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EC number: 947-394-9 | 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:
- 12 - 15 January, 1994
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 994
- Report date:
- 1994
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)
- Version / remarks:
- Commission Directive 92/69/EEC
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Fatty acids, C12-18, α-sulfo, 1-Me esters, sodium salts
- EC Number:
- 288-224-7
- EC Name:
- Fatty acids, C12-18, α-sulfo, 1-Me esters, sodium salts
- Cas Number:
- 85681-86-3
- Molecular formula:
- C13H25NaO5S - C19H37NaO5S
- IUPAC Name:
- Fatty acids, C12-18, α-sulfo, 1-Me esters, sodium salts
- Reference substance name:
- Fatty acids, C12-18, α-sulfo, disodium salts
- EC Number:
- 286-085-7
- EC Name:
- Fatty acids, C12-18, α-sulfo, disodium salts
- Cas Number:
- 85186-99-8
- Molecular formula:
- C12H22Na2O5S - C18H34Na2O5S
- IUPAC Name:
- Fatty acids, C12-18,α-sulfo, disodium salts
Constituent 1
Constituent 2
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: David Percival Ltd, Moston, Sandbach, Cheshire, UK
- Age at study initiation: 12-16 weeks old
- Weight at study initiation: 2.96 kg
- Housing: Individually housed in a suspended metal cage.
- Diet: ad libitum - STANRAB SQC Rabbit Diet, Special Diet Services Ltd., Witham, Essex, UK
- Water: ad libitum - mains water
- Acclimation period:
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18-21
- Humidity (%): 51-58
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: To:
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 100 mg
VEHICLE
- Amount(s) applied (volume or weight with unit): Not applicable - Duration of treatment / exposure:
- 72 hours
- Observation period (in vivo):
- 72 hours
- Number of animals or in vitro replicates:
- One animal was used.
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): Not washed
- Time after start of exposure:Not applicable
SCORING SYSTEM: Assessment of ocular damage/irritation was made approximately 1 hour and 24, 48 and 72 hours following treatment using the Draize system.
TOOL USED TO ASSESS SCORE: Light source from a standard ophthalmoscope
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1.3
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks:
- based on 72 h score
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 2
- Reversibility:
- not reversible
- Remarks:
- based on 72h score
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 3
- Reversibility:
- not reversible
- Remarks:
- based on 72 h score
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 2.3
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks:
- based on 72 h score
- Irritant / corrosive response data:
- Refer to Table 1 below for scores at each time point.
- Other effects:
- Vocalisation was noted approximately 15 seconds after dosing.
Residual test material was noted around the treated eye one hour after treatment.
A dulling of the normal lustre of the corneal surface was noted in the treated eye one hour after treatment. Areas of diffuse corneal opacity were noted in teh treated eye at the 24 and 48-hour observations with areas of translucent corneal opacity at the 72-hour observation.
Iridial inflammation was noted in the treated eye one hour after treatment and at subsequent observations.
Sever conjuctival irritation was noted in the treated eye one hour after treatment with moderate conjunctival irritation at the 24 and 48-hour observations and severe conjunctival irritation at the 72-hour observations. Haemorrhage of the nictitating membrane was noted in the treated eye at the 24, 48 and 72-hour observations. Pale appearance of the nictitating membrane and blood stained discharge were noted in the treated eye at the 72-hour observation.
The animal was killed for humane reasons immediately after the 72-hour observation. No further animals were treated.
Any other information on results incl. tables
Table 1: Scores at each time point
Rabbit Number and Sex (Bodyweight Kg) |
IPR 4 Vo 29 Male (2.96) |
|||
Time after treatment |
1 hour |
24 hours |
48 hours |
72 hoursK |
CORNEA |
|
|
|
|
E = Degree of Opacity |
d |
1 |
1 |
2+ |
F = Area of Opacity |
4 |
4 |
4 |
4 |
Score (E x F) x 5 |
0 |
20 |
20 |
40 |
IRIS |
|
|
|
|
D |
1 |
1+ |
1+ |
1+ |
Score (D x 5) |
5 |
5 |
5 |
5 |
CONJUNCTIVAE |
|
|
|
|
A = Redness |
2 |
2H |
2H |
2HBsP |
B = Chemosis |
3 |
2+ |
2+ |
3+ |
C = Discharge |
3Re |
3 |
3 |
3 |
Score (A + B + C) x 2 |
16 |
14 |
14 |
16 |
Total Score |
21 |
39 |
39 |
61 |
Key:
IPR = initial pain reaction; D = dulling of the normal lustre of the corneal surface; Vo = vocalisation of approx. 15 seconds after dosing; P = pale appearance of the nictitating membrane; K = animal killed immediately after observation; H = Haemorrhage of the nictitating membrane; Re = residual test material around the treated eye; Bs = blood-stained discharge; + = positive criterion
Applicant's summary and conclusion
- Interpretation of results:
- Category 1 (irreversible effects on the eye) based on GHS criteria
- Conclusions:
- Mean scores following grading at 24, 48 and 72 hours for corneal opacity (1.3), iritis (1), conjunctival redness (2) and chemosis (2.3) do not meet CLP criteria for irreversible effects on the eye (category 1). However, the animal exhibited distinct ocular effects and was killed for humane reasons immediately after the 72-hour observation. There are consequently grounds for concluding that the effects seen would not have been reversible and that classification for category 1 eye effects is warranted.
- Executive summary:
In a study performed according to OECD TG 405 and EU Method B.5, a single application of the test material was made to the non-irrigated eye of one rabbit. Areas of translucent corneal opacity, iridial inflammation and severe conjunctival irritation were produced. Other ocular effects noted were a dulling of the normal lustre of the corneal surface, haemorrhage and pale appearance of the nictitating membrane and blood stained discharge. The animal was killed for humane reasons immediately after the 72-hour observation. No further animals were treated. Mean scores following grading at 24, 48 and 72 hours for corneal opacity (1.3), iritis (1), conjunctival redness (2) and chemosis (2.3) do not meet CLP criteria for irreversible effects on the eye (category 1). However, the animal exhibited distinct ocular effects that required premature termination. There are consequently grounds for concluding that the effects seen would not have been reversible and that classification for category 1 eye effects is warranted.
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