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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
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- May 25 - June 5, 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
- Year:
- 1 993
- Report date:
- 1993
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
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: yellow liquid
- Lot/batch No.: 4567
- Expiration date of the lot/batch: April 31,1994
- Storage condition of test material: ambient
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Harald Schriever; Kaninchenfarm, D-2740 Bremervorde, Neuendamm 88
- Age at study initiation: no data available
- Weight at study initiation: no data available
- Fasting period before study: None
- Housing: individual housing (50 x 45 x 40 cm, L x B x H) in a battery of cages, each equipped with a paper roll disposal system
- Diet (e.g. ad libitum): 2030 Teklad Global Rabbit diet. ad libitum
- Water (e.g. ad libitum):ad libitum
- Acclimation period: no data available
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 2O +/- 3 °C
- Humidity (%): 30-70 %
- Photoperiod (hrs dark / hrs light): artificial lighting (120 lux) from 7.00 a.m. - 7.00 p.m.
IN-LIFE DATES: No data available
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- other: clipped
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 ml
- Concentration (if solution): 100%
VEHICLE
- Amount(s) applied (volume or weight with unit):None
- Concentration (if solution): N/A
- Lot/batch no. (if required): N/A
- Purity: N/A - Duration of treatment / exposure:
- 4 hours
- Observation period:
- Animals were examined for signs of skin reactions at 30-60 min, 24, 48 and 72 h after patch removal.
- Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: Dorsal, ca. 6 cm2 in size
- % coverage: No Data Available
- Type of wrap if used: Each test area was covered with a semi-occlusive dressing consisting of Ypsiplast@ (Holthaus Medical, Remscheid- Luttringhausen), which was held in place by non-irritating tape Elastoplast@ (Beiersdorf AG, Hamburg), and Stiilpa@ (P. Hartmann AG, Heidenheim-Brenz), which enveloped the whole of the animal's trunk.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): none
- Time after start of exposure: 4 hours after application
SCORING SYSTEM: Evaluation of skin reactions (as stipulated by OECD 404); Skin reactions were classified with special consideration to the EEC directive 91/325/EEC of March 1, 1991 and GefStoffV, 1987 (BGBl. I, p. 2721).
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 30-60 min
- Score:
- ca. 0
- Max. score:
- 0
- Reversibility:
- other: no adverse effect
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 24h
- Score:
- ca. 0
- Max. score:
- 0
- Reversibility:
- other: no adverse effect
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 48h
- Score:
- ca. 0
- Max. score:
- 0
- Reversibility:
- other: no adverse effect
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 72h
- Score:
- ca. 0
- Max. score:
- 0
- Reversibility:
- other: no adverse effect
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 30-60 min
- Score:
- ca. 0
- Max. score:
- 0
- Reversibility:
- other: no adverse effect
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 24h
- Score:
- ca. 0
- Max. score:
- 0
- Reversibility:
- other: no adverse effect
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 48h
- Score:
- ca. 0
- Max. score:
- 0
- Reversibility:
- other: no adverse effect
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 72h
- Score:
- ca. 0
- Max. score:
- 0
- Reversibility:
- other: no adverse effect
- Irritant / corrosive response data:
- See table below for Individual Skin Reactions
- Other effects:
- None.
Any other information on results incl. tables
PH of the substance is not available.
Under the experimental conditions described above, the following results were obtained:
Table I: Individual values of skin reactions
Animal # |
Time after patch removal |
|||||||||||||||
30-60 min |
24h |
48 h |
72h |
|||||||||||||
Ery |
Oed |
Ery |
Oed |
Ery |
Oed |
|
|
|
|
|||||||
T |
C |
T |
C |
T |
C |
T |
C |
T |
C |
T |
C |
T |
C |
T |
C |
|
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
2 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
3 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
T= test site
C= control site
Ery= erythema
Oed = oedema
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The substance is considered as not irritating according to the EU criteria for classification.
- Executive summary:
INTRODUCTION AND AIM
The aim of the test was to assess the irritant and/or corrosive effect of "Becrosan 6920"on the skin. Information derived from this test serves to indicate the existence of possible hazards likely to arise from exposure of the skin to the test article.
The test was conducted according to the OECD guideline for the testing of chemicals no. 404 (May 12, 1981) and the EEC directive 84/449/EEC (September 19, 1984). The study was carried outasdescribed in the corresponding protocol approved by the testing facility and the study sponsor on April 28 and 30, 1993, respectively. The principles of Good Laboratory Practice for the testing of chemicalsasspecified by national (BGB1. I, no. 13,Q19a, March 22, 1990) and international (OECD, Paris, 1982) legislation were followed during the performance of the study.
SUMMARY
The potential toxicity of"Becrosan 6920"was assessed in an acute dermal initationkorrosion test on 3 albino rabbits. The skin was exposed to the test article for 4 h. Animals were examined for signs of erythema and oedema at 30-60 min, 24,48 and 72 h after patch removal.
Clinical observations
No test article-dependent findings were observed.
Assessment
The mean grades of skin reactions at 24, 48 and 72 h after patch removal were lower than the value classified as irritant by the EEC directive 91/325/EEC of March 1, 1991 and the Gefahrstoffverordnung (GefStoffV), 1987 (BGB1. I, p. 2721). When applied to the skin for 4 h, the test article"Becrosan 6920"may therefore be considered to ben on-irritant.
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