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EC number: 262-975-0 | CAS number: 61788-44-1
- 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:
- Experimental test result performed using standard test guidelines
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 014
- Report date:
- 2014
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:
- To assess the toxicity potential of test chemical after single oral administration in rats and an observation period of 14 days.
- GLP compliance:
- yes
- Test type:
- acute toxic class method
- Limit test:
- yes
Test material
- Reference substance name:
- Phenol, styrenated
- EC Number:
- 262-975-0
- EC Name:
- Phenol, styrenated
- Cas Number:
- 61788-44-1
- Molecular formula:
- C88H88O4
- IUPAC Name:
- Phenol, styrenated
- Test material form:
- liquid: viscous
- Details on test material:
- Identification : STYRENATED PHENOL
Appearance : Clear yellowish viscous liquid
Batch number : Lot 2/04
CAS No. : 61788-44-1
AI Content : Monostyryl Phenol – 11.20%
Distyryl Phenol– 44.65%
Tristyryl Phenol– 43.59%
Manufactured date : May, 2013
Expiry Date : September, 2014
Storage conditions : Room temperature (20 - 30 °C)
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- Supplier / Source: In-house animals, bred at Animal House, sa-FORD. CPCSEA Registration No. 1256/bc/09/CPCSEA.
Health Status :Healthy young adult animals were used for the study. Females were nulliparous and non pregnant.
Body weight of animals :Minimum: 132 g Maximum: 158 g (Individual body weights were within ± 6% prior to treatment after overnight fasting)
Age: 8- 10 weeks at the time of dosing.
Acclimatisation:Animal nos. 1-3 were acclimatized for 5 days and 4-6 for 10 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.
Husbandry Conditions
Diet :All animals were provided conventional laboratory rodent diet (Nutrivet Life Sciences, Pune) ad libitum. Batch No.: 400004.
Bedding :All cages were provided with corn cobs (Sparconn Life Sciences Bangalore) SPAR – 25 /2014.
Water : Aqua guard filtered tap water was provided ad libitum via drinking bottles.
Husbandry :The animals were housed individually in polycarbonate cages.
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.
Experimental Room Condition
Temperature :Minimum: 19.80 °C Maximum: 23.20 °C
Relative humidity :Minimum: 48.70% Maximum: 69.20%
Light-dark-rhythm : 12:12
Air Changes : More than 12 changes per hour
Administration / exposure
- Route of administration:
- oral: feed
- Vehicle:
- corn oil
- Details on oral exposure:
- The maximum dose volume administered was 10 ml/kg body weight.
Six female Wistar rats fasted for 16-18 hrs; were selected for acute oral toxicity study. The feed was withheld prior to dosing and 4 hours post dosing but drinking water was provided ad libitum. The time interval between dosing was determined by the onset, duration and severity of toxic signs. Three rats of first group were dosed with starting dose of 2000 mg/kg body weight and the animals did not show any mortality so another three animals of the same group were dosed with 2000 mg/kg body weight and one mortality was observed on day 1 post dosing. Hence, further dosing was stopped. The duration of dosing was between 11:09 to 11:29 a.m. - Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- Six femal rates
- Control animals:
- yes
- 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.
- 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. - Statistics:
- Not specified
Results and discussion
Effect levels
- Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: no mortality observed
- Mortality:
- No mortality was observed in the animals treated with 2000 mg/kg dose throught out the 14 days observation period, except animal no. 5 was found dead on day 1 post dosing (refer table 4).
- Clinical signs:
- other: At 2000 mg/kg, animal no. 1 was observed with normal signs at 30 minutes and 1 hour, mild lethargy at 2, 3 and 4 hours, mild diarrhea at 2, 3, 4 hours and on day 1 and normal thereafter till the end. Animal no. 2 was observed with normal signs at 30 minut
- Gross pathology:
- Found dead animal no. 5 was observed with soiled anal region with feces during external examination, whereas mild red discoloration of lungs and moderately enlarged adrenals during internal examination. No external and internal gross pathological changes were seen in the other 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 |
Found Dead |
Day 0-7 |
Day 0-14 |
||
1 |
G1/ 2000 |
138 |
165 |
180 |
- |
19.57 |
30.43 |
2 |
144 |
183 |
189 |
- |
27.08 |
31.25 |
|
3 |
132 |
157 |
156 |
- |
18.94 |
18.18 |
|
4 |
158 |
174 |
186 |
- |
10.13 |
17.72 |
|
5 |
137 |
- |
- |
122 |
- |
- |
|
6 |
139 |
162 |
175 |
- |
16.55 |
25.90 |
Key:- = Not applicable
Table 2: Summary of Animal Body Weight (g) and Body Weight Changes (%)
Sex:Female
Group/ Dose (mg/kg) |
Rats Body Weight (g) |
Body Weight Changes (%) |
||||
Day 0 |
Day 7 |
Day 14 |
0-7 |
0-14 |
||
G1/ 2000 |
Mean |
141.33 |
168.20 |
177.20 |
18.45 |
24.70 |
SD |
9.03 |
10.33 |
13.03 |
6.10 |
6.49 |
|
n |
6 |
5 |
5 |
5 |
5 |
Keys:SD = Standard Deviation, n = Number of Animals
Table 3: Individual Animal Clinical Signs and Symptoms
Sex:Female
Animal No. |
Group/ Dose (mg/kg) |
Hours (Day 0) |
||||
1/2 |
1 |
2 |
3 |
4 |
||
1 |
G1/ 2000 |
1 |
1 |
49+ 99+ |
49+ 99+ |
49+ 99+ |
2 |
1 |
1 |
49+ 99+ |
49+ 99+ |
49+ 99+ |
|
3 |
1 |
1 |
99+ |
49+ 99+ |
49+ 99+ |
|
4 |
1 |
1 |
49+ 99+ |
49+ 99+ |
49+ 99+ |
|
5 |
1 |
1 |
99+ |
99+ |
99+ |
|
6 |
1 |
1 |
99+ |
49+ 99+ |
49+ 99+ |
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 |
49+ |
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 |
49+ |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
|||||||||||||||||
4 |
99+ |
99+ |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
|||||||||||||||||
5 |
49+ 99+ 4+ 2 |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
|||||||||||||||||
6 |
99+ |
99+ |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
Keys: - = Not applicable, 1 = Normal, 2 = Found dead, 4 = Abdominal breathing, 49 = Diarrhoea, 99 = Lethargy,+= Mild.
Table 4: Individual Animal Mortality Record
Sex:Female
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 till day 1 Found dead on day 1 |
No mortality and morbidity on day 0
|
|
6 |
No mortality and morbidity |
No mortality and morbidity |
Table 5: Gross Necropsy Observation
Sex:Female
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 |
Found dead |
No abnormality detected |
Lungs: Red discoloration (mild) Adrenal glands: Enlarged (moderate) |
|
6 |
Terminal sacrifice |
No abnormality detected |
No abnormality detected |
Applicant's summary and conclusion
- Interpretation of results:
- other: Not classified
- Conclusions:
- Acute Oral Toxicity of test chemical was studied in Rats, This study was performed as per OECD No. 423.
Under the condition of the study,Acute oral LD50 of test chemical was determined to be >2000 mg/kg body weight - Executive summary:
Acute Oral Toxicity of test chemical was studied in Rats, This study was performed as per OECD No. 423.
Six female Wistar rats were selected for acute oral toxicity study. 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 first group were dosed with starting dose of 2000 mg/kg body weight and the animals did not show any mortality so another three animals of the same group were dosed with 2000 mg/kg body weight and one mortality was observed on day 1 post dosing. Hence, further dosing was stopped.
Body weights of surviving animals were recorded on day 0 (prior to dosing) 7 and 14. The animal was weighed immediately after found dead. Mean Body weight of all surviving animals treated with 2000 mg/kg body weight was observed with gain on day 7 and 14, as compared to day 0
Under the conditions of this; the LD50 value of test chemical in female rats was >2000 mg/kg body weight.
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