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EC number: 235-166-5 | CAS number: 12108-13-3
- 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
For acute oral toxicity, the LD50 of 51.8 mg/kg bw/day) was used for
purposes of classification and labeling of mmt as it was the lowest LD50
from a study of sufficient quality.
For acute inhalation toxicity, the LC50 of 0.000076 mg/m3 was used for
purposes of classification and labeling of mmt as it was the lowest LC50
from a study of sufficient quality.
For acute dermal toxicity, the LD50 of 140 mg/kg was used for purposes
of classification and labeling of mmt as it was the lowest LD50 from a
study of sufficient quality.
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: Well documented study, similar to OECD 401 with sufficient information on methodology and result for assessment.
- Reason / purpose for cross-reference:
- reference to same study
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Deviations:
- no
- Remarks:
- Information on body weight and complete description of necropsy results is missing.
- GLP compliance:
- not specified
- Test type:
- acute toxic class method
- Limit test:
- no
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: No data
- Age at study initiation: No data
- Weight at study initiation: 180-230 g
- Fasting period before study: No data
- Housing: No data
- Diet : ad libitum
- Water : ad libitum
- Acclimation period: No data
ENVIRONMENTAL CONDITIONS
- Photoperiod (hrs dark / hrs light): 12 hrs / 12 hrs - Route of administration:
- oral: gavage
- Vehicle:
- corn oil
- Details on oral exposure:
- mmt was given in corn oil (3 ml/kg)
- Doses:
- 30, 47.4, 75 and 118 mg/kg.
- No. of animals per sex per dose:
- 5 male rats per dose.
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: observations for mortality performed daily
- Necropsy of survivors performed: no data - Statistics:
- Student's t test was used for determination of statistical significance. The moving average interpolation method of Thompson and Weil (1952) was used to estimate the LD50.
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- 51.8 mg/kg bw
- Remarks on result:
- other: ± 10.9 (SD)
- Mortality:
- Yes, detailed information on table 1.
- Clinical signs:
- other: Not recorded.
- Gross pathology:
- Necroscopy of animals that died within 24 hrs after mmt dosing, showed grossly distended lungs with a blood-containing fluid.
- Other findings:
- - Potential target organs: lungs
- Interpretation of results:
- toxic
- Remarks:
- Migrated information Acute oral toxicant category 3: H300 "Toxic if swallowed"..
- Conclusions:
- The oral LD50 for mmt in male rats was determined to be 51.8 mg/kg day.
- Executive summary:
In an acute oral toxicity study, groups of 5 male Sprague-Dawley rats were given a single oral dose of mmt in corn oil (3ml/kg) at doses of 30, 47.4, 75 and 118 mg/kg, and observed for 14 days. In a concurrent study, 125 mg/kg of mmt in corn oil (3 ml/kg) was administrated orally to rats with or without pre-treatment with phenobarbital (PB) to assess effects on body and lung weight, GPT, G-6-Pase and hepatic triglyceride. Effects were measured at 12 and 24 hours after treatment.
Necropsy of examination of animals which died within 24 hours after mmt showed lungs grossly distended with a blood-containing fluid.
For the study of the effect of mmt on liver and lung, the following were observed:
- Rats without PB pre-treatment exhibited a significant increase of lung weight (the weight doubled in relation to the control);
- Rats pretreated with PB had lung weights comparable to the control;
- The concentration of GPT increased greatly in rats pretreated with PB in relation to both control and mmt-treated rats.
- No significant elevation in GPT in mmt rats without PB pretreatment.
As elevated concentrations of GPT is a potential indicator of liver damage, the results indicate that that Phenobarbital pre-treatment may shift the toxicity of mmt from the lungs to the liver.
The male rat oral LD50 was determined to be 51.8 ± 10.9 mg/kg
Reference
Table 1 - Mortality in rats following administration of mmt
Dosea (mg/kg) |
Mortalityb/Dosed |
Length of survival Of animals dying |
30 |
0/5 |
|
47.4 |
2/5 |
2 – 3 days |
75 |
5/5 |
2 – 3 days |
118 |
4/5 |
<48 hr |
ammt doses given in corn oil (3 ml/kg) to rats weighting 190-210 g.
bCummulative mortality during 14 after dosing.
Table 2 - Effects of MMT on liver and lung
Treatment Groupa |
N |
Body wt (g) |
Lung wt x 10³/ Body wt |
GPT (units/ml) |
G-6-Pase (mg Pi/g Liver/20 min |
Hepatic Triglyceride (mg/g liver) |
A. Control |
7 |
198 ± 4 |
5.58 ± 0.21 |
34 ± 2 |
7.47 ± 0.70 |
5.29 ± 0.27 |
mmtb |
6 |
218 ± 12 |
11.95 ± 1.18c |
29 ± 1 |
8.96 ± 0.53 |
5.42 ± 0.98 |
mmt+PB |
7 |
210 ± 12 |
5.78 ± 0.30d |
133 ± 34d |
5.68 ± 0.52d |
5.94 ± 1.33 |
B. Control |
5 |
196 ± 3 |
6.52 ± 0.15 |
32 ± 2 |
14.32 ± 0.32 |
nd |
mmt |
5 |
189 ± 2 |
16.09 ± 3.52c |
36 ± 4 |
13.29 ± 0.94 |
nd |
ammt was administered po at a dose of 125 mg/kg in corn oil (3 ml/kg). Part A reports results (mean ± SE) obtained 24 h and part B 12 h after dosing with mmt. Rats were given Phenobarbital (60 mg/kg, ip) for 3 days.
bThese data are from 6 survivors of 14 treated animals.
cSignificantly different from control, p<0.05
dSignificantly different from mmt alone, p<0.05
eNot determined
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 51.8 mg/kg bw
Acute toxicity: via inhalation route
Link to relevant study records
- Endpoint:
- acute toxicity: inhalation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- No data
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Study conducte similar to OECD 402 with sufficient information on methodology and results for assessment.
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 403 (Acute Inhalation Toxicity)
- Deviations:
- yes
- Remarks:
- Only male rats were used. No information on animal husbandry. Also information on temperature and humidity is missing.
- GLP compliance:
- no
- Remarks:
- Study conducted prior to GLP guidelines.
- Test type:
- acute toxic class method
- Limit test:
- no
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles Breeding Laboratories
- Age at study initiation: No information
- Weight at study initiation: 210-444 g
- Fasting period before study: No
- Housing: Caged in groups of 10
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 7 days
ENVIRONMENTAL CONDITIONS: No information - Route of administration:
- inhalation: vapour
- Type of inhalation exposure:
- whole body
- Vehicle:
- other: unchanged (no vehicle)
- Details on inhalation exposure:
- GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure apparatus: Stainless steel exposure chamber
- Exposure chamber volume: 300 liter
- Method of holding animals in test chamber: No information
- Source and rate of air: 200 L/min
- Method of conditioning air:
- System of generating particulates/aerosols: A syringe drive fed the compound, at a known and constant rate, to the 500 ml vaporization flask. Compressed nitrogen was metered at a constant flow rate of 10 L/min past a quartz immersion heating element which raised the temperature, and was then fed to the vaporization flask. The vaporization flask was heated with a heating mantle. Preliminary experiments were conducted in order to define the flask temperature and nitrogen temperature necessary to completely vaporize the experimental compound when added at the highest expected rate.
TEST ATMOSPHERE
- Brief description of analytical method used: Chamber air samples were drawn at a constant flow rate through 20 cmx 2.3 cm diameter fritted tubes packed with 4gr of chromosorb 102. The same sample flow rate was used (0.5 L/min). Duration of the sample was adjusted to collect an amount of sample estimated to be in the middle of the analytical standard curve. Three absorbers were run simultaneouly for each exposure, hexane was used for the elution of mmt, and the volume of hexane recovered was eluted in a volumetric flask. The spectrum of these hexane solution were then recorded from 2000/cm to 1900/cm against a hexane blank utilizing a Perkin-Elmer Model 267 infrared spectrophotometer fitted with matched 0.5 mm cells. The absorption band at 1935/cm was used for analytical purposes. Standards of mmt were prepared in hexane and a series runs performed prior to running chamber samples.
- Samples taken from breathing zone: no
CLASS METHOD (if applicable)
- Rationale for the selection of the starting concentration: No data. - Analytical verification of test atmosphere concentrations:
- yes
- Duration of exposure:
- 1 - 4 h
- Concentrations:
- Animals exposed to mmt vapour for 1 hour
Groups:
I - 0.108 mg/L
II - 0.221 mg/L
III - 0.264 mg/L
IV - 0.309 mg/L
Animals exposed to mmt vapour for 4 hours
Groups:
V - 0.047 mg/L
VI - 0.054 mg/L
VII - 0.070 mg/L
VIII - 0.087 mg/L
IX- 0.100 mg/L - No. of animals per sex per dose:
- 10 male rats per concentration/time group; 90 total male rats
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: all groups were held for 14-days after exposure for observation of latent effects. Rats were observed dail y for clinical signs. Body weights were recorded prior to exposure and after 7 and 14 days.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs - Statistics:
- The 1-hour and 4-hour exposure data were plotted according to Litchfield and Wilcoxon with 95% confidence limit.
- Sex:
- male
- Dose descriptor:
- LC50
- Effect level:
- 0.247 mg/L air (analytical)
- 95% CL:
- 0.229 - 0.271
- Exp. duration:
- 1 h
- Sex:
- male
- Dose descriptor:
- LC50
- Effect level:
- 0.076 mg/L air (analytical)
- 95% CL:
- 0.067 - 0.087
- Exp. duration:
- 4 h
- Mortality:
- A dose-response relationship was observed. Mortality in rats exposed for 1 hour, the concentrations applied were higher than for the rats exposed for 4 hours to mmt.
For detailed information please refer to table 1 on the field 'Remarks on results including tables and figures'. - Clinical signs:
- other: A decrease in general activity, labored respiration (Dyspnea) and slight incidence of tissue inflamation around the eyes (conjunctivitis) were the clinical toxicity signs were observed. For the 1-hour exposures, dyspnea and a decrease in activity persis
- Body weight:
- On average, rats exposed to mmt vapours for 1-hour to concentrations between 0.108 and 0.264 mg/l, lost weight or did not gain body weight during the seven days post-exposure. By 14-days of post-exposure, these same rats regained and increased their body weight .
Rats exposed to mmt vapour for 4-hours at a concentration of 0.047 mg/L, showed some weight gain during the first seven days of the post-exposure period, and normal weight gain by 14-days post-exposure. Rats exposed to mmt vapours for 4-hours surviving concentrations between 0.054 and 0.087 mg/L, exhibited weight loss during the first 7 days, but resumed normal weight gain by 14-days post-exposure. - Gross pathology:
- Rats surviving 1-hour exposures to mmt vapours and sacrificed 14 days post-exposure exhibited a moderate incidence of focal areas of hemorrhage in the lungs while animals exposed for 4-hours showed only a slight incidence of these hemorrhagic foci. These were the only gross abnormalities observed.
- Other findings:
- - Potential target organs: Lungs
- Interpretation of results:
- Toxicity Category I
- Remarks:
- Migrated information Category 1 Acute inhalation toxicant: H330: ‘Fatal if inhaled’, per EC/1272/2008.
- Conclusions:
- Based on the results, the male rat LC50 based on a 1-hour exosure to mmt vapour was 0.247 mg/L (CL= 0.229 - 0.271 mg/L). the male rat LC50 based on a 4-hour mmt vapour exposire was determined to be 0.076 mg/L (Cl = 0.067 to 0.087 mg/L). For classification purposes, using the four hour exposure values, mmt would be classified as a Category 1 Acute inhalation toxicant: H330: ‘Fatal if inhaled’, per EC/1272/2008.
- Executive summary:
An acute inhalation toxicity study was performed in nine groups of ten male Sprague-Dawley rats. The rats were exposed via a whole body inhalation to mmt vapours. The groups consisted of 1-hour exposures to concentrations of 0.108, 0.221, 0.264 or 0.309 mg/L or 4-hour exposures to concentrations of 0.047, 0.054, 0.070, 0.087 or 0.100 mg/L. Animals were observed for 14-days post-exposure. Decreased activity and dyspnea persisted for a maximum of 4 days post-exposure in the 1-hour exposure for 1-hour, and for two days in the 4-hour exposure groups. Animals surviving 1-hour exposures to concentrations between 0.108 and 0.264 mg/L did not gain body weight during the first 7 days post-exposure, but resumed weight gain by 14 days post-exposure. Body weights were depressed in animals exposed for 4-hours to concentrations between 0.054 and 0.087 mg/L for the first seven days only. The only gross abnormality observed at necropsy in animals surviving the full 14 days was a moderate incidence of focal haemorrhagic areas in the lungs of rat exposed for 1-hour exposures and slight incidence in rats exposed 4-hours.
Based on the results, the 1-hour male rat LC50 for mmt vapours was determined to be 0.247 mg/L (Cl 0.229 - 0.271 mg/L), and the 4-hour male rat LC50 for mmt vapours was determined to be 0.076 mg/L (Cl = 0.067 to 0.087 mg/L).
Reference
Table 1 - Mortality of the rats exposed to mmt
Group No. |
Exposure Conc. Mg/L |
Duration of exposure (Hours) |
Number dead Days post-exposure |
CUMM. Mortality % |
||||
1 |
2 |
3 |
4 |
5 |
||||
I |
0.108 |
1.0 |
0 |
0 |
0 |
0 |
0 |
0 |
II |
0.221 |
1.0 |
0 |
1 |
0 |
0 |
0 |
10 |
III |
0.264 |
1.0 |
2 |
3 |
1 |
2 |
0 |
80 |
IV |
0.309 |
1.0 |
5 |
2 |
3 |
|
|
100 |
|
|
|
|
|
|
|
|
|
V |
0.047 |
4.0 |
0 |
0 |
0 |
0 |
0 |
0 |
VI |
0.054 |
4.0 |
0 |
1 |
0 |
0 |
0 |
10 |
VII |
0.070 |
4.0 |
0 |
0 |
3 |
0 |
0 |
30 |
VIII |
0.087 |
4.0 |
1 |
5 |
1 |
0 |
0 |
70 |
IX |
0.100 |
4.0 |
7 |
3 |
|
|
|
100 |
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- LC50
- Value:
- 0 mg/m³ air
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:
- Not mentioned
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Study performed comparable to OECD 402 with acceptable deviations.
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Deviations:
- yes
- Remarks:
- No information on the sex of the animals or environmental conditions. Only four animals were used, two of which had their skin abraded prior to exposure.
- GLP compliance:
- no
- Remarks:
- Test conducted prior to GLP guidelines.
- Test type:
- standard acute method
- Limit test:
- no
- Species:
- rabbit
- Strain:
- New Zealand White
- Sex:
- not specified
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: the laboratory stock colony
- Age at study initiation: No data
- Weight at study initiation: 3.323-4.875 Kg
- Fasting period before study: No
- Housing: Individually
- Diet: ad libitum
- Water : ad libitum
- Acclimation period: not relevant, animals bred in the laboratory
ENVIRONMENTAL CONDITIONS
No data - Type of coverage:
- occlusive
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- TEST SITE
- Area of exposure: upper back area
- % coverage: no data
- Type of wrap if used: impervious band
REMOVAL OF TEST SUBSTANCE
- Washing: no data
- Time after start of exposure: N.A.
TEST MATERIAL
No data.
- Duration of exposure:
- 24 hours.
- Doses:
- 112, 126, 141 and 158 mg/kg
- No. of animals per sex per dose:
- 4 animals per dose, (2 with abraded skin, 2 with intact skin) no information on the sex.
- Control animals:
- not required
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Frequent observations after dosing and daily for 14 days for illness and mortality. Body weighting were recorded on days 0, 3, 7, 10 and 14.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight and skin reactions. - Statistics:
- Dermal LD50 calculated according to the methods of Litchfield and Wilcoxon, 1949.
- Sex:
- not specified
- Dose descriptor:
- LD50
- Effect level:
- 140 mg/kg bw
- 95% CL:
- 122 - 159
- Mortality:
- Number of Dead/Dosed per concentration applied:
- 112 mg/kg: 0/4
- 126 mg/kg: 1/4
- 141 mg/kg: 2/4
- 158 mg/kg: 3/4 - Clinical signs:
- other: General appearance and behaviour of the rabbits were not effected.
- Gross pathology:
- Gross observations of the viscera reveal congested organs with blood tinged urine at the higher dose levels. Two rabbits with respiratory ailments and one with kidney stones were believed to be non-compound related. A general pattern of red discoloration of the kidneys is present at all dose levels. For detailed information see table 2.
- Interpretation of results:
- toxic
- Remarks:
- Migrated information H310: Fatal in contact with skin Criteria used for interpretation of results: EU
- Conclusions:
- Evidence of congestion or possible internal hemorrhage are present in the major organs. Blood tinged urine at the higher dose levels was noted.
Mortality occurred within 24 hours and up to 3 days after application. Dermal reaction were limited to slight to well defined erythema and slight edema persisting to maximum 4 days after application. The dermal LD50 was calculated at 140 mg/kg-bw (95% CL of 122-159 mg/kg-bw). - Executive summary:
In an acute dermal toxicity study, groups of 4 mature healthy New Zealand albino rabbits (2 with abraded skin and 2 with intact skin) were dermally exposed to mmt for 24 hours at doses of 112, 126, 141 or 158 mg/kg bw. Animals were observed for 14 days after dosing. Although the general appearance and behavior of the animals was not altered, dermal reactions like erythema and a slight edema were seen with symptoms subsiding in 1-4 days. A pathological observations indicating evidence of congestion or possible internal hemorrhage were present in the major organs. Blood tinged urine at the higher dose levels was also seen.
Dermal LD50= 140 mg/kg bw (95% C.I. 122-159 mg/kg). This LD50 would result in mmt being classified as a Category 2 Acute Dermal Toxicant, H310: Fatal in contact with skin per EC/1272/2008.
Reference
Table 1 - Individual body weights
Rabbit No. |
Mg/kg |
Day 0 |
3 |
7 |
10 |
14 |
216 Abraded |
112 |
4.070 |
3.987 |
3.863 |
3.965 |
4.002 |
217 A. |
4.412 |
4.116 |
4.025 |
4.102 |
4.233 |
|
212 Intact |
4.730 |
4.503 |
4.470 |
4.526 |
4.670 |
|
214 I. |
4.875 |
4.675 |
4.600 |
4.675 |
4.827 |
|
|
||||||
204 A. |
126 |
4.525 |
|
|||
294 A. |
3.345 |
3.506 |
3.640 |
3.407 |
3.504 |
|
228 I. |
3.323 |
3.4199 |
3.475 |
3.168 |
3.273 |
|
306 I. |
3.660 |
3.696 |
3.743 |
3.969 |
4.105 |
|
|
||||||
218 A. |
141 |
3.595 |
3.326 |
3.189 |
3.195 |
3.357 |
219 A. |
4.070 |
|
||||
220 I. |
4.465 |
|||||
231 I. |
3.870 |
3.813 |
3.765 |
3.791 |
3.920 |
|
|
||||||
183 A. |
158 |
4.185 |
4.132 |
4.006 |
4.085 |
4.108 |
205 A. |
3.780 |
|
||||
247 I. |
4.141 |
3.646 |
|
|||
203 I. |
4.085 |
|
A - abraded skin
I - intact skin
Table 2 - Clinical signs and gross pathology
Rabbit # |
mg/kg |
Daily observations |
Necropsy |
216 Abraded |
112 |
None noted |
None noted. |
217 A. |
None noted |
Liver margin swollen |
|
212 Intact |
None noted |
Kidneys congested. |
|
214 I. |
None noted |
Kidneys congested. |
|
|
|||
204 A. |
126 |
Died, Day 2 |
Lungs discolored. Red tinged urine in bladder. Red tinged kidney – cortex red. |
294 A. |
None noted |
Red tinged kidney – cortex red. |
|
228 I. |
None noted |
Renal calculi. Red tinged kidney, small with much scar tissue. |
|
306 I. |
None noted |
Red tinged kidney – spotted red. |
|
|
|||
218 A. |
141 |
None noted |
Kidneys discolored. |
219 A. |
Died, Day 3 |
Lungs and liver discolored; small intestine contains yellow fluid. |
|
220 I. |
Died, Day 3 |
Lungs, liver and kidney discolored; small intestine contains yellow fluid. |
|
231 I. |
None noted |
Respiratory infection |
|
|
|||
183 A. |
158 |
Died within 24 hours |
Lungs dark red, liver spotted red. Spleen discolored red. Kidneys abnormal shape and nodular. Small intestine filled with yellow fluid. |
205 A. |
None noted |
Respiratory disease. Spleen appears swollen; kidneys discolored red. |
|
247 I. |
Died, Day 3 |
Lungs, liver, spleen and kidneys discolored red. Urine red tinged and contains clotted blood. Small intestine filled with yellow fluid. |
|
203 I. |
Died, Day 2 |
Lungs, liver, spleen and kidneys discolored red. Small intestine filled with yellow fluid. |
Table 3 - Daily observations of skin
Rabbit No. |
Mg/kg |
Days |
|||||||||||||
1 |
2 |
3 |
4 |
5 |
6 |
7 |
8 |
9 |
10 |
11 |
12 |
13 |
14 |
||
216 A. Erythema Edema |
112 |
1 2 |
1 1 |
1 0 |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
217 A. Erythema Edema |
2 2 |
1 1 |
1 0 |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
|
212 I. Erythema Edema |
2 2 |
1 1 |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
|
214 I. Erythema Edema |
1 1 |
1 1 |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
|
204 A. Erythema Edema |
126 |
1 2 |
1 1 |
|
|||||||||||
294 A. Erythema Edema |
1 1 |
1 0 |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
|
228 I. Erythema Edema |
1 1 |
1 1 |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
|
306 I. Erythema Edema |
1 2 |
1 1 |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
|
218 A. Erythema Edema |
141 |
1 2 |
1 1 |
1 0 |
1 0 |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
219 A. Erythema Edema |
2 1 |
1 1 |
|
||||||||||||
220 I. Erythema Edema |
1 1 |
1 1 |
|||||||||||||
231 I. Erythema Edema |
1 2 |
1 1 |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
|
183 A. Erythema Edema |
158 |
2 2 |
1 1 |
1 0 |
1 0 |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
205 A. Erythema Edema |
|
||||||||||||||
247 I. Erythema Edema |
1 1 |
1 1 |
|
||||||||||||
203 I. Erythema Edema |
1 0 |
|
Evaluation of skin reaction
Erythema and eschar formation:
No erythema 0
Very slight erythema 1
Well-defined erythema 2
Moderate to severe erythema 3
Severe erythema (beet redness to slight
eschar formation (injuries in depth) 4
Edema formation:
No edema 0
Very slight edema 1
Slight edema 2
Moderate edema 3
Severe edema 4
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 140 mg/kg bw
Additional information
Oral exposure
Multiple K2 studies were available for acute oral toxicity with LD50s ranging from 51.8 to 230 mg/kg. For purposes of classification and labeling, the LD50 of 51.8 mg/kg was used for the CSA as it was the lowest value from a study of sufficient quality.
Inhalation exposure
A single inhalation toxicity study of sufficient quality on pure mmt was available. For purposes of classification and labeling, the LC50 from this study of 0.076 mg/L (0.000076 mg/m3) was used for the CSA
Dermal exposure
Four K2 acute dermal toxicity studies were available on mmt with LD50s ranging from 140 to 795 mg/kg bw/day. For purposes of classification and labeling, the LD50 of 140 mg/kg was used for the CSA as it was the lowest value from the studies of sufficient quality.
Justification for classification or non-classification
The LD50 of 51.8 mg/kg was selected for purposes of classification and labeling. For substances with an LD50 between 50 and 300 mg/kg, a classification category 3 is warranted for acute oral toxicity. Therefore, the proposed classification is category 3 H301: Toxic if swallowed.
The LC50 of 0.076 mg/L (0.000076 mg/m3) was selected for purposes of classification and labeling. For substances with an LC50 between 0 and 0.5 mg/L, a category 1 classification is warranted for acute inhalation toxicity. Therefore, the proposed classification is category 1 H330: Fatal if inhaled.
The LD50 of 140 mg/kg was selected for purposes of classification and labeling. For substances with an LD50 between 50 and 200 mg/kg a category 2 classification is warranted for acute dermal toxicity. Therefore, the proposed classification is category 2 H310: Fatal in contact with skin
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