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EC number: 947-945-3 | CAS number: -
- 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://echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
Acute Toxicity: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
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 402 (Acute Dermal Toxicity)
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- Reaction mass of Cardanol diene and Cardanol monoene and Cardanol triene
- Cas Number:
- 37330-39-5
- Molecular formula:
- C(21)H(31-36)O
- IUPAC Name:
- Reaction mass of Cardanol diene and Cardanol monoene and Cardanol triene
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- Species:Rat (Rattus norvegicus)Strain:Wistar Sex:Male and FemaleNumber of Animals:10 (Five per sex)Supplier/Source:In-House Bred Health Status:Healthy young adult animals were used for the study. Females were nulliparous and non pregnantBody weight of animals:Male:Minimum: 249 g and Maximum: 276 g (Prior to Treatment) Female:Minimum: 236 g and Maximum: 254 g Acclimatisation :All animals were acclimatized to the test conditions for 6 days prior to administration of the test itemIdentification:During Acclimatization, animals were temporarily marked by permanent marker, on their tails. After acclimatization, the animals were marked bytoe 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.Randomization :Animals were selected manually. No computer generated randomization program was used.Diet:All animals were provided conventional laboratory rodent diet (Nutrivet Life Sciences, Pune) ad libitum. Batch No 400010 and 400011.Bedding:All cages were provided with corn cobs 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 weekTemperature:Minimum: 20.00 °C Maximum: 22.30 °CRelative humidity :Minimum: 49.10% Maximum: 67.30%Light-dark-rhythm:12 hour light and 12 hour darkAir Changes:More than 12 changes per hour
Administration / exposure
- Type of coverage:
- occlusive
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- The test item was applied uniformly over clipped dorsal area of rat skin. Individual rat was applied with a volume of test item, calculated based on the density (0.93237) and latest body weight. Test item was held in contact with the skin with a porous gauze dressing (Approx. 10% of body surface area of rat) and non-irritating tape throughout a 24-hour exposure period. It was ensured that the animals cannot ingest the test item.At the end of the exposure period, residual test item was removed by using distilled water
- Duration of exposure:
- The test item was applied uniformly over clipped dorsal area of rat skin. Individual rat was applied with a volume of test item, calculated based on the density (0.93237) and latest body weight. Test item was held in contact with the skin with a porous gauze dressing (Approx. 10% of body surface area of rat) and non-irritating tape throughout a 24-hour exposure period. It was ensured that the animals cannot ingest the test item. At the end of the exposure period, residual test item was removed by using distilled water. The animals were dosed between 12:06 to 12:13 p.m
- Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 5 male & 5 female
- Control animals:
- yes
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: not specified
- Mortality:
- No mortality was observed at limit dose of 2000 mg/kg body weight during the 14 day observation period
- Clinical signs:
- At 2000 mg/kg, all the animals were observed normal at 1, 2, 3 and 4 hours post dosing. Animal nos. 1, 4, 7, 8 and 9 were observed with erythema on day 1 and scale formation from day 2 to 8 followed by normal clinical sign till day 14. Animal nos. 5 and 6 were observed with erythema on day 1 and scale formation from day 1 to 6 followed by normal clinical sign till day 14. Animal nos. 2, 3 and 10 were observed with erythema on day 1 and scale formation from day 2 to 7 followed by normal clinical sign till day 14.
- Body weight:
- Decrease in mean body weight was observed on day 7 and increase in mean body weight was observed on day 14 in male rats whereas in female rats decrease in mean body weight was observed on day 7 and 14 when compared to day 0 mean body weight
- Gross pathology:
- The external and internal gross pathological observation of all terminally sacrificed animals did not show any pathological abnormality
Any other information on results incl. tables
TABLES
Table 1: Dose Volume, Individual Animal Body Weight (g) andBody Weight Changes(%)
Dose:2000 mg/ kg bodyweight Density:0.93237
Animal No. | Sex | Dose Volume* (ml) | Body Weight (gram) | Body Weight Change (%) | |||
Day 0 | Day 7 | Day 14 | Day 0-7 | Day 0-14 | |||
1 | Male | 0.56 | 261 | 257 | 278 | -1.53 | 6.51 |
2 | 0.59 | 276 | 275 | 276 | -0.36 | 0.00 | |
3 | 0.53 | 249 | 248 | 276 | -0.40 | 10.84 | |
4 | 0.59 | 275 | 269 | 312 | -2.18 | 13.45 | |
5 | 0.55 | 255 | 257 | 316 | 0.78 | 23.92 | |
6 | Female | 0.54 | 254 | 239 | 239 | -5.91 | -5.91 |
7 | 0.52 | 243 | 229 | 230 | -5.76 | -5.35 | |
8 | 0.54 | 251 | 226 | 236 | -9.96 | -5.98 | |
9 | 0.51 | 236 | 228 | 235 | -3.39 | -0.42 | |
10 | 0.54 | 252 | 241 | 248 | -4.37 | -1.59 |
Keys: * = based on the test item density and day 0 body weight
Table 2: Individual Animal Clinical Signs and Symptoms
Dose:2000 mg/kg body weight
Animal No. | Sex | Hour(s) - Day 0 | Day | |||||||||
1 | 2 | 3 | 4 | 1 | 2 | 3 | 4 | 5 | 6 | 7 | ||
1 | Male | 1 | 1 | 1 | 1 | 65+ | 147+ | 147++ | 147++ | 147++ | 147++ | 147+ |
2 | 1 | 1 | 1 | 1 | 65+ | 147+ | 147++ | 147++ | 147++ | 147+ | 147+ | |
3 | 1 | 1 | 1 | 1 | 65+ | 147+ | 147++ | 147++ | 147++ | 147+ | 147+ | |
4 | 1 | 1 | 1 | 1 | 65+ | 147+ | 147++ | 147++ | 147++ | 147+ | 147+ | |
5 | 1 | 1 | 1 | 1 | 65+ | 147++ | 147++ | 147++ | 147+ | 147+ | 1 | |
6 | Female | 1 | 1 | 1 | 1 | 65+ | 147+ | 147++ | 147+ | 147+ | 147+ | 1 |
7 | 1 | 1 | 1 | 1 | 65+ | 147+ | 147++ | 147++ | 147++ | 147++ | 147+ | |
8 | 1 | 1 | 1 | 1 | 65+ | 147+ | 147++ | 147++ | 147++ | 147++ | 147+ | |
9 | 1 | 1 | 1 | 1 | 65+ | 147+ | 147++ | 147++ | 147++ | 147+ | 147+ | |
10 | 1 | 1 | 1 | 1 | 65+ | 147+ | 147+ | 147+ | 147+ | 147+ | 147+ |
Animal No. | Sex | Day | ||||||
8 | 9 | 10 | 11 | 12 | 13 | 14 | ||
1 | Male | 147+ | 1 | 1 | 1 | 1 | 1 | 1 |
2 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | |
3 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | |
4 | 147+ | 1 | 1 | 1 | 1 | 1 | 1 | |
5 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | |
6 | Female | 1 | 1 | 1 | 1 | 1 | 1 | 1 |
7 | 147+ | 1 | 1 | 1 | 1 | 1 | 1 | |
8 | 147+ | 1 | 1 | 1 | 1 | 1 | 1 | |
9 | 147+ | 1 | 1 | 1 | 1 | 1 | 1 | |
10 | 1 | 1 | 1 | 1 | 1 | 1 | 1 |
Key: 1 = Normal, 65 =Erythema, 147 = Scale, + = Mild (slight), ++ = Moderate
Table 3: Individual Animal Mortality Record
Dose:2000 mg/kg body weight
Animal No. | Sex | Days of Observation (0 to 14) | |
Morning Observations | Evening Observations | ||
1 | Male | 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 | Female | No mortality and morbidity | No mortality and morbidity |
7 | No mortality and morbidity | No mortality and morbidity | |
8 | No mortality and morbidity | No mortality and morbidity | |
9 | No mortality and morbidity | No mortality and morbidity | |
10 | No mortality and morbidity | No mortality and morbidity |
Table 4:Summaryof Animal Body Weight (g) and Body Weight Changes (%)
Dose:2000 mg/kg body weight
Sex | Body Weight (gram) | Body Weight Changes (%) | ||||
Day 0 | Day 7 | Day 14 | Day 0-7 | Day 0-14 | ||
Male | Mean | 263.20 | 261.20 | 291.60 | -0.74 | 10.95 |
SD | 12.01 | 10.73 | 20.51 | 1.15 | 8.86 | |
n | 5 | 5 | 5 | 5 | 5 | |
Female | Mean | 247.20 | 232.60 | 237.60 | -5.88 | -3.85 |
SD | 7.53 | 6.88 | 6.66 | 2.51 | 2.64 | |
n | 5 | 5 | 5 | 5 | 5 |
Keys:SD= Standard deviation, n = Number of animals
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Conclusions:
- The acute dermal median lethal dose of “Reaction mass of Cardanol diene and Cardanol monoene and Cardanol triene (CAS No. – 37330-39-5)” was > 2000 mg/kg body weight.
- Executive summary:
Acute Dermal Toxicity Study of“ Reaction mass of Cardanol diene and Cardanol monoene and Cardanol triene (CAS No. – 37330-39-5)”in Wistar Rats This study was performed as per OECD No. 402.
Five male and five female healthy young adult rats were randomly selected and used for conducting acute dermal toxicity study. Ratsfree from injury and irritation of skin were selected for the study. .
At 2000 mg/kg, all the animals were observed normal at 1, 2, 3 and 4 hours post dosing. Animal nos. 1, 4, 7, 8 and 9 were observed with erythema on day 1 and scale formation from day 2 to 8 followed by normal clinical sign till day 14. Animal nos. 5 and 6 were observed with erythema on day 1 and scale formation from day 1 to 6 followed by normal clinical sign till day 14. Animal nos. 2, 3 and 10 were observed with erythema on day 1 and scale formation from day 2 to 7 followed by normal clinical sign till day 14.
The external and internal gross pathological observation of all terminally sacrificed animals did not show any pathological abnormality.
The acute dermal median lethal dose of “ Reaction mass of Cardanol diene and Cardanol monoene and Cardanol triene (CAS No. – 37330-39-5)”was> 2000 mg/kg body weight.thus based on above results we can conclude that the test substance Cardanol does not exhibit the acute toxcity (Dermal route) as per CLP criteria set by EU.
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