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Diss Factsheets
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EC number: 907-745-9 | 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
![](https://echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
Endpoint summary
Administrative data
Description of key information
Oral acute toxicity:
LD50= 2976 mg/kg bw , key study with 5 rats per sex and per dose according to OECD Test Guideline 401.
Dermal acute toxicity:
LD50 > 2000 mg/kg, key study with 5 rats per sex and per dose according to OECD Test Guideline 402.
Inhalation: Data waiving: In accordance with column 2 of REACH Annex VIII, the study does not need to be conducted since exposure of humans via inhalation is not likely taking into account the vapour pressure of the substance and/or the possibility of exposure to aerosols, particles or droplets of an inhalable size.
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:
- From February 18 to February 28, 1991
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Necropsy of animals was not conducted. However, this deviation was not considered to have affected the scientific validity and interpretation of the results. No GLP.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Deviations:
- yes
- Remarks:
- (Necropsy of animals was not conducted. However, this deviation was not considered to have affected the scientific validity)
- GLP compliance:
- no
- Test type:
- standard acute method
- Limit test:
- no
- Species:
- rat
- Strain:
- Fischer 344
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River U.K. Ltd.
- Age at study initiation: 9-11 weeks
- Weight at study initiation: males: 190-269 g; females: 128-161 g
- Fasting period before study: fasted overnight
- Housing: Single sex groups of up to three rats in cages with stainless steel wire-mesh walls, floors and tops (33 cm x 22 cm x 16 cm). Paper-lined trays for excreta were placed beneath each cage and changes three times weekly.
- Diet (e.g. ad libitum): Pelleted diet (LAD1, Special Diet Services Ltd.), ad libitum.
- Water (e.g. ad libitum): from the public supply, ad libitum.
- Acclimation period: The animals were quarantined for a minimum of four days in a non-barrier animal room with access restricted to essential personnel. At least five days before dosing the animals were rehoused.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-23 ºC
- Humidity (%): 30-70%
- Air changes (per hr): not documented.
- Photoperiod (hrs dark / hrs light): 12 hour day and 12 hour night
IN-LIFE DATES: From February 18 to February 28, 1991 - Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Details on oral exposure:
- Animals were fasted overnight, weighed and given a single dose of the undiluted test material by gavage, using a ball pointed cannula and syringe.
- Doses:
- Animals were dosed at 1000, 1710, 2924 and 5000 mg/kg. The undiluted test material was administered at dose volumes of 1.06, 1.82, 3.11 and 5.32 ml/kg.
- No. of animals per sex per dose:
- Five animals per sex per dose
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: A detailed clinical examination was made six times on the day of dosing and twice daily thereafter for the remainder of the 14 day observation period. The initial (Day 1), Day 8 and Day 15 bodyweights were recorded and changes in bodyweight calculated.
- Necropsy performed: no - Statistics:
- The 14 day LD50, 95% confidence interval and the dose-mortality slope were calculated using a method based on probit analysis (Finney, 1977).
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- 2 976 mg/kg bw
- Based on:
- test mat.
- 95% CL:
- 2 667 - 3 551
- Mortality:
- Mortalities occurred on Days 2, 3 and 4 among rats dosed at 2924 and 5000 mg/kg. No rat survived treatment at the highest of these dose-levels.
- Clinical signs:
- other: The principal clinical signs observed among rats dosed with the test substance were piloerection, lachrymation, hunched posture, abasia/ataxia and/or prostration, diarrhoea, yellow staining of the anogenital fur and an unkempt appearance. There were addit
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The acute oral LD50 for the test substance is 2976 mg/kg.
- Executive summary:
Groups of five rats per sex were dosed at 1000, 1710, 2924 and 5000 mg/kg. A detailed clinical examination was made six times on the day of dosing and twice daily thereafter for the remainder of the 14 day observation period. The initial (Day 1), Day 8 and Day 15 bodyweights were recorded and changes in bodyweight calculated. Animals surviving to the end of the study were killed by carbon dioxide asphyxiation. Mortalities occurred on Days 2, 3 and 4 among rats dosed at 2924 and 5000 mg/kg. No rat survived treatment at the highest of these dose-levels. The acute oral LD50 for the test substance is 2976 mg/kg.
Reference
Table 7.2.1: Summary of Acute Oral Toxicity
Males |
Females |
||||
Dose |
Mortality |
Time of death |
Dose |
Mortality |
Time of death |
1000 mg/kg |
0/5 |
-- |
1000 mg/kg |
0/5 |
-- |
1710 mg/kg |
0/5 |
-- |
1710 mg/kg |
0/5 |
-- |
2924 mg/kg |
1/5 |
Day 4 |
2924 mg/kg |
3/5 |
Day 2 |
5000 mg/kg |
5/5 |
Days 2-3 |
5000 mg/kg |
5/5 |
Days 2 -3 |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 2 976 mg/kg bw
- Quality of whole database:
- Klimisch 2. Non-GLP study.
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:
- From February 18 to March 5, 1991
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: There are no deviations from the OECD Guideline 402 (Acute Dermal Toxicity). No GLP.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Deviations:
- no
- GLP compliance:
- no
- Test type:
- standard acute method
- Limit test:
- yes
- Species:
- rat
- Strain:
- Fischer 344
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River U.K. Ltd.
- Age at study initiation: 9-11 weeks
- Weight at study initiation: males: 219-262 g; females: 142-166 g
- Housing: Single sex groups of up to three rats in cages with stainless steel wire-mesh walls, floors and tops (33 cm x 22 cm x 16 cm). Paper-lined trays for excreta were placed beneath each cage and changes three times weekly.
- Diet (e.g. ad libitum): Pelleted diet (LAD1, Special Diet Services Ltd.), ad libitum.
- Water (e.g. ad libitum): from the public supply, ad libitum.
- Acclimation period: The animals were quarantined for a minimum of four days in a non-barrier animal room with access restricted to essential personnel. At least five days before dosing the animals were rehoused.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-23 ºC
- Humidity (%): 30-70%
- Air changes (per hr): not documented.
- Photoperiod (hrs dark / hrs light): 12 hour day and 12 hour night
IN-LIFE DATES: From February 18 to March 5, 1991 - Type of coverage:
- occlusive
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- On the day before dosing the dorsal fur was removed from the animals using electric clippers. A single dose of the undiluted test material was applied to the skin. The test material was held in place with a gauze dressing (approx 6 x 8 cm) covered with waterproof adhesive tape.
- Duration of exposure:
- Following a 24 hour exposure the dressings were removed, the skin washed with warm dilute detergent solution and dried.
- Doses:
- Animals received a single dermal application at 2000 mg/kg. The undiluted test material was administered at a dose volume of 2.13 ml/kg.
- No. of animals per sex per dose:
- Five animals per sex per dose
- Control animals:
- not required
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: A detailed clinical examination was made five times on the day of dosing and twice daily thereafter for the remainder of the 14 day observation period. The initial (Day 1), Day 8 and Day 15 bodyweights were recorded and changes in bodyweight calculated.
- Necropsy performed: no - Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- None of the rats died.
- Clinical signs:
- other: There were no signs of systemic reaction to treatment. Sites of application of the test material showed erythema and, in one case, oedema from Day 2 and yellow discolouration from Day 3. The inflammatory reaction resolved by Day 5 and the treated skin was
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The acute dermal LD50 for the test substance is greater than 2000 mg/kg.
- Executive summary:
Five rats per sex were dosed at 2000 mg/kg. Following a 24 hour exposure the dressings were removed. A detailed clinical examination was made five times on the day of dosing and twice daily thereafter for the remainder of the 14 day observation period. The initial (Day 1), Day 8 and Day 15 bodyweights were recorded and changes in bodyweight calculated. Animals surviving to the end of the study were killed by carbon dioxide asphyxiation. None of the rats died. The acute dermal LD50 for the test substance is greater than 2000 mg/kg.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- discriminating dose
- Value:
- 2 000 mg/kg bw
- Quality of whole database:
- Klimisch 2. Non-GLP study.
Additional information
Oral acute toxicity:
Key study. Study with 5 rats per sex and per dose according to OECD test guideline 401.
The result was as follows: LD50 =2976 mg/kg bw.
Dermal acute toxicity:
Key study. Study with 5 rats per sex and per dose according to OECD test guideline 402.
The result was as follows: LD50 >2000 mg/kg bw.
Inhalation: Data waiving: In accordance with column 2 of REACH Annex VIII, the study does not need to be conducted since exposure of humans via inhalation is not likely taking into account the vapour pressure of the substance and/or the possibility of exposure to aerosols, particles or droplets of an inhalable size.
Justification for selection of acute toxicity – oral endpoint
Only one reliable study available.
Justification for selection of acute toxicity – inhalation endpoint
In accordance with column 2 of REACH Annex VIII, the study does not need to be conducted since exposure of humans via inhalation is not likely taking into account the vapour pressure of the substance and/or the possibility of exposure to aerosols, particles or droplets of an inhalable size.
Justification for selection of acute toxicity – dermal endpoint
Only one reliable study available.
Justification for classification or non-classification
Oral acute toxicity:
LD50 =2976 mg/kg bw : not classified
Dermal acute toxicity:
LD50> 2000 mg/kg bw: not classified
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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