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EC number: 271-240-3 | CAS number: 68526-92-1 A complex combination of hydrocarbons produced by the distillation of products from the hydrogenation of isotridecanal from the hydroformylation of dodecene. It consists predominantly of C10-12 olefins and paraffins and C13 alcohols and aldehydes and boils in the range of approximately 160°C to 253°C (320°F to 487°F).
- 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 July 2008 - 27 August 2008
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study conducted in compliance with agreed protocols and GLP, with no or minor deviations from standard test guidelines and/or minor methodological deficiencies, which do not affect the quality of relevant results.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 008
- Report date:
- 2009
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 420 (Acute Oral Toxicity - Fixed Dose Method)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Date of Inspection - 21/08/07 Date of Signature - 15/10/07
- Test type:
- fixed dose procedure
- Limit test:
- yes
Test material
- Reference substance name:
- Dodecene, hydroformylation products, low-boiling
- EC Number:
- 271-240-3
- EC Name:
- Dodecene, hydroformylation products, low-boiling
- Cas Number:
- 68526-92-1
- Molecular formula:
- The substance consists of 46 isomers of unsaturated and branched dodecene structures (see Test Report No. A170002983).
- IUPAC Name:
- Dodecene, hydroformylation products, low-boiling
- Details on test material:
- Sponsor's identification : Oxooil LS 13 (CAS No. 68526-92-1)
Description : clear colourless liquid
Date received : 14 July 2008
Storage conditions : room temperature in the dark
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Harlan UK Limited, Bicester, Oxon, UK.
- Age at study initiation: eight to twelve weeks
- Weight at study initiation: The bodyweight variation did not exceed ± 20% of the initial/mean bodyweight of any previously dosed animal(s).
- Fasting period before study: One night before the start of the study
- Housing: housed in suspended solid floor polypropylene cages furnished with woodflakes.
- Diet (e.g. ad libitum): free access to food (Certified Rat and Mouse Diet) was allowed throughout the study
- Water (e.g. ad libitum):free access to mains drinking water (Certified Rat and Mouse Diet) was allowed throughout the study
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 to 25°C
- Humidity (%): 30 to 70%
- Air changes (per hr): 15 per hour
- Photoperiod (hrs dark / hrs light): twelve hours continuous light (06:00 to 18:00) followed by twelve hours of darkness.
IN-LIFE DATES: From: Day 0 To: Day 14
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- arachis oil
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 30 mg/ml for 300 mg/kg dose level. Not stated for 2000 mg/kg.
- Amount of vehicle (if gavage): The volume administered to each animal was calculated according to the fasted bodyweight at the time of dosing.
- Justification for choice of vehicle: test material was freshly prepared, as required, as a solution in arachis oil BP. Arachis oil BP was used because the test material did not dissolve/suspend in distilled water.
- Lot/batch no. (if required): Not stated
- Purity: Not stated
MAXIMUM DOSE VOLUME APPLIED: 10 ml/kg (300 dose level)
All animals were dosed once only by gavage, using a metal cannula attached to a graduated syringe.
DOSAGE PREPARATION (if unusual): The volume administered to each animal was calculated according to the fasted bodyweight at the time of dosing.
CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose:
In the absence of data regarding the toxicity of the test material, 300 mg/kg was chosen as the starting dose. - Doses:
- 300 mg/kg and 2000 mg/kg
- No. of animals per sex per dose:
- 1 female was dosed at 300 mg/kg; 5 females were dosed at 2000 mg/kg.
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing:
Clinical observations were made ½, 1, 2, and 4 hours after dosing and then daily for fourteen days. Morbidity and mortality checks were made twice daily.
Individual bodyweights were recorded on Day 0 (the day of dosing) and on Days 7 and 14.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, organ weights, histopathology, other: - Statistics:
- not stated in report
Results and discussion
- Preliminary study:
- Dose Level: 300mg/kg.
Mortality: There was no mortality.
Clinical Observations: No signs of systemic toxicity were noted during the observation period.
Bodyweight: The animal showed expected gains in bodyweight over the observation period.
Necropsy: No abnormalities were noted at necropsy.
Effect levelsopen allclose all
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: limit test: 1 female was dosed at 300 mg/kg; 5 females were dosed at 2000 mg/kg
- Sex:
- female
- Dose descriptor:
- other: LOAEL
- Effect level:
- 2 000 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: Signs of systemic toxicity noted in one animal treated at a dose level of 2000 mg/kg
- Mortality:
- For dose level 2000 mg/kg bw particular study there were no deaths.
- Clinical signs:
- other: Signs of systemic toxicity noted in one animal treated at a dose level of 2000 mg/kg were hunched posture, lethargy, ataxia, decreased respiratory rate and pilo-erection.
- Gross pathology:
- No abnormalities were noted at necropsy
- Other findings:
- - Other observations: None
Any other information on results incl. tables
Table1 Individual Clinical Observations and Mortality Data -300mg/kg
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 |
||
300 |
1-0 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 Bodyweights and Bodyweight Changes -300mg/kg
Dose Level mg/kg |
Animal Number and Sex |
Bodyweight (g) at Day |
Bodyweight Gain (g) |
|||
0 |
7 |
14 |
1 |
2 |
||
300 |
1-0 Female |
160 |
182 |
202 |
22 |
20 |
Table 3 Necropsy Findings -300 mg/kg
Dose Level |
Animal Number |
Time of Death |
Macroscopic Observations |
300 |
1-0 Female |
Killed Day 14 |
No abnormalities detected |
Table 4 Individual Clinical Observations and Mortality Data -2000mg/kg
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 |
||
2000 |
2-0 Female |
HLARd |
H L A Rd |
H LP |
H P |
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 |
|
3-1 Female |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
3-2 Female |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
3-3 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
H= hunched posture
L= lethargy
A= ataxia
Rd= decreased respiratory rate
P= pilo-erection
Table 5 Individual Bodyweights and Bodyweight Changes-2000mg/kg
Dose Level mg/kg |
Animal Number and Sex |
Bodyweight (g) at Day |
Bodyweight Gain (g) During Week |
|||
0 |
7 |
14 |
1 |
2 |
||
2000 |
2-0 Female |
157 |
167 |
190 |
10 |
23 |
3-0 Female |
171 |
193 |
215 |
22 |
22 |
|
3-1 Female |
156 |
168 |
180 |
12 |
12 |
|
3-2 Female |
171 |
182 |
214 |
11 |
32 |
|
3-3 Female |
178 |
186 |
206 |
8 |
20 |
Table 6 Individual Necropsy Findings-2000mg/kg
Dose Level |
Animal Number |
Time of Death |
Macroscopic Observations |
2000 |
2-0 Female |
Killed Day 14 |
No abnormalities detected |
3-0 Female |
Killed Day 14 |
No abnormalities detected |
|
3-1 Female |
Killed Day 14 |
No abnormalities detected |
|
3-2 Female |
Killed Day 14 |
No abnormalities detected |
|
3-3 Female |
Killed Day 14 |
No abnormalities detected |
The acute oral median lethal dose (LD50) of the test material in the female Sprague Dawley CD strain rat was estimated to be greater than 2000 mg/kg bodyweight.
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 in the female Sprague Dawley CD strain rat was estimated to be greater than 2000 mg/kg bodyweight (EC Regulation 1272/2008 - not classified).
- Executive summary:
Introduction. The study was performed to assess the acute oral toxicity of the test material in the Sprague‑Dawley CD strain rat. The method was designed to meet the requirements of the following:
§ OECD Guidelines for Testing of Chemicals No 420 “Acute Oral Toxicity - Fixed Dose Method” (2001)
§ Method B1 bis Acute Toxicity (Oral) of Commission Directive 2004/73/EC
Method. Following a sighting test at dose levels of 300 mg/kg and 2000 mg/kg, a further group of four fasted females was given a single oral dose of undiluted test material at a dose level of 2000 mg/kg bodyweight. Clinical signs and bodyweight development were monitored during the study. All animals were subjected to gross necropsy.
Mortality. There were no deaths.
Clinical Observations. Signs of systemic toxicity noted in one animal treated at a dose level of 2000 mg/kg were hunched posture, lethargy, ataxia, decreased respiratory rate and pilo-erection.
Bodyweight. All animals showed expected gains in bodyweight.
Necropsy. No abnormalities were noted at necropsy.
Conclusion. The acute oral median lethal dose (LD50) of the test material in the female Sprague‑Dawley CD strain rat was estimated to be greater than 2000 mg/kg bodyweight (Globally Harmonised Classification System-Category 5).
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