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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 614-295-4 | CAS number: 68131-40-8
- 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, other
- Remarks:
- An in vivo (already existing) study is available)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study conducted according to internationally accepted guidelines and to GLP.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 996
- Report date:
- 1996
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Qualifier:
- according to guideline
- Guideline:
- EPA OTS 798.4500 (Acute Eye Irritation)
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- GLP compliance:
- yes
Test material
- Reference substance name:
- Alcohols, secondary C11-15, ethoxylated
- EC Number:
- 614-295-4
- Cas Number:
- 68131-40-8
- Molecular formula:
- C(11-15) H(23-31) O (C2H4O)xH where n= approximately 3
- IUPAC Name:
- Alcohols, secondary C11-15, ethoxylated
- Details on test material:
- - Name of test material (as cited in study report): softanol 30
- Substance type: organic
- Physical state: colourless to slightly yellow liquid
- Analytical purity: >99% by wt
- Lot/batch No.: W60130
- Expiration date of the lot/batch: August 31, 1996
- Stability under test conditions: stable at storage conditions
- Storage condition of test material: at room temperature (ca. 20°C), away from sunlight
- Other:
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Dr. Karl Tomae GmbH
- Age at study initiation: 14-15 weeks
- Weight at study initiation: male: 2.7kg; fem 2.6-2.8 kg
- Housing: individually in stainless steel cages with an automatic cleaning system, equipped with feed hoppers, drinking water bowls and wood for gnawing.
- Diet (e.g. ad libitum): Pelleted standard Kliba 341 rabbit maintenance diet (batch 93/96) ad libitum from Kliba Muhlen AG, CH-4303 Kaiseraugst). Results of analysis for contaminants are included in this report.
- Water (e.g. ad libitum): Community tap water from Itingen, ad libitum.
- Acclimation period: four days under laboratory conditions after health examination. Only healthy animals were used for the study.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20+/-3°C
- Humidity (%): 40-70%
- Air changes (per hr): 10 to 15 per hour
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: April 10, 1996 To: April 18, 1996
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: Each animal was only treated in left eye. The right eye was left untreated to act as control.
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit):0.1 ml undiluted - Duration of treatment / exposure:
- once
- Observation period (in vivo):
- 1, 24, 48 and 72 hours after administration
- Number of animals or in vitro replicates:
- 1 male, 2 females
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): none
SCORING SYSTEM:
CORNEA
Opacity: degree of density (densest area used for assessment)
No ulceration or opacity,0;
Scattered or diffuse areas of opacity (other than slight dulling of normal luster), details of iris clearly visible, 1 *;
Easily discernible translucent area, details of iris slightly obscured, 2 *;
Nacrous area, no details of iris visible, size of pupil barely discernible, 3*;
Opaque cornea, iris not discernible through the opacity, 4*.
IRIS
Normal, 0;
Markedly deepened rugae, congestion, swelling, moderate circumcorneal hyperemia, or injection, any of these or combination thereof, iris still reacting to light (sluggish reaction is positive), 1 *;
No reaction to light, hemorrhage, gross destruction (any or all of these), 2 *
CONJUNCTIVE REDNESS (refers to palpebral and bulbar conjunctivae, excluding cornea and iris).
Blood vessels normal, 0;
Some blood vessels definitely hyperaemic (injected), 1;
Diffuse, crimson colour, individual vessels not easily discernible, 2;
diffuse beefy red, 3.
CHEMOSIS: lids and/or nictitating membranes
No swelling, 0;
Any swelling above normal (includes nictitating membranes), 1;
Obvious swelling with partial eversion of lids, 2;
swelling with lids about half closed, 3;
swelling with lids more than half closed, 4.
Maximum scores: Cornea: 4; Iris: 2; Conjunctival Redness:3; Conjunctival Chemosis:4
Maximum attainable score: 13
When present, corrosion of and/or staining of sclera and cornea by the test article were recorded and reported.
TOOL USED TO ASSESS SCORE: Eye examination were made with a Varta Cliptrix diagnostic lamp
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- other: 24h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- other: 24h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- other: 24h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- other: 24h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- other: 24h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- other: 24h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- other: 24h
- Score:
- 0
- Max. score:
- 3
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- other: 24h
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48h
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- other: 24h
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48h
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- other: 24h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- other: 24h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- other: 24h
- Score:
- 0
- Max. score:
- 4
- Irritant / corrosive response data:
- Softanol 30 showed a primary irritation score of 0.22 when applied to the conjuctival sac of the rabbit eye. No corrosion of the cornea was observed at any of the reading times.
- Other effects:
- No clinical signs of systemic toxicity were observed in the animals during the test and observation period, and no mortality occurred. Based upon the referred classification criteria the test article SOFTANOL 30 is classified as 'not irritating" to the eye.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: OECD GHS
- Conclusions:
- Based upon the GHS classification criteria the test article SOFTANOL 30 is Classified as 'not irritating" to the eye.
- Executive summary:
In a primary eye irritation study realised according to the OECD guideline 405 and in compliance with GLP, 0.1ml of undiluted Softanol 30 was instilled into the conjunctival sac of left eye (right remained as control) of New Zealand rabbits (1 male, 2 females) for 1, 24, 48 and 72 hours (RCC 1996, report 622438). Eyes were not washed and animals then were observed for irritation at 1, 224, 48 and 72 hours.
Softanol 30 showed a primary irritation score of 0.22 when applied to the conjuctival sac of the rabbit eye. No corrosion of the cornea was observed at any of the reading times.
Based upon the GHS classification criteria the test article SOFTANOL 30 is Classified as 'not irritating" to the eye.
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.