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EC number: 600-872-8 | CAS number: 108419-35-8
- 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, other
- Remarks:
- Human Repeated Patch Test
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 22 July 1991 - 1 November 1991
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- test procedure in accordance with generally accepted scientific standards and described in sufficient detail
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:
- other: Modified Draize Patch Test
- Principles of method if other than guideline:
- - Principle of test: To evaluate the test materials for the induction of contact sensitization by repetitive applications to the skin of human volunteers and to report any irritation observed with the test material.
- Short description of test conditions: Patches were applied for 24-hour contact to the lateral surface of the right and left upper arm. Nine induction applications were made to the same site unless reactions
became so strong that a first or second adjacent site had to be employed to complete induction. A 10 to 15 day rest period following the last induction application. A naive alternate site and the original
induction site were used for the challenge applications. The test material was applied under semi-occlusive conditions, using the Professional Medical Products, Inc. patches. Challenge application consisted
of a single 24-hour contact period. Rechallenge application was a single 24-hour contact period applied to the lower back. - GLP compliance:
- not specified
- Type of study:
- patch test
Test material
- Reference substance name:
- Acetic acid, C11-14-isoalkyl esters, C13-rich
- EC Number:
- 283-740-9
- EC Name:
- Acetic acid, C11-14-isoalkyl esters, C13-rich
- Cas Number:
- 84712-50-5
- Molecular formula:
- C15H30O2
- IUPAC Name:
- Acetic acid, C11-14-isoalkyl esters, C13-rich
Constituent 1
- Specific details on test material used for the study:
- The study investigated the skin sensitization potential of four test samples: MRD 90-726, MRD 91-009, MRD 91- 972, and MRD 90-903.
In vivo test system
Test animals
- Species:
- other: Human
- Sex:
- male/female
- Details on test animals and environmental conditions:
- One hundred thirty-nine volunteers entered the study. One hundred eighteen subjects completed the study. Subjects consisted of 74 females and 44 males.
Study design: in vivo (non-LLNA)
Induction
- Route:
- epicutaneous, semiocclusive
- Vehicle:
- unchanged (no vehicle)
- Concentration / amount:
- 0.1 ml
- Day(s)/duration:
- 24 hours, three times per week for three weeks
Challengeopen allclose all
- No.:
- #1
- Route:
- epicutaneous, semiocclusive
- Vehicle:
- unchanged (no vehicle)
- Concentration / amount:
- 0.1ml of MRD 90-726, MRD 91-009, MRD 91- 972, and MRD 90-903.
- Day(s)/duration:
- 24 hours
- No.:
- #2
- Route:
- epicutaneous, semiocclusive
- Vehicle:
- other: Mineral Oil
- Concentration / amount:
- 10% dilution of Samples MRD 9D-009 and 93-903 was prepared in Mineral Oil and 0.05 ml was applied to the patches.
- Day(s)/duration:
- 24 hours
- No. of animals per dose:
- 74 females and 44 male
- Details on study design:
- Nine induction applications were made to the same site. Patches were applied for 24-hour contact to the lateral surface of the right and left upper arm. Nine induction applications were made to the same site unless reactions became so strong that a first or second adjacent site had to be employed to complete induction. A 10 to 15 day rest period following the last induction application. A naive alternate site and the original induction site were used for the challenge applications. The test material was applied under semi-occlusive conditions, using the Professional Medical Products, Inc. patches. Challenge application consisted of a single 24-hour contact period. Rechallenge application was a single 24-hour contact period applied to the lower back.
- Challenge controls:
- 0.05 ml Mineral Oil was used as the negative control in the mineral oil rechallange.
- Positive control substance(s):
- not specified
Results and discussion
- Positive control results:
- Not Specified
In vivo (non-LLNA)
Results
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 0.1 ml
- No. with + reactions:
- 51
- Total no. in group:
- 118
- Clinical observations:
- 51 subjects showed cutaneous reactions consistent with erythema, papules and edema. 31 of these responses had no observable or mild erythema by the 96 hr. reading.
Any other information on results incl. tables
Sixty-one subjects exhibited strong erythema, edema, papules and vesicular responses to Sample MRD 91-972 at the first induction evaluation. Subsequent applications of the sample were discontinued on July 26, 1991.
Sixty-two subjects exhibited reactions consisting of strong erythema and/or edema accompanied by erythema to Sample MRD 90-903 beginning with the first induction evaluation. Fifty-nine subjects exhibited cutaneous reactions consisting of erythema, papules and edema at the 48 hour challenge evaluation. Thirty-one of these responses had subsided to no observable or mild erythema at the 96 hour challenge evaluation.
Fourteen subjects exhibited reactions consisting of mild erythema to Sample MRD 91-009 beginning with the second induction evaluation. Seven subjects exhibited cutaneous reactions consisting of strong erythema or edema at the 48 challenge evaluation. One subject exhibited mild erythema on the original and naive sites and one subject exhibited a papular response on the original
at the 96 hour evaluation. One subject exhibited the same response at the 96 hr evaluation and the responses of the remaining subjects subsided to no observable or mild erythema.
Two subjects were asked to participate in a subsequent confirmatory rechallenge to sample MRD-91 -009 and twenty-nine subjects to samples MRD-90 -903. There was no evidence of cutaneous reactions observed at the 48 and 96 hour evaluation for the twenty-four subjects conpleting the re-challenge. The overall response patterns (induction, challenge, and rechallenge) to Samples MRD 91-009 and MRD 90-903 are consistent with clinically irritation.
Under the test conditions, no identifiable cutaneous reactions were observed for Sample MRD 90-726.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the test conditions, no identifiable cutaneous reactions were observed for Sample MRD 90-726. The responses to Sample MRD 91-972 is consistent with a severe clinical irritant and the responses to Samples MRD 91-009 and 90-903 are consistent with clinical irritation.
- Executive summary:
One hundred thirty - nine subjects entered the study. One hundred eighteen subjects completed the study. Twenty-one subjects withdrew for reasons unrelated to the study. All exposures were by 24-hour contact semi-occlusive patches applied to sites on the upper arms.
Sixty-one subjects exhibited strong erythema, edema, papules and vesicular responses to Sample MRD 91-972 at the first induction evaluation.
Sixty-two subjects exhibited reactions consisting of strong erythema and/or edema accompanied by erythema to Sample MRD 90- 903 beginning with the first induction evaluation. Fifty-nine subjects exhibited cutaneous reactions consisting of erythema, papules and edema at the 48 hour challenge evaluation. Thirty-one of these responses had subsided to no observable or mild erythema at the 96 hour challenge evaluation.
Fourteen subjects exhibited reactions consisting of mild erythema to Sample MRD 91-009 beginning with the second induction evaluation. Seven subjects exhibited cutaneous reactions consisting of strong erythema or edema at the 48 challenge evaluation. One subject exhibited a papular response and one subject exhibited mild erythema at the 96 hour evaluation with the remaining reactions exhibiting mild or no observable erythema.
After discussion with the sponsor, thirty-one subjects were asked to participate in a subsequent confirmatory rechallenge. No observable cutaneous reactions were observed during rechallenge. The overall response patterns (induction, challenge, and rechallenge) to Samples MRD 91-009 and MRD 90- 903 are consistent with clinically identifiable irritation.
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