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EC number: 417-060-2 | CAS number: 151006-61-0 1-DODECENE DIMER, HYDROGENATED; ALKANE 2
- 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:
- Between 27 October 1994 and 17 November 1994
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study conducted in compliance with agreed protocols, with no or minor deviations from standard test guidelines and/or minor methodological deficiencies, which do not affect the quality of the relevant results.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 995
- Report date:
- 1995
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Version / remarks:
- adopted 24 Feb 1987
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OTS 798.1175 (Acute Oral Toxicity)
- Version / remarks:
- Toxic Substances Control Act (TSCA), Health Effects Testing Guidelines: Subpart 8, Section 798.1175 "Acute Oral Toxicity"
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPP 81-1 (Acute Oral Toxicity)
- Version / remarks:
- FIFRA, Pesticide Assessment Guidelines Subdivision F; Hazard Evaluation Human and Domestic Animals Section 81-1 "Acute Oral Toxicity Study". Revised Edition Nov 1984.
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- The work described was performed in compliance with the UK principles of Good Laboratory Practice (The United Kingdom Compliance Programme, Department of Health 1989).
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- A mixture of isomers of branched tetracosane
- EC Number:
- 417-060-2
- EC Name:
- A mixture of isomers of branched tetracosane
- Cas Number:
- 151006-61-0
- Molecular formula:
- C24 H50
- IUPAC Name:
- A mixture of isomers of branched tetracosane
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source:
Charles River (UK) Ltd., Margate, Kent, UK.
- Age at study initiation:
Approximately eight weeks old.
- Weight at study initiation:
The males weighed 207 - 234 g and the females 202 - 219 g.
- Fasting period before study:
Overnight fast immediately before dosing and two hours after dosing.
- Housing:
Housed in groups of five by sex in grid bottom polypropylene cages.
- Diet (e.g. ad libitum):
Free access to food (Rat and Mouse Expanded Diet No. 1, Special Diets Services Limited, Witham, Essex, UK) was allowed throughout the study.
- Water (e.g. ad libitum):
Free access to water was allowed throughout the study
- Acclimation period:
Minimum acclimation period of at least seven days
ENVIRONMENTAL CONDITIONS
- Temperature (°C):
The animal room was maintained at a temperature of 19 to 21 deg C
- Humidity (%):
The animal room was maintained at a relative humidity of 49 to 54%
- Air changes (per hr):
The rate of air exchange was approximately 15 changes per hour
- Photoperiod (hrs dark / hrs light):
Lighting was controlled by a time switch to give 12 hours continuous light and 12 hours darkness.
IN-LIFE DATES: From: Day one To: Day fourteen
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle:
Not applicable
- Amount of vehicle (if gavage):
Not applicable
- Justification for choice of vehicle:
Not applicable
- Lot/batch no. (if required):
Not applicable
- Purity:
Not applicable
MAXIMUM DOSE VOLUME APPLIED:
6.28 ml/kg
DOSAGE PREPARATION (if unusual):
For the purpose of the study the test material was used as supplied. The specific gravity was determined by Safepharm Laboratories Limited and used to calculate the appropriate dose volume for the required dose level.
The absorption of the test material was not determined.
All animals were dosed once only by gavage using a metal cannula attached to a graduated syringe. The volume of test material administered to each animal was calculated according to its fasted bodyweight at the time of dosing.
CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose:
A range finding study was performed to establish a dosing regime. Based on the results of the range-finding study a further group of animals was treated. - Doses:
- Range-finding study: 5000 mg/kg
Main study: 5000 mg/kg - No. of animals per sex per dose:
- Range finding study:
1 male
1 female
Main study
5 male
5 female - Control animals:
- no
- Details on study design:
- - Duration of observation period following administration:
14 days
- Frequency of observations and weighing:
The animals were observed for deaths or overt signs of toxicity 1, 2.5 and 4 hours after dosing and subsequently once daily for 14 days.
Individual bodyweights were recorded prior to dosing on Day 0 and on Days 7 and 14.
- Necropsy of survivors performed:
At the end of the study the animals were killed by an overexposure of CO2 and subjected to gross pathological examination. This consisted of an external examination and opening of the abdominal and thoracic cavities. The appereance of any macroscopic abnormalities was recorded. No tissues were retained.
- Other examinations performed:
clinical signs and body weight - Statistics:
- Data evaluations included the relationship, if any, between the animals' exposure to the test material and the incidence and severity of all abnormalities including behavioural and clinical observations, gross pathological lesions, bodyweight changes, mortality and any other toxicological effects.
Using the mortality data obtained, an estimate of the acute oral median lethal dose LD50 of the test material was made.
Results and discussion
- Preliminary study:
- Individual clinical observations an mortality data are given in Table 1. Individual necropsy findings are given in Table 2.
There were no deaths or clinical signs of toxicity. No abnormalities were noted at necropsy.
Based on this information, a dose level of 5000 mg/kg bodyweight was selected for the main study.
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 5 000 mg/kg bw
- Remarks on result:
- other: 95% CL not recorded
- Mortality:
- Individual mortality data are given in Table 3.
There were no deaths. - Clinical signs:
- Individual clinical observations are given in Table 3.
No signs of systemic toxicity were noted during the study. - Body weight:
- Individual bodyweights, together with weekly bodyweight gains are given in Table 4.
All animals showed expected gain in bodyweight during the study. - Gross pathology:
- Individual necropsy findings are given in Table 5.
No abnormalities were noted at necropsy. - Other findings:
- No other findings recorded.
Any other information on results incl. tables
Table 1 Individual Clinical Observations and Mortality Data in the Range-Finding Study
Dose Level mg/kg | Animal Number and Sex | Effects Noted After Dosing (Hours) | Effects Noted During Period After Dosing (Days) | ||||||
1 | 2.5 | 4 | 1 | 2 | 3 | 4 | 5 | ||
5000 | 1-0 Male | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
2-0 Female | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Table 2 Individual Necropsy Findings in the Range-Finding Study
Dose Level mg/kg | Animal Number and Sex | Time of Death | Macrospopic Observations |
5000 | 1-0 Male | Killed Day 5 | No abnormalities detected |
2-0 Female | Killed Day 5 | No abnormalities detected |
Table 3 Individual Clinical Observations and Mortality Data in the Main Study
Dose Level mg/kg | Animal Number and Sex | Effects Noted After Dosing (Hours) | Effects Noted During Period After Dosing (Days) | |||||||||||||||
1 | 2.5 | 4 | 1 | 2 | 3 | 4 | 5 | 6 | 7 | 8 | 9 | 10 | 11 | 12 | 13 | 14 | ||
5000 | 3-0 Male | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
3-1 Male | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
3-2 Male | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
3-3 Male | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
3-4 Male | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
4-0 Female | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
4-1 Female | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
4-2 Female | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
4-3 Female | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
4-4 Female | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Table 4 Individual Bodyweights and Weekly Bodyweight Gain in the Main Study
Dose Level mg/kg | Animal Number and Sex | Bodyweight (g) at Day | Bodyweight Gain (g) During Week | |||
0 | 7 | 14 | 1 | 2 | ||
5000 | 3-0 Male | 231 | 304 | 355 | 73 | 51 |
3-1 Male | 219 | 270 | 304 | 51 | 34 | |
3-2 Male | 207 | 276 | 329 | 69 | 53 | |
3-3 Male | 234 | 293 | 333 | 59 | 40 | |
3-4 Male | 215 | 280 | 328 | 65 | 48 | |
4-0 Female | 202 | 230 | 250 | 28 | 20 | |
4-1 Female | 203 | 225 | 340 | 22 | 15 | |
4-2 Female | 219 | 259 | 276 | 40 | 17 | |
4-3 Female | 203 | 215 | 230 | 12 | 15 | |
4-4 Female | 206 | 242 | 261 | 36 | 19 |
Table 5 Individual Necropsy Findings in the Main Study
Dose Level mg/kg | Animal Number and Sex | Time of Death | Macroscopic Observations |
5000 | 3-0 Male | Killed Day 14 | No abnormalities detected |
3-1 Male | Killed Day 14 | No abnormalities detected | |
3-2 Male | Killed Day 14 | No abnormalities detected | |
3-3 Male | Killed Day 14 | No abnormalities detected | |
3-4 Male | Killed Day 14 | No abnormalities detected | |
4-0 Female | Killed Day 14 | No abnormalities detected | |
4-1 Female | Killed Day 14 | No abnormalities detected | |
4-2 Female | Killed Day 14 | No abnormalities detected | |
4-3 Female | Killed Day 14 | No abnormalities detected | |
4-4 Female | Killed Day 14 | No abnormalities detected |
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The acute oral median lethal dose (LD50) of the test material, Alkane 2, in the Sprague-Dawley strain rat was found to be greater than 5000 mg/kg bodyweight.
- Executive summary:
1. A study was performed to assess the acute oral toxicity of the test material in the Sprague-Dawley strain rat.
The study was designed to comply with the requirements of the U.S Environmental Protection Agency (EPA) Guidelines, the OECD Guidelines for Testing of Chemicals No. 401 "Acute Oral Toxicity" (adopted 24 Feb 1987) and Method B1 of Commission Directive 92/69/EEC (which constitutes Annex V of Council Directive 67/548/EEC) and the Japanese Ministry of Agriculture, Forestry and Fisheries (MAFF), Testing Guidelines for Toxicological Studies, 59 NohSan No. 4200, January 28 1985.
2. Following a range-finding study, a group of ten fasted animals (five males and five females) was given a single oral dose of undiluted test material at a dose level of 5000 mg/kg bodyweight. The animals were observed for fourteen days after the day of dosing and were then killed and subjected to gross necropsy.
3. There were no deaths. No signs of systemic toxicity were noted during the study.
4. All animals showed expected gain in bodyweight during the study.
5. No abnormalities were noted at necropsy.
6. The acute oral median lethal dose (LD50) of the test material in the Sprague-Dawley strain rat was found to be greater than 5000 mg/kg bodyweight.
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