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Diss Factsheets
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EC number: 452-110-7 | CAS number: -
- 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
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Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2003-04-30 to 2003-05-14
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP study performed in accordance to guideline with no deviations
Cross-reference
- Reason / purpose for cross-reference:
- reference to same study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 003
- Report date:
- 2003
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- Deviations:
- no
- Principles of method if other than guideline:
- NA
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- mouse local lymph node assay (LLNA)
Test material
- Test material form:
- liquid: viscous
- Details on test material:
- - Name of test material (as cited in study report): DEA/ACID ANHYDRIDE REACTION PRODUCT
- Physical state: highly viscous amber liquid
- Composition of test material, percentage of components:
Monomers: <17-35% (9-16% diethanolamine; 2-8% tetrahydrophthalic acid; 5-11% trimellitic acid; <0.1% tetrahydrophthalic anhydride; <0.8% trimellitic anhydride)
Dimers/trimers: <24-45%
Polymers: <10-25%
Not removable water: 5-15%
- Lot/batch No.: 200501.UN2810
- Expiration date of the lot/batch: september 2003
- Stability under test conditions: stable under storage condition
Constituent 1
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- CBA
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: mouse, CBA/CaOlaHsd
- Age at study initiation: 8 - 12 weeks (beginning of acclimatization)
- Weight at study initiation: 16.9 g - 21.0 g (beginning of acclimatization period)
- Housing: In groups of five in Makrolon type-3 cages with standard softwood bedding ("Lignocel", Schill AG, CH 4132 Muttenz).
- Diet (e.g. ad libitum): Pelleted standard Kliba 3433, batch no. 84/02 mouse maintenance diet available ad libitum.
- Water (e.g. ad libitum): Community tap water from Itingen, available ad libitum.
- Acclimation period: Under test conditions after health examination. Only animals without any visible signs of illness were used for the study.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 + 3 °C
- Humidity (%): 30 - 70 %
- Air changes (per hr): 10 - 15 air changes per hour
- Photoperiod (hrs dark / hrs light): 12 hour fluorescent light / 12 hour dark cycle with at least 8 hours music during the light period.
IN-LIFE DATES: From 30-APR-2003 to 14-MAY-2003
Study design: in vivo (LLNA)
- Vehicle:
- dimethylformamide
- Concentration:
- Test groups: 5 %, 10 % and 25 % AAA reaction product (w/w) in N,N-Dimethylformamide .
Positive control group: 25 % (w/w) ALPHA-HEXYLCINNAMALDEHYDE in N,N-Dimethylformamide.
Negative control group: N,N-Dimethylformamide - No. of animals per dose:
- Number of animals in test group: three groups each of 5 female mice - a total of 15
Number of animals in negative control group: 5 female mice
Number of animals in positive control group: 5 female mice - Details on study design:
- RANGE FINDING TESTS:
- Compound solubility: To determine the highest non-irritant and technically applicable test item concentration, a non-GLP pretest was performed in 2 mice with concentrations of 1 %, 5 %, 10 % and 25 % (w/w) (pretest excluded from Statement of Compliance).
- Irritation: No irritation effects were observed at these concentrations after a single application. The test item in the main study was assayed at three consecutive concentrations. The top dose is the highest technically achievable concentration whilst avoiding systemic toxicity and excessive local irritation. No severe irritant effects were tolerated choosing the test concentrations.
- Lymph node proliferation response: not determined in the range finding test
MAIN STUDY
ANIMAL ASSIGNMENT AND TREATMENT
- Name of test method:
- Criteria used to consider a positive response: A test item is regarded as a sensitizer in the LLNA if the following criteria are fulfilled. First, that exposure to at least one concentration of the test item resulted in an incorporation of 3HTdR at least 3-fold or greater than that recorded in control mice, as indicated by the stimulation index (S.I.). Second, that the data are compatible with a conventional dose response, although allowance must be made (especially at high topical concentrations) for either local toxicity or immunological suppression.
TREATMENT PREPARATION AND ADMINISTRATION: - Positive control substance(s):
- hexyl cinnamic aldehyde (CAS No 101-86-0)
- Statistics:
- The mean values and standard deviations of body weights and DPM values were calculated. T-test and Dunnett-test were conducted for assessment of the difference significance between the test item groups, positive control group and the negative control (vehicle) group.
Results and discussion
- Positive control results:
- Stimulation index of 7.7. was obtained for the positive control substance ( Alpha hexyl-cinnamaldehyde in N,N-Dimethylformamide)
In vivo (LLNA)
Resultsopen allclose all
- Parameter:
- SI
- Remarks on result:
- other: 5%: 1.2 10%: 1.0 25%: 1.2 Positive control: 7.7
- Parameter:
- other: disintegrations per minute (DPM)
- Remarks on result:
- other: see Remark
- Remarks:
- The proliferative responses of lymph node cell is expressed as the number of radioactive disintegrations per minute per mouse (DPM/MOUSE). The test and control group mean DPM per mouse were calculated. The ratio of 3HTdR incorporated into lymph node cells of test lymph nodes relative to that recorded for control lymph nodes (STIMULATION INDEX) (S.I.) was calculated by dividing the mean DPM for each test group by the mean DPM of the vehicle group. Before DPM/MOUSE values were determined, mean scintillation-background DPM was subtracted from test and control raw data. 3H-methyl thymidine (3HTdR) was purchased from Amersham International (Amersham product code no. TRA 310; specific activity, 2 Ci/mmol; concentration, 1 mCi/ml). Five days after the first topical application, all mice were administered with 250 µl of 88.3 µCi/ml 3HTdR (equal to 22.1 µCi 3HTdR) by intravenous injection via a tail vein. The following mean DPM values were obtained: Negative control group: 819±84 Positive control group: 6280±2269 5%: 1024±256 10%: 857±291 25%: 985±152
Any other information on results incl. tables
Summary table.
Group |
% (w/w) |
DPM/MOUSE M±SD |
SI (SD) |
Statistical Analysis a)t-test b)Dunnett-test |
||
t value |
Conclusion |
|||||
NCG 1 |
- |
819±84 |
- |
- |
- |
|
PCG 2 |
25 |
6280±2269 |
7.7 (2.8) |
5.38a) |
** |
|
TG 3 |
5 |
1024±256 |
1.2 (0.3) |
1.53b) |
-- |
|
TG 4 |
10 |
857±291 |
1.0 (0.4) |
0.28b) |
-- |
|
TG 5 |
25 |
985±152 |
1.2 (0.2) |
1.24b) |
-- |
** |
significant difference at p£0.05 (two sides) |
-- |
no significant difference at p£0.05 (two sides) |
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The possible contact allergenic potential of AAA reaction product was evaluated in accordance to OECD 429 (LLNA test). Stimulation index of 1.2, 1.0 and 1.2 were determined with AAA reaction product at concentrations of 5 %, 10 % and 25 % (w/w), respectively. For the positive control substance, the stimulation index was 7.7 indicative of a valid study design. Based on these data, AAA reaction product was found to be a non-sensitizer when tested at concentrations of up to 25 % (w/w) in N,N-Dimethylformamide.
- Executive summary:
The possible contact allergenic potential of AAA reaction product was evaluated in accordance to OECD 429 (LLNA test).
Three groups each of five female mice were treated daily with AAA reaction product at concentrations of 5 %, 10 % and 25 % (w/w) in N,N-Dimethylformamide by topical application to the dorsum of each ear lobe (left and right) for three consecutive days. A positive control group of five mice was treated with 25 % (w/w) Alpha-hexylcinnamaldehyde in N,N-Dimethylformamide. A negative control group of five mice was treated with the vehicle (N,N-Dimethylformamide) only.
Five days after the first topical application the mice were injected intravenously into a tail vein with radio-labelled thymidine (3H-methyl thymidine). Approximately five hours after intravenous injection, the mice were sacrificed, the draining auricular lymph nodes excised and pooled per mouse. Single cell suspensions of lymph node cells were prepared from pooled lymph nodes.
No test item-related clinical signs were observed in any animals of negative control group, Group 3 (TI at 5 %) or Group 4 (TI at 10 %). At the observation of two hours after the first application, a slight ear swelling was observed at both dosing sites in all mice of the positive control group. On the third application day and one day after, the swelling increased to moderate and slight ear erythema at both dosing sites was also noted. The ear swelling persisted for the remainder of the in-life phase of the study. On the third application day, a slight ear swelling was observed at both dosing sites in all mice of Group 4 (TI at 25 %), persisting for two days. Three days after the first application, one animal (No. 25) showed hair loss, persisting for the remainder of the in-life phase of the study.
In this study, stimulation index of 1.2, 1.0 and 1.2 were determined with AAA reaction product at concentrations of 5 %, 10 % and 25 % (w/w), respectively. For the positive control substance, the stimulation index was 7.7 indicative of a valid study design. Based on these data, AAA reaction product was found to be a non-sensitizer when tested at concentrations of up to 25 % (w/w) in N,N-Dimethylformamide.
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.
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