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EC number: 947-427-7 | 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
Short-term toxicity to fish
Administrative data
Link to relevant study record(s)
- Endpoint:
- short-term toxicity to fish
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 14 Jun - 18 Jun 1993
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Guideline study with acceptable restrictions
- Qualifier:
- according to guideline
- Guideline:
- ISO 7346-1 (Determination of the Acute Lethal Toxicity of Substances to a Freshwater Fish [Brachydanio rerio Hamilton-Buchanan (Teleostei, Cyprinidae)] - Part 2: Semi-static method)
- GLP compliance:
- yes
- Analytical monitoring:
- yes
- Details on sampling:
- - Concentrations: 100 and 1000 mg/L
- Vehicle:
- no
- Details on test solutions:
- PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
- Method: The test solution was prepared with dilution water. The final volume was 5 L. The test concentration was prepared by direct weighing of the test substance due to its insolubility. After mixing, the aquaria were treated with ultraturrax for approximately 10 seconds.
- Controls: 1 - Test organisms (species):
- Danio rerio (previous name: Brachydanio rerio)
- Details on test organisms:
- TEST ORGANISM
- Common name: zebrafish
- Source: Fa. Westaquarium, delivered on 02 Mar 1993
- Feeding during test: not stated
- Food type: Altromin N-1324
ACCLIMATION
- Health during acclimation (any mortality observed): Mortality was < 0.1% one week before starting the test. - Test type:
- semi-static
- Water media type:
- freshwater
- Limit test:
- no
- Total exposure duration:
- 96 h
- Test temperature:
- 21.2 - 22.9 °C
- pH:
- 7.2 - 7.9
- Dissolved oxygen:
- 68 - 93%
- Nominal and measured concentrations:
- nominal concentrations: 0; 100; 300; 1000; 3000; 10,000 mg/L
- Details on test conditions:
- TEST SYSTEM
- Material, size, headspace, fill volume: Aquaria, final volume 5 L
- Renewal rate of test solution (frequency/flow rate): Once every 24 hours the test solution was renewed.
- No. of organisms per vessel: 10
- No. of vessels per concentration (replicates): 1
- No. of vessels per control (replicates): 1
TEST MEDIUM / WATER PARAMETERS
- Measurements of parameter for water quality were performed with WTW pH-91 (pH-value) and WTW Oxi-91 (dissolved oxygen).
EFFECT PARAMETERS MEASURED (with observation intervals if applicable):
Mortality was determined at 0, 6, 24, 48, 72 and 96 hours.
TEST CONCENTRATIONS
- Spacing factor for test concentrations: 3 to 3.33 - Duration:
- 96 h
- Dose descriptor:
- LC0
- Effect conc.:
- 10 000 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- mortality (fish)
- Key result
- Duration:
- 96 h
- Dose descriptor:
- LC50
- Effect conc.:
- > 10 000 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- mortality (fish)
- Details on results:
- - Mortality of control: 0%
- No sublethal effects were observed.
- Effect concentrations exceeding solubility of substance in test medium: A slight foam formation was observed at 3000 mg/L at test start, at 10000 mg/L during the whole test duration. TOC analysis was not successful as test substance gathered at the surface despite treatment with ultraturrax. - Sublethal observations / clinical signs:
Table 1: Mortality (%) of Brachydanio rerio.
Conc. (mg/L)
Test time (hours)
0
6
24
48
72
96
0
0
0
0
0
0
0
100
0
0
0
0
0
0
300
0
0
0
0
0
0
1000
0
0
0
0
0
0
3000
0
0
0
0
0
0
10000
0
0
0
0
0
0
Table 2: Analytical results.
Nominal concentration of
Measured concentration after
mg
Product/L
mg
TOC/L
0 h
(14 Jun)
24 h
(15 Jun)
0 h
(16 Jun)
24 h
(17 Jun)
mg TOC/L
mg TOC/L
mg TOC/L
mg TOC/L
100
77.23
0.6
4.5
0.5
1.1
1000
772.30
1.8
11.6
1.4
4.8
- Endpoint:
- short-term toxicity to fish
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 19 - 23 Sep 1994
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- other: Annex of 92/69/EWG
- Deviations:
- yes
- Remarks:
- - only 4 test concentrations, temperature deviates more than +/- 1 °C but the temperature was in the proposed optimal range for the zebrafish
- GLP compliance:
- yes
- Analytical monitoring:
- yes
- Vehicle:
- no
- Details on test solutions:
- PREPARATION AND APPLICATION OF TEST SOLUTION
- Method: stock solutions (100 µg/mL, volume 100 mL) were prepared in drinking water and stired for 30 minutes with a magnetic stirrer
- Controls: drinking water - Test organisms (species):
- Danio rerio (previous name: Brachydanio rerio)
- Details on test organisms:
- TEST ORGANISM
- Common name: Zebrafish
- Source: Westaquarium (deliveration date: 1994-08-30); no pre-treatment
ACCLIMATION
- Health during acclimation (any mortality observed): < 0.1% one week before the test was performed
- Food type: Altromin 1324 (Charge 041294/0843) - Test type:
- semi-static
- Water media type:
- freshwater
- Limit test:
- no
- Total exposure duration:
- 96 h
- Hardness:
- not stated
- Test temperature:
- 22.0 - 24.3 °C
- pH:
- 7.8 - 8.2
- Dissolved oxygen:
- 69 - 89%
- Nominal and measured concentrations:
- Nominal concentrations: control, 2, 4, 8, 16 mg/L
Measured concentrations for the nominal concentraiton of 2 mg/L: 1.8 (day 1, 0 h), 1.7 (day 2, 24 h), 2.7 (day 3, 0 h), 3.6 (day 4, 24 h) mg/L
Measured concentrations for the nominal concentration of 8 mg/L: 7.5 (day 1, 0 h), 7.0 (day 2, 24 h), 7.3 (day 3, 0 h), 7.5 (day 4, 24 h) mg/L - Details on test conditions:
- TEST SYSTEM
- Test vessel:
- Fill volume: 5 L
- No. of organisms per vessel: 10
- No. of vessels per concentration (replicates): 1
- No. of vessels per control (replicates): 1
EFFECT PARAMETERS MEASURED: the mortality was observed every day
TEST CONCENTRATIONS
- Spacing factor for test concentrations: 2 - Reference substance (positive control):
- no
- Duration:
- 96 h
- Dose descriptor:
- LC0
- Effect conc.:
- 2 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- act. ingr.
- Basis for effect:
- mortality (fish)
- Key result
- Duration:
- 96 h
- Dose descriptor:
- LC50
- Effect conc.:
- 2.95 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- act. ingr.
- Basis for effect:
- mortality (fish)
- Duration:
- 96 h
- Dose descriptor:
- LC100
- Effect conc.:
- 8 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- act. ingr.
- Basis for effect:
- mortality (fish)
- Duration:
- 96 h
- Dose descriptor:
- LC0
- Effect conc.:
- 4 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- mortality (fish)
- Duration:
- 96 h
- Dose descriptor:
- LC50
- Effect conc.:
- 5.9 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- mortality (fish)
- Duration:
- 96 h
- Dose descriptor:
- LC100
- Effect conc.:
- 16 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- mortality (fish)
- Details on results:
- - Behavioural abnormalities: unbalancing was observed at 8 mg/L after 24 h
- Mortality of control: 0% - Reported statistics and error estimates:
- Determination of the EC50 with similogarithmic inter- and extrapolation with EC0/EC100.
- Sublethal observations / clinical signs:
The test resulted in a LC0 of 4 mg/L (= 2 mg active matter/L), a LC50 of 5.9 mg/L (= 2.95 mg acitve matter/L) and a LC100 of 16 mg/L (= 8 mg active matter/L) after 96 hours.
- Endpoint:
- short-term toxicity to fish
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Justification for type of information:
- REPORTING FORMAT FOR THE ANALOGUE APPROACH
1. HYPOTHESIS FOR THE ANALOGUE APPROACH
This read-across is based on the hypothe sis that source and target substances have similar toxicological properties because
• they are manufactured from similar or identical precursors under similar conditions
• they share structural similarities with common functional groups: D-Glucopyranose monomers and oligomers and fatty alcohols C16 / C18 linear
• the metabolism pathway leads to comparable products (Glucose and glucose oligomers) and non-common products predicted to have no toxicological effects (long chain fatty alcohols).
Therefore, read-across from the existing acute toxicity studies on the source substances is considered as an appropriate adaptation to the standard information requirements of REACH regulation
2. SOURCE AND TARGET CHEMICAL(S) (INCLUDING INFORMATION ON PURITY AND IMPURITIES)
see attached justification
3. ANALOGUE APPROACH JUSTIFICATION
see attached justification
4. DATA MATRIX
see attached justification
Justification attached at chap. 13 - Reason / purpose for cross-reference:
- read-across source
- Reason / purpose for cross-reference:
- read-across source
- Key result
- Duration:
- 96 h
- Dose descriptor:
- LC50
- Effect conc.:
- 2.95 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- act. ingr.
- Basis for effect:
- mortality (fish)
- Remarks on result:
- other: effect concentration based on analytically verified nominal concentrations
- Sublethal observations / clinical signs:
Test results from two read-across substances are considered:
1: (key, Henkel, 1993, R9300061, RL2) with test material, percentage of components: 30% C16/C18-APG, 70% C16/C18 fatty alcohols
30% of test material consists of the target substance;
accordingly the EC50 of the original test material (>10000mg/l) is reduced to 30%: EC50>3000mg/l
2. (key, BASF, 1995a, BPCN, R9400701, RL1) with test material (D-Glucopyranose, oligomeric, C10-16-alkyl glycosides; 50% active ingredient)
The test resulted shows a LC50 of 5.9 mg/L (= 2.95 mg acitve matter/L) after 96 hours.
The second test was performed with a test material having the same chemical structures as the target substance but instead of C16/C18 fatty alcohols the source substance contains C10-C16 fatty alcohols.
As a worst case approach, the lowest LC50 is used: fish acute 96-LC50 = 2.95mg/L
- Conclusions:
- Test results from two read-across substances arte considered:
1: (key, Henkel, 1993, R9300061, RL2) with test material, percentage of components: 30% C16/C18-APG, 70% C16/C18 fatty alcohols
30% of test material consists of the target substance;
accordingly the EC50 of the original test material (>10000mg/l) is reduced to 30%: EC50>3000mg/l
2. (key, BASF, 1995a, BPCN, R9400701, RL1) with test material (D-Glucopyranose, oligomeric, C10-16-alkyl glycosides; 50% active ingredient)
The test resulted shows a LC50 of 5.9 mg/L (= 2.95 mg acitve matter/L) after 96 hours.
The second test was performed with a test material having the same chemical structures as the target substance but instead of C16/C18 fatty alcohols the source substance contains C10-C16 fatty alcohols.
As a worst case approach, the lowest LC50 is used: fish acute 96-LC50 = 2.95mg/L
Referenceopen allclose all
Description of key information
Test results from two read-across substances are considered:
1: (key, Henkel, 1993, R9300061, RL2) with test material, percentage of components: 30% C16/C18-APG, 70% C16/C18 fatty alcohols
30% of test material consists of the target substance;
accordingly the EC50 of the original test material (>10000mg/l) is reduced to 30%: EC50>3000mg/l
2. (key, BASF, 1995a, BPCN, R9400701, RL1) with test material (D-Glucopyranose, oligomeric, C10-16-alkyl glycosides; 50% active ingredient)
The test resulted shows a LC50 of 5.9 mg/L (= 2.95 mg acitve matter/L) after 96 hours.
The second test was performed with a test material having the same chemical structures as the target substance but instead of C16/C18 fatty alcohols the source substance contains C10-C16 fatty alcohols.
As a worst case approach, the lowest LC50 is used: fish acute 96-LC50 = 2.95mg/L
Key value for chemical safety assessment
Fresh water fish
Fresh water fish
- Effect concentration:
- 2.95 mg/L
Additional information
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.