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EC number: 700-893-3 | 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
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 26 July 2011 to 3 October 2011
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP study according to guideline.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 011
- Report date:
- 2011
Materials and methods
Test guidelineopen allclose all
- 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
- GLP compliance:
- yes
- Test type:
- acute toxic class method
- Limit test:
- yes
Test material
- Reference substance name:
- DOPO-OX-Ammonium
- IUPAC Name:
- DOPO-OX-Ammonium
- Details on test material:
- Name of test material (as cited in study report): "DOPO-OX-Ammonium"
Chemical name: 9,10-dihydro-10-hydroxy-9-oxa-10-phosphaphenanthren-10-on- resp. 10-oxid-ammonium salt, corrected later to: 9,10-dihydro-10-hydroxy-9-oxa-10-phosphaphenanthren-10-oxid-ammonium salt
Trade name: DOPO-OX-Ammonium
Hill formula: C12H12NO3P
Lot No.: DAS-1101
Appearance: White to slight yellow solid
Conditions of storage: Room temperature
Expiry date: According to the sponsor, the stability of the test item is guaranteed throughout the study period when stored under the conditions stated.
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: Crl: CD(SD)
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- Species, strain: Rats, Crl:CD(SD).
Supplier: Charles River Deutschland GmbH, D-97633 Sulzfeld.
Number and sex: 6 females.
Age: Between 8 and 9 weeks at the time of the administration.
Health conditions: A health inspection was performed prior to the commencement of treatment to ensure that the animals were in a good state of health.
Hygiene: Optimal hygienic conditions.
Room number: EH1-23.
Room temperature: a mean of 20.95 °C (continuous control and recording).
Relative humidity: a mean of 58.53 % (continuous control and recording).
Air exchange: 12 per hour.
Light: Artificial light from 6 a.m. to 6 p.m.
Cages: Single caging in Makrolon cages type III (37.5 cm x 21.5 cm bottom area, 18 cm height). Wire mesh lids. Sanitation of cages once a week.
Bedding material: Aspen wood chips, supplied by ABEDD®, LAB & VET Service GmbH, Vienna, autoclaved. Random samples of the bedding material are analysed for contaminants by the supplier. Changes 1 / week..
Environmental enrichment: Nibbling wood bricks (10 cm x 2 cm x 2 cm) and nesting material, both from the same material and source as the bedding material, were offered to the animals once a week.
Feed: Ssniff R/M-H maintenance diet for rats and mice (item V1534-300) ad libitum, supplied by Ssniff Spezialdiäten GmbH, 59494 Soest, Germany. Analysis of the feed for ingredients and contaminants is performed randomly by Ssniff.
Exception: The feed was withdrawn the evening before the administration of the test substance and was offered again about three hours afterwards.
Water: Tap water from an automatic watering system, ad libitum. Random samples of the water are analysed by the "AGES", A-1226 Vienna, to check, if the water fulfils the requirements for drinking water for humans.
Identification: Labelling with felt-tipped pen on the tail and on the cage.
Acclimatisation: At least 7 days.
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Remarks:
- (deionised)
- Details on oral exposure:
- A peroral administration was performed once in the morning by stomach intubation using a metal gavage.
Vehicle: deionised water.
Dose volume: 20 mL per kg body weight. The individual dose volumes were calculated using the body weights determined on the day of the administration.
Justification: The test substance was not soluble in water, but a homogeneous suspension could be prepared with water and water shall be used preferably, according to the guidelines.
Annex 2d of the OECD guideline and Annex 1d of the EC-Directive were used for the stepwise dosing to groups of 3 females each.
The sequence of dosing of the test substance was:
• Step 1: 2000 mg per kg body weight.
• Step 2: 2000 mg per kg body weight.
A Limit-Test with the starting dose of 2000 mg/kg body weight was requested by the sponsor. The further proceeding was in accordance with the guideline/directive. - Doses:
- 2000 mg per kg body weight
- No. of animals per sex per dose:
- 3 per step (6 females per dose)
- Control animals:
- no
- Details on study design:
- Observations were performed within the periods 0 - 0.5, 0.5 - 1, 1 - 2, 2 - 4 and 4 - 6 hours after administration (p.a.) of the test substance and then at least once a day for a total of 14 days. Observations included but were not limited to changes in skin, fur, eyes, the occurrence of secretions and excretions, autonomic activity, changes in gait, posture and the presence of convulsions.
Body weights were determined
• before administration.
• 7 days p.a.
• 14 days p.a.
Body weight gain was calculated for each week of the study, i.e. between
• 0 and 7 days p.a.
• 7 and 14 days p.a.
The animals were sacrificed by inhalation of 80 % CO2 + 20 % air 14 days p.a. and subjected to a necropsy including a gross pathological examination.
- Statistics:
- Not applicable
Results and discussion
Effect levelsopen allclose all
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 5 000 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: Based on the guidance given in OECD guideline 423 (annex 2d), the LD50, oral can be assessed to be > 5000 mg/kg body weight.
- Mortality:
- No mortality occurred.
- Clinical signs:
- No toxic effects of the test substance were noted by signs in life and post mortem at a dose of 2000 mg test substance per kg body weight.
- Body weight:
- 5/6 animals gained weight in both weeks p.a., 1/6 animals gained no weight in the second week p.a.
- Gross pathology:
- No abnormal findings were made in all animals at the necropsy 14 d p.a.
Any other information on results incl. tables
Table: Body weights and body weight gain
Individual data, means and standard deviations SD.
Dose |
Animal |
Body weight (g) |
Body weight gain (g) |
||||
mg/kg (Step No.) |
No. |
before |
7 days |
14 days |
death |
0-7 days |
7-14 days |
2000 |
51 |
209 |
247 |
255 |
- |
38 |
8 |
(1) |
52 |
208 |
227 |
234 |
- |
19 |
7 |
|
53 |
210 |
238 |
238 |
- |
28 |
0 |
|
mean |
209.0 |
237.3 |
242.3 |
- |
28.3 |
5.0 |
|
SD |
1.0 |
10.0 |
11.2 |
- |
9.5 |
4.4 |
2000 |
54 |
200 |
235 |
253 |
- |
35 |
18 |
(2) |
55 |
199 |
237 |
254 |
- |
38 |
17 |
|
56 |
196 |
231 |
250 |
- |
35 |
19 |
|
mean |
198.3 |
234.3 |
252.3 |
- |
36.0 |
18.0 |
|
SD |
2.1 |
3.1 |
2.1 |
- |
1.7 |
1.0 |
Table: Observations in life
Findings |
Dose |
Animal Nos. |
Observation time |
no clinical signs |
2000, 1 |
51, 52, 53 |
0 h / 14 d |
no clinical signs |
2000, 2 |
54, 55, 56 |
0 h / 14 d |
Table: Necropsy findings
Number of animals examined: 6 females.
SYSTEM |
Dose |
Step No. |
Animal Nos. |
no abnormal findings |
2000 |
1 |
51, 52, 53 |
no abnormal findings |
2000 |
2 |
54, 55, 56 |
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- According to Commission Directive 2001/59/EC "DOPO-OX-Ammonium" does not require classification for acute oral toxicity.
- Executive summary:
Methods and investigations were performed in conformance with the OECD-Guideline 423, 17 December 2001 and the Council Regulation (EC) No 440/2008,Method B.1 tris.
Administration of the test substance
"DOPO-OX-Ammonium" was administered once orally via gavage as a suspension in deionised water to female Crl:CD(SD) rats.
The dosing was performed sequentially to groups of 3 animals per step using a starting dose of 2000 mg per kg body weight. The dose volume was 20 mL per kg body weight for all groups.
Investigations
· Body weights: before administration, 7 and 14 days after the administration (p.a.).
· Clinical observations: at least once per day.
· Necropsy: The animals were sacrificed and necropsied 14 days p.a.
Results
Dose
(mg/kg)Step No.
No. of animals
Prominent findings
exposed
affected
deceased
in life
post mortem
2000
1
3
0
0
none
none
2000
2
3
0
0
none
none
Presence of signs in life
no signs
Full recovery of the animals
not applicable
Body weights
5/6 animals gained weight in both weeks p.a.,
1/6 animals gained no weight in the 2ndweek p.a.Findings in life and post mortem indicate
no toxic effects present
LD50, oralaccording to OECD
> 5000 mg/kg body weight
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