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EC number: 232-477-8 | CAS number: 8050-18-8
- 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
- Study period:
- 2020-10-27 to 2020-12-16
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 021
- Report date:
- 2021
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- acute toxic class method
- Limit test:
- yes
Test material
- Reference substance name:
- Decarboxylated Rosin
- Cas Number:
- 8050-18-8
- Molecular formula:
- Not availabe for UVCB substance
- IUPAC Name:
- Decarboxylated Rosin
- Test material form:
- liquid
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- Animal information
Healthy nulliparous and non-pregnant female RccHan®:WIST albino rats were obtained from
- Source: Envigo RMS (UK) Ltd.
- housing: Group housed by three rats of the same sex. Solid bottomed polycarbonate cages with a stainless steel mesh lid.
- acclimatisation: at least five days
- body weights: 163 to 179 g, the body weight variation did not exceed ± 20% of the mean weight of any previously treated animals.
- age of animals: approximately eight to twelve weeks of age prior to dosing (Day 1).
Each cage of animals was provided with Aspen chew blocks or balls for environmental enrichment. Chew blocks or balls were provided throughout the study and were replaced when necessary. Each cage of animals was provided with a plastic shelter for environmental enrichment, which was replaced at the same time as the cages.
Diet: standard rodent pelleted diet (Teklad 2014C Diet) ad libitum (except for overnight prior to and approximately four hours after dosing)
Water:Potable water taken from the public supply ad libitum
Environmental conditions
-Temperature range:20 to 24°C
-Relative humidity range: 40 to 70%
-artificial lighting: a cycle of 12 hours continuous light and 12 hours continuous dark per 24 hours.
- air changes: not reported
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- corn oil
- Details on oral exposure:
- The appropriate dose volume of the test item was administered to each rat by oral gavage using a plastic syringe and plastic catheter. A record of the weight of each formulation dispensed and the amount remaining after dosing was made. The balance of these two weights was compared with the predicted usage as a check that the doses had been administered correctly. Formulations were stirred before and throughout the dosing procedure.
- Doses:
- 2000 mg/kg
- No. of animals per sex per dose:
- 3 female rats/dose
- Control animals:
- no
- Details on study design:
- One group of three animals was treated as follows:
Dose level (mg/kg): 2000
Dose volume (mL/kg): 10
Number of rat (female): 3
In the absence of mortality or toxicity at a dose level of 2000 mg/kg, an additional group of three animals was treated as follows:
Dose level (mg/kg): 2000
Dose volume (mL/kg): 10
Number of rat (female): 3
Results and discussion
Effect levels
- Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- There were no deaths during the study.
- Clinical signs:
- other: other: There were no clinical signs of reaction to treatment throughout the study.
- Body weight:
- other body weight observations
- Remarks:
- All animals were considered to have achieved satisfactory body weight gains throughout the study.
- Other findings:
- Macroscopic Examination
No abnormalities were noted in any animal at the macroscopic examination at study
termination on Day 15.
Any other information on results incl. tables
Table 1 – individual and group mean body weight (g)
Dose (mg/kg) |
Sex |
Animal Number |
Body weight(s) at Day |
||
1* |
8 |
15 |
|||
2000 |
Female |
41 |
163 |
186 |
199 |
42 |
174 |
203 |
209 |
||
43 |
170 |
201 |
215 |
||
Mean |
169 |
197 |
208 |
||
2000 |
Female |
44 |
167 |
183 |
202 |
45 |
170 |
190 |
210 |
||
46 |
179 |
209 |
225 |
||
Mean |
172 |
194 |
212 |
* Prior to dosing
Table 2 – individual body weight change (g)
Dose (mg/kg) |
Sex |
Animal Number |
Body weight(s) at Day |
|
1-8 |
8-15 |
|||
2000 |
Female |
41 |
23 |
13 |
42 |
29 |
6 |
||
43 |
31 |
14 |
||
2000 |
Female |
44 |
16 |
19 |
45 |
20 |
20 |
||
46 |
30 |
16 |
Applicant's summary and conclusion
- Interpretation of results:
- Category 5 based on GHS criteria
- Conclusions:
- Under the conditions of the study, the acute median lethal oral dose (LD50) to rats of AA- 948- 61 (Decarboxylated Rosin, CAS no. 8050-18-8) was demonstrated to be greater than 2000 mg/kg body weight. AA-948-61 (Decarboxylated Rosin, CAS no. 8050-18-8) is included in Category 5/Unclassified, according to the Globally Harmonised System (GHS).
- Executive summary:
The study was performed to assess the acute oral toxicity of AA-948-61 (Decarboxylated Rosin, CAS No. 8050-18-8) to the rat. A group of three fasted female rats received a single oral gavage dose of the test item, formulated in corn oil, at a dose level of 2000 mg/kg body weight. As results at this dose level indicated the acute lethal oral dose of the test item to be greater than 2000 mg/kg body weight, in compliance with the study guidelines, a further group of three fasted females was similarly dosed at 2000 mg/kg body weight to complete the study. During the study, clinical condition, body weight and macropathology investigations were undertaken. Under the conditions of the study, the acute median lethal oral dose (LD50) to rats of AA-948- 61 (Decarboxylated Rosin, CAS No. 8050-18-8) was demonstrated to be greater than 2000 mg/kg body weight. AA-948-61 (Decarboxylated Rosin, CAS No. 8050-18-8) is included in Category 5/Unclassified, according to the Globally Harmonised System (GHS).
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