Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 827-581-0 | 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
- Remarks:
- Read-across SCI
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
- Justification for type of information:
- Refer to read-across justification document for SCMI in section 13
Cross-reference
- Reason / purpose for cross-reference:
- read-across: supporting information
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 983
- Report date:
- 1983
Materials and methods
Test guideline
- Guideline:
- other: In house method
- Principles of method if other than guideline:
- Eight animals were exposed to each of the test materials applied under individual semi occlusive patches for 4 hours after which the area was wiped clean of any excess material. Treatments were sited in a randomised manner.
Irritation reactions were assessed immediately after removal of the patch and at 24, 48 and 72 hours. - GLP compliance:
- no
Test material
- Reference substance name:
- Fatty acids, coco, 2-sulfoethyl esters, sodium salts
- EC Number:
- 263-052-5
- EC Name:
- Fatty acids, coco, 2-sulfoethyl esters, sodium salts
- Cas Number:
- 61789-32-0
- Molecular formula:
- C10H20O5S.Na-C20H40O5S.Na
- IUPAC Name:
- Fatty acids, coco, 2-sulfoethyl esters, sodium salts
- Details on test material:
- - Name of test material: Fenopron AC78
- Physical state: Fine white powder
- Analytical purity: 83%
- Lot/batch No.: S13607T1-1A
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Age at study initiation: 8-12 weeks
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- water
- Controls:
- no
- Amount / concentration applied:
- Test material was applied as supplied or diluted in distilled water to give concentrations of 10, 25, 40, 55 and 70% active substance.
0.2 g solid test substance (i.e. substance as supplied) was applied to moistened pad or 0.5 ml of test solution applied to dry pad. - Duration of treatment / exposure:
- 4 hours
- Observation period:
- 72 hours
- Number of animals:
- 8 rabbits used in study. Six test groups investigated. Each rabbit received all six test groups.
- Details on study design:
- TEST SITE
- Area of exposure: A 2.5 cm square of 8 ply cotton gauze folded in was laid on the polythene such that the edges of the pad were attached to the zinc oxide plaster. The patches were firmly attached to ensure good contact between the skin and test substance.
- % coverage:
- Type of wrap if used: Thin flexible polythene (3 x 3 cm) was attached to a piece of zinc oxide plaster (9 x 2.5 cm).
REMOVAL OF TEST SUBSTANCE
When the test patches are removed the treatment sites are wiped clean of excess material.
- Time after start of exposure: 4 hours
SCORING SYSTEM:
cracking using an 8 point scale, ranging from very slight (1) to severe (8).
-: no reaction
a : marginal/very slight
b : slight
c: fairly distinct
d: quite distinct
e: becoming well developed
f: well developed
g: becoming severe
h: severe
An overall irritation score was calculated as follows:
0: normal skin -
1: marginal slight erythema and oedema (grade a) at 24 hours but no effects at 72 hours
2: slight slight erythema and oedmema (grades up to bbbb) at 24 and 72 hours
3: slight/moderate slight/moderate erythema and oedema (grades ca /cc) at 24 hours. The reaction generally reduces to slight at 72 hours but sometimes the slight/moderate reaction may be maintained.
4: moderate moderate erythema and oedema (grades c and d) with slight cracking and scaling at 24 hours with the erythema and oedema being maintained at least at slight/moderate level with cracking and scaling developed at 72 hours
5: Strong As for 4 above or greater erythema and oedema with evidence of up to ¼ of the site affected by necrosis.
6: Severe Most of the site affected by suspected necrosis
7: Extreme Deep necrosis over the whole site identified by depressed, hard scab/ tissue and surrounding inflammatory reaction.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- Treatment Group A
- Time point:
- 24/48/72 h
- Score:
- 1.21
- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- Treatment Group B
- Time point:
- 24/48/72 h
- Score:
- 1.79
- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- Treatment Group C
- Time point:
- 24/48/72 h
- Score:
- 1.83
- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- Treatment Group D
- Time point:
- 24/48/72 h
- Score:
- 0.96
- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- Treatment Group E
- Time point:
- 24/48/72 h
- Score:
- 0.92
- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- Treatment Group F
- Time point:
- 24/48/72 h
- Score:
- 1.375
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- Treatment Group A
- Time point:
- 24/48/72 h
- Score:
- 0.96
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- Treatment Group B
- Time point:
- 24/48/72 h
- Score:
- 1.25
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- Treatment Group C
- Time point:
- 24/48/72 h
- Score:
- 1.5
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- Treatment Group D
- Time point:
- 24/48/72 h
- Score:
- 0.79
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- Treatment Group E
- Time point:
- 24/48/72 h
- Score:
- 0.66
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- Treatment Group F
- Time point:
- 24/48/72 h
- Score:
- 1
Any other information on results incl. tables
Exposure to the test material as supplied, resulted in only marginal/very slight to slight erythema and oedema in the most animals and time points.
At the 24 hour time point, one animal (351) showed quite distinct erythema and one animal (404) fairly distinct erythema. At 48 hours this was reduced to slight erythema in both of these animals, with all other animals either showing marginal/slight effects or no reaction. At 72 hours all animals except 351 (which showed slight erythema) had either no reaction or marginal/very slight erythema or oedema. Marginal/ slight cracking and scaling was observed in three animals and was still evident in two of these at the 72 hour time point
When the test substance was diluted in water to give a 70% a.i. concentration, only marginal/very slight or slight erythema and oedema was observed in all animals at 4 hours and 24 hours (apart from animal 404 where fairly distinct erythema was observed at 24 hours). After 48 and 72 hours skin was normal in the majority of cases, with only two animals exhibiting marginal/slight erythema and oedema. In these animals marginal/slight cracking and scaling was observed at the 72 hours time point
The study was not extended past the 72 hour time point, and therefore it is not possible to determine how long the reactions still evident at 72 hours would have persisted
An interpolation of the recorded results to the Draize scale gives the following results. The totals presented are mean scores from the treatment groups.
Treatment Group |
24 hours |
48 hours |
72 hours |
Mean 24 -72 hours |
||||
Erythema |
Oedema |
Erythema |
Oedema |
Erythema |
Oedema |
Erythema |
Oedema |
|
A= 10% ai |
1.75 |
1.125 |
1.125 |
1 |
0.75 |
0.75 |
1.21 |
0.96 |
B= 25% ai |
1.875 |
1.375 |
1.75 |
1.125 |
1.75 |
1.25 |
1.79 |
1.25 |
C= 40% ai |
1.75 |
1.625 |
2 |
1.375 |
1.75 |
1.5 |
1.83 |
1.5 |
D= 55% ai |
1.375 |
1 |
0.875 |
0.875 |
0.625 |
0.5 |
0.96 |
0.79 |
E= 70% ai |
1.375 |
1.125 |
0.625 |
0.375 |
0.75 |
0.5 |
0.92 |
0.66 |
F= as supplied |
1.75 |
1.25 |
1.25 |
1 |
1.125 |
0.75 |
1.375 |
1 |
These scores indicate that the solutions of SCI are mildly irritating.
Applicant's summary and conclusion
- Interpretation of results:
- slightly irritating
- Remarks:
- Migrated information
- Conclusions:
- The results of the study indicate that the test substance produced some irritation to rabbit skin, which was reversible. However, the test was not extended past 72 hours, so it is not possible to demonstrate conclusively when the oedema, erythema, cracking and scaling was resolved. These effects were only scored as slight by the 72 hour time point and therefore it is likely that skin would have returned to normal should the test have been continued to 14 days.
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.