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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 500-213-3 | CAS number: 68439-50-9 1 - 2.5 moles ethoxylated
- 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 sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 16 Sep - 27 Oct 1996
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 996
- Report date:
- 1997
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Version / remarks:
- adopted in 1992
- Deviations:
- yes
- Remarks:
- 10 test and 5 control animals per group were used instead of 20 test and 10 control animals. Since there is a second test on skin sensitiation in guinea pigs available, no additional testing was performed in the present study.
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.6 (Skin Sensitisation)
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- The Department of Health of the Government of the United Kingdom
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- Test was done before LLNA as first-choice method for in-vivo testing was set into force.
Test material
- Reference substance name:
- Alcohols, C12-14, ethoxylated
- EC Number:
- 500-213-3
- EC Name:
- Alcohols, C12-14, ethoxylated
- Cas Number:
- 68439-50-9
- Molecular formula:
- n.a.
- IUPAC Name:
- Alcohols, C12-14, ethoxylated, < 2.5 EO
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: David Hall Limited, Staffordshire, United Kingdom
- Age at study initiation: 12 weeks
- Weight at study initiation: 329 - 427g
- Housing: singly or in pairs in solid-floor polypropylene cages furnished with woodflakes
- Diet: Guinea Pig FD1 Diet (Special Diet Services Limited, Witham, Essex, United Kingdom), ad libitum
- Water: tap water, ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18-22
- Humidity (%): 47-68
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12
Study design: in vivo (non-LLNA)
Induction
- Route:
- intradermal and epicutaneous
- Vehicle:
- arachis oil
- Concentration / amount:
- Intradermal Induction: 1%
Topical Induction: 100% - Day(s)/duration:
- epicutaneous induction: 48 h
- Adequacy of induction:
- other: induction doses based on dose-range finding test using concentrations of 1 and 5% for dermal injection and 25, 50, 75 and 100% for epicutaneous induction
Challenge
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- arachis oil
- Concentration / amount:
- Topical Challenge: 25 and 50%
- Day(s)/duration:
- 24 h
- Adequacy of challenge:
- other: dose levels for topical challenge were selected based on the results of a dose-range finding test; the highest concentration was the highest non-irritant concentration
- No. of animals per dose:
- 10 (in test group), 5 (control)
- Details on study design:
- RANGE FINDING TESTS:
Two guinea pigs were dermally injected with test item concentrations of 1 and 5%. The animal induced with the 1% formulation showed erythema of grade 3 at the 24, 48 and 72 h reading and erythema of grade 2 at the 7 day reading. The animal induced with the 5% formulation showed erythema of grade 3-4 and green necrosis 24 h after induction and erythema of grade 4 with green necrosis findings and eschar formation at the 48 h, 72 h and 7 day reading. Thus, the 1% formulation was chosen for intradermal induction.
In addition, two animals were topically treated with 25, 50, 75 and 100% concentrations for 48 h. One hour after induction, both animals showed erythema of grade 2-3 at all concentration levels. Edema of grade 2 was observed for both animals at 100% and for one animal at 75 and 50%. Edema of grade 1 was noted in one animal at 25% and at 50 and 75% in the second animal. At the 24 h reading, erythema persisted in both animals at the 75% (score 1) and 100% formulation (score 2) and in one animal at the 50% formulation (score 1). One of the animals shiwed edema formation (grade 1) at 100 and 50%, whereas no edema was observed in the second animal.
At the 48 h reading, both animals showed erythema of grade 2 at the 100% formulation test site and erythema of grade 1 at the 75% formulationt test site. In one of the animals, edema was observed (grade 1) at the 100% formulation test site.
Two additional animals were used for a sighting test on topical challenge. One hour after challenge, erythema of grade 2 was noted in both animals at 100 and 75% and erythema of grade 1 was observed at 50 and 25% in both animals. Edema of gradde 1 was noted at 100% in both animals and at 50% in one of the guinea pigs. At the 24 h reading, both animals showed erythema of grade 1 when treated at 50 and 100%. Erythma of score 1 at challenge wirh 100% persisted in one of the animals up to the 48 h time point. At the 24 and 48 h reading, no finding of edema was observed in any animal.
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 2 (intradermal and epicutaneous, respectively)
- Exposure period: single injection (intradermal) and 48 h (epicutaneous)
- Test groups:
Intradermal (3 pairs of injections): 0.1 mL each
Injection 1: 1:1 mixture complete Freund's adjuvant (FCA) and distilled water
Injection 2: 1% test substance in arachis oil BP
Injection 3: 1% test substance in a 1:1 mixture of complete Freund's adjuvant (FCA) and distilled water
Epicutaneous: filter paper patch saturated with undiluted test material
- Control group:
Intradermal (3 pairs of injections):
Injection 1: 1:1 mixture complete Freund's adjuvant (FCA) and distilled water
Injection 2: 100% arachis oil BP
Injection 3: a 50% formulation of arachis oil BP in a 1:1 mixture of complete Freund's adjuvant (FCA) and distilled water
Epicutaneous: filter paper patch saturated with arachis oil BP
- Site: shoulder region
- Frequency of applications: topical induction was performed one week after the intradermal induction
- Duration: 7 days
- Concentrations: intradermal 1%, epicutaneous 100%
B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: 3 weeks after intradermal induction (study Day 21)
- Exposure period: 24 h
- Test groups: test substance and vehicle
- Control group: test substance and vehicle
- Site: left flank (test item) and right flank (vehicle)
- Concentrations: 25 and 50%
- Evaluation (hr after challenge): 48 and 72 h (24 and 48 h after dressing removal) - Challenge controls:
- The control group is actually a challenge control
- Positive control substance(s):
- yes
- Remarks:
- Historical data on ethyl-4-aminobenzoate, 2,4-dinitrochlorobenzene, neomycin sulphate and 2-mercaptobenzothiazole were provided.
Results and discussion
- Positive control results:
- Historical control data on several positive control chemicals were provided. Challenge with 2-mercaptobenzothiazole (intrademally induced with 10% in arachis oil, topically induced with 50% in acetone and topically challenged with 25 and 50% in acetone : PEG 400 in a 70:30 ratio), exhibited dermal alterations in 70% of the test animals, thus meeting the reliability criteria for the GPMT test (≥ 15% positive reactions).
In vivo (non-LLNA)
Resultsopen allclose all
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- intradermal induction: 1%; epicutaneous induction: 100%; epicutaneous challenge: 25%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- intradermal induction: 1%; epicutaneous induction: 100%; epicutaneous challenge: 25%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- challenge: 25%
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- challenge: 25%
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- intradermal induction: 1%; epicutaneous induction: 100%; epicutaneous challenge: 50%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- intradermal induction: 1%; epicutaneous induction: 100%; epicutaneous challenge: 50%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- challenge: 50%
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- challenge: 50%
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Group:
- positive control
- Dose level:
- intradermal induction: 10%; epicutaneous induction: 50%; epicutaneous challenge: 25 and 50%
- Remarks on result:
- other: Historical positive control data provided in study report
Any other information on results incl. tables
Local skin reactions:
After intradermal induction, well-defined or moderate to severe erythema was noted at the induction sites of all test group animals at the 24- and 48-h observation. Very slight erythema was noted at the intradermal induction sites of 4 control animals at the 24 and 48 h reading.
After topical induction, very slight to moderate to severe erythema with or without very slight edema was noted at the induction sites of all test group animals at the 1-h observation. Very slight to well-defined erythema with or without very slight to slight edema was noted at the induction sites of seven test group animals at the 24-h observation. Dried blood was noted at the induction sites of six test group animals at the 24 -h observation. Skin reactions prevented the accurate evaluation of erythema and edema at the induction sites of two test group animals at the 24 -h observation. No skin reactions were noted at the treatment sites of control group animals at the 1- and 24-h observations.
After
topical challenge, no skin reactions were observed in any control or
test item-treated animal at the 24 and 48 -h observation.
Table 1: Skin sensitisation results
Animals Number | skin Reactions (Hours After Removal of Dressing) |
|||||||||||
24 h | 48 h | |||||||||||
50% | 25% | 50% | 25% | |||||||||
Er | Oe | Other | Er | Oe | Other | Er | Oe | Other | Er | Oe | Other | |
1 | 0 | 0 | - | 0 | 0 | - | 0 | 0 | - | 0 | 0 | - |
2 | 0 | 0 | - | 0 | 0 | - | 0 | 0 | - | 0 | 0 | - |
3 | 0 | 0 | - | 0 | 0 | - | 0 | 0 | - | 0 | 0 | - |
4 | 0 | 0 | - | 0 | 0 | - | 0 | 0 | - | 0 | 0 | - |
5 | 0 | 0 | - | 0 | 0 | - | 0 | 0 | - | 0 | 0 | - |
6 | 0 | 0 | - | 0 | 0 | - | 0 | 0 | - | 0 | 0 | - |
7 | 0 | 0 | - | 0 | 0 | - | 0 | 0 | - | 0 | 0 | - |
8 | 0 | 0 | - | 0 | 0 | - | 0 | 0 | - | 0 | 0 | - |
9 | 0 | 0 | - | 0 | 0 | - | 0 | 0 | - | 0 | 0 | - |
10 | 0 | 0 | - | 0 | 0 | - | 0 | 0 | - | 0 | 0 | - |
Er=erythema
Oe=oedema
- = no other reactions noted
Er=erythema
Oe=oedema
- = no other reactions noted
Systemic toxicity: Not reported.
Body weight: All animals gained weight as expected.
Applicant's summary and conclusion
- Interpretation of results:
- other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No. 1272/2008.
- Executive summary:
A study was performed to assess the contact sensitisation potencial of the test material in the albino guinea pig. Ten test and five control animals were used for the main study. Based on the results of sighting test, the concentration of the test material for the induction and challenge phases were selected as follows:
Intradermal Induction: 1% w/v in arachis oil BP
Topical Induction: undiluted as supplied
Topical Challenge: 50% and 25% v/v in arachis BP
The test material produced a 0% (0/10) sensitisation rate and was classified as a NON-SENSITISER to guinea pig skin. The test material did not meet the criteria for classification as a sensitiser according to EU labelling regulations. No risk phrase is required.
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.