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EC number: 203-973-1 | CAS number: 112-45-8
- 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
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Justification for type of information:
- Data is from study report
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 014
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Principles of method if other than guideline:
- The aim of this study was to assess the toxicity potential of test chemical after single oral administration in rats and 14 day observation period
- GLP compliance:
- yes
- Test type:
- acute toxic class method
Test material
- Reference substance name:
- Undec-10-enal
- EC Number:
- 203-973-1
- EC Name:
- Undec-10-enal
- Cas Number:
- 112-45-8
- Molecular formula:
- C11H20O
- IUPAC Name:
- undec-10-enal
- Test material form:
- other: Clear Colorless liquid
- Details on test material:
- - Name of test material (as cited in study report): Undec-10-enal
- Molecular formula (if other than submission substance): C11H20O
- Molecular weight (if other than submission substance): 168.28 g/mol
- Substance type: Organic
- Physical state: Liquid
- Analytical purity: 98.62%
- Lot/batch No.: KC/C11/1402070
- Expiration date of the lot/batch: July, 2014
- Storage condition of test material: Refrigerator (2 - 8 °C)
- Other:
Handling and Disposal
Safety precautions: Aprons, masks, caps, gloves and goggles were used to ensure the health and safety of the Personnel.
Disposal: The remaining unused test item formulations were disposed as per internal SOPs of sa-FORD and the same was documented in the raw data
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: In-House Bred at Sa-FORD, Animal Facility
- Health Status : Healthy young adult animals were used for the study. Females were nulliparous and non pregnant.
- Age at study initiation: 8- 10 weeks at the time of dosing
- Weight at study initiation: Minimum: 136 g and Maximum: 156 g (Individual body weights were within ± 5% prior to treatment after overnight fasting)
- Fasting period before study: Overnight
- Housing: The animals were housed individually in polycarbonate cages and
- Bedding: All cages were provided with corn cobs
- Diet (e.g. ad libitum): All animals were provided conventional laboratory rodent diet (Nutrivet Life Sciences, Pune) ad libitum. Batch No 400004
- Water (e.g. ad libitum): Aqua guard filtered tap water was provided ad libitum via drinking bottles
- Acclimation period: Animal nos. 1-3 were acclimatized for 6 days and 4-6 for 9 days prior to administration of the test item
- Identification : The animals were marked temporarily on tail, permanently on toe pad micro tattooing and cage cards. Individual cage cards were labelled with study no., study type, test system, group, dose, sex, animal number, experimental start and completion date
- Room Sanitation: The experimental room floor and work tops were swept and mopped with disinfectant solution every day.
- Cages and water bottle: All the cages and water bottles were changed at least twice every week
ENVIRONMENTAL CONDITIONS
- Temperature (°C): Minimum: 19.80°C andMaximum: 23.20°C
- Humidity (%): Minimum: 48.60 % and Maximum: 63.20 %
- Air changes (per hr): More than 12 changes per hour
- Photoperiod (hrs dark / hrs light): 12:12
Administration / exposure
- Route of administration:
- oral: drinking water
- Vehicle:
- corn oil
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 2000 mg/Kg bw
- Amount of vehicle (if gavage): The maximum dose volume administered was 10 ml/kg body weight.
- Justification for choice of vehicle: Corn oil was selected as a vehicle because test item was not miscible in the distilled water during solubility testing
- Lot/batch no. (if required):
- Purity:
DOSAGE PREPARATION:
Added slowly vehicle in to the test item and mixed well. Transferred the formulation to the measuring cylinder and made the volume up to desired quantity. The dosing solution was prepared freshly, shortly prior to dose administration
CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: - Doses:
- 2000 mg/kg body weight
- No. of animals per sex per dose:
- 6
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: After test item administration, individual animals were frequently observed at 30 minutes, 1, 2, 3 and 4 hours post dosing on day 0 (day of dosing). Subsequently, all animals were observed once a day during the 14 day observation period. All rats were weighed on days 0 (prior to dosing), 7 and 14.
- Necropsy of survivors performed: yes
- Other examinations performed:
Clinical Observation
After test item administration, individual animals were frequently observed at 30 minutes, 1, 2, 3 and 4 hours post dosing on day 0 (day of dosing). Subsequently, all animals were observed once a day during the 14 day observation period.
Mortality
All animals were observed twice daily (morning and evening) for morbidity and mortality, throughout the acclimatization and study period.
Body weight
All rats were weighed on days 0 (prior to dosing), 7 and 14.
Pathology
At the end of 14 day observation period, all rats were euthanised by overdose of CO2 for external and internal observations.
Results and discussion
Effect levels
- Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- 5 000 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other:
- Remarks:
- No mortality observed
- Mortality:
- No mortality was observed througout the experimentation period. (refer table 4).
- Clinical signs:
- other: At 2000mg/kg, all the six animals were observed with normal clinical sign till day 14 (refer table 3).
- Gross pathology:
- No external and internal gross pathological examination were seen in all the six animals treated with 2000 mg/kg body weight during terminal sacrifice (refer table 5).
Any other information on results incl. tables
Table 1: Individual Animal Body Weight (g) and Body Weight Changes(%)
Sex:Female
Animal No. |
Group/ Dose (mg/kg) |
Body Weight (gram) |
Body Weight Change (%) |
|||
Day 0 |
Day 7 |
Day 14 |
Day 0-7 |
Day 0-14 |
||
1 |
G1/ 2000 |
153 |
186 |
202 |
21.57 |
32.03 |
2 |
136 |
169 |
179 |
24.26 |
31.62 |
|
3 |
145 |
171 |
189 |
17.93 |
30.34 |
|
4 |
156 |
190 |
193 |
21.79 |
23.72 |
|
5 |
146 |
178 |
186 |
21.92 |
27.40 |
|
6 |
154 |
187 |
200 |
21.43 |
29.87 |
Table 2: Summary of Animal Body Weight (g) and Body Weight Changes (%)
Group/ Dose (mg/kg) |
Rats Body Weight (g) |
Body Weight Changes (%) |
||||
Day 0 |
Day 7 |
Day 14 |
0-7 |
0-14 |
||
G1/ 2000 |
Mean |
148.33 |
180.17 |
191.50 |
21.48 |
29.16 |
SD |
7.50 |
8.84 |
8.69 |
2.03 |
3.13 |
|
n |
6 |
6 |
6 |
6 |
6 |
Keys:SD = Standard Deviation, n = Number of Animals.
Table 3: Individual Animal Clinical Signs and Symptoms
Animal No. |
Group/ Dose (mg/kg) |
Hours (Day 0) |
||||
1/2 |
1 |
2 |
3 |
4 |
||
1 |
G1/ 2000 |
1 |
1 |
1 |
1 |
1 |
2 |
1 |
1 |
1 |
1 |
1 |
|
3 |
1 |
1 |
1 |
1 |
1 |
|
4 |
1 |
1 |
1 |
1 |
1 |
|
5 |
1 |
1 |
1 |
1 |
1 |
|
6 |
1 |
1 |
1 |
1 |
1 |
Animal No. |
Group/ Dose (mg/kg) |
Days post dosing |
|||||||||||||
1 |
2 |
3 |
4 |
5 |
6 |
7 |
8 |
9 |
10 |
11 |
12 |
13 |
14 |
||
1 |
G1/ 2000 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
2 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
|
3 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
|
4 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
|
5 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
|
6 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
Keys: 1 = Normal
Table 4: Individual Animal Mortality Record
Animal No. |
Group/ Dose (mg/kg) |
Day of Observation (Day 0 to 14) |
|
Morning Observations |
Evening Observations |
||
1 |
G1/ 2000 |
No mortality and morbidity |
No mortality and morbidity |
2 |
No mortality and morbidity |
No mortality and morbidity |
|
3 |
No mortality and morbidity |
No mortality and morbidity |
|
4 |
No mortality and morbidity |
No mortality and morbidity |
|
5 |
No mortality and morbidity |
No mortality and morbidity |
|
6 |
No mortality and morbidity |
No mortality and morbidity |
Table 5: Gross Necropsy Observation
Animal No. |
Group/ Dose (mg/kg) |
Mode of Death |
Gross Observation |
|
External |
Internal |
|||
1 |
G1/ 2000 |
Terminal sacrifice |
No abnormality detected |
No abnormality detected |
2 |
Terminal sacrifice |
No abnormality detected |
No abnormality detected |
|
3 |
Terminal sacrifice |
No abnormality detected |
No abnormality detected |
|
4 |
Terminal sacrifice |
No abnormality detected |
No abnormality detected |
|
5 |
Terminal sacrifice |
No abnormality detected |
No abnormality detected |
|
6 |
Terminal sacrifice |
No abnormality detected |
No abnormality detected |
Applicant's summary and conclusion
- Interpretation of results:
- other: Not classified
- Conclusions:
- Acute oral toxicity study of teswt chemical in female rats is as given below:
The acute oral LD50 was 5000 mg/kg body weight.Test chemical is being classified as non toxic by oral administration - Executive summary:
Acute oral toxicity study was conducted for the test compound in female Wistar rats as per OECD No. 423. The animals were fasted for minimum 16-18 hours prior to dosing and for 4 hours post dosing, with food withheld but drinking water provided ad libitum. The time intervals between dosing were determined by the onset, duration and severity of toxic signs. Three rats of group G1 were dosed with starting dose of 2000 mg/kg body weight and the animals showed no mortality post dosing, so another three rats of the same group were dosed with 2000 mg/kg weight and no mortality was observed. Hence, further dosing was stopped. Body weights were recorded on day 0 (prior to dosing), 7 and 14. Mean body weight of animals treated with 2000 mg/kg body weight was observed with gain on day 7 and 14, as compared to day 0. At 2000mg/kg, all the six animals were observed with normal clinical sign till day 14. No external and internal gross pathological examination were seen in all the six animals treated with 2000 mg/kg body weight during terminal sacrifice.The acute oral LD50of test chemical was5000 mg/kgbody weight.
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