Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
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: 209-008-0 | CAS number: 552-30-7
- 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 (LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- 2005
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Well documented, peer reviewed study forming part of the ICCVAM/NICEATM method validation of LLNA methods
Data source
Reference
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 1 999
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 442A (Skin Sensitization: Local Lymph Node Assay: DA)
- Principles of method if other than guideline:
- LLNA: DA determines sensitisation potential by measuring the proliferation of lymphocytes in the auricular lymph nodes draining the site of exposure (ears). The method employs non-radioactive techniques to assess lymphocyte proliferation by measuring adenosine triphosphate (ATP) content in the lymph nodes, thus eliminating the use of tritiated thymidine or iodine-125 based measurements used by the traditional LLNA.
In the traditional LLNA, the test substance is administered on three consecutive days (days 1, 2, and 3). On day 6, tritiated thymidine or iodine-125 is administered via the tail vein and the lymph nodes are excised five hours later. A lymph node cell suspension is then prepared and tritiated thymidine or iodine-125 incorporation is determined by scintillation counting. In the LLNA: DA method the test substance is applied on days 1, 2, 3, and 7. One hour prior to each application of the test substance, 1% sodium lauryl sulfate (SLS) is applied to the dorsum of the treated ears to increase absorption of the test substance across the skin. Twenty-four to 30 hours after the last test substance application, the auricular lymph nodes are excised, a lymph node cell suspension is prepared, and the ATP content is measured by luciferin-luciferase assay. - GLP compliance:
- no
- Type of study:
- mouse local lymph node assay (LLNA)
Test material
- Reference substance name:
- Benzene-1,2,4-tricarboxylic acid 1,2-anhydride
- EC Number:
- 209-008-0
- EC Name:
- Benzene-1,2,4-tricarboxylic acid 1,2-anhydride
- Cas Number:
- 552-30-7
- Molecular formula:
- C9H4O5
- IUPAC Name:
- 1,3-dioxo-1,3-dihydro-2-benzofuran-5-carboxylic acid
- Details on test material:
- - Name of test material (as cited in study report): Trimellitic anhydride
Constituent 1
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- CBA
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Charles River Japan
- Age at study initiation: 11 weeks
- Weight at study initiation: 20.7 - 24.4 g
- Housing:
- Diet (e.g. ad libitum):
- Water (e.g. ad libitum):
- Acclimation period:
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 25 deg C
- Humidity (%): 40 - 70%
- Air changes (per hr): 8 - 10
IN-LIFE DATES: From: 2005-08-24 To: 2005-08-31
Study design: in vivo (LLNA)
- Vehicle:
- acetone/olive oil (4:1 v/v)
- Concentration:
- 0.1, 0.25 and 0.5%
- No. of animals per dose:
- 3 - 4
- Details on study design:
- RANGE FINDING TESTS:
- Compound solubility: Soluble
MAIN STUDY
ANIMAL ASSIGNMENT AND TREATMENT
- Name of test method: LLNA-DA
- Criteria used to consider a positive response: Si > 3
TREATMENT PREPARATION AND ADMINISTRATION: Dorsum of both ears treated with 1% sodium lauryl sulphate (SLS). One hour later 25 µL of 3 concentrations of test substance, positive control or vehicle alone applied to the dorsum of both ears. This treatment regime was followed on Days 1, 2, 3 and 7. On Day 8 (24-30 hours after last application) draining auricular lymph nodes were excised, weighed, and pooled. Lymph node cells were crushed and spread between two glass slides and then scraped and suspended in 1 mL phosphate buffered saline PBS). The cell suspension obtained was then diluted 1:100 in PBS and a 100 µL aliquot was used to measure ATP content by luciferin-luciferase assay. - Positive control substance(s):
- hexyl cinnamic aldehyde (CAS No 101-86-0)
- Statistics:
- The mean relative light unit (RLU) value for each experimental group was calculated, and the Stimulation Index (SI) calculated as the mean ATP content in the LNC suspension obtained from the test group relative to that in the LNC suspension obtained from the control group. The cut-off point for a positive result was SI ≥3 and any result with an SI <3 was considered negative.
Results and discussion
In vivo (LLNA)
Results
- Parameter:
- SI
- Remarks on result:
- other: Vehicle - 1.00 TMA 0.1% - 2.46 TMA 0.25% - 3.58 TMA 0.5% - 4.96 Positive control (15% HCA) - 5.67
Any other information on results incl. tables
|
Body |
Lymph node weight |
|
ATP luminescence (RLU) |
|
||
Treatment |
weight |
Individual |
Mean ± SD |
SI |
Individual |
Mean ± SD |
SI |
|
(g) |
(mg) |
(mg) |
|
|
|
|
|
22.6 |
3.30 |
|
|
3101 |
|
|
Vehicle |
22.3 |
3.54 |
3.48 ± 0.51 |
1.00 ± 0.15 |
3253 |
3362 ± 736 |
1.00 ± 0.22 |
control |
23.1 |
2.93 |
|
|
2687 |
|
|
|
22.9 |
4.15 |
|
|
4407 |
|
|
|
21.6 |
10.21 |
|
|
22800 |
|
|
Positive |
24.2 |
9.42 |
9.29 ± 0.76 |
2.67 ± 0.22 |
16696 |
19056 ± 2636 |
5.67 ± 0.78 |
control |
20.7 |
8.38 |
|
|
17973 |
|
|
|
21.4 |
9.15 |
|
|
18757 |
|
|
|
21.8 |
4.61 |
|
|
5681 |
|
|
TMA 0.1% |
23.0 |
6.36 |
5.76 ± 0.99 |
1.65 ± 0.29 |
7841 |
8272 ± 2831 |
2.46 ± 0.84 |
|
24.1 |
6.30 |
|
|
11293 |
|
|
|
22.5 |
7.46 |
|
|
13902 |
|
|
TMA 0.25% |
23.4 |
6.43 |
6.81 ± 0.57 |
1.96 ± 0.16 |
11270 |
12045 ± 1615 |
3.58 ± 0.48 |
|
23.6 |
6.54 |
|
|
10963 |
|
|
|
21.9 |
8.31 |
|
|
14361 |
|
|
TMA 0.5% |
24.4 |
10.50 |
9.15 ± 1.18 |
2.63 ± 0.34 |
18976 |
16670 ± 2308 |
4.96 ± 0.69 |
|
21.7 |
8.65 |
|
|
16673 |
|
|
Applicant's summary and conclusion
- Interpretation of results:
- sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Trimellitic anhydride was sensitising in the mouse Local Lymph Node Assay.
- Executive summary:
Trimellitic anhydride was sensitising in the reported variant of the mouse Local Lymph Node Assay, the authors stating an EC3 of 0.20% compared with an EC3 of 0.22% obtained with the traditional LLNA.
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.