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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
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- June 2 - 7,1993.
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Comparable to guideline study; well documented study report
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 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye 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 / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Harald Schriever, Kaninchenfarm, D-2740 BremerviSrde, Neuendamm 88
- Age at study initiation: No data available
- Weight at study initiation:No data available
- 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):ad libitum
- Water (e.g. ad libitum):ad libitum
- Acclimation period: No data available
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 2O +/- 3"C
- Humidity (%): 30 - 70 %
- Air changes (per hr): No data available
- Photoperiod (hrs dark / hrs light): artificial lighting (120 lux) from 7.00 a.m. - 7.00 p.m.
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 ml
- Concentration (if solution): 100%
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 treatment / exposure:
- Not washed.
- Observation period (in vivo):
- Ocular reactions were assessed 1, 24,48 and 72 h after treatment.
- Number of animals or in vitro replicates:
- 3
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 1 h
- Score:
- ca. 0
- Max. score:
- 0
- Reversibility:
- other: all scores were zeros.
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 1 h
- Score:
- ca. 0
- Max. score:
- 0
- Reversibility:
- other: all scores were zeros.
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 1 h
- Score:
- ca. 2
- Max. score:
- 2
- Reversibility:
- fully reversible within: 24 h
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: 1 h
- Score:
- ca. 1
- Max. score:
- 1
- Reversibility:
- fully reversible within: 24 h
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- other: 24, 48 and 72 h
- Score:
- ca. 0
- Max. score:
- 0
- Reversibility:
- other: all scores were zero.
- Irritant / corrosive response data:
- See below section.
- Other effects:
- none.
Any other information on results incl. tables
Under the experimental conditions described above, the following results were obtained:
Table 1: Individual values of oculurgradings
Animal Number |
Ocular lesion |
Time after treatment (h) |
|||||||
1 |
24 |
48 |
72 |
||||||
T |
C |
T |
C |
T |
C |
T |
C |
||
1 |
Cornea |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Iris |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
Conjunctivae redness |
2 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
Conjunctivae chemosis |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
2 |
Cornea |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Iris |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
Conjunctivae redness |
2 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
Conjunctivae chemosis |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
3 |
Cornea |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Iris |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
Conjunctivae redness |
2 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
Conjunctivae chemosis |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Table 2: Mean values of ocular reactions at 24,48 and 72 h afer treatment (test site)
Animal Number |
Cornea |
Iris |
Conjunctivae |
|
redness |
chemosis |
|||
1 |
0 |
0 |
0 |
0 |
2 |
0 |
0 |
0 |
0 |
3 |
0 |
0 |
0 |
0 |
Clinical observations
Redness and chemosis of the conjunctivae were apparent in all animals up to 1 h p.a.
Reversibility
The observed findings were reversible within 24 h p.a.
Toxic effects other than ocular irritation
No other toxic effects were observed.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The mean grades of ocular reactions at 24, 48 and 72 h p.a. (see Table 2) were lower than the value classified as irritant by the EEC directive 91/325/EEC of March 1, 1991 and the Gefahrstoffverordnung (GefStoffV), 1987 (BGBl. I, p. 2721). When applied to the eye, the test article "Becrosan 6920" might therefore be considered to be non-irritant.
- Executive summary:
INTRODUCTION AND AIM
The aim of the test was to assess the irritant and/or corrosive effect(s) of"Becrosan 6920"on the eyes and associated mucous membranes. Information derived from this test serves to indicate the existence of possible hazards likely to arise from exposure of the eyes to the test article.
The test was conducted according to the OECD guideline for the testing of chemicals no. 405 (February 24, 1987) and to 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 chemicals as specified by national (BGB1. I, no 13, $19 a, 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 eye irritationlcorrosion test on 3 albino rabbits. In each animal, 0.1 ml of the test article was introduced into the conjunctival sac of one eye, the untreated eye serving as a control, Both eyes were examined at 1, 24, 48 and 72 h post application.
Clinical observations
All animals showed conjunctival redness and chemosis which were reversible within 24 h p.a. Toxic effects other than ocular irritation were not observed.
Assessment
The mean grades of ocular reactions at 24,48 and 72 h p.a. were lower than the value classified as irritant by the EEC directive 91/325/EEC of March 1, 1991 and the Gefahrstoffverordnung (GefStoffV), 1987 (BGBl. I, p. 2721). When applied to the eye, the test article"Becrosan 6920"
might therefore be considered to be non-irritant.
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