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EC number: 292-835-4 | CAS number: 91001-64-8
- 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
Endpoint summary
Administrative data
Description of key information
Oral rat (standard acute method): LD50 > 8295 mg/kg bw (0% male and 20% female mortality at 8295 mg/kg bw, no death at 6615 mg/kg bw)
Acute dermal and inhalation toxicity testing: waiving of testing
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
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- The study was conducted according to internationally accepted technical guidelines in a contract research organization. The study is scientifically valid and adequate for assessment with acceptable restrictions (e.g. due to limited reporting). Purity and stability of the test material were not reported for the batch of test material used.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Version / remarks:
- of 1981
- Deviations:
- yes
- Remarks:
- Doses of test material were quite high. Therefore, this was dosed undiluted and dose volumes could not be kept constant but increased with increasing dose.
- Qualifier:
- according to guideline
- Guideline:
- other: Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics, Division of Pharmacology, FDA, 1959
- Deviations:
- not specified
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- no
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Wistar rats, strain: Winkelmann, Paderborn (SPF-Quality) with appropriate range of bodyweight at study start.
- Weight at study initiation (day of dosing): 200 to 218 g
- Housing: Group housing with up to 5 animals by sex in cages.
- Fasting period: From 16 hours before test start.
- Diet (except for fasting period): Commercially available standard laboratory animal diet:
"Rat/Mouse Mainenance" from Altromin, Lage, Germany
- Water was provided ad libitum
ENVIRONMENTAL CONDITIONS
The animal room was maintained at:
- Temperature (°C): 22 ± 1°C
- Relative Humidity (%): 45 to 55%
- Photoperiod (artificial lighting): 12 h/day - Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Details on oral exposure:
- - Dose volume: The administered volume of test material, increased with increasing dose thus achieving quite high target doses.
Individual dose volume was calculated based on individual bodyweight
- For different doses and dose volumes, see Table 1 in "Any other information on materials and methods incl. tables"
- Rationale for doses selected: Based on a pre-test, which was not detailed in the study report. - Doses:
- see Table 1 in "Any other information on materials and methods incl. tables"
- No. of animals per sex per dose:
- 5
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations:
It has not been clearly specified in the report at what time points clinical signs and mortality were recorded, but the following records have been
reported:
Clinidal signs: At least at 2, 4 (Day 0), 24 and 48 hours post dosing, 3, 5, 7 and 14 days post dosing.
Mortality: At least at 24 hours, 48 hours, 7 days and 14 days post dosing.
Weighing of each animal: All animals on Day 0 for calculation of individual dose volume, and survivors on Day 14 (end of observation period).
- Necropsy performed: Yes, all animals of Groups 1, 2 and 4 and the 9 animals of Group 3 which survived until observation Day 14 were necropsied.
The report does not clearly state whether or not the one premature death of Group 3 was also necropsied. - Statistics:
- LD50 was estimated for 24 hours and 14 days post dosing according to Litchfield and Wilcoxon in connection with the Integral of Gauss.
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 8 295 mg/kg bw
- Based on:
- test mat.
- Remarks:
- unchanged, no vehicle
- Remarks on result:
- other: At 8295 mg/kg bw , 0% male and 20% female mortality. The one death over the 14 day post dosing observation period happened within 24 h post dosing.
- Mortality:
- Mortality during the 14-day observation period post dosing:
Dose of Test Material: Equivalent Dose of WS400109: Mortality
5.0 mL/kg bw 5250 mg/kg bw 0/5 (m); 0/5 (f)
6.3 mL/kg bw 6615 mg/kg bw 0/5 (m); 0/5 (f)
7.9 mL/kg bw 8295 mg/kg bw 0/5 (m); 1/5 (f)*
10.0 mL/kg bw 10500 mg/kg bw 5/5 (m); 5/5 (f)*
m = male, f = female
* All premature death happened within 24 h post dosing. - Clinical signs:
- Group 1
Shortly after dosing, diminished reflexes, decreased respiration.
Group 2
Haircoat bristle, reflexes slightly decreased; shortly after dosing, apathy, pinched eyes, decreased reflexes, stomach-ache, increased frequency of respiration.
Group 3
Haircoat bristle and untidy, reflexes slightly decreased; at the beginning of the observation period, faeces wet; shortly after dosing, heavy apathy, pinched eye, severely diminished reflexes, stomach-ache, severely decreased frequency of respiration.
Group 4
Shortly after dosing, heavy apathy, pinched eyes, severely diminished reflexes, stomach-ache, severely increased frequency of respiration.
In Groups 1, 2 and 3 differences in appearance and behaviour from "normal" were no longer evident in the survivors at 7 and 14 days post dosing. - Body weight:
- There was a dose-related decline in overall group mean body weight gain over the 14 day observation period in the surviving animals of Groups 1, 2 and 3, whereby the bodyweight gain in Group 1 was considered to be normal.
- Gross pathology:
- In the survivors of Groups 1, 2 and 3 slight haemorrhagia was recorded in the small and large intestine. In the premature deaths in Groups 3 and 4 hyperaemia was noted in gastro-intestinal organs.
- Other findings:
- For Groups 1, 2 and 3 normal or physiological food consumption was mentioned.
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- In view of the attained oral LD50 of test material > 7.9 mL/kg bodyweight corresponding to an LD50 > 8295 mg/kg bw for neat WS400109, the outcome of the present study does not necessitate any labelling regarding acute oral toxicity according to EU regulations (DIRECTIVE 67/548/EEC and REGULATION (EC) 1272/2008). In addition, relevant sex-related differences in toxicity of the test material after single oral administration were not evident.
Reference
LD50 oral of test material according to Litchfield and Wilcoxon in connection with the Integral of Gauss:
24 h LD50 = 8.3 (7.4 – 9.3) mL/kg bw, Slope function = 1.28 (1.17 - 1.39)
24 h LD50 = 8.3 (7.4 – 9.3) mL/kg bw, Slope function = 1.28 (1.17 - 1.39)
Equivalent LD50 oral for neat WS400109:
24 h LD50 = 8715 (7770 - 9765) mg/kg bw,
14 d LD50 = 8715 (7770 - 9765) mg/kg bw
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 8 295 mg/kg bw
Acute toxicity: via inhalation route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Acute toxicity: via dermal route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
The acute oral toxicity study demonstrated that the LD50 of WS400109 is higher than the limit dose of 2000 mg/kg b.w.
As detailed in the justification for data waiving, the conduct of an acute dermal toxicity study would not have added relevant toxicological hazard information and adequate protection of human health will be granted anyway, as WS400109 has been classified as a skin sensitizer necessitating whole body protective precautions during its handling and use.
The conduct of an acute inhalation toxicity study with WS400109 is not warranted, as the inhalation exposure of humans to WS400109 vapour or aerosol is unlikely, because of its very low vapour pressure, its decomposition at high temperature without boiling, its viscosity (medium in degree) and/or the above whole body protective precautions during its handling and use.
Justification for classification or non-classification
In the acute oral toxicity study, all animals survived the dose of 6615 mg/kg bw and the LD50 was > 8295 mg/kg bw. Therefore, classification of WS400109 for acute oral toxicity is not required [DIRECTIVE 67/548/EEC and REGULATION (EC) 1272/2008].
Non-classification of WS400109 by the dermal route was reasonable, because of the absence of adverse effects indicative of relevant systemic toxicity (apart from the sensitization response) in the available skin irritation study, local lymph node assay and repeat dose oral toxicity studies with WS400109 and the systemic exposure probably being higher by the oral than by the dermal administration route.
Non-classification of WS400109 by the inhalation route was justified, because WS400109 has a very low vapour pressure, decomposes before boiling, is a viscous liquid (medium in degree) and its sensitizing potential necessitates whole body protective precautions, making the inhalation exposure of humans to vapour or a droplet aerosol unlikely.
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