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EC number: 228-937-2 | CAS number: 6375-46-8
- 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: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- data from handbook or collection of data
- Justification for type of information:
- Data is from safety assesment report
Data source
Reference
- Reference Type:
- review article or handbook
- Title:
- IUCLID DATASET
- Author:
- OECD
- Year:
- 2 005
- Bibliographic source:
- OECD HPV Chemicals Programme, SIDS Dossier, approved at SIAM 15 (22-APR-2005)
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: as mentioned below
- Principles of method if other than guideline:
- The skin sensitization potential of Trimellitic anhydride (CAS no: 552-30-7) was conducted on ten male Hartley guinea pigs by mean of Modified Buehler Dermal Sensitization method under occlusive condition.
- GLP compliance:
- not specified
- Type of study:
- other: Modified Buehler Dermal Sensitization
- Justification for non-LLNA method:
- not specified
Test material
- Reference substance name:
- 1,3-dioxo-1,3-dihydro-2-benzofuran-5-carboxylic acid
- Cas Number:
- 552-30-7
- Molecular formula:
- C9H4O5
- IUPAC Name:
- 1,3-dioxo-1,3-dihydro-2-benzofuran-5-carboxylic acid
- Test material form:
- solid
- Details on test material:
- - Name of test material (as cited in study report): Trimellitic anhydride (TMA)
- Molecular formula: C9H4O5
- Molecular weight: 192.1256 g/mol
- Substance type: Organic
- Physical state: Solid
-Smiles: c1cc2c(cc1C(=O)O)C(=O)OC2=O
-InChI: 1S/C9H4O5/c10-7(11)4-1-2-5-6(3-4)9(13)14-8(5)12/h1-3H,(H,10,11)
Constituent 1
- Specific details on test material used for the study:
- - Name of test material (as cited in study report): Trimellitic anhydride (TMA)
- Molecular formula: C9H4O5
- Molecular weight: 192.1256 g/mol
- Substance type: Organic
- Physical state: Solid
-Smiles: c1cc2c(cc1C(=O)O)C(=O)OC2=O
-InChI: 1S/C9H4O5/c10-7(11)4-1-2-5-6(3-4)9(13)14-8(5)12/h1-3H,(H,10,11)
- Purity :98%
-Impurities:2%
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Hartley
- Sex:
- male
- Details on test animals and environmental conditions:
- No data available
Study design: in vivo (non-LLNA)
Induction
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: Vehicle used but not detailed information available.
- Concentration / amount:
- 300mg (0.3g)
- Day(s)/duration:
- 3 weeks
- Adequacy of induction:
- not specified
Challengeopen allclose all
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: Vehicle used but not detailed information available.
- Concentration / amount:
- 300mg (0.3g)
- Day(s)/duration:
- 13 days
- Adequacy of challenge:
- not specified
- No.:
- #2
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: Vehicle used but not detailed information available.
- Concentration / amount:
- 300mg (0.3g)
- Day(s)/duration:
- 48 hours
- Adequacy of challenge:
- not specified
- No. of animals per dose:
- 20 (ten control and 10 test )
- Details on study design:
- RANGE FINDING TESTS:
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 2
- Exposure period: 6 hours
- Test groups:10
- Control group: no data
- Site: backs of guinea pigs
- Frequency of applications: once per week for three weeks
- Duration: 3 weeks
- Concentrations: 300mg (0.3g)
B. CHALLENGE EXPOSURE
- No. of exposures:1
- Day(s) of challenge: Two weeks following the last induction phase
- Exposure period: 6 hours
- Test groups: 10 guinea pigs
- Control group: 10 guinea pigs
- Site: backs of guinea pigs
- Concentrations: 300mg (0.3g)
- Evaluation (hr after challenge): no data
C. RECHALLENGE EXPOSURE
- No. of exposures:1
- Day(s) of challenge: 13 days later
- Exposure period: 6 hours
- Test groups: 10 guinea pigs
- Control group: 10 guinea pigs
- Site: backs of guinea pigs
- Concentrations: 300mg (0.3g)
- Evaluation (hr after challenge): 24 and 48 hours after patch removal - Challenge controls:
- Yes concurrent vehicle. (10 guine pigs )
Study design: in vivo (LLNA)
- Statistics:
- Bishop, Fineberg, and Holland Discrete Multivariate Analysis, 1975. The use of solvents appeared to increase the dermal sensitization potential of TMA, presumable by increasing uptake.
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 300mg (0.3g)
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- Positive erythema reactions (score > 2) were not observed in any treated or sham animals following either challenge dose.
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 300mg (0.3g)
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- Positive erythema reactions (score > 2) were not observed in any treated or sham animals following either challenge dose.
- Remarks on result:
- no indication of skin sensitisation
In vivo (LLNA)
- Cellular proliferation data / Observations:
- Positive erythema reactions (score > 2) were not observed in any treated or sham animals following either challenge dose.A reaction with a Draize erythema score of 2 or greater in the treated animals was considered a positive response. The amount of test article used during the challenge phase was intended to produce a Draize erythema reaction of 1 or less in control animals.
Any other information on results incl. tables
Number of animals per erythema score |
|||||||||||
Group |
Challenge |
Time of scoring |
|||||||||
24 hours |
48 hours |
||||||||||
Erythema score |
Erythema score |
||||||||||
0 |
1 |
2 |
3 |
4 |
0 |
1 |
2 |
3 |
4 |
||
Treated |
1 |
7 |
3 |
0 |
0 |
0 |
9 |
1 |
0 |
0 |
0 |
Sham |
1 |
10 |
0 |
0 |
0 |
0 |
10 |
0 |
0 |
0 |
0 |
Treated |
2 |
10 |
0 |
0 |
0 |
0 |
10 |
0 |
0 |
0 |
0 |
Sham |
2 |
9 |
1 |
0 |
0 |
0 |
10 |
0 |
0 |
0 |
0 |
Applicant's summary and conclusion
- Interpretation of results:
- other: Not sensitizing
- Conclusions:
- Positive erythema reactions (score > 2) were not observed in any treated or sham animals following either challenge dose. Therefore chemical Trimellitic anhydride (CAS no: 552-30-7) was considered to be not sensitizing to the skin ten male Hartley guinea pigs.
- Executive summary:
The skin sensitization potential of Trimellitic anhydride (CAS no: 552-30-7) was conducted on ten male Hartley guinea pigs by mean of Modified Buehler Dermal Sensitization method under occlusive condition.
About 300mg (0.3g) of TMA was applied to the backs of 10 guinea pigs once per week for three weeks. Dosing material was held in place using an elastic adhesive bandage. All wrappings were removed 6 hours after each application. Two weeks following the last induction phase animals were challenged at dose of 300mg (0.3g) to the backs of each ten treated and ten control animals. Test article was held in place for 6 hours.
A second challenge dose was applied in the same manner 13 days later. Approximately 24 and 48 hours after removal of each challenge patch, the test sites were scored for edema and erythema according to the method of Draize. A reaction with a Draize erythema score of 2 or greater in the treated animals was considered a positive response. The amount of chemical used during the challenge phase was intended to produce a Draize erythema reaction of 1 or less in control animals.
Since the Positive erythema reactions (score > 2) were not observed in any treated or sham animals following either challenge dose, the chemical Trimellitic anhydride (CAS no: 552-30-7) was considered to be not sensitizing to the skin ten male Hartley guinea pigs.
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