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EC number: 221-800-8 | CAS number: 3238-40-2
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
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- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
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- Auto flammability
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- Endpoint summary
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- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
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- 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
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- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
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Endpoint summary
Administrative data
Description of key information
In an LLNA skin sensitisation study, performed according to OECD 429 test guideline and GLP principles, FDCA was found not be a skin sensitiser, as the SI was not ≥ 3 when tested up to 50%.
Key value for chemical safety assessment
Skin sensitisation
Link to relevant study records
- Endpoint:
- skin sensitisation: in vivo (LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 30 March 2011 to 11 April 2011
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- Version / remarks:
- (2010)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.42 (Skin Sensitisation: Local Lymph Node Assay)
- Version / remarks:
- (2008)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2600 (Skin Sensitisation)
- Version / remarks:
- (2003)
- Deviations:
- no
- GLP compliance:
- yes
- Type of study:
- mouse local lymph node assay (LLNA)
- Species:
- mouse
- Strain:
- other: CBA/J
- Sex:
- female
- Details on test animals and environmental conditions:
- - Source: Janvier, Le Genest-Saint-Isle, France
- Age at study initiation: Young adult animals (approx. 9 weeks old)
- Weight at study initiation: Body weight variation was within +/- 20% of the sex mean.
- Housing: Animals were group housed in labeld makrolon cages.
- Diet: Free access to pelleted rodent diet (SM R/M-Z from SSNIFF® Spezialdiäten GmbH, Soest, Germany).
- Water: Free access to tap water.
- Acclimation period: At least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19.5 - 23.4
- Humidity (%): 38 - 65
- Air changes (per hr): approx 15
- Photoperiod (hrs dark / hrs light): 12/12
Temporary deviations from the minimum level of relative humidity occurred.
Evaluation: Laboratory historical data do not indicate an effect of the deviations.
IN-LIFE DATES: From 30 March 2011 to 11 April 2011 - Vehicle:
- other: Water (Elix, Millipore S.A.S., Molsheim, France) with 1% pluronic L92 (BASF, New Jersey, USA)
- Concentration:
- 0, 10, 25 and 50%
- No. of animals per dose:
- 5
- Details on study design:
- RANGE FINDING TESTS:
A weight of evidence analysis was performed prior to start of this study. All available information was evaluated
MAIN STUDY
ANIMAL ASSIGNMENT AND TREATMENT
- Name of test method: Local Lymph Node Assay
- Criteria used to consider a positive response: DPM values are presented for each animal and for each dose group. A Stimulation Index (SI) is calculated for each group. The SI is the ratio of the DPM/group compared to DPM/vehicle control group. If the results indicate a SI ≥ 3, the test substance may be regarded as a skin sensitizer, based on the test guideline and recommendations done by ICCVAM. Consideration was given to the EC3 value (the estimated test substance concentration that will give an SI =3; Basketter et al., J Appl Toxicol 1999;19:261-266).
ANIMAL ASSIGNMENT
Three groups of five animals were treated with one test substance concentration per group. One group of five animals was treated with vehicle and another group of five animals was treated with the positive control substance.
TREATMENT PREPARATION AND ADMINISTRATION:
The test substance formulations (w/w) were prepared within 4 hours prior to each treatment. No adjustment was made for specific gravity of the vehicle. Homogeneity was obtained to visually acceptable levels.
Rationale for vehicle: The vehicle was selected based on trial formulations performed at NOTOX and on test substance data supplied by the sponsor. Trial formulation results showed that no suitable formulation could be prepared using the commonly used vehicles Acetone/Olive oil (4:1 v/v), N,N-dimethylformamide, methylethylketone, propylene glycol or dimethylsulfoxide. Therefore, 1% watery pluronic L92 was selected as suitable vehicle based on trial formulations performed at NOTOX. L92 provides good skin wetting properties for prolonged dermal contact and has been shown to yield positive LLNA results using a number of watersoluble dermal sensitizers (Basketter et al., J Appl Toxicol 1999;19:261-266).
Induction - Days 1, 2 and 3; Excision of nodes - Day 6; Tissue processing for radioacitivity - Day 6; Radioactivity measurements - Day 7; Performed according to test guidelines.
Observations:
Mortality/Viability: Twice daily.
Body weights: On Day 1 (pre-dose) and Day 6 (prior to necropsy).
Clinical signs: Once daily on Days 1-6 (on Days 1-3 between 3 and 4 hours after dosing).
Irritation: Once daily on Days 1-6 (on Days 1 - 3 immediately after dosing) according to the guideline. Furthermore, a description of all other (local) effects was recorded according to guidelines.
Necropsy: All animals were sacrificed at day 6 by intra-peritoneal injection with Euthasol® 20% (0.2 mL/animal). - Positive control substance(s):
- hexyl cinnamic aldehyde (CAS No 101-86-0)
- Statistics:
- Not performed.
- Positive control results:
- The reliability check with Alpha-hexylcinnamicaldehyde (performed in March 2011) indicates that the Local Lymph Node Assay as performed at NOTOX is an appropriate model for testing for contact hypersensitivity.
- Parameter:
- SI
- Value:
- 0.9
- Test group / Remarks:
- Concentration: 10%
- Parameter:
- SI
- Value:
- 0.8
- Test group / Remarks:
- Concentration: 25%
- Parameter:
- SI
- Value:
- 0.7
- Test group / Remarks:
- Concentration: 50%
- Parameter:
- other: disintegrations per minute (DPM)
- Remarks on result:
- other: Mean DPM/animal values for the experimental groups treated with test substance concentrations 10, 25 and 50% were 406, 340 and 309 DPM respectively. The mean DPM/animal value for the vehicle control group was 433.
- Interpretation of results:
- not sensitising
- Remarks:
- According to Regulation (EC) No 1272/2008
- Conclusions:
- In an LLNA skin sensitisation study, performed according to OECD 429 test guideline and GLP principles, FDCA was found not be a skin sensitiser, as the SI was not ≥ 3 when tested up to 50%.
- Executive summary:
An LLNA skin sensitisation study was performed according to OECD 429 test guideline and GLP principles. No irritation of the ears was observed in any of the animals examined. All auricular lymph nodes of the animals of the experimental and control groups were considered normal in size. Mean DPM/animal values for the experimental groups treated with test substance concentrations 10, 25 and 50% were 406, 340 and 309 DPM respectively. The mean DPM/animal value for the vehicle control group was 433. The SI values calculated for the substance concentrations 10, 25 and 50% were 0.9, 0.8 and 0.7% respectively. Based on these results FDCA is not regarded as a skin sensitizer and is not classified.
Reference
Results Pre-screen test:
No irritation and no signs of systemic toxicity were observed in any of the animals examined. Variations in ear thickness during the observation period were less than 25% from Day 1 pre-dose values. Based on these results, the highest test substance concentration selected for the main study was a 50% concentration.
Other results - main study:
No irritation of the ears was observed in any of the animals examined. White staining of the ears was noted, not hampering the scoring of the ears.
All auricular lymph nodes of the animals of the experimental and control groups were considered normal in size. No macroscopic abnormalities of the surrounding area were noted in any of the animals.
Body weights and body weight gain of experimental animals remained in the same range as controls over the study period. The slight body weight loss, noted in some animals, was considered not toxicologically significant.
No mortality occurred and no symptoms of systemic toxicity were observed in the animals of the main study.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
An LLNA skin sensitisation study with FDCA was performed according to OECD 429 test guideline and GLP principles. No irritation of the ears was observed in any of the animals examined. All auricular lymph nodes of the animals of the experimental and control groups were considered normal in size. Mean DPM/animal values for the experimental groups treated with test substance concentrations 10, 25 and 50% were 406, 340 and 309 DPM respectively. The mean DPM/animal value for the vehicle control group was 433. The SI values calculated for the substance concentrations 10, 25 and 50% were 0.9, 0.8 and 0.7% respectively. Based on these results, SI was not ≥ 3, FDCA is not regarded as a skin sensitizer.
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
Based on the results, FDCA is not regarded as a skin sensitizer and is not classified according to Regulation (EC) No 1272/2008 on classification, labelling and packaging of substances and mixtures.
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