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reaction product of: saturated, monounsaturated and multiple unsaturated long-chained partly estrified alcohols of vegetable origin (Brassica napus L., Brassica rapa L., Helianthus annuus L., Glycine hispida, Gossypium hirsutum L., Cocos nucifera L., Elaeis guineensis) with O,O-diisobutyldithiophosphate and 2-ethylhexylamine and hydrogen peroxide
EC number: 428-630-5 | 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: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- December 29, 1992 - January 19,1993.
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study conducted to GLP in accordance with recognised guideline
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Report date:
- 1993
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.3 (Acute Toxicity (Dermal))
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- -
- EC Number:
- 428-630-5
- EC Name:
- -
- Molecular formula:
- Not applicable
- IUPAC Name:
- reaction product of Z-9-octadecen-1-ol and O,O-diisobutyl hydrogen dithiophosphate
- Details on test material:
- - Name of test material (as cited in study report): Becrosan 6920
- Physical state: clear, brown liquid
- Lot/batch No.: 395 1
- Expiration date of the lot/batch: December 3 1,1993
- Storage condition of test material: ambient
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: Han: WIST (Syn: Wistar), white
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source:
Zentralinstitut fiir
Versuchstierzucht GmbH
Hermann-Ehlers-Alee 57
3000 Hannover 91
- Age at study initiation: no data
- Weight at study initiation: m: 218 - 247 g, f: 169 - 191 g
- Fasting period before study: None
- Housing: individual housing in cages (Makrolon@ type 11)
- Diet (e.g. ad libitum): 2014 Teklad Global Rodent Diet. ad libitum
- Water (e.g. ad libitum):ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22+/- 3 °C
- Humidity (%): 30-70 %
- Photoperiod (hrs dark / hrs light): artificial lighting (120 lux) from 7.00 a.m. - 7.00 p.m.
Administration / exposure
- Type of coverage:
- semiocclusive
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- TEST SITE
- Area of exposure: back
- Type of wrap if used: with a porous gauze dressing and Elastoplast" (Beiersdorf).
REMOVAL OF TEST SUBSTANCE
- Washing (if done): none.
- Time after start of exposure:not applicable
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): The test article was applied undiluted in a volume of 2.04 ml/kg, or 2000 mg/kg
- Concentration (if solution): N/A
- Constant volume or concentration used: yes
- For solids, paste formed: N/A
VEHICLE
- Amount(s) applied (volume or weight with unit):N/A
- Concentration (if solution):N/A
- Lot/batch no. (if required): N/A
- Purity: N/A - Duration of exposure:
- 24 h
- Doses:
- Single dose level of 2000 mg/kg bodywight
- No. of animals per sex per dose:
- 5m, 5f, dosed at 2000 mg/kg bw
- Control animals:
- not required
- Details on study design:
- - Duration of observation period following administration: The animals were examined at the following post-treatment intervals: 10 min, 1 h, 2 h, 6 h,
24 h, and thereafter once daily up to day 14.
- Frequency of observations and weighing: Body weights were recorded immediately before treatment (day 0) and on days 7 and 14 p.a. (termination).
- Necropsy of survivors performed: The animals were sacrificed by C02 asphyxiation after 14 days and gross pathological examinations were subsequently performed.
- Other examinations performed: clinical signs, body weight, dermal irritation - Statistics:
- Using the mortality data obtained, an estimate of the acute dermal median lethal dose (LD50) of the test material was made.
Results and discussion
- Preliminary study:
- not applicable.
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- 0
- Clinical signs:
- other: No abnormal clinical signs were observed.
- Gross pathology:
- Gross pathological examinations at 14 days p. a. (terminal necropsy) revealed no test article-dependent findings. That macroscopic change observed was attributable to the sacrificing procedure or to minor variations which can occur spontaneously in rats of this strain and age.
- Other findings:
- - Organ weights: No data available
- Histopathology: No data available
- Potential target organs: No data available
- Other observations: No signs of erythema and oedema were observed.
Any other information on results incl. tables
Under the experimental conditions described above, the following results were obtained.
Range finding
There were no deaths in the preliminary study
Main study
Pre-tenninul deaths
No animals died during the course of the main study.
Clinical observations
No abnormal clinical signs were observed.
Body weight
Weight gains were normal in all animals.
Skin reactions
No signs of erythema and oedema were observed.
Necropsy
Gross pathological examinations at 14 days p. a. (terminal necropsy) revealed no test article-dependent findings. That macroscopic change observed was attributable to the sacrificing procedure or to minor variations which can occur spontaneously in rats of this strain and age.
LD50 values
According to the requirementsofthe limit test, theLD50values after 24 h and 14 days were as follows:male and female>2000mgkg
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- According to the requirements of the limit test, the LD50 values after 24 h and 14 days were as follows: male and female > 2000mgkg
- Executive summary:
INTRODUCTION AND AIM
The aim of the test was to determine the acute median lethal dose of "Becrosan 6920". Information derived from this test serves to indicate the existence of possible hazards likely to arise from short-term exposure to the test article by the dermal route.
The test was conducted according to the OECD guideline for the testing of chemicals OECD 402 (February 24, 1987) and to theEECdirective 84/449/EEC (September 19, 1984). The study was carried out as described in the corresponding protocol approved by the testing facility and the study sponsor on November 25 and 30, 1992. The principles of Good Laboratory Practice for the testing of chemicals as specified by national (BGB1.I,no 13,919 a, March 22, 1990) and international (OECD, Paris, 1982) legislation were followed during the performance of the study.
SUMMARY
The acute dermal toxicity of "Becrosan 6920" was investigated in5male and5female Wistar rats.
On the basis of the range finding results, each animalwasgiven a single dermal administration of "Becrosan 6920" at a dose of 2000 mg/kg body weight. The skin was exposed to the test article for 24 h and signs of erythema and oedema were subsequently evaluated once daily for 14 days.
Clinical observations were conducted at regular intervals during the 14-day observation period. Body weights were measured at days 0, 7 and 14 p.a. Gross pathological examinations were performed on animals at termination.
The following results were obtained:
1. No abnormal clinical signs were observed.
2. No signs of erythema and oedema were observed.
3. Weight gains were normal in all animals.
4. Gross pathological examinations at 14 days p.a. (terminal necropsy) revealed no test article-dependent findings.
5.According to the requirements of the limit test, the LD50 values after 24 h and
14days were as follows:male and female > 2000 mgkg
6.The above value is higher than the limit specifiedasharmful by the EEC directive 91/325/EEC and the Gefahrstoffverordnung (GefStoffV), 1987 (BGBL.1 p. 2721). When applied to the skin, the test article"Becrosurz 6920"may therefore be classifiedas"non-toxic".
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