Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 240-211-7 | CAS number: 16066-38-9
- 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
Acute oral toxicity
The single-dose oral toxicity of Lupersol 221 was evaluated in Sprague-Dawley rats (Douds, 1996a). An LD50 study was performed in which three groups of five male and five female rats received a single oral administration of the test article at graded dosage levels. Following dosing, the LD50 study rats were observed daily and weighed weekly. A gross necropsy examination was performed on all LD50 study animals at the time of death or scheduled euthanasia (day 14).
Mortality occurred during the LD50 study as follows:
Dose Level (mg/kg) |
No. Dead/No. Dosed |
||
Males |
Females |
Combined |
|
2000 |
015 |
1/5 |
1/10 |
3500 |
2/5 |
315 |
5/10 |
4500 |
415 |
515 |
9/10 |
All mortality occurred by study day 3. The most notable clinical abnormalities observed during the study included decreased activity, salivation, soft/mucoid stools, dark material around facial area, decreased/no defecation, diarrhea, gelatinous material on litter, fecal/urine stain, rough haircoat, wobbly gait, breathing abnormalities, piloerection, prostration, hunched posture, eyelids partially closed, and apparent hypothermia. The majority of these observations were noted in bath the animals that died and those surviving to study termination. ln the 2000 mg/kg and 3500 mg/kg dose groups, most of the notable observations were generally noted during the first 3-4 days following dosing with the exception of fecal/urine stain which were noted through days 8-9. The clinical observations in the surviving 4500 mg/kg male were generally noted through study day 10. Body weight gain was noted for all surviving animals during the test period. The most notable gross internal findings observed in the animals that died included abnormal content in the digestive tract and abdominal cavity, perforated stomach, reddened mucosa in the stomach and small intestine, firm and rubbery stomach, white foci on the liver, discoloration on internal viscera, and mottled liver. The most notable gross internal findings which were observed in the animals that survived included abnormal content and thickened mucosa in the stomach.
Under the conditions of this test, the acute oral LD50 of Lupersol 221 in the sexes combined was determined to be 3158 mg/kg.
Acute dermal toxicity
The single-dose dermal toxicity of Lupersol 221 was evaluated on Sprague-Dawley rats (Douds, 19969b). A limit test was performed in which one group of five male and five female rats received a single dermal administration of the test article at a dose of 2000 mg/kg body weight. Following dosing, the limit test rats were observed daily and weighed weekly. A gross necropsy examination was performed on all limit test animals at the time of scheduled euthanasia (day 14). No mortality occurred during the limit test. The most notable clinical abnormalities observed during the study included transient incidences of dark material around the facial area and urine stain. Severe dermal irritation was noted at the site of test article application. Slight body weight loss was noted for two female rats during the study day 7- 14 body weight interval. Body weight gain was noted for all other animais during the test period. No gross internai findings were observed at necropsy on study day 14. Under the conditions of this test, the acute dermal LD0 of Lupersol 221 was estimated to be greater than 2000 mg/kg in the rat.
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:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- no
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Laboratories, Portage, Michigan
- Females (if applicable) nulliparous and non-pregnant: yes
- Age at study initiation: no data
- Weight at study initiation: males 215-234 g, females 207-235 g
- Fasting period before study: overnight
- Housing: individually in suspended stainless steel cages
- Diet: PMI Certified Rodent Chow #5002 (Purina Mills, lnc.) was provided ad libitum
- Water: Municipal tap water treated by reverse osmosis was available ad libitum
- Acclimation period: >= 5 days
ENVIRONMENTAL CONDITIONS
- Temperature: 61-71°F
- Humidity: 56-74%
- Air changes (per hr): 10-15
- Photoperiod (hrs dark / hrs light): 12/12 - Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Doses:
- 2000, 3500 and 4500 mg/kg (1.82, 3.18 and 4.09 ml/kg)
- No. of animals per sex per dose:
- 5
- Control animals:
- no
- Details on study design:
- - Clinical Observations
LD50 study animals were observed for clinical abnormalities two times on study day 0 (postdose) and daily thereafter (days 1-14). A general health/mortality check was performed twice daily (in the morning and in the afternoon).
- Body Weights
lndividual body weights were obtained for the LD50 study animals prior to fasting (day -1), prior to dosing on day 0 and for all surviving animals on days 7 and 14. Animals found dead after day 0 were also weighed.
- Gross Necropsy
All LD50 study animals which died spontaneously during the study or were euthanized by carbon dioxide inhalation at study termination (day 14) were necropsied. Body cavities (cranial, thoracic, abdominal and pelvic) were opened and examined. No tissues were retained. - Statistics:
- The LD50 and 95% confidence intervals were calculated separately for males, females and the combined sexes using a computer adaption of the method of Litchfield and Wilcoxon.
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- 3 158 mg/kg bw
- Based on:
- test mat.
- 95% CL:
- 2 670.6 - 3 734.8
- Mortality:
- See table.
- Clinical signs:
- The most notable clinical abnormalities observed during the study included decreased activity, salivation, soft mucoid stools, dark material around facial area, decreased/no defecation, diarrhea, gelatinous material on litter, fecal/urine stain, rough haircoat, wobbly gait, breathing abnormalities, piloerection, prostration, hunched posture, eyelids partially closed, and apparent hypothermia. The majority of these observations were noted in bath the animals that died and those surviving to study termination. ln the 2000 mg/kg and 3500 mg/kg dose groups, most of the notable observations were generally noted during the first 3-4 days following dosing with the exception of fecal/urine stain which were noted through days 8-9. The clinical observations in the surviving 4500 mg/kg male were generally noted through study day 10.
- Body weight:
- Body weight gain was noted for all suriving animals during the test period.
- Gross pathology:
- The most notable gross internal findings observed in the animals that died included abnormal content in the digestive tract and abdominal cavity, perforated stomach, reddened mucosa in the stomach and small intestine, firm and rubbery stomach, white foci on the liver, discoloration on internal viscera, and mottled liver. The most notable gross internal findings which were observed in the animals that survived included abnormal content and thickened mucosa in the stomach.
- Interpretation of results:
- Category 5 based on GHS criteria
- Conclusions:
- Under the conditions of this test, the acute oral LD50 of Lupersol 221 in the sexes combined was determined to be 3158 mg/kg.
- Executive summary:
The single-dose oral toxicity of Lupersol 221 was evaluated in Sprague-Dawley rats. An LD50 study was performed in which three groups of five male and five female rats received a single oral administration of the test article at graded dosage levels. Following dosing, the LD50 study rats were observed daily and weighed weekly. A gross necropsy examination was performed on all LD50 study animals at the time of death or scheduled euthanasia (day 14).
Mortality occurred during the LD50 study as follows:
Dose Level (mg/kg)
No. Dead/No. Dosed
Males
Females
Combined
2000
015
1/5
1/10
3500
2/5
315
5/10
4500
415
515
9/10
All mortality occurred by study day 3. The most notable clinical abnormalities observed during the study included decreased activity, salivation, soft/mucoid stools, dark material around facial area, decreased/no defecation, diarrhea, gelatinous material on litter, fecal/urine stain, rough haircoat, wobbly gait, breathing abnormalities, piloerection, prostration, hunched posture, eyelids partially closed, and apparent hypothermia. The majority of these observations were noted in bath the animals that died and those surviving to study termination. ln the 2000 mg/kg and 3500 mg/kg dose groups, most of the notable observations were generally noted during the first 3-4 days following dosing with the exception of fecal/urine stain which were noted through days 8-9. The clinical observations in the surviving 4500 mg/kg male were generally noted through study day 10. Body weight gain was noted for all surviving animals during the test period. The most notable gross internal findings observed in the animals that died included abnormal content in the digestive tract and abdominal cavity, perforated stomach, reddened mucosa in the stomach and small intestine, firm and rubbery stomach, white foci on the liver, discoloration on internal viscera, and mottled liver. The most notable gross internal findings which were observed in the animals that survived included abnormal content and thickened mucosa in the stomach.
Under the conditions of this test, the acute oral LD50 of Lupersol 221 in the sexes combined was determined to be 3158 mg/kg.
Reference
SUMMARY OF MORTALITY
|
|
|
Study Day |
|
||||||||||||||
Sex |
Dose Level (mg/kg) |
No. of Animals |
0 |
1 |
2 |
3 |
4 |
5 |
6 |
7 |
8 |
9 |
10 |
11 |
12 |
13 |
14 |
Mortality |
Male |
2000 |
5 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
015 |
|
3500 |
5 |
2 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
2/5 |
|
4500 |
5 |
4 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
4/5 |
Female |
2000 |
5 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1/5 |
|
3500 |
5 |
2 |
0 |
0 |
|
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
3/5 |
|
4500 |
5 |
4 |
1 |
|
|
|
|
|
|
|
|
|
|
|
|
|
5/5 |
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 3 158 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
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- yes
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Laboratories, Portage, Michigan
- Females (if applicable) nulliparous and non-pregnant: yes
- Age at study initiation: no data
- Weight at study initiation: males 254-292 g, females 230-248 g
- Fasting period before study: no
- Housing: individually in suspended stainless steel cages
- Diet: PMI Certified Rodent Chow #5002 (Purina Mills, lnc.) was provided ad libitum
- Water: Municipal tap water treated by reverse osmosis was available ad libitum
- Acclimation period: a minimum of five days
ENVIRONMENTAL CONDITIONS
- Temperature: 61-71°F
- Humidity (%): 61-71
- Air changes (per hr): 10-15
- Photoperiod (hrs dark / hrs light): 12/12 - Type of coverage:
- occlusive
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- TEST SITE
- Area of exposure:
- % coverage: 10
- Type of wrap if used: plastic wrap
REMOVAL OF TEST SUBSTANCE
- Washing (if done): gauze moistened with distilled water followed by dry gauze
- Time after start of exposure: 24 h
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 1.82 ml/kg - Duration of exposure:
- 24 h
- Doses:
- 2000 mg/kg
- No. of animals per sex per dose:
- 5
- Control animals:
- no
- Details on study design:
- Dermal Observations
Limit test animals were examined for erythema and edema following patch removal on study day 1 and daily thereafter (days 2-14) according to the Macroscopic Dermal Grading System provided in Protocol Appendix B which is based on Draize. The dermal test sites were reclipped as necessary to allow clear visualization of the skin.
Clinical Observations
Limit test animais were observed for clinical abnormalities three times on study day 0 (postdose) and daily thereafter (days 1-14). A general health/mortality check was performed twice daily (in the morning and in the afternoon).
Body Weights
lndividual body weights were obtained for the limit test animais prior to dosing on day 0 and on days 7 and 14.
Gross Necropsy
All limit test animals were euthanized by carbon dioxide inhalation at study termination (day 14) and necropsied. Body cavities (cranial, thoracic, abdominal and pelvic) were opened and examined. No tissues were retained. - Sex:
- male/female
- Dose descriptor:
- LD0
- Effect level:
- >= 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortality occurred during the limit test.
- Clinical signs:
- The most notable clinical abnormalities observed during the study included transient incidences of dark material around the facial area and urine stain. Severe dermal irritation was noted at the site of test article application.
- Body weight:
- Slight body weight loss was noted for two female rats during the study day 7-14 body weight interval. Body weight gain was noted for all other animais during the test period.
- Gross pathology:
- No gross internai findings were observed at necropsy on study day 14.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the conditions of this test, the acute dermal LD0 of Lupersol 221 was estimated to be greater than 2000 mg/kg in the rat.
- Executive summary:
The single-dose dermal toxicity of Lupersol 221 was evaluated on Sprague-Dawley rats. A limit test was performed in which one group of five male and five female rats received a single dermal administration of the test article at a dose of 2000 mg/kg body weight. Following dosing, the limit test rats were observed daily and weighed weekly. A gross necropsy examination was performed on all limit test animals at the time of scheduled euthanasia (day 14). No mortality occurred during the limit test. The most notable clinical abnormalities observed during the study included transient incidences of dark material around the facial area and urine stain. Severe dermal irritation was noted at the site of test article application. Slight body weight loss was noted for two female rats during the study day 7- 14 body weight interval. Body weight gain was noted for all other animais during the test period. No gross internai findings were observed at necropsy on study day 14. Under the conditions of this test, the acute dermal LD0 of Lupersol 221 was estimated to be greater than 2000 mg/kg in the rat.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- discriminating dose
- Value:
- 2 000 mg/kg bw
Additional information
According to CLP criteria:
No classification
According to GHS criteria:
Acute oral cat. 5, H303: May be harmful if swallowed
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.