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EC number: 423-630-1 | CAS number: 62435-71-6
- 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)
- Remarks:
- an in vitro or in chemico skin sensitisation study does not need to be conducted because adequate data from an in vivo skin sensitisation study are available.
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Remarks:
- The work described was performed in compliance with UK GLP standards (Schedule 1, Good Laboratory Practice Regulations 1997 (SI 1997/654)). These Regulations are in accordance with GLP standards published as OECD Principles on Good Laboratory Practice (revised 1997, ENV/MC/CHEM(98)17); and are in accordance with, and implement, the requirements of Directives 87/18/EEC and 88/320/EEC.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 999
- Report date:
- 1999
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.6 (Skin Sensitisation)
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- see below
Test material
- Reference substance name:
- -
- EC Number:
- 423-630-1
- EC Name:
- -
- Cas Number:
- 62435-71-6
- Molecular formula:
- C7H14O2
- IUPAC Name:
- 2-(ethoxymethyl)oxolane
- Details on test material:
- Description, Identification and Storage Conditions
Sponder's identification: ETHYL TETRAHYDROFURFURYL ETHER
Date received: 18 November 1998
Description: colourless liquid
Storage conditions: room temperature under nitrogen in the dark
Data relating to the identity, purity and stability of the test material are the responsibility of the sponser.
For the purpose of this study the test material was freshly prepared as follows:
Intradermal Induction: 1% w/v in distilled water, 1% w/v in a mixture of Freund's, Complete Adjuvant plus distilled in water (1:1)
Topical Induction: undiluted as supplied
Topical Challenge: undiluted as supplied and 75% v/v in distilled water.
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- male
- Details on test animals and environmental conditions:
- 21 male albino Dunkin Hartley guinea pigs supplied by David Hall Limited, Burton-on-Trent, Stafforshire, UK were used. At the start of the main study the animals weighed 305 to 369g, and were approximately eight to twelve weeks old. After an acclimatisation period of at least five days, each animal was selected at random and given a unique number within the study which was written on a small area of clipped rump using a black indelible marker-pen.
The animals were housed singly or in pairs in solid-floor polypropylene cages furnished with woodflakes. Free access to mains tap water and food (Guinea Pig FD1 Diet, Special Diets Services Limited, Witham, Essex, UK) was allowed throughout the study.
The animal room was maintained at a temperature of 19 to 22°C and relative humidity of 44 to 54%. The rate of air exchange was approximately fifteen changes per hour and the lighting was controlled by a time switch to give twelve hours continuous light and twelve hours darkness.
Study design: in vivo (non-LLNA)
Induction
- Route:
- intradermal
- Vehicle:
- arachis oil
- Concentration / amount:
- Intradermal: 10% in arachis oil BP.
Topical: 50% acetone: PEG 400 (70:30)
Challenge
- Route:
- intradermal
- Vehicle:
- arachis oil
- Concentration / amount:
- Intradermal: 10% in arachis oil BP.
Topical: 50% acetone: PEG 400 (70:30)
- No. of animals per dose:
- A group of fifteen guinea pigs were used for the main study, ten test and five control. The bodyweight of each animal was recorded at the start and end of the study.
- Challenge controls:
- Intradermal injections were administered using an identical procedure to that used for the test animals, except that the injections were:
a) Freund's Complete Adjuvant plus distilled water in the ratio 1:1
b) distilled water
c) a 50% w/v formulation of distilled water in Freund's Complete Adjuvant/distilled water 1:1 - Positive control substance(s):
- yes
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- positive control
- Dose level:
- 10% in arachis oi
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- Please see discussion on results
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 1% w/v
- No. with + reactions:
- 21
- Total no. in group:
- 21
- Clinical observations:
- Please see discussion on results
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 1% w/v
- No. with + reactions:
- 9
- Total no. in group:
- 21
- Clinical observations:
- Please see discussion on results
- Remarks on result:
- no indication of skin sensitisation
Any other information on results incl. tables
Interpretation of Results
The precentage of test animals that showed a more severe reaction at the test material challenge site than the most severe reaction seen in the control animals, was compared with the following scale:
Percentage of animals sensitised | Classification of sensitisation potential |
0 | non-sensitiser |
> 0 - 8 | weak sensitiser |
> 8 - 28 | mild sensitiser |
> 28 - 64 | moderate sensitiser |
> 64 - 80 | strong sensitiser |
> 80 - 100 | extreme sensitiser |
The data obtained may be used to classify the test material according to Commission Directive 93/21/EEC adapting Council Directive 67/54/EEC on the classification, packaging, and labelling of dangerous substances.
The test material will be classified as sensitising and assigned the symbol "Xi", the indication of danger 'irritant' and the risk phrase R 43 "MAY CAUSE SENSITISATION BY SKIN CONTACT" if 30% or more of the test animals show a sensitisation response.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test material, ETHYL TETRAHYDROFURFURYL ETHER, 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.
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