyweight Changes
Dose Level mg/kg | Animal Number and Sex |
Bodyweight (g) at Day | Bodyweight Gain (g) During Week | |||
0 | 7 | 14 | 1 | 2 | ||
2000 | 1-0 Male | 205 | 235 | 278 | 30 | 43 |
1-1 Male | 225 | 251 | 290 | 26 | 39 | |
1-2 Male | 218 | 250 | 294 | 32 | 44 | |
1-3 Male | 216 | 252 | 312 | 36 | 60 | |
1-4 Male | 224 | 257 | 309 | 33 | 52 | |
2-0 Female | 201 | 205 | 223 | 4 | 18 | |
2-1 Female | 215 | 222 | 240 | 7 | 18 | |
2-2 Female | 234 | 238 | 256 | 4 | 18 | |
2-3 Female | 225 | 225 | 247 | 0 | 22 | |
2-4 Female | 212 | 219 | 231 | 7 | 12 |
For all treated animals and killed on day 14, no abnormalities during macroscopic observation were reported.
Evaluation of Data
Data evaluations included the relationship, if any, between the animal's exposure to the test material and the incidence and severity of all abnormalities
including behavioural and clinical observations, gross lesions, bodyweight changes, mortality and any other toxicological effects.
Using the mortality data obtained, an estimate of the acute dermal median lethal dose (LD50) of the test material was made.
Evaluation of Skin Reaction
Erythema and Eschar Formation Value
0 - No erythema
1 - Very slight erythema (barely perceptible)
2 - Well-defined erythema
3 - Moderate to severe erythema
4 - formation (injuries in depth)
5 - Severe erythema (beet redness) to slight eschar
Oedema Formation
0 - No oedema
1 - Very slight oedema (barely perceptible)
2 - Slight oedema (edges of area well-defined by definite raising)
3 - Moderate oedema (raised approximately 1 millimetre)
4 - Severe oedema (raised more than 1 millimetre and extending beyond the area of exposure)
Any other skin reactions, if present were also recorded.
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: other: EU-GHS
- Conclusions:
- The acute dermal median lethal dose (LD50) of phosphoric acid, mono- and di-(C8-C10) ester, compds. with C12-14 amine in the Sprague-Dawley CD strain rat was found to be greater than 2000 mg/kg bodyweight. According to Regulation (EC) 1272/2008, the substance is not classified as acutely toxic by dermal route of exposure.
- Executive summary:
A OECD Guideline 402 study was performed to assess the acute dermal toxicity of phosphoric acid, mono- and di-(C8 -C10) ester, compds. with C12-14 amine in the Sprague-Dawley CD strain rat in compliance with GLP. A group of ten animals (five males and five females) was given a single 24-hour, semi-occluded dermal application to intact skin at a dose level of 2000 mg/kg bodyweight. The animals were observed for fourteen days after the day of treatment and were then killed for gross pathological examination. There were no deaths. No signs of systemic toxicity were noted during the study. Signs of skin irritation noted during the study included very slight to well-defined erythema and crust formation. All animals showed an expected gain in bodyweight during the study. No abnormalities were noted at necropsy. The acute dermal median lethal dose (LD50) of the test material in the Sprague- Dawley CD strain rat was found to be greater than 2000 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.
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