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EC number: 418-310-3 | CAS number: 126050-54-2
- 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
Acute Toxicity: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 24 August and 7 September 1999
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 999
- Report date:
- 1999
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.3 (Acute Toxicity (Dermal))
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- yes
Test material
Reference
- Name:
- Unnamed
- Type:
- Constituent
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- Identity: HP-10
Chemical name: 2,4,8,10-tetrakis(1,1-dimethyl ethyl)-6-(2-ethylhexyloxy)-12H-dibenzo[d,g][1,3,2]dioxaphosphocin
Intended use: Chemical use in production of plastics (As an antioxidant and/or a stabilizer)
Appearance: White powder
Storage conditions: Room temperature in the dark
Lot number: 10549
Expiry: 6 months from date of receipt
Purity: 100%
Sample received: 3 August 1999
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- The animals chosen for this study were selected from a stock supply of healthy male and female CD rats of Sprague-Dawley origin (Hsd:Sprague-Dawley (CD)) obtained from Harlan U.K. Ltd., Bicester, Oxon, England.
They were in the weight range of 221 to 249 g and approximately eight to eleven weeks of age prior to dosing (Day 1). All the rats were acclimatised to the experimental environment for a period of five days prior to the start of the study.
The rats were allocated without conscious bias to cages within the treatment group. They were housed individually in metal cages (RS Biotech Sub-Dividable Rodent Cages- polished stainless steel (20cm high x 39cm wide x 39cm long)) until Day 3 when they were returned to group housing. The cages were fitted with grid floors to ensure rapid removal of waste material to undertrays. The cages were suspended in mobile stainless steel racks in Room 6 of Building R14.
A standard laboratory rodent diet (Special Diet Services RMI(E) SQC expanded pellet) and drinking water were provided ad libitum. The batch(es) of diet used for the study was analysed for certain nutrients, possible contaminants and micro-organisms. Results of routine physical and chemical examination of drinking water, as conducted by the supplier, are made available to Huntingdon Life Sciences Ltd. as quarterly summaries.
Thermostatic controls were set to maintain a temperature of 22 ± 3°C. Relative humidity was not fully controlled but was anticipated to be in the range 30 - 70%. Temperature and humidity were recorded continuously using a seven day recorder. Actual measurement of these parameters revealed that animal room temperature was in the range 21.5 to 24.5°C and relative humidity was in the range 37 - 63%. Permanent daily recordings of these parameters were made and these are archived with other Departmental raw data. Lighting was controlled by means of a time switch to provide 12 hours of artificial light (0700- 1900 hours) in each 24-hour period.
Each animal was identified by cage number and ear punching. Each cage was identified by a coloured label displaying the dose level, study schedule number, animal mark and the initials of the Study Director and Home Office licensee.
Administration / exposure
- Type of coverage:
- occlusive
- Vehicle:
- other: aqueous methylcellulose
- Details on dermal exposure:
- TEST SUBSTANCE PREPARATION: HP-10 was formulated at a maximum practical concentration of 55% w/v m 1% w/v aqueous methylcellulose and administered at a dose volume of 3.64 ml/kg bodyweight.
The test substance was prepared on the day of dosing.
ADMINISTRATION OF TEST SUBSTANCE: A group often rats (five males and five females) was treated at 2000 mg/kg bodyweight.
One day prior to treatment, hair was removed from the dorso-lumbar region of each rat with electric clippers taking care to avoid damaging the skin, exposing an area equivalent to approximately 10% of the total body surface area.
The test substance was applied by spreading it evenly over the prepared skin. The treatment area (approximately 50 mm x 50 mm) was covered with porous gauze held in place with a non irritating dressing, and further covered by a waterproof dressing encircled firmly around the trunk of the animal.
Treatment in this manner was performed on Day 1 (day of dosing) of the study only.
At the end of the 24 hours exposure period the dressings was carefully removed and the treated area of skin was washed with warm water (38°C) to remove any residual test substance. The treated area was blotted dry with absorbent paper.
Control animals: No control animals were included in this study. - Duration of exposure:
- 24 h
- Doses:
- Single dose 2000 mg/kg bw (dose volume: 3.64 mg/kg bw)
- No. of animals per sex per dose:
- 10 animals (five males & five females).
- Control animals:
- no
- Details on study design:
- Mortality: Cages of rats were checked at least twice daily for mortalities.
Clinical signs: Animals were observed soon after dosing and at frequent intervals for the remainder of Day 1. On subsequent days animals were observed once in the morning and again at the end of the experimental day (with the exception of Day 15 - morning only). The nature and severity of the clinical signs and time were recorded at each observation.
All animals were observed for 14 days after dosing.
Dermal responses: Local dermal irritation at the treatment site was assessed daily using the following numerical scoring system:
Erythema and eschar formation:
No erythema 0
Slight erythema 1
Well defined erythema 2
Moderate erythema 3
Severe erythema (beet redness) to slight eschar formation (injuries in depth) 4
Oedema formation:
No oedema 0
Slight oedema 1
Well-defined oedema (edges of area well-defined by definite raising) 2
Moderate oedema (raised approximately 1 millimetre) 3
Severe oedema (raised more than 1 millimetre and extending beyond the area of exposure) 4
Bodyweight: The bodyweight of each rat was recorded on Days 1 (prior to dosing), 8 and 15. Individual weekly bodyweight changes and group mean bodyweights were calculated.
TERMINAL STUDIES
Termination: All animals were killed on Day 15 by cervical dislocation.
Macroscopic pathology: All animals were subjected to a macroscopic examination which consisted of opening the thoracic and abdominal cavities. The macroscopic appearance of all examined organs was recorded. - Statistics:
- Not specified in the study report.
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- dissolved
- Mortality:
- There were no mortalities throughout the study following a single dermal application of HP-10 to a group often rats (five males and five females) at a dose level of2000 mg/kg bodyweight.
- Clinical signs:
- There was no systemic response in any animal throughout the study.
- Body weight:
- All animals were considered to have achieved satisfactory bodyweight gains throughout the study.
- Gross pathology:
- No abnormalities were recorded at the macroscopic examination on Day 15.
- Other findings:
- Transient very slight dermal irritation (Grade 1 erythema) was seen in three females following removal of the dressings, resolving completely by Day 3. No dermal irritation was noted in any other animal during the study.
Any other information on results incl. tables
TABLE 1 – Dermal reactions
Dose (mg/kg) |
Sex |
Animal No |
E=Erythema O=Oedema |
Day |
|
2 |
3 to 15 |
||||
2000 |
Male |
1 |
E |
0 |
0 |
O |
0 |
0 |
|||
2 |
E |
0 |
0 |
||
O |
0 |
0 |
|||
3 |
E |
0 |
0 |
||
O |
0 |
0 |
|||
4 |
E |
0 |
0 |
||
O |
0 |
0 |
|||
5 |
E |
0 |
0 |
||
O |
0 |
0 |
|||
Female |
6 |
E |
1 |
0 |
|
O |
0 |
0 |
|||
7 |
E |
1 |
0 |
||
O |
0 |
0 |
|||
8 |
E |
1 |
0 |
||
O |
0 |
0 |
|||
9 |
E |
0 |
0 |
||
O |
0 |
0 |
|||
10 |
E |
1 |
0 |
||
O |
0 |
0 |
TABLE 2 – Individual and group mean bodyweights (g)
Dose (mg/kg) |
Sex |
Animal Number |
Bodyweight (g) at Day |
||
1 |
8 |
15 |
|||
2000 |
Male |
1 |
232 |
256 |
282 |
2 |
240 |
278 |
317 |
||
3 |
233 |
248 |
269 |
||
4 |
240 |
270 |
298 |
||
5 |
249 |
291 |
333 |
||
Mean |
239 |
269 |
300 |
||
Female |
6 |
221 |
227 |
236 |
|
7 |
225 |
237 |
247 |
||
8 |
225 |
238 |
248 |
||
9 |
230 |
248 |
262 |
||
10 |
224 |
231 |
237 |
||
Mean |
225 |
236 |
246 |
TABLE 3 – Individual bodyweight changes (g)
Dose (mg/kg) |
Sex |
Animal Number |
Bodyweight change at Day (g) |
|
8 |
15 |
|||
2000 |
Male |
1 |
24 |
26 |
2 |
38 |
39 |
||
3 |
15 |
21 |
||
4 |
30 |
28 |
||
5 |
42 |
42 |
||
Female |
6 |
6 |
9 |
|
7 |
12 |
10 |
||
8 |
13 |
10 |
||
9 |
18 |
14 |
||
10 |
7 |
6 |
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The acute lethal dermal dose to rats of HP-1 0 was demonstrated to be greater than 2000 mg/kg bodyweight.
- Executive summary:
A study was performed to assess the acute dermal toxicity of HP-1 0 to the rat. The method followed was based on that described in:
EEC Methods for the determination of toxicity, Annex to Directive 92/69/EEC (Official Journal No. L383A, 29.12.92), Part B, Method B.3. Acute toxicity (dermal).
OECD Guideline for Testing of Chemicals No. 402 "Acute Dermal Toxicity". Adopted: 24 February 1987.
A group of ten rats (five males and five females) received a single topical application of the test substance, formulated at a maximum practical concentration in I% w/v aqueous methylcellulose, at a dose level of 2000 mg/kg bodyweight All animals were killed and examined macroscopically on Day 15, the end of the observation period.
There was no systemic response in any animal throughout the study.
Transient very slight dermal irritation (Grade 1 erythema) was seen in three females following removal of the dressings, resolving completely by Day 3. No dermal irritation was noted in any other animal during the study.
All animals were considered to have achieved satisfactory bodyweight gains throughout the study.
No abnormalities were recorded at the macroscopic examination on Day 15.
The acute lethal dermal dose to rats of HP-1 0 was demonstrated to be greater than 2000 mg/kg bodyweight.
HP-10 will not require labelling with the risk phase R21 "Harmful in contact with skin", in accordance with Commission Directive 93/21/EEC.
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