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EC number: 294-862-7 | CAS number: 91770-75-1 Extractives and their physically modified derivatives such as tinctures, concretes, absolutes, essential oils, oleoresins, terpenes, terpene-free fractions, distillates, residues, etc., obtained from Tagetes minuta, Compositae.
- 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
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 01 - 30 April 2009
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Remarks:
- GLP study conducted in compliance with OECD Guideline No. 425 without any deviation.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 009
- Report date:
- 2009
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 425 (Acute Oral Toxicity: Up-and-Down Procedure)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.1100 (Acute Oral Toxicity)
- Principles of method if other than guideline:
- Not applicable
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- The Swiss GLP Monitoring Authorities (inspected on 05-09 and 26-30 November 2007 / signed on 12 November 2008)
- Test type:
- up-and-down procedure
- Limit test:
- yes
Test material
- Reference substance name:
- Tagetes minuta, ext.
- EC Number:
- 294-862-7
- EC Name:
- Tagetes minuta, ext.
- Cas Number:
- 91770-75-1
- Molecular formula:
- Not relevant, UVCB substance
- IUPAC Name:
- Essential oil of Tagetes minuta ( Compositae ) obtained from flowers by steam distillation
- Test material form:
- liquid
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: Plant Impact plc / X25902
- Appearance: Yellow to orange liquid
- Expiration date of the lot/batch: 01 May 2009
- Purity test date: 15 May 2008
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: At room temperature (range of 20 ± 5 °C), light protected.
- Stability: Stable under storage conditions
Test animals
- Species:
- rat
- Strain:
- other: HanRcc: WIST
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Harlan Laboratories Ltd., Laboratory Animal Services, Wölferstrasse 4, 4414 Füllinsdorf / Switzerland.
- Females - nulliparous and non-pregnant: Yes
- Age at study initiation: 11-12 weeks
- Weight at study initiation: 179.4-205.7 g
- Fasting period before study: Overnight fasting period (approximately 17 to 19 hours) prior to intubation and approximately 3-4 hours post dose
- Housing: Animals were housed individually in Makrolon type-3 cages with standard softwood bedding (‘Lignocel’ Schill AG, 4132 Muttenz / Switzerland) during treatment and observation.
- Diet: Pelleted standard Provimi Kliba 3433 rat/mouse maintenance diet, batch no. 76/08 (Provimi Kliba AG, 4303 Kaiseraugst / Switzerland); ad libitum
- Water: Community tap water from Füllinsdorf, ad libitum
- Acclimation period: 6 days
ENVIRONMENTAL CONDITIONS
- Temperature: 22 ± 3 °C
- Humidity: 30-70 % (values above 70 % during cleaning process possible)
- Air changes: Air-conditioned with 10-15 air changes per hour
- Photoperiod: Automatically controlled light cycle of 12 hours light and 12 hours dark, music during the daytime light period
IN-LIFE DATES: 01 - 30 April 2009
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- polyethylene glycol
- Remarks:
- Polyethylene glycol 300 (PEG 300)
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 500 mg/mL
MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg bw
DOSAGE PREPARATION
- The dose formulations were prepared shortly before each dosing occasion using a magnetic stirrer as homogenizer. 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.
TEST ITEM ADMINISTRATION
- Animals received a single dose of the test item by oral gavage administration after being fasted for approximately 17 to 19 hours (access to water was permitted). Food was provided again approximately 3 hours after dosing. - Doses:
- 5000 mg/kg bw
- No. of animals per sex per dose:
- 3 females (total)
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing:
Viability/Mortality: 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 (in common with the clinical signs) and twice daily during days 2-15.
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, depending on the occurrence of clinical signs of toxicity. Once daily during days 2-15.
Body weights: On test day -1 (prior to removal of food), on test days 1 (prior to administration), 8 and 15.
- Necropsy of survivors performed: Yes; all animals were killed at the end of the observation period by carbon dioxide asphyxiation and discarded after macroscopic examinations were performed. No organs or tissues were retained. - Statistics:
- The statistical programme (AOT 425 Stat Pgm) version: 1.0, 2001 was used for the selection of dose levels and calculation of the LD50 values.
Results and discussion
Effect levels
- Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 5 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No deaths occurred during the study.
- Clinical signs:
- other: The three 5000 mg/kg treated animals were observed with slightly ruffled fur, hunched posture and slight sedation between 1 hour after treatment and test days 3, 6 or 7. One animal was additionally observed with almost to completely closed eyes on test da
- Gross pathology:
- No macroscopic findings were recorded at necropsy.
- Other findings:
- None
Any other information on results incl. tables
None
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the test conditions, the oral LD50 for test substance is > 5000 mg/kg bw in female rats therefore it is not classified according to the CLP Regulation (EC) N° (1272-2008).
- Executive summary:
In an acute oral toxicity study (limit test) performed according to OECD Guideline 425 and in compliance with GLP, 3 female HanRcc:WIST (SPF) rats were given a single oral (gavage) dose of test substance at 5000 mg/kg bw. The test substance was formulated in PEG 300 at a concentration of 500 mg/mL and administered at a dosing volume of 10 mL/kg bw. Animals were then observed for mortality, clinical signs and bodyweights for 14 days and were all sacrificed for macroscopic examination.
All animals survived until the end of the study period. Slight clinical signs including ruffled fur, hunched posture and slight sedation on the day of treatment were observed in the three animals treated at 5000 mg/kg body weight which persisted up to test day 7 at the latest. One animal was additionally observed with almost to completely closed eyes on test day 2. By day 4, 7 or 8 all the animals were free of any clinical signs until the end of the study (test day 15). The body weight of the animals was within the range commonly recorded for rats of this strain and age. No macroscopic findings were recorded at necropsy.
Under the test conditions, the oral LD50 for test substance is > 5000 mg/kg bw in female rats therefore it is not classified according to the CLP Regulation (EC) N° (1272-2008).
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