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EC number: 451-190-0 | CAS number: 156558-98-4
- 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:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- 26 Jan - 22 Mar 1998
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- GLP - Guideline study, tested with the source substance Reaction product of pentaerythritol and trimethylolpropane with n-pentanoic acid, 2-methylbutyric acid, n-heptanoic acid, 3,5,5-trimethylhexanoic acid, n-octanoic acid and n-decanoic acid. According to the ECHA guidance document “Practical guide 6: How to report read-across and categories (ECHA, 2012)”, the reliability was changed from RL1 to RL2 to reflect the fact that this study was conducted on a read-across substance.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 998
- Report date:
- 1998
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Version / remarks:
- adopted in 1992
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.6 (Skin Sensitisation)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2600 (Skin Sensitisation)
- Deviations:
- no
- 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
Test material
- Reference substance name:
- Reaction product of pentaerythritol and trimethylolpropane with n-pentanoic acid, 2-methylbutyric acid, n-heptanoic acid, 3,5,5-trimethylhexanoic acid, n-octanoic acid and n-decanoic acid
- IUPAC Name:
- Reaction product of pentaerythritol and trimethylolpropane with n-pentanoic acid, 2-methylbutyric acid, n-heptanoic acid, 3,5,5-trimethylhexanoic acid, n-octanoic acid and n-decanoic acid
- Details on test material:
- - Name of test material (as cited in study report): Only trade name available
- Physical state: colourless liquid
- Analytical purity: 100% (UVCB)
- Storage condition of test material: room temperature in the dark
Constituent 1
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, UK
- Age at study initiation: 8-12 weeks
- Weight at study initiation: 301-441 g
- Housing: animals were housed individually or in pairs in solid-floor polypropylene cages furnished with woodflakes.
- Diet: Guinea Pig FD1 diet, Special Diets Services Limited, Wirtham, UK, ad libitum
- Water: mains tap water, ad libitum
- Acclimation period: at least five days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-21
- Humidity (%): 34-66
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal and epicutaneous
- Vehicle:
- arachis oil
- Concentration / amount:
- Induction: 25% (intradermal), undiluted (topical)
Challenge: undiluted and 75%
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- arachis oil
- Concentration / amount:
- Induction: 25% (intradermal), undiluted (topical)
Challenge: undiluted and 75%
- No. of animals per dose:
- 10 (controls), 20 (in test groups)
- Details on study design:
- RANGE FINDING TESTS:
Intradermal Induction:
Four concentrations (1%, 5%, 10% and 25% w/v in arachis oil BP) were investigated. A total of four guinea pigs were used. Each guinea pig received four 0.1 mL injections of only one concentration of the test material. The degree of erythema at the injection sites was assessed approximately 24, 48 and 72 h and up to 7 days after injection according to the Draize scale. The degree of oedema was not evaluated. Any evidence of systemic toxicity was also recorded. The highest concentration that caused only mild to moderate skin irritation, and which was well tolerated systemically, was selected for the intradermal induction stage of the main study.
Topical induction:
Two guinea pigs (intradermally injected with Freund´s Complete Adjuvant 17 days earlier) were treated with the undiluted test material and three preparations of the test material (75%, 50% and 25% v/v in arachis oil BP). Applications were made to the clipped flanks under occlusive dressing for 48 h. The degree of erythema and oedema was evaluated approximately 1, 24, and 48 h after dressing removal. The highest concentration producing only mild to moderate dermal irritation was selected for the topical induction stage of the main study.
Topical Challenge:
The undiluted test material and three preparations of the test material (75%, 50 % and 25% v/v in arachis oil BP) were applied to the clipped flanks of the two guinea pigs under occlusive dressings for 24 h. These guinea pigs did not form part of the main study but have treated identically to the control animals of the main study, up to Day 14. The degree of erythema and oedema was evaluated approximately 1, 24, and 48 h after dressing removal. The highest non-irritant concentration of the test material and one lower concentration were selected for the topical challenge stage of the main study.
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):
Injection 1: a 1:1 mixture (v/v) FCA/ water
Injection 2: test substance (25%) in arachis oil
Injection 3: test substance (25%) in a 1:1 mixture (v/v) FCA/ water
Epicutaneous: undiluted
- Control group:
Injection 1: a 1:1 mixture (v/v) FCA/ water
Injection 2: in arachis oil
Injection 3: arachis oil at 50% (w/v) in a 1:1 mixture (v/v) FCA/ water
Epicutaneous : nothing
- Site: flanks (intradermal) + shoulder region (topical)
- Frequency of applications: every 7 days
- Duration: 0-7
- Concentrations: 25% (intradermal), undiluted (topical)
B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: Day 21
- Exposure period: 24 h
- Test groups: test substance
- Control group: test substance
- Site: right flank (undiluted test substance), left flank (75%)
- Concentrations: undiluted and 75%
- Evaluation (hr after challenge): 24 and 48 h - Positive control substance(s):
- no
- Remarks:
- positve control tested every six months
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 25% (intradermal) + 100% (challenge, right flank))
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 25% (intradermal) + 100% (challenge, right flank)). No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 25% (intradermal) + 75% (challenge, left flank)
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 25% (intradermal) + 75% (challenge, left flank). No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 25% (intradermal)+ 100% (challenge, right flank)
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 25% (intradermal)+ 100% (challenge, right flank). No with. + reactions: 0.0. Total no. in groups: 20.0.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 25% (intradermal) + 75% (challenge, left flank)
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 25% (intradermal) + 75% (challenge, left flank). No with. + reactions: 0.0. Total no. in groups: 20.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 25% (intradermal)+ 100% (challenge, right flank)
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 25% (intradermal)+ 100% (challenge, right flank). No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 25% (intradermal)+ 75% (challenge, left flank)
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 25% (intradermal)+ 75% (challenge, left flank). No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 25% (intradermal)+ 100% (challenge, right flank)
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 25% (intradermal)+ 100% (challenge, right flank). No with. + reactions: 0.0. Total no. in groups: 20.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 25% (intradermal) + 75% (challenge, left flank)
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 25% (intradermal) + 75% (challenge, left flank). No with. + reactions: 0.0. Total no. in groups: 20.0.
Any other information on results incl. tables
Range finding study
On the basis of the results of the range finding study the following concentrations were selected for the main study:
Intradermal Induction: 25% in arachis oil BP
Topical Induction: 100% (undiluted as supplied)
Topical Challenge: 100% (undiluted as supplied) and 75% v/v in arachis oil BP
Main study
Skin reactions observed after intradermal induction
Very slight or well-defined erythema was noted at the intradermal induction sites of all test group animals at the 24 h observation and in nineteen test group animals at the 48 hour observation.
Very slight erythema was noted at the intradermal induction sites of all control group animals at the 24 and 48 h observations.
Skin reaction observed after topical induction
Very slight or well-defined erythema and incidents of very slight oedema were noted at the induction sites of all test group animals at the 1 h observation with very slight erythema in ten test group animals at the 24 h observation. Bleeding from the intradermal induction sites of four test group animals was noted at the 1 h observation. Isolated incidents of small superficial scattered scabs or hardened dark brown/black-coloured scab were noted at the 24 h observation.
Bleeding from the intradermal induction sites was noted in one control group animal at the 1 h observation. No signs of erythema or oedema were noted at the treatment sites of control group animals at the 1 and 24 h observations.
Skin reaction observed after topical challenge
No skin reactions were noted at the challenge sites of the test or control group animals at the 24 or 48 h observations.
Body weights
Body weight gains of guinea pigs in the test group, between Day 0 and Day 24, were comparable to those observed in the control group over the same period.
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- CLP: not classified
DSD: not classified
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