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EC number: 942-471-3 | CAS number: 1581740-29-5
- 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:
- 30 June 2014 to 24 July 2014
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study conducted to GLP and in compliance with agreed protocols, with no or minor deviations from standard test guidelines and/or minor methodological deficiencies, which do not effect the quality of the relevant results.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 014
- Report date:
- 2014
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 425 (Acute Oral Toxicity: Up-and-Down Procedure)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- up-and-down procedure
- Limit test:
- yes
Test material
- Reference substance name:
- 1.25H Farnesene
- IUPAC Name:
- 1.25H Farnesene
- Test material form:
- other: liquid
- Details on test material:
- A Certificate of Analysis supplied by the Sponsor is given in Appendix 1 (attachment 1)
Identification: 1.25H Farnesene
Batch: RV-752-153-2
Purity: 98.92%
Physical state / Appearance: clear, colorless liquid
Expiry date: 01 March 2015
Storage Conditions: room temperature in the dark
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- Female Wistar (RccHan™:WIST) strain rats were supplied by Harlan Laboratories UK Ltd., Oxon, UK. On receipt the animals were randomly allocated to cages. The females were nulliparous and non-pregnant. After an acclimatization period of at least five days the animals were selected at random and given a number unique within the study which was written on a cage card. At the start of the study the animals were eight to twelve weeks of age. The body weight variation did not exceed ±20% of the body weight of the initially dosed animal.
The animals were individually housed in suspended solid floor polypropylene cages furnished with woodflakes. With the exception of an overnight fast immediately before dosing and for approximately three to four hours after dosing, free access to mains drinking water and food (2014C Teklad Global Rodent diet supplied by Harlan Laboratories UK Ltd., Oxon, UK) was allowed throughout the study. The diet, drinking water and bedding were routinely analyzed and were considered not to contain any contaminants that would reasonably be expected to affect the purpose or integrity of the study.
The temperature and relative humidity were set to achieve limits of 19 to 25 °C and 30 to 70% respectively. The rate of air exchange was at least fifteen changes per hour and the lighting was controlled by a time switch to give twelve hours continuous light (06:00 to 18:00) and twelve hours darkness.
The animals were provided with environmental enrichment items which were considered not to contain any contaminant of a level that might have affected the purpose or integrity of the study.
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Details on oral exposure:
- All animals were dosed once only by gavage, using a metal cannula attached to a graduated syringe.
- Doses:
- Using available information on the toxicity of the test item, 5000 mg/kg was chosen as the starting dose.
- No. of animals per sex per dose:
- 3 females at 5000 mg/kg
- Control animals:
- no
- Details on study design:
- Using available information on the toxicity of the test item, 5000 mg/kg was chosen as the starting dose.
Three individual fasted female animals were treated as follows:
Test Sequence (Animal number) Dose Level, mg/kg Specific Gravity Dose Volume (mL/kg) Short-Term Result
1
(1-0) 5000 0.809 6.19 0
2
(2-0) 5000 0.809 6.19 0
3
(3-0) 5000 0.809 6.19 0
0 = Animal survived
The test was complete after the third animal had been dosed as the following stopping criterion was met:
Three consecutive animals survived at the maximum dose level (5000 mg/kg)
All animals were dosed once only by gavage, using a metal cannula attached to a graduated syringe. The volume administered to each animal was calculated according to the fasted bodyweight at the time of dosing. Treatment of animals was sequential. Sufficient time was allowed between each individual animal to confirm the survival of the previously dosed animals.
The animals were observed for deaths or overt signs of toxicity ½, 1, 2 and 4 hours after dosing and subsequently once daily for fourteen days.
Individual bodyweights were recorded prior to dosing and seven and fourteen days after treatment.
At the end of the observation period the animals were killed by cervical dislocation. All animals were subjected to gross pathological examination. This consisted of an external examination and opening of the abdominal and thoracic cavities for examination of major organs. The appearance of any macroscopic abnormalities was recorded. No tissues were retained. - Statistics:
- None
Results and discussion
Effect levels
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 5 000 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: 95% confidence limits not given in study report.
- Mortality:
- Individual mortality data are given in Table 1.
There were no deaths. - Clinical signs:
- other: Individual clinical observations are given in Table 1. No signs of systemic toxicity were noted during the observation period.
- Gross pathology:
- Individual necropsy findings are given in Table 3.
No abnormalities were noted at necropsy. - Other findings:
- None
Any other information on results incl. tables
Table 1 Individual Clinical Observations and Mortality Data
Dose Level mg/kg |
Animal Number and Sex |
Effects Noted After Dosing |
Effects Noted During Period After Dosing |
||||||||||||||||
½ |
1 |
2 |
4 |
1 |
2 |
3 |
4 |
5 |
6 |
7 |
8 |
9 |
10 |
11 |
12 |
13 |
14 |
||
5000 |
1-0 Female |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
2-0 F2male |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
3-0 Female |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0= No signs of systemic toxicity
Table 2 Individual Body Weights and Body Weight Changes
Dose Level mg/kg |
Animal Number |
Body Weight (g) at Day |
Body Weight Gain (g) During Week |
|||
0 |
7 |
14 |
1 |
2 |
||
5000 |
1-0 Female |
159 |
170 |
184 |
11 |
14 |
2-0 Female |
160 |
178 |
191 |
18 |
13 |
|
3-0 Female |
154 |
161 |
173 |
7 |
12 |
Table 3 Individual Necropsy Findings
Dose Level |
Animal Number |
Time of Death |
Macroscopic Observations |
5000 |
1-0 Female |
Killed Day 14 |
No abnormalities detected |
2-0 Female |
Killed Day 14 |
No abnormalities detected |
|
3-0 Female |
Killed Day 14 |
No abnormalities detected |
Applicant's summary and conclusion
- Interpretation of results:
- other: The acute oral median lethal dose (LD50) of the test item in the female Wistar strain rat was found to be greater than 5000 mg/kg body weight.
- Remarks:
- Criteria used for interpretation of results: not specified
- Conclusions:
- The acute oral median lethal dose (LD50) of the test item in the female Wistar strain rat was found to be greater than 5000 mg/kg body weight.
- Executive summary:
Introduction
The study was performed to assess the acute oral toxicity of the test item in the Wistar strain rat.
Methods
One fasted female animal was treated with the test item at a dose level of 5000 mg/kg body weight. The animal survived, therefore two additional females were treated sequentially at a dose level of 5000 mg/kg body weight so that a total of three animals were treated.
The test item was administered orally undiluted. Clinical signs and body weight development were monitored during the study. All animals were subjected to gross necropsy.
Results
Mortality. There were no deaths.
Clinical Observations. There were no signs of systemic toxicity.
Body Weight. All animals showed expected gains in body weight.
Necropsy. No abnormalities were noted at necropsy.
Conclusion
The acute oral median lethal dose (LD50) of the test item in the female Wistar strain rat was found to be greater than 5000 mg/kg body weight.
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