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EC number: - | 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
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- Auto flammability
- Flammability
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- Oxidation reduction potential
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- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
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- Endpoint summary
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- 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
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- Acute Toxicity
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- Specific investigations
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- Additional toxicological data
![](https://echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
Acute Toxicity: oral
Some information in this page has been claimed confidential.
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2005
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 005
- Report date:
- 2005
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Version / remarks:
- OECD Guidelines for the Testing of Chemicals, Number 423 "Acute Oral Toxicity - Acute
Toxic Class Method", adopted 17 December 2001. - Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
- Version / remarks:
- Directive 2004/73/EC, B.1 tris "Acute Oral Toxicity-Acute Toxic Class Method", April 29, 2004.
- Deviations:
- no
- Principles of method if other than guideline:
- Guidelines followed
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- acute toxic class method
- Limit test:
- no
Test material
Reference
- Name:
- Unnamed
- Type:
- Constituent
- Test material form:
- solid
- Details on test material:
- Batch: P2/05 UL
Appearance: light orange crystalline powder
Expiration date: 31.05.2011
Storage: at room temperature
- Specific details on test material used for the study:
- - Identity: FAT 41039/A
- Description: Light orange crystalline powder
- Batch number: P2/05 UL
- Purity / Formulation: content of organic pigments > 99 %; main components: 97 %
- Stability of test item: Stable under storage conditions.
- Expiry date: 31-MAY-2011
- Stability of test item dilution: Stable in PEG 300 for at least 7 days at room temperature.
- Storage conditions: At room temperature (range of 20 ± 5 °C), light protected.
- Safety precautions: Routine hygienic procedures were used to ensure the health and safety of the personnel.
Test animals
- Species:
- rat
- Strain:
- other: HanRcc:WIST (SPF)
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST SYSTEM
- Test system: Rat, HanRcc:WIST (SPF)
- Rationale: Recognized by the international guidelines as a recommended test system.
- Source: RCC Ltd, Laboratory Animal Services, CH-4414 Füllinsdorf / Switzerland
- Number of animals per group: 3 females
- Total number of animals: 6 females
- Age when treated: 12 weeks
- Identification: By unique cage number and corresponding color-coded spots on the tail. The animals were marked at acclimatization start.
- Randomization: Selected by hand at time of delivery. No computer generated randomization program.
- Acclimatization: Under laboratory conditions, after health examination. Only animals without any visible signs of illness were used for the study.
HUSBANDRY
Conditions:
Standard Laboratory Conditions. Air-conditioned with 10-15 air changes per hour, and continuously monitored environment with ranges for room temperature 22 ± 3 °C and for relative humidity between 30-70 % (values above 70 % during cleaning process possible), automatically controlled light cycle of 12 hours light and 12 hours dark, music during the daytime light period.
Accommodation:
In groups of three in Makrolon type-4 cages with wire mesh tops and standard softwood bedding ('Lignocel' Schill AG, CH-4132 Muttenz/Switzerland).
Diet:
Pelleted standard Provimi Kliba 3433 rat/mouse maintenance diet, batch no. 25/05 (Provimi Kliba AG, CH-4303 Kaiseraugst/Switzerland) ad libitum. Results of analyses for contaminants are archived at RCC Ltd.
Water Community tap water from Füllinsdorf ad libitum. Results of bacteriological, chemical and contaminant analyses are archived at RCC Ltd.
IN LIFE PERIOD
Experimental Starting Date: 09-AUG-2005
Experimental Completion Date: 01-SEP-2005
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- other: Polyethylenglycol (PEG 300)
- Details on oral exposure:
- VEHICLE
VEHICLE
- Identification: Polyethylene glycol 300 (PEG 300)
- Description: Colorless viscous liquid
- Lot number: 1157790 51105271
- Source: FLUKA Chemie GmbH, CH-9471 Buchs
- Stability of vehicle: Stable under storage conditions;
- Expiration date: 19-JUL-2006
- Storage conditions: At room temperature (range of 20 ± 5 °C), light protected.
- Safety precautions: Routine hygienic procedures were used to ensure the health and safety of the personnel.
The vehicle was chosen after a non-GLP solubility trial which was performed before the study initiation date. This formulation trial is excluded from the GLP statement of compliance.
MAXIMUM DOSE VOLUME APPLIED: 10 ml/kg bw
DOSAGE PREPARATION: The dose formulations were made shortly before each dosing occasion using a magnetic stirrer and a spatula as homogenizers.
The test item was weighed into a tared glass beaker on a suitable precision balance and the vehicle added (weight:volume).
Homogeneity of the test item in the vehicle was maintained during administration using a magnetic stirrer. - Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 3 per step
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Mortality / Viability: Daily during the acclimatization period, during the first 30 minutes and at approximately 1, 2, 3 and 5 hours after administration on test day 1 (with the clinical signs) and twice daily during days 2-15.
- Body weights: On test days 1 (prior to administration), 8 and 15.
- Clinical signs: Daily during the acclimatization period, during the first 30 minutes and at approximately 1 , 2 , 3 and 5 hours after administration on test day 1. Once daily during days 2-15. All abnormalities were recorded.
- Necropsy of survivors performed: yes. All animals were killed at the end of the observation period by an intraperitoneal injection of Vetanarcol at a dose of at least 2.0 mL/kg body weight (equivalent to at least 324 mg sodium pentobarbitone/kg body weight) and discarded after macroscopic examinations were performed. No organs or tissues were retained. - Statistics:
- No statistical analysis was used.
Results and discussion
Effect levels
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No deaths occurred during the study.
- Clinical signs:
- Slightly ruffled fur was noted in all animals at the 2-hour reading and persisted in four out of six animals at the 3-hour reading. Hunched posture was also noted in two animals at the 2- and 3-hour reading.
- Body weight:
- The body weight of the animals was within the range commonly recorded for this strain and
age. - Gross pathology:
- No macroscopic findings were observed at necropsy.
Any other information on results incl. tables
None
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The median lethal dose of FAT 41039/A after single oral administration to female rats, observed over a period of 14 days was >2000 mg/kg body weight.
- Executive summary:
FAT 41039/A was evaluated for acute oral toxicity in a study conducted according to OECD Guideline 401 and EU Method B.1. Two groups, each of three female HanRcc:WIST (SPF) rats, were treated with FAT 41039/A
by oral gavage administration at a dosage of 2000 mg/kg body weight. The test item was diluted in vehicle PEG 300) at a concentration of 0.2 g/mL and administered at a volume dosage of 10 mL/kg. The animals were examined daily during the acclimatization period and mortality, viability and clinical signs were recorded. All animals were examined for clinical signs at approximately 30 minutes, 1, 2, 3 and 5 hours after treatment on day 1 and once daily during test days 2-15. Mortality/viability was recorded at approximately 30 minutes, 1, 2, 3 and 5 hours after administration on test day 1 (with the clinical signs) and twice daily during days 2-15. Body weights were recorded on day 1 (prior to administration) and on days 8 and 15. All animals were necropsied and examined macroscopically.
All animals survived until the end of the study period. Slightly ruffled fur was noted in all animals at the 2-hour reading and persisted in four out of six animals at the 3-hour reading. Hunched posture was also noted in two animals at the 2 - and 3-hour reading. Orange feces were noted in the cages of both groups on test day 2. The body weight of the animals was within the range commonly recorded for this strain andage. No macroscopic findings were recorded at necropsy. Hence, based on the findings of the study, the median lethal dose of FAT 41039/A after single oral administration to female rats, observed over a period of 14 days was >2000 mg/kg body weight.
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