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EC number: 202-216-2 | CAS number: 93-08-3
- 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
![](https://poisoncentres.echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
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 repport
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 018
- Report date:
- 2018
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 425 (Acute Oral Toxicity: Up-and-Down Procedure)
- Principles of method if other than guideline:
- The objective of this acute oral toxicity study was to assess the toxicological profile of the test item when administered to rats by a single oral gavage.
- GLP compliance:
- yes
- Test type:
- up-and-down procedure
- Limit test:
- no
Test material
- Reference substance name:
- 2'-acetonaphthone
- EC Number:
- 202-216-2
- EC Name:
- 2'-acetonaphthone
- Cas Number:
- 93-08-3
- Molecular formula:
- C12H10O
- IUPAC Name:
- 1-(naphthalen-2-yl)ethan-1-one
- Test material form:
- solid
- Details on test material:
- IUPAC name: 1-(2-naphthalenyl)-ethanone
Smiles: c12c(ccc(c1)C(C)=O)cccc2
InChI
1S/C12H10O/c1-9(13)11-7-6-10-4-2-3-5-12(10)8-11/h2-8H,1H3
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Invivo Biosciences, Bengaluru
- Females (if applicable) nulliparous and non-pregnant: yes
- Age at study initiation: 8 to 11 Weeks
- Weight at study initiation: 199.46 g to 224.12 g
- Fasting period before study: overnight fasted (16 to 18 hours)
- Housing: Rats were housed individually in standard polysulfone cages (Size: approximately L 425 x B 266 x H 185 mm), with stainless steel top grill having facilities for pelleted food and drinking water in polycarbonate bottle. Additionally, polycarbonate rat huts were placed inside the cage as an enrichment object and were changed along with the cage at least once a week. Bedding: steam sterilized corn cob was used and changed at least once a week along with the cage.
- Diet (e.g. ad libitum): Rat & Mice pellet feed, manufactured by Krishna Valley Agro Tech LLP
- Water (e.g. ad libitum): Deep bore-well water passed through activated charcoal filter and exposed to UV rays in Aquaguard on-line water filter-cum-purifier manufactured by Eureka Forbes Ltd, Mumbai
- Acclimation period: After physical examination for good health and suitability for experiment, the animals were acclimatized six to twenty two days prior to treatment. Animals were observed once daily during acclimatization period. Females were nulliparous and non-pregnant.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 to 24°C
- Humidity (%): 64 to 66%,
- Air changes (per hr): 13.2-13.8 air changes/hour.
- Photoperiod (hrs dark / hrs light): 12 hours light and 12 hours dark cycle.
IN-LIFE DATES: From: To:31.08.2018 to 06.10.2018
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- other: 0.5% w/v Sodium carboxy methyl cellulose in Milli-Q water
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 550, 730, 970, 1290,1750 and 2300 mg/kg
- Amount of vehicle (if gavage): 10 mL/kg
- Justification for choice of vehicle: Based on solubility test, the test item forms a suspension in 0.5% sodium
carboxy methyl cellulose (NaCMC) in Milli-Q water and used to prepare the
dose formulations.
- Lot/batch no. (if required): SLBR1692V
MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg body weight
DOSAGE PREPARATION (if unusual):A required quantity (g) of test item was weighed in an aluminum foil and transferred into clean mortar and gently triturated using pestle to obtain fine powder. Small volume of vehicle was added gradually to the mortar with continuous trituration until a uniform suspension was obtained. The mixture was quantitatively transferred to a measuring cylinder. Further, a small volume of vehicle was added to the mortar and rinsed with the vehicle, all the rinsing was quantitatively transferred into the measuring cylinder. The final volume was made up to the mark with vehicle to get the desired test item concentration (mg/mL). The prepared dose formulation was transferred to the dedicated labeled beaker. Preparation were made prior to dosing.Homogeneity of the test item in the vehicle was maintained during treatment by constant stirring using a magnetic stirrer.
- Doses:
- G1A/ 1-550 mg/kg
G2/2- 730 mg/kg
G3/3- 970 mg/kg
G4/4- 1290 mg/kg
G5/5- 1750 mg/kg
G6/6- 2300 mg/kg - No. of animals per sex per dose:
- 1 female per dose
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: At each step, the animals were observed five times on test day 1 (day of administration) i.e. at 30 minutes and four times at hourly intervals and once
daily during days 2 to 15 post administration.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight,organ weights, histopathology, other: Clinical signs:Observations included changes in skin and fur, eyes and mucous membranes, and also respiratory, circulatory, autonomic and central nervous systems and somatomotor activity and behaviour pattern. Attention was directed to the observations of tremors, convulsions, salivation, diarrhoea, lethargy, sleep and coma and all observed clinical signs were recorded.
Body weights
The body weights were recorded on test day 1 (pre-administration), day 8 (7 days post administration) and day 15 (14 days post administration).
Necropsy
The rats surviving to the end of the observation period were euthanized by using isoflurane anaesthesia and subjected to detailed necropsy. Gross pathological findings were recorded and reported. Microscopic examination was not carried out as no gross pathological changes were observed.
Results and discussion
Effect levels
- Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 300 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other:
- Remarks:
- No mortality observed
- Mortality:
- No mortality observed
- Clinical signs:
- other: G1/Step-1 to G6/Step-6: There were no clinical sings and pre-terminal deaths.
- Gross pathology:
- There were no gross pathological changes at necropsy
- Other findings:
- Not specified
Any other information on results incl. tables
Table 3:Body weight, body weight change and pre-terminal deaths
Group/Step and Dose (mg/kg body weight) |
Rat No. |
Sex |
Body weight (g) |
Day of Death(Time of Death) |
No. dead/ No. tested |
Preterminal deaths (%)
|
|||||
Initial (Day 1) |
8th day |
Weight change (day 8 – Initial) |
15th day
|
Weight change (day 15 – Initial) |
At Death |
||||||
G1/Step 1/550 |
Rw979 |
F |
221.37 |
225.61 |
4.24 |
230.26 |
8.89 |
NA |
NA |
NIL |
- |
G1A/Step 1/550 |
Rw980 |
F |
224.12 |
226.76 |
2.64 |
231.79 |
7.67 |
NA |
NA |
NIL |
- |
G2/Step 2/730 |
Rw981 |
F |
210.84 |
213.26 |
2.42 |
221.12 |
10.28 |
NA |
NA |
NIL |
- |
G3/Step 3/970 |
Rw982 |
F |
209.16 |
214.03 |
4.87 |
220.24 |
11.08 |
NA |
NA |
NIL |
- |
G4/Step 4/1290 |
Rw983 |
F |
201.90 |
214.17 |
12.27 |
219.38 |
17.48 |
NA |
NA |
NIL |
- |
G5/Step 5/1750 |
Rw984 |
F |
206.64 |
210.32 |
3.68 |
214.96 |
8.32 |
NA |
NA |
NIL |
- |
G6/Step 6/2300 |
Rw985 |
F |
199.46 |
203.61 |
4.15 |
208.52 |
9.06 |
NA |
NA |
NIL |
- |
F: Female NA: Not Applicable mg: milligram kg: kilogram g: gram
Note: G1/Step 1 was not considered for results and assessment of toxicity as the food was provided before dosing
Applicant's summary and conclusion
- Interpretation of results:
- other: Not classified
- Conclusions:
- Based on the results of the present study, the median lethal dose LD50 for test chemical is greater than 2000 mg/kg body weight
- Executive summary:
The acute oral toxicity study was conducted to assess the toxicological profile of the test item as per OECD Guideline 425 (Acute Oral Toxicity: Up-and-Down Procedure) in Wistar rats.
The dose formulation was prepared by using Milli-Q water and administered as a single oral gavage to overnight fasted (16 to 18 hours) female rats at each step. There were no clinical signs of toxicity and pre-terminal deaths.
The stopping criteria met as 3 consecutive animals survive at the upper bound. Hence, the further dosing was stopped as per AOT 425 Stat program result (version: 1.0). There were no clinical signs of toxicity and pre-terminal deaths.
The rats were observed for mortality and clinical signs for 14 days post treatment. Body weights were recorded prior to dosing on day 1 and on days 8 and 15. Necropsy was performed for all the rats at termination. All survived rats gained weight during experimental period. There were no gross pathological changes at necropsy.
Based on the results of the present study, the LD50 value of the given test chemical is >2000 mg/kg bw. Thus, the test item is not classified for acute oral toxicity. CLP criteria "Not Classified".
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