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EC number: 936-831-9 | 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
Endpoint summary
Administrative data
Description of key information
The substance is virtually non-toxic after a single ingestion and after single dermal exposure.
Oral: LD50 = >2000 mg/kg bw (OECD 423)
Dermal: LD50 = >2000 mg/kg bw (OECD 402)
Key value for chemical safety assessment
Acute toxicity: via oral route
Link to relevant study records
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2003
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- acute toxic class method
- Species:
- rat
- Strain:
- other: HanBrI: Wist (SPF)
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: RCC Ltd, Laboratory Animal Services CH-4414 Fullinsdorf / Switzerland
- Age at study initiation: 12-13 weeks
- Weight at study initiation: 170 - 195 g
- Fasting period before study: 17 hours
- Housing: Groups of three in Makrolon type-4 cages with wire mesh tops and standard softwood bedding ('Lignocel' Schill AG, CH-4132 Muttenz/Switzerland)
- Diet: Pelleted standard Provimi Kliba 3433 rat/mouse maintenance diet, batch no. 84/02 (Provimi Kliba AG, CH-4303 Kaiseraugst/Switzerland) ad libitum.
- Water: Community tap water from Fiillinsdorf ad libitum.
- Acclimation period: 6 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3
- Humidity (%): 30-70
- Air changes (per hr): 10-15
- Photoperiod (hrs dark / hrs light): 12/12 - Route of administration:
- oral: gavage
- Vehicle:
- polyethylene glycol
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 0.2 g/mL
- Amount of vehicle (if gavage): 10 ml/kg body weight
- Justification for choice of vehicle: The vehicle was chosen after a non-GLP solubility trial which was performed before the study initiation date.
- Lot/batch no. : 442989/154502013
MAXIMUM DOSE VOLUME APPLIED: 10 ml/kg body weight
DOSAGE PREPARATION: The test item was weighed Into a tared glass beaker on a suitable precision balance and the vehicle added (weight:volume). Homogeneity of the test item in the vehicle was maintained during administration using a magnetic stirrer. - Doses:
- 2000 mg/kg
- No. of animals per sex per dose:
- 2 x 3 females
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 15 days
- Frequency of observations: Daily during acclimatization and at approximately 1, 2, 3 and 5 hours after administration on test day 1. During days 2-15 twice daily for viability and once daily for clinical signs.
- Frequency of weighing: On test days 1 (prior to administration), 8 and 15
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, viability - Statistics:
- No statistical analysis was used.
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Mortality:
- All animals survived until the end of the study period.
- Clinical signs:
- other: No clinical signs were observed during the course of the study.
- Gross pathology:
- No macroscopic findings were recorded at necropsy.
- Interpretation of results:
- practically nontoxic
- Conclusions:
- The acute oral LD50 of the test substance in female rats is greater than 2000 mg/kg body weight.
- Executive summary:
Six female HanBrI: WIST (SPF) rats were treated with the test substance by oral gavage administration at a dosage of 2000 mg/kg body weight. The test item was diluted in vehicle (PEG 300) at a concentration of 0.2 g/mL and administered at a volume dosage of 10mL/kg. All animals survived until the end of the study period. No clinical signs were observed during the course of the study. One female showed a loss of body weight (0.5 %) between test day 8 and the end of the observation period. The body weight of the other animals was within the range commonly recorded for this strain and age. No macroscopic findings were recorded at necropsy.
In conclusion, the median lethal dose of the test substance after single oral administration to female rats, observed over a period of 14 days is greater than 2000 mg/kg body weight.
Reference
Body weights (g)
Dose (mg/kg) | Animal No. | Sex | Day 1(treatment) | Day 8 | Day 15 |
2000 | 1 | F | 185.0 | 193.3 | 197.4 |
2 | F | 170.6 | 185.4 | 193.0 | |
3 | F | 178.4 | 189.0 | 200.4 | |
2000 | 4 | F | 181.1 | 188.3 | 187.4 |
5 | F | 177.6 | 191.4 | 196.6 | |
6 | F | 194.7 | 200.5 | 205.6 |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 2 000 mg/kg bw
Acute toxicity: via inhalation route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Acute toxicity: via dermal route
Link to relevant study records
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2003
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.3 (Acute Toxicity (Dermal))
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- standard acute method
- Limit test:
- yes
- Species:
- rat
- Strain:
- other: HanBrI: WIST (SPF)
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: RCC Ltd, Laboratory Animal Services CH-4414 Fullinsdorf / Switzerland
- Age at study initiation: Males: 9-10 weeks; Females: 12-13 weeks
- Weight at study initiation: Males: 235-275 g; Females: 180-200 g
- Housing: During acclimatization in groups of five per sex in Makrolon type-4 cages with standard softwood bedding. Individually in Makrolon type-3 cages with standard softwood bedding ("Lignocel", Schill AG, CH-4132 Muttenz) during treatment and observation.
- Diet: Pelleted standard Provimi Kliba 3433 rat/mouse maintenance diet, batch no. 84/02 (Provimi Kliba AG, CH-4303 Kaiseraugst/ Switzerland) ad libitum.
- Water: Community tap water from FQllinsdorf acf libitum
- Acclimation period: 6 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3
- Humidity (%): 10-70
- Air changes (per hr): 10-15
- Photoperiod (hrs dark / hrs light): 12/12 - Type of coverage:
- semiocclusive
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- TEST SITE
- Area of exposure: the backs of the animals
- % coverage: 10
- Type of wrap if used: gauze patch with a semi-occlusive dressing fixed with an elastic adhesive bandage.
REMOVAL OF TEST SUBSTANCE
- Washing: with lukewarm tap water and dried with disposable paper towels
- Time after start of exposure: 24 hours
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2g/kg bodyweight - Duration of exposure:
- 24 hours
- Doses:
- 2000 mg/kg
- No. of animals per sex per dose:
- 5
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 15 days
- Frequency of observations: Daily during acclimatization and at approximately 1, 2, 3 and 5 hours after administration on test day 1. During days 2-15 twice daily for viability and once daily for clinical signs.
- Frequency of weighing: On test days 1 (prior to administration), 8 and 15
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, viability - Statistics:
- No statistical analysis was used.
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Mortality:
- No deaths occurred during the study.
- Clinical signs:
- other: No systemic or local signs of toxicity were observed during the study period.
- Gross pathology:
- No macroscopic findings were observed at necropsy.
- Interpretation of results:
- practically nontoxic
- Conclusions:
- The acute dermal LD50 of the test substance in rats of both sexes is greater than 2000 mg/kg body weight.
- Executive summary:
Five male and five female HanBrI: WIST (SPF) rats were treated with the test substance at 2000 mg/kg by dermal application. The test item was applied undiluted as delivered from the sponsor at an amount dosage of 2 g/kg. The application period was 24 hours. No deaths occurred during the study. No clinical signs were observed during the observation period. One female animal showed a loss of body weight (0.9 %) one week after treatment. It recovered between test day 8 and the end of the observation period. Another female animal lost body weight (1.5 %) from test day 8 to 15. The body weight of the remaining animals was within the range commonly recorded for this strain and age. No macroscopic findings were observed at necropsy.
In conclusion, the median lethal dose of the test substance after single dermal administration to rats of both sexes, observed over a period of 14 days is greater than 2000 mg/kg body weight.
Reference
Individual body weights in grams
Sex / dose | Animal No. | Day of treatment | Day 8 | Day 15 |
male / 2000 mg/kg | 1 | 236.4 | 249.3 | 267.7 |
2 | 269.3 | 285 | 298.6 | |
3 | 271.5 | 29.38 | 318.8 | |
4 | 243.4 | 266.0 | 287.2 | |
5 | 254.4 | 280.3 | 301.1 | |
female / 2000 mg/kg | 1 | 180.5 | 184.8 | 182.1 |
2 | 186.6 | 194.8 | 197.7 | |
3 | 186.9 | 185.2 | 197.1 | |
4 | 194.5 | 201.4 | 211.3 | |
5 | 197.0 | 208.4 | 216.6 |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 2 000 mg/kg bw
Additional information
According to regulation (EC) No 1907/2006, Annex XI, paragraph 1.5., substances whose physicochemical, toxicological and ecotoxicological properties are likely to be similar or follow a regular pattern as a result of structural similarity may be considered as a group, or "category" of substances. Environmental effects or environmental fate may be predicted from data for reference substance(s) within the group by interpolation to other substances in the group (read-across approach).
The source (CAS 376588-17-9) and target (EC 936-831-9) substance share identical structural elements, the only difference being the length of the carbon chain at the ester function. The source chemical is esterified with stearic acid (C18), whereas the target compound is a mixture of stearate (C18) and palmitate (C16), with the stearate version accounting for about 60% of the chemicals present in the target compound. Therefore, 60% of the target compound are identical with the source chemical and the remaining molecules of the target compound are nearly identical with the only difference being the chain length at the ester group. It is expected that the structural difference between the octadecanoate and the hexadecanoate does not affect the physico-chemical properties, the toxicological and ecotoxicologocal profile as well as the environmental fate. Both substances are characterized by similar values for water solubility, vapor pressure and log POW. Furthermore, it can be assumed that the degradation products of CAS 376588-17-9 are very similar to the degradation products of the mixture containing the octadecanoate and the hexadecanoate. In addition, both substances triggered comparable (eco)toxicological effects. Therefore read-across to CAS 376588-17-9 is scientifically justified for physico-chemical properties, the toxicological and ecotoxicological profile as well as environmental fate. For more information on the read-across approach, please refer to the Chapter 13 (attached read-across justification).
Acute toxicity was evaluated in two GLP compliant guideline studies according to OECD 423 (RCC, 848423, 2003) and OECD 402 (RCC, 848424, 2003) with the source substance. According to the analogues approach, no additional information is needed to conclude classification and labelling. The test substance was considered as not acute toxic after oral and dermal application.
Justification for classification or non-classification
Classification, Labeling, and Packaging Regulation (EC) No. 1272/2008
The available experimental test data are reliable and suitable for the purpose of classification under Regulation (EC) No.1272/2008. Based on the data, classification for acute toxicity is not warranted under Regulation (EC) No.1272/2008.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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