Registration Dossier
Registration Dossier
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: 442-300-8 | 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

Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2002-04-25 to 2002-07-13
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 002
- Report date:
- 2002
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Version / remarks:
- adopted 17 July 1992
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.6 (Skin Sensitisation)
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Safepharm Laboratories Limited, U.K.
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- A valid guinea pig maximization study is available.
Test material
- Reference substance name:
- -
- EC Number:
- 442-300-8
- EC Name:
- -
- IUPAC Name:
- 2-(2-hydroxyethoxy)ethyl 2-oxo-2-phenylacetate; 2-{2-[(2-oxo-2-phenylacetyl)oxy]ethoxy}ethyl 2-oxo-2-phenylacetate
- Details on test material:
- - State of aggregation: liquid
Constituent 1
- Specific details on test material used for the study:
- STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: room temperature, in the dark
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- male
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: David Hall Limited, Burton-on-Trent, Staffordshire, UK
- Age at study initiation: 8 - 12 weeks
- Weight at study initiation: 300 to 450 g
- Housing: singly or in pairs in solid-floor polypropylene cages finnished with woodflakes.
- Diet: ad libitum; Certified Guinea Pig Diet (Code 5026) supplied by PMI Nutrition International, Nottingham, UK and IPS Product Supplies Limited, Northants, UK
- Water: e.g. ad libitum
- Acclimation period: at least five days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17 to 23
- Humidity (%): 30 - 70
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal
- Vehicle:
- arachis oil
- Concentration / amount:
- 1 %
- Day(s)/duration:
- day 0
- Route:
- epicutaneous, occlusive
- Vehicle:
- unchanged (no vehicle)
- Concentration / amount:
- 100 %
- Day(s)/duration:
- day 8 / 48 h
Challenge
- Route:
- epicutaneous, occlusive
- Vehicle:
- arachis oil
- Concentration / amount:
- 25 and 50 % (v/v)
- Day(s)/duration:
- day 21 / 24 h
- No. of animals per dose:
- 10 test animals
5 control animals - Details on study design:
- RANGE FINDING TESTS: intradermal induction: 1 and 5% (w/v) in arachis oil
epidermal applications (induction and challenge): 25, 50% and 75% (v/v) in arachis oil and 100% (undiluted)
The concentrations of test material to be used at each stage of the main study were determined by 'sighting tests'. In a first pre-test the test substance was intradermally injected in various concentrations and the highest concentration that caused only mild to moderate skin irritation, and which was well tolerated systemically, was selected for the intradermal induction stage. In a second pre-test, the highest concentration producing only mild to moderate dermal irritation after topical application in two animals intradermally injected with Freund's Complete Adjuvant fifteen days earlier was selected for the topical induction stage. Finally, in a third pre-test the highest non-irritant concentration of the test material after topical application and one lower concentration were selected for the topical challenge stage.
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 3 pairs of intradermal injections and one epidermal induction
- Test group:
Three pairs of intradermal applications (0.1 mL per injection): 1:1 mixture of adjuvant and distilled water, a 1% v/v formulation of the test compound in arachis oil, and a 1% v/v formulation of the test material in a 1:1 preparation of Freund's Complete Adjuvant plus distilled water. Epicutaneous application: 1 week after intradermal application, with undiluted test compound for 48 h under occlusive condition, patch 2x4 cm.
- Control group: Treated with adjuvant and the vehicle during induction period.
- Site: shoulder
- Concentrations: intradermal injection: 1%, epidermal application: 100%
B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: 21 (2 weeks after the epicutaneous induction application)
- Exposure period: 24 hours
- Test and control groups: test compound in arachis oil BP, patch 2x2 cm
- Site: left and right flank clipped free of hair with veterinary clippers
- Concentrations: 25 and 50% v/v
- Evaluation (hr after challenge): 24, 48 and 72 hours after challenge
OTHER:
After 24 hours challenge exposure, the sites were swabbed with cotton wool soaked in diethyl ether to remove residual material. The position of the treatment sites was identified by using a black indelible marker-pen.
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 50 %
- No. with + reactions:
- 9
- Total no. in group:
- 10
- Clinical observations:
- Erythema score 1 (4 animals) and 2 (5 animals).
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 50 %
- No. with + reactions:
- 10
- Total no. in group:
- 10
- Clinical observations:
- Erythema scores of 1 (2 animals) and 2 (2 animals) observed. Severe desquamation, preventing the evaluation of erythema and oedema in 6/10 animals.
- Key result
- Reading:
- other: 3rd reading
- Hours after challenge:
- 72
- Group:
- test chemical
- Dose level:
- 50%
- No. with + reactions:
- 10
- Total no. in group:
- 10
- Clinical observations:
- Erythema score of 3 in 1/10 animals; severe desquamation, preventing the evaluation of erythema and oedema in 9/10 test group animals.
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 25%
- No. with + reactions:
- 9
- Total no. in group:
- 10
- Clinical observations:
- Erythema score 1 (3 animals) and 2 (6 animals) and edeam score 1 (2 animals).
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 25%
- No. with + reactions:
- 9
- Total no. in group:
- 10
- Clinical observations:
- Erythema score 1 (3 animals) and 2 (1 animal). Severe desquamation, preventing the evaluation of erythema and oedema in 5/10 animals.
- Key result
- Reading:
- other: 3rd reading
- Hours after challenge:
- 72
- Group:
- test chemical
- Dose level:
- 25%
- No. with + reactions:
- 9
- Total no. in group:
- 10
- Clinical observations:
- Erythema score of 3 in one animal. Severe desquamation, preventing the evaluation of erythema and oedema in 8/10 animals.
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 0 %
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 0 %
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Key result
- Reading:
- other: 3rd reading
- Hours after challenge:
- 72
- Group:
- negative control
- Dose level:
- 0 %
- No. with + reactions:
- 0
- Total no. in group:
- 5
Any other information on results incl. tables
50% v/v in Arachis Oil BP:
Positive skin responses were noted at the topical challenge sites of all test group animals. Discrete or patchy to moderate and confluent erythema was noted at the topical challenge sites of nine test group animals at the 24-hour observation and in four test group animals at the 48-hour observation. Intense erythema and swelling was noted at the topical challenge site of one test group animal at the 72-hour observation. Severe desquamation, which prevented evaluation of erythema and oedema, was noted at the topical challenge sites of six test group animals at the 48-hour observation and in nine test group animals at the 72-hour observation. Desquamation was noted at the topical challenge sites of four test group animals at the 48-hour observation and in one test group animal at the 72-hour observation. The reaction extended beyond the topical challenge site of one test group animal at the 48 and 72-hour observations. No skin reactions were noted at the challenge sites of the control group animals at the 24, 48 or 72-hour observations.
25% v/v in Arachis Oil BP:
Positive skin responses were noted at the topical challenge sites of all test group animals. Discrete or patchy to moderate and confluent erythema was noted at the topical challenge sites of nine test group animals at the 24-hour observation and in four test group animals at the 48-hour observation. Very slight oedema was also noted at the topical challenge sites of two test group animals at the 24-hour observation. Intense erythema and swelling was noted at the topical challenge site of one test group animal at the 72-hour observation. Severe desquamation, which prevented evaluation of erythema and oedema, was noted at the topical challenge sites of five test group animals at the 48-hour observation and in eight test group animals at the 72-hour observation. Desquamation was noted at the topical challenge sites of five test group animals at the 48-hour observation and in two test group animals at the 72-hour observation. The reaction extended beyond the topical challenge site of one test group animal at the 48 and 72-hour observations. No skin reactions were noted at the challenge sites of the control group animals at the 24, 48 or 72-hour observations.
Applicant's summary and conclusion
- Interpretation of results:
- Category 1A (indication of significant skin sensitising potential) based on GHS criteria
- Conclusions:
- Under the conditions of the test, the test material produced a 100% (10/10) sensitisation rate and was classified as an extreme sensitiser to guinea pig skin.
- Executive summary:
In a GLP compliant guinea pig maximization test according to OECD guideline 406, the contact sensitization potential of the test material was assessed. Ten test and five control animals were used for the study. Two phases were involved in the main study; an induction of a response by intradermal injection and topical application and a topical challenge of that response. Based on the results of sighting tests, the concentrations of test material for the induction and challenge phases were selected as:
Intradermal Induction 1% v/v in arachis oil BP.
Topical Induction undiluted as supplied.
Topical Challenge : 50% and 25% v/v in arachis oil BP.
Under the conditions of the test, the test material produced a 100% (10/10) sensitization rate and was classified as strong sensitizer to guinea pig skin.
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.
