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EC number: 216-971-0 | CAS number: 1709-70-2
- 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
Effect level for the dermal route determined using OECD method 402. LD50 > 2000 mg/kg bw
Effect level for the oral route not determined to a specified method, however study written with clear and consice study plan. LD50 >10000 mg/kg/bw
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:
- Not specified
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Study conducted to no specified methods
- Reason / purpose for cross-reference:
- reference to same study
- Qualifier:
- according to guideline
- Guideline:
- other: not specified
- GLP compliance:
- not specified
- Test type:
- other: Not specified
- Limit test:
- yes
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- Five male and 5 female rats of the Sprague-Dawley strain (obtained from Harlan Industries, Inc., Indianapolis, Indiana), weighing from 200 to 208 grams, were used for this study. The rats were housed by sex, in groups of 5 rats per cage, in hanging wire-mesh cages in temperature and humidity controlled quarters. They were maintained in accordance with the recommendations contained in H.E.W. Publication No. 74-23 (N.I.H.) entitled "Guide for the Care and Use of Laboratory Animals". The rats were conditioned for a minimum of 5 days prior to study initiation. Water and Purina Laboratory Chow were available ad libitum, except for an overnight period of approximately 18 hours Immediately preceding oral administration during which food, but not water, was withheld.
- Route of administration:
- oral: gavage
- Vehicle:
- corn oil
- Details on oral exposure:
- The test material was administered orally by gavage as a suspension in corn oil at the following dosage level to male and female rats: 10,000 mg/kg.
The dosage level was administered at a volume of 40 ml/kg. - Doses:
- 10,000 mg/kg
- No. of animals per sex per dose:
- 5 male
5 female - Control animals:
- not specified
- Details on study design:
- Observations for pharmacotoxic signs were recorded during the first 4 hours following dosing, at 24 hours and daily thereafter for a total of 14 days. The rats were observed for mortality during the first four hours following dosing and twice daily thereafter for a total of 14 days. Body weights were recorded immediately prior to dosing (control weight) and at 7 and 14 days. All rats which died on study were subjected to gross necropsy examination as were all survivors at the end of the 14 day observation period
- Statistics:
- Not specified
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 10 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- One female rat died on the first day of the 14 day study period. None of the other rats died.
- Clinical signs:
- other: Presented in table form, please see any otherinformation on results incl. tables.
- Gross pathology:
- Necropsy Findings: The following necropsy observations were obtained during the 14 day study period:
The rat (#82570) which died during the study period: Partital cannibalization, yellow stained anogenital region, stomach contains yellow creamy fluid, small intestines contain yellow creamy fluid.
Rats which were sacrificed following 14 day of observation:
No gross lesions 3/5 males, 1/4 females
Kidneys, mottled colouration 2/5 males, 3/4 females
Uterus, hydrometra 1/4 females - Other findings:
- Not specified
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The acute oral LD50 value was found to be greater than 10,000 mg/kg
- Executive summary:
The acute oral LD50 value was found to be greater than 10,000 mg/kg
Reference
NUMBER OF RATS SHOWING PHARMACOTOXIC SIGNS AND TIME [HOUR] (DAY) OBSERVED
|
MALES |
FEMALES |
OBSERVATION |
10,000 mg/kg |
10,000 mg/kg |
Normal |
2 [1], 5 (2 – 14) |
3 [1], 4 (2 – 14) |
Hypoactivity |
3 [1], 5 [2 ½, 4], 5 (1) |
2 [1], 5 [2 ½, 4], 4 (1) |
Death |
|
1 (1) |
The following body weights were obtained during the 14 day observation period
Dosage Level (mg/kg) |
Individual Rat Number |
Sex |
Control Weight (grams) |
7 Day Weight (grams) |
14 Day Weight (grams) |
10,000 |
82571 |
Male |
202 |
274 |
328 |
82572 |
Male |
201 |
259 |
340 |
|
82573 |
Male |
202 |
225 |
285 |
|
82574 |
Male |
200 |
242 |
302 |
|
82575 |
Male |
204 |
250 |
280 |
|
82566 |
Female |
205 |
226 |
232 |
|
82567 |
Female |
206 |
258 |
290 |
|
82568 |
Female |
208 |
246 |
264 |
|
82569 |
Female |
202 |
231 |
235 |
|
82570 |
Female |
201 |
Died |
Died |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 10 000 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:
- 1982
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP-compliant guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Deviations:
- yes
- Remarks:
- Due to the physical-chemical properties, the test substance had to be applied by weight.
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- yes
- Species:
- rat
- Strain:
- other: Tif: RAI f (SPF)
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: CIBA-GEIGY Limited, Animal Production, 4332 Stein / Switzerland
- Age at study initiation: young adult rats were used
- Weight at study initiation: 217 to 268 g
- Housing: individually housed in Macrolon cages type 3, with standardized soft wood bedding (Societe Parisienne des Sciures, Pantin, France).
- Diet: NAFAG 890 Tox, NAFAG, Gossau/SG, Switzerland, ad libitum
- Water: ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 2
- Humidity (%): 50 +/- 10
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12 - Type of coverage:
- semiocclusive
- Vehicle:
- other: 0.5 % (w/v) carboxymethylcellulose in 0.1 % (w/v) aqueous polysorbate 80
- Details on dermal exposure:
- TEST SITE
- Area of exposure: back
- % coverage: 10%
- Type of wrap if used: gauze-lined semiocclusive dressing fastened around the trunk with an adhesive elastic bandage
REMOVAL OF TEST SUBSTANCE
- Washing (if done): the skin was cleaned with lukewarm water
- Time after start of exposure: After 24 hours
VEHICLE
- Amount(s) applied (volume or weight with unit): 4 g/kg bw (corresponding approximately to 4 ml). - Duration of exposure:
- 24 h
- 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: 14 days
- Frequency of observations:
Mortality: daily; a.m. and p.m. on working days, a.m. on weekend days
Signs and symptoms: daily for 14 days
Body weight: immediately before application and on days 7 and 14
Necropsies: The animals were submitted to a gross necropsy at the end of the observation period. - Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortalities occurred in this study.
- Clinical signs:
- other: Piloerection and hunched posture were seen, being common symptoms in acute dermal tests. The animals recovered within 2 days.
- Gross pathology:
- At necropsy, no deviations from normal morphology were found.
- Interpretation of results:
- not classified
- Remarks:
- Migrated information
- Conclusions:
- LD50 > 2000 mg/kg bw
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 2 000 mg/kg bw
Additional information
Study written with clear and concise study plan.
Justification for selection of acute toxicity – dermal endpoint
Study performed using OECD method 402
Justification for classification or non-classification
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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