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EC number: 214-688-7 | CAS number: 1185-81-5
- 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
Acute Toxicity: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- In life dates: 9th September to 15th October 2010
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline study conducted to GLP.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 010
- Report date:
- 2010
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- standard acute method
- Limit test:
- no
Test material
- Reference substance name:
- Dibutylbis(dodecylthio)stannane
- EC Number:
- 214-688-7
- EC Name:
- Dibutylbis(dodecylthio)stannane
- Cas Number:
- 1185-81-5
- Molecular formula:
- C32H68S2Sn
- IUPAC Name:
- dibutylbis(dodecylsulfanyl)stannane
- Details on test material:
- Identity: Dabco T120 Catalyst
Batch No.: 817231
Date Received: 08/13/10
Storage: Room temperature and humidity
Description: Clear liquid
Specific Gravity: 1.00
Sample Preparation: The test article was used as received.
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Animals were received from Myrtle's Rabbitry Incorporated, Thompsons Station, TN on 08/26/10 & 09/23/10.
- Age at study initiation: The animals were born on 05/13/10 & 05/30/10 and so were approximately 15-17 weeks old.
- Weight at study initiation: The pretest body weight range was 2.6 - 3.4 kg. The weight variation of the animals used did not exceed + 20% of the mean weight.
- Housing: The animals were identified by cage notation and a uniquely numbered metal eartag and housed 1/cage in suspended wire cages. Paper bedding was placed beneath the cages and changed at least three times/week.
- Diet: Fresh PMI Rabbit Chow (Diet #5321) was provided daily.
- Water: Water was available ad libitum
- Acclimation period: Following an acclimation period of at least one week, six healthy, non-pregnant and nulliparous female New Zealand White rabbits were randomly assigned to the treatment group using standard methods of randomization.
ENVIRONMENTAL CONDITIONS
The animal room, reserved exclusively for rabbits on acute tests, was temperature controlled, had a 12-hour light/dark cycle, and was kept clean and vermin free.
Administration / exposure
- Type of coverage:
- occlusive
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- TEST SITE
- Area of exposure: ~10 x 15 cm
- % coverage: The prepared site was approximately 10% of the body surface and remained intact.
- Type of wrap if used: The torso was wrapped with plastic that was secured with non-irritating tape.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): Residual test article was removed by gently washing with water.
- Time after start of exposure: 24 hours
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): The doses were based on the sample weight as calculated from the specific gravity. - Duration of exposure:
- 24 hours
- Doses:
- 1000 & 2000 mg/kg
- No. of animals per sex per dose:
- 3
- Control animals:
- not specified
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: The animals were observed 1, 2 and 4 hours postdose and once daily for 14 days for toxicity and pharmacological effects. The animals were observed twice daily for 14 days for mortality.
Body weights were recorded pretest, weekly and at death, or termination in the survivors.
- Necropsy of survivors performed: yes
- Other examinations performed: All animals were examined for gross pathology. Abnormal tissues were preserved in 10% neutral buffered formalin for possible future histological examination. - Statistics:
- An estimate of the LD50 was made based on the survival during the study.
Results and discussion
- Preliminary study:
- n/a
Effect levels
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 1 000 - < 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- 1000 mg/kg: Two out of three survived.
2000 mg/kg: One out of three female animals survived. - Clinical signs:
- other: 1000 mg/kg: All animals were normal through Day 2. On Days 3 - 5, two out of three animals were observed with few feces, one was normal. On Day 6, one animal was found dead. Out of the remaining two animals, one remained normal through the end of the stud
- Gross pathology:
- 1000 mg/kg: A moderately pale liver and markedly pale stomach filled with brown liquid and white mucous were noted for animal H3667 female, that was found dead on Day 6. One of the remaining two animals had fluid in the peritoneal cavity and scattered red areas on the walls of the cavity. Both animals had treated skin abnormalities and localized areas of alopecia with thickened crusty skin around the muzzle similar to what was observed on the treated dorsal site.
2000 mg/kg: Moderately pale livers and markedly pale stomachs were noted for all animals. Two were noted with brown fluid and white mucous in the stomach and one had markedly red areas on the intestines. The two animals that were found dead had soiled anogenital areas. The animal that was found dead on Day 5 had an area of the stomach that appeared to be ulcerated, a small opening in the wall and excessive amounts of fluid in the peritoneal cavity. The spleen appeared smaller than normal and pale. A blood clot approximately 2.5 cm was located beneath the stomach. The animal that survived to Day 14 had an enlarged gallbladder that was distended with brown fluid. This animal also exhibited localized areas of alopecia with thickened crusty skin around the muzzle similar to what was observed on the treated dorsal site. Reddened and pale areas and sloughing skin was also observed on the ears of the surviving animal, most likely due to the contact with the treated dorsal site. - Other findings:
- - Other observations: Dermal observations at 24 hours were absent to very slight (erythema and edema). On Day 7, erythema remained absent to very slight while edema was moderate. By Day 14, the remaining animals had severe erythema with moderate eschar and necrosis, one was noted with cracking and peeling skin. Edema was slight.
Any other information on results incl. tables
Table 1. Body weights, Dose volumes and Dermal observations.
Animal number | Sex | Dose Volume (mL) | Bodyweight (kg) | 24 hours | Day 7 | Day 14 | |||||
Day 0 | Day 7 | Day 14 | Erythema | Edema | Erythema | Edema | Erythema | Edema | |||
Dose: 1000mg/kg | |||||||||||
H3666 | F | 3.4 | 3.4 | 2.6 | 3.1 | 1 | 1 | 0 | 3 | >4m | 2 |
H3667 | F | 3.3 | 3.3 | 1 | 1 | Dead Day 6 | |||||
H3668 | F | 3.3 | 3.3 | 3.2 | 3.3 | 1 | 0 | 1 | 3 | >4n,c,pe | 2 |
Mean | 3 | 2.9 | 3.2 | ||||||||
S.D. | 0.1 | 0.4 | 0.1 | ||||||||
# | 3 | 2 | 2 | ||||||||
Dose: 2000 mg/kg | |||||||||||
H3734 | F | 5.2 | 2.6 | 2 | 3 | 1 | 3,p | 3 | Dead Day 8 | ||
H3735 | F | 5.4 | 2.7 | 2.2 | 1.8 | 2 | 0 | 2,c,e | 3 | 1,c,e | 2 |
H3736 | F | 5.4 | 2.7 | 1 | 1 | Dead Day 5 | |||||
Mean | 2.7 | 2.1 | |||||||||
S.D. | 0.1 | 0.1 | |||||||||
# | 3 | 2 |
S.D. = standard deviation
# = number of surviving animals
c = cracking skin
e = eschar formation
p = pale areas
Table 2. Systemic observations.
Dose levels | ||||||
1000 mg/kg | 2000 mg/kg | |||||
Animal number | H3666 | H3367 | H3668 | H3734 | H3735 | H3736 |
Time periods | ||||||
Hour 1 | ||||||
Hour 2 | ||||||
Hour 4 | ||||||
Day 1 | ||||||
Day 2 | ||||||
Day 3 | X | X | X | X | X | |
Day 4 | X | X | X | X | X | |
Day 5 | X | X | X | X, D | Z (2.4kg) | |
Day 6 | X, W | Z (2.8 kg) | X | X | - | |
Day 7 | W, X | - | X, W | X, W | - | |
Day 8 | X, W | - | Z | X, W | - | |
Day 9 | X, W | - | - | X, W | - | |
Day 10 | X, W | - | - | X, W | - | |
Day 11 | X, W | - | - | X, W | - | |
Day 12 | W | - | - | X, W | - | |
Day 13 | - | - | X, W | - | ||
Day 14 | - | - | X, W | - |
No entry indicates the animal appeared normal at that observation period.
D = diarrhea
X = few feces
W = emaciated
Z = dead
Table 3. Necropsy observations.
Dose levels | 1000 mg/kg | 2000 mg/kg | |||||
Animal number | H3666 | H3367 | H3668 | H3734 | H3735 | H3736 | |
Sex | F | F | F | F | F | F | |
Death (D) / Sacrifice (S) | S | D | S | D | S | D | |
Observations | |||||||
Emaciated | X | ||||||
Treated skin abnormalities | X | X | X | X | X | ||
Anogenital area: soiled | X | X | |||||
Gall bladder: enlarged and distended with brown fluid | X | ||||||
Liver: pale areas | 2 | 2 | 2 | 2 | |||
Stomach: pale | 3 | ||||||
Stomach: filled with dark brown liquid and white mucous | X | X | X | ||||
Intestines: red areas | 3 | ||||||
Ears: areas of erythema and paleness with the outermost layers of skin sloughing off, the skin was very soft and mucous-like. | X | ||||||
Peritoneal cavity: excess fluid | X | ||||||
Cavity walls: red areas | 1 | ||||||
Alopecia: localised alopecia on muzzle with thickened crusty skin appearing similar to the dorsal dose site | X | X | X | ||||
Stomach: area appeared to be ulcerated (small opening on the stomach wall) | X | ||||||
Stomach contents: white mucous and dark brown/red substance | X | ||||||
Peritoneal cavity: excessive amounts of red fluid | X | ||||||
Spleen: appeared smaller than normal and pale | X | ||||||
Kidney sized blood clot located beneath the stomach | X |
X = observed
1 = slight or scattered
2 = moderate or few
3 = pronounced or many
Applicant's summary and conclusion
- Interpretation of results:
- harmful
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The dermal LD50 of the test material is greater than 1000 mg/kg but less than 2000 mg/kg of body weight.
- Executive summary:
The study was conducted to determine the potential for toxicity of the test article when applied dermally and was designed to comply with the standards set forth in OECD Guidelines for Testing Chemicals, Number 402, adopted February 24, 1987.
Three healthy female New Zealand White rabbits were dosed dermally with the test material at 1000 mg/kg of body weight. The test article was kept in contact with the skin for 24 hours. Dermal responses were recorded at 24 hours postdose and on days 7 and 14. Animals were observed for toxicity and pharmacological effects at 1, 2 and 4 hours postdose and once daily for 14 days. Based on the data from the 1000 mg/kg level and at the request of the Sponsor, an additional three female rabbits were dosed and observed at 2000 mg/kg in the same manner as the 1000 mg/kg level. All animals were observed twice a day for mortality. Body weights were recorded pretest, weekly and at death or termination in the survivors. All animals were examined for gross pathology. Abnormal tissues were preserved in 10% neutral buffered formalin for possible future histological examination.
In the 1000 mg/kg dose, two out of three survived. All animals were normal through Day 2. On Days 3 - 5, two out of three animals were observed with few feces, one was normal. On Day 6, one animal was found dead. Out of the remaining two animals, one remained normal through the end of the study and the other (H3666) was emaciated with few feces until Day 13 and 14 when it was observed as normal. All animals lost weight, the animal that had remained normal weighed the same as pretest on Day 14.
Dermal observations at 24 hours were absent to very slight (erythema and edema). On Day 7, erythema remained absent to very slight while edema was moderate. By Day 14, the remaining animals had severe erythema with moderate eschar and necrosis, one was noted with cracking and peeling skin. Edema was slight.
A moderately pale liver and markedly pale stomach filled with brown liquid and white mucous were noted for animal H3667 female, that was found dead on Day 6. One of the remaining two animals had fluid in the peritoneal cavity and scattered red areas on the walls of the cavity, Both animals had treated skin abnormalities and localized areas of alopecia with thickened crusty skin around the muzzle similar to what was observed on the treated dorsal site.
In the 2000 mgkg dose, one out of three female animals survived. All animals were normal through Day 2. On Days 3 and 4, all animals were observed with few feces. On Day 5, one animal was found dead. Out of the remaining two animals both had few feces and one had diarrhea. On Day 6, both had few feces and by Day 7 were also emaciated. On Day 8, another animal was found dead. The remaining animal had few feces and was emaciated until the end of the study. Due to the condition of the animals the cervical collar was removed from the surviving animal on Day 5, this did not have an affect on the animal's condition. All animals lost weight.
Moderately pale livers and markedly pale stomachs were noted for all animals. Two were noted with brown fluid and white mucous in the stomach and one had markedly red areas on the intestines. The two animals that were found dead had soiled anogenital areas. The animal that was found dead on Day 5 had an area of the stomach that appeared to be ulcerated, a small opening in the wall and excessive amounts of fluid in the peritoneal cavity. The spleen appeared smaller than normal and pale. A blood clot approximately
2.5 cm was located beneath the stomach. The animal that survived to Day 14 had an enlarged gallbladder that was distended with brown fluid. This animal also exhibited localized areas of alopecia with thickened crusty skin around the muzzle similar to what was observed on the treated dorsal site. Reddened and pale areas and sloughing skin was also observed on the ears of the surviving animal, most likely due to the contact with the treated dorsal site.
The dermal LD50 of the test material is greater than 1000 mg/kg but less than 2000 mg/kg of body weight.
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