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EC number: 229-934-9 | CAS number: 6846-50-0
- 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:
- 2001-04-09 to 2001-06-29
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: A human Repeat Insult Patch Test was performed in 2001 in accordance with Good Clinical Practices.
Data source
Referenceopen allclose all
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 001
- Report date:
- 2001
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 2 003
Materials and methods
- Principles of method if other than guideline:
- The Modified Draize Procedure is used as a predictive test for contact sensitization in humans. The procedure involves the application of a discontinuous series of multiple occlusive patches to human skin over a three week induction period. Induction is followed by an approximate two week rest period. Challenge consists of a single application to naive skin.
- GLP compliance:
- yes
- Remarks:
- Good Clinical Practice
- Type of study:
- patch test
- Justification for non-LLNA method:
- The study was conducted before the requirement to use the LLNA
Test material
- Reference substance name:
- "TXIB" Plasticizer
- IUPAC Name:
- "TXIB" Plasticizer
Constituent 1
In vivo test system
Test animals
- Species:
- human
- Sex:
- male/female
- Details on test animals and environmental conditions:
- Two hundred fifty-five (49 males, 206 females) subjects were screened for the study. Two hundred forty-one (44 males, 197 females) subjects, ages 18 and older, signed the informed consent and were enrolled into the study.
Thirty-eight subjects, who were enrolled, failed to complete the study.
Two hundred three subjects (40 males, 163 females) completed all phases of the study.
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: acetone
- Concentration / amount:
- 1% v/v in acetone
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: acetone
- Concentration / amount:
- 1% v/v in acetone
- Details on study design:
- Procedure from Protocol:
A series of paraspinal skin sites on the subject's back will be utilized for the Induction applications. Challenge patches will be applied to the opposite side of the back from the induction patches.
Test areas will be identified for each test article that will include the original (O) and move (M and M-1) sites. When multiple test articles are used, the assignment of test articles to individual skin sites will be rotated so that each test article occupies individual skin sites within the panel of test subjects, with approximately equal frequency, in order to elilninate any position bias.
The subjects enrolled for this study will be issued printed instructions and a test schedule.
Individual test articles will be applied to assigned sites on the skin for a contact period of approximately 24 hours per application. Test subjects will be instructed verbally to remove these patches the following day. Induction applications will be made three times per week for three successive weeks. The nine applications made during these three weeks will be termed Induction Application Nos. 1 through 9, respectively. The observation of the test sites and the subsequent applications are to be conducted at the test facility on Monday, Wednesday, and Friday during the same designated time frames. During the fourth week, any subject who was absent for one of the regularly scheduled induction applications will receive a make-up induction application.
All induction applications for an individual test article will be made to the same site (the site receiving the original test article at Induction Application No.1) unless reactions become so strong as to make this inadvisable. Assessment of an accumulated score of 2 or greater is considered to be a strong reaction (See 11.0 EVALUATIONS). In this case, subsequent applications of the offending test article will be made to an adjacent area, and a second change of site will be made if a second strong reaction occurs. If a third strong reaction to the test article is manifested, patches of this test article will be discontinued until after the rest period has been completed. Subjects experiencing unexpectedly strong reactions may also be excused from further induction patches by the Investigator. The use of a first and second adjacent site will be identified on the source document as M and M-1 sites, respectively, to indicate movement of test site from the original (O) application site.
A 10 to 17-day rest period will follow the final induction application. Following the rest period a challenge application of the test article(s) will be made to each subject. During the challenge application, the test article(s) will remain in contact with the skin for a period of approximately 24 hours. Test subjects will be instructed verbally to remove these patches the following day. Challenge will consist of application to a naive site (A) located away from the original (O) application site (e.g., opposite side of the back). Observations of the challenge sites will be conducted during the designated time frame on the second and fourth days post application.
Observations at the naive site during challenge and the patterns of reactivity during the induction period will provide a basis for an interpretation of contact sensitization. - Challenge controls:
- Challenge controls not used in human studies, reaction evaluated by comparison to naive skin.
- Positive control substance(s):
- not specified
- Remarks:
- positive controls not used in human studies, reaction evaluated by comparison to naive skin.
Results and discussion
- Positive control results:
- Positive controls not used in human studies, reaction evaluated by comparison to naive skin.
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 1.0% TXIB
- No. with + reactions:
- 2
- Total no. in group:
- 203
- Clinical observations:
- 2 subjects out of 203 exhibited "slight, confluent or patchy erythema"
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 48.0. Group: test group. Dose level: 1.0% TXIB. No with. + reactions: 2.0. Total no. in groups: 203.0. Clinical observations: 2 subjects out of 203 exhibited "slight, confluent or patchy erythema".
- Reading:
- 2nd reading
- Hours after challenge:
- 96
- Group:
- test chemical
- Dose level:
- 1.0% TXIB
- No. with + reactions:
- 2
- Total no. in group:
- 203
- Clinical observations:
- 2 subjects out of 203 exhibited "slight, confluent or patchy erythema"
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 96.0. Group: test group. Dose level: 1.0% TXIB. No with. + reactions: 2.0. Total no. in groups: 203.0. Clinical observations: 2 subjects out of 203 exhibited "slight, confluent or patchy erythema".
- Reading:
- other:
- Hours after challenge:
- 0
- Group:
- negative control
- No. with + reactions:
- 0
- Total no. in group:
- 0
- Remarks on result:
- not measured/tested
- Reading:
- other:
- Hours after challenge:
- 0
- Group:
- positive control
- No. with + reactions:
- 0
- Total no. in group:
- 0
- Remarks on result:
- not measured/tested
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information
- Conclusions:
- Under the conditions of the study, HTR Code B (EAN 002800, PM 01315 "TXIB" Plasticizer) was found to be non-irritating and did not
elicit evidence of sensitization. - Executive summary:
A summary of the induction and challenge reactions, for the 203 subjects completing the study, and the overall conclusion of the irritation and sensitization potential of each test article is presented below:
Subject No. 147 experienced spreading of reaction beyond the patch area with all test articles which developed into a papular rash of the entire torso. The subject described a history of such reactions. The subject was discontinued from the study and followed to resolution on May 18,2001.
Subject No.102 exhibited slight reactions at challenge with every test article which were generally consistent with irritation.
HTR Code B (EAN 002800, PM 01315 "TXIB" Plasticizer): Responses during induction consisted of isolated instances of slight erythema and 2 occurrences of mild erythema. Responses during challenge consisted of 2 instances of slight erythema at 48 hours, one of which resolved by 96 hours and one of which did not (Subject No. 102). There was a single instance of slight erythema first appearing at the 96-hour evaluation (Subject No. 93). Under the conditions of the study, EAN 002800, PM 01315 "TXIB" Plasticizer was found to be non-irritating and did not elicit evidence of sensitization.
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