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Diss Factsheets
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EC number: 907-131-0 | 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
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Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 991
- Report date:
- 1991
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.6 (Skin Sensitisation)
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- Currently no LLNA study is available for assessment. The Guinea Pig Maximization Test (GPMT) has been carried out as an animal test to predict human sensitization for over a decade and is recommended by international test guidelines such as OECD.
Test material
- Reference substance name:
- 2,2'-oxydiethanol
- EC Number:
- 203-872-2
- EC Name:
- 2,2'-oxydiethanol
- Cas Number:
- 111-46-6
- Molecular formula:
- C4H10O3
- IUPAC Name:
- 2,2'-oxydiethanol
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- other: Pirbright White, Dunkin
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Lippische Versuchstierzucht, Hagemann GmbH & Co. KG, Germany
- Weight at study initiation: 294 - 331 g
- Housing: 5 per cage, in Makrolon cages, type IV; bedding: Granulat Typ 3/4 (staubfrei); SSNIFF
- Diet: Kliba 341.4 mm (Kaninchen-Meerschweinchen-Haltungsdiaet), ad libitum
- Water: tap water ad libitum; about 2 g of ascorbic acid per 10 litres were added to the drinking water twice a week
- Acclimation period: at least 7 days
ENVIRONMENTAL CONDITIONS
- Temperature: 20 - 24°C
- Humidity: 30 - 70%
- Air changes: fully air-conditioned rooms in which a central air-conditioning system
- Photoperiod (hrs dark / hrs light): 12/12
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal
- Vehicle:
- water
- Remarks:
- distilled
- Concentration / amount:
- 5%
- Route:
- epicutaneous, occlusive
- Vehicle:
- water
- Remarks:
- distilled
- Concentration / amount:
- 75%
- Day(s)/duration:
- 48 hours
Challenge
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- water
- Remarks:
- distilled
- Concentration / amount:
- 50%
- Day(s)/duration:
- 24 hours
- Adequacy of challenge:
- highest non-irritant concentration
- No. of animals per dose:
- 10 (test groups), 5 (control groups)
- Details on study design:
- PRETEST
For detecting a possible influence on irritating effects of previous intradermal treatment with Freund´s adjuvant, animals pretreated with Freund´s adjuvant / 0.9% aqueous NaCl-solution (1:1) each, in the same manner as intradermal induction about 3 weeks prior to the application of the test substance were used. In the preliminary test after two 24-hour percutaneous occlusive applications within 96 hours the minimum irritant concentration was found to be a 75% test substance preparation in aqua bidest. and the maximum non-irritant concentration a 50% test substance preparation in aqua bidest.
Applicability: it was possible to inject a 5% test substance preparation in 0.9% aqueous NaCl-solution resp. in Freund´s adjuvant / 0.9% aqueous NaCl-solution (1:1) with a syringe.
MAIN STUDY
A. INDUCTION:
- Intradermal induction: 6 intradermal injections in groups of two per animal
Injections for the test group:
A) front row: 2 injections each of 0.1 mL Freund´s adjuvant without test substance emulsified with 0.9% aqueous NaCl-solution in a ratio of 1:1;
B) middle row: 2 injections each of 0.1 mL of the test substance formulation;
C) back row: 2 injections each of 0.1 mL Freund´s adjuvant / 0.9% aqueous NaCl-solution (1:1) with test substance.
Injections for control groups 1 and 2: The animals were given the same injections (A, B, C) but without test substance, only with the formulating agent.
- Site of application: shoulder
- Readings: 24 h after the beginning of application
- Assessment of the skin findings: analogous to the pretest
- Percutaneous induction: Percutaneous induction was carried out one week after intradermal induction.
- Amount applied: 2 x 4 cm filter paper strips were applied to the skin of the shoulder under an occlusive dressing. In the case of liquids the filter paper strip was soaked in the test substance formulation; thus, the animals were exposed to about 0.3 g of the test substance formulation. The control animals were not treated since the distilled water used as formulating agent was not expected to influence the result of the study.
- Duration of exposure: 48 hours
- Site of application: shoulder, same area as in the case of the previous intradermal application
- Readings: 48 h after the beginning of application
- Assessment of skin findings: analogous to the pretest
B. CHALLENGE:
- Test concentration: non-irritant concentration (50%) challenge 21 days after intradermal induction.
- Amount applied: 2 x 2 cm filter paper strips were applied to the skin of the flank under an occlusive dressing. In the case of liquids the test filter paper strip was soaked in the test substance formulation; thus the animals were exposed to about 0.15 g of the test substance formulation. Treatment of the test group and of control group 1 with the test substance formulation (control group 2 remained untreated).
- Duration of exposure: 24 hours
- Site of application: intact clipped flank
- Readings: 24 and 48 h after the removal of the patch
- Assessment of skin findings: analogous to the pretest - Challenge controls:
- yes
- Positive control substance(s):
- yes
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 50%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- none
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 50%
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Clinical observations:
- none
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- After the challenge with the 50% test substance aqueous preparation, no skin reactions could be observed neither in the test animals nor in the animals of control group. Thus, under the present test conditions, the test item diethylene glycol is not a skin sensitizer.
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