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EC number: 209-218-2 | CAS number: 561-41-1
- 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 acute oral toxicity dose (LD50) was considered based on experimental studies conducted on rats for the test chemical. The LD50 value is between 300-2000 mg/kg bw for acute oral toxicity. Thus, comparing this value with the criteria of CLP regulation, the given test chemical can be classified as “Category IV” for acute oral toxicity.
Acute Inhalation Toxicity:
In accordance with column 2 of Annex VIII, this end point was considered for waiver since the vapour pressure of 4,4'-bis(dimethylamino)-4''-(methylamino)trityl alcohol is very low (0.00000000052 Pa) and thus there is no possibility of exposure by the inhalation route in this case. Also, considering that the particle size of this chemical ranges between 53 to 250 micrometer in size; there is no possibility of inhalable dust particles (size usually in nano meters) being generated during the use.
Acute Dermal toxicity:
The acute dermal toxicity dose (LD50) was considered based on experimental study report conducted on rats for the test chemical. The studies concluded that LD50 value is >2000 mg/kg bw, for acute dermal toxicity. Thus, comparing this value with the criteria of CLP regulation, the given test chemical cannot be classified for acute dermal toxicity.
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
- Justification for type of information:
- Data is from experimental study report
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Principles of method if other than guideline:
- The aim of this study was to assess the toxicity potential of test chemical after single oral administration in rats.
- GLP compliance:
- yes
- Test type:
- acute toxic class method
- Limit test:
- no
- Species:
- rat
- Strain:
- Wistar
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source:Bharat Serum and Vaccines Limited, Mumbai, India.
- Age at study initiation:9 - 11 weeks at the time of dosing.
- Health Status :Healthy young adult animals were used for the study. Females were nulliparous and non pregnant.
- Weight at study initiation:Minimum: 178 g and Maximum: 211 g (Individual body weights were within ± 6% prior to treatment after overnight fasting)-.Fasting period:Rats were fasted for 16-18 hrs
- Housing:The animals were housed individually in polycarbonate cages.
- Bedding:All cages were provided with corn cobs.
- Room Sanitation:The experimental room floor and work tops were swept and mopped with disinfectant solution every day.
- Cages and water bottle:All the cages and water bottles were changed at least twice every week.
- Diet (e.g. ad libitum):All animals were provided conventional laboratory rodent diet (Nutrivet Life Sciences, Pune) ad libitum.
- Water (e.g. ad libitum):Aqua guard filtered tap water was provided ad libitum via drinking bottles.
- Acclimation period:Animal nos. 1-3 were acclimatized for six days, 4-6 for nine days and 7-9 for seven days prior to administration of the test item.
ENVIRONMENTAL CONDITIONS
- Temperature (°C):Minimum: 20.00 °C and Maximum: 23.60 °C
- Humidity (%):Minimum: 37.40% and Maximum: 61.80%
- Air changes (per hr):More than 12 changes per hour.
- Photoperiod (hrs dark / hrs light):12:12 - Route of administration:
- oral: unspecified
- Vehicle:
- corn oil
- Details on oral exposure:
- VEHICLE
- Amount of vehicle (if gavage):10 ml
- Justification for choice of vehicle:Corn oil was selected as a vehicle because test item was not soluble in distilled water.
- Lot/batch no. (if required):MKBD4650
- Purity:N/A
MAXIMUM DOSE VOLUME APPLIED:10 ml/kg body weight. - Doses:
- G1 = 2000 mg/kg bw
G2 = 300 mg/kg bw - No. of animals per sex per dose:
- 9 female rats
- Control animals:
- not specified
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing:Daily
- Necropsy of survivors performed: yes
At the end of 14 day observation period, all the survived rats were euthanised by overdose of CO2 for external and internal observations.
- Other examinations performed:
Clinical Observation
After test item administration, individual animals were frequently observed at 30 minutes, 1, 2, 3 and 4 hours post dosing on day 0 (day of dosing). Subsequently, all the surviving animals were observed once a day during the 14 day observation period.
Body weight
All surviving rats were weighed on days 0 (prior to dosing), 7 and 14. Animals were weighed immediately after found dead.
other:
Mortality
All the surviving animals were observed twice daily (morning and evening) for morbidity and mortality, throughout the acclimatization and study period. - Statistics:
- not specified
- Preliminary study:
- not specified
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 300 - <= 2 000 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: no mortality was observed
- Mortality:
- At 2000 mg/kg, all the three animals (animal nos. 1-3) were found dead on day 1 post dosing, whereas no mortality was observed in the animals treated with 300 mg/kg dose throught out the 14 days observation period.
- Clinical signs:
- other: At 2000 mg/kg, animal nos. 1 and 3 were observed normal at 30 minutes, 1, 2, 3 and 4 hours post dosing, severe abdominal breathing and sternal recumbency on day 1 followed by found dead. Animal no. 2 observed normal at 30 minutes, 1, 2, 3 and 4 hours post
- Gross pathology:
- At 2000 mg/kg, all three animals (animal nos. 1-3) were observed with blue colour around perineal area, whreas no external gross pathological changes were observed in the animals treated with 300 mg/kg dose.
At 2000 mg/kg, animal nos. 1 and 3 were observed with moderate red discoloration of all the lobes of lungs, severe dark colour observed in all the lobes of liver, moderate dark colour observed in the kidney, blue tinched urine observed in the urinary bladder and blue discoloration of test item observed in the stomach and intestine. Animal no. 2 was observed with severe red discoloration of all the lobes of lungs, severe dark colour observed in all the lobes of liver, moderate dark colour observed in the kidney, blue tinched urine observed in the urinary bladder and blue discoloration of test item observed in the stomach and intestine, whreas no internal gross pathological changes were observed in the animals treated with 300 mg/kg dose. - Other findings:
- not specified
- Interpretation of results:
- Category 4 based on GHS criteria
- Conclusions:
- The lethal concentration LD50 value for acute oral toxicity test was considered to be >300-<2000 mg/kg bw,when nine female wisatr rats were treated with test chemical orally via gavage according to OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method).
- Executive summary:
The acute oral toxicity profile of test chemical in nine wistar rats at dose concentration of 300 mg/kg and 2000 mg/kg bw.corn oil was used as vehicle.This study was performed as per OECD No. 423. Nine female Wistar rats were selected for acute oral toxicity study. The animals were fasted for minimum 16-18 hours prior to dosing and for 3-4 hours post dosing, with food withheld but drinking water providedad libitum. The time intervals between dosing were determined by the onset, duration and severity of toxic signs.Three rats of group G1 were dosed with starting dose of 2000 mg/kg body weight, as the animals were found dead (on day 1 post dosing). Hence three animals of the group G2 were dosed with 300 mg/kg body weight and no mortality was observed, therefore another three animals of same group G2 were dose with 300 mg/kg and no mortality was observed. Hence, further dosing was stopped.Body weights were recorded on day 0 (prior to dosing) 7 and 14 and of found dead. Mean body weight of the animals treated with 300 mg/kg was observed with gain on day 7 and 14, as compared to day 0.At 2000 mg/kg, all the found dead animals were observed with decreased body weight as compared to day 0. At 2000 mg/kg, animal nos. 1 and 3 were observed normal at 30 minutes, 1, 2, 3 and 4 hours post dosing, severe abdominal breathing and sternal recumbency on day 1 followed by found dead. Animal no. 2 observed normal at 30 minutes, 1, 2, 3 and 4 hours post dosing, severe lethargy, moderate abdominal breathing and lateral recumbency on day 1 followed by found dead. At 300 mg/kg, all the six animals (animal nos. 4-9) were observed normal throughout the experimental period.At 2000 mg/kg, all three animals (animal nos. 1-3) were observed with blue colour around perineal area, whreas no external gross pathological changes were observed in the animals treated with 300 mg/kg dose.At 2000 mg/kg, animal nos. 1 and 3 were observed with moderate red discoloration of all the lobes of lungs, severe dark colour observed in all the lobes of liver, moderate dark colour observed in the kidney, blue tinched urine observed in the urinary bladder and blue discoloration of test item observed in the stomach and intestine. Animal no. 2 was observed with severe red discoloration of all the lobes of lungs, severe dark colour observed in all the lobes of liver, moderate dark colour observed in the kidney, blue tinched urine observed in the urinary bladder and blue discoloration of test item observed in the stomach and intestine, whreas no internal gross pathological changes were observed in the animals treated with 300 mg/kg dose.The acute oral LD50value of test chemical was >300 - ≤2000 mg/kg body weight.Thus by considering the CLP criteria for acute toxicity rating for the test chemicals, it infers that test chemical exhibit acute oral toxicity in “Category 4” LD50 > 300 to ≤ 2000 mg/kg body weight.
Reference
Table 1: Individual Animal Body Weight (g) andBody Weight Changes(%)
Sex:Female
Animal No. |
Group/ Dose (mg/kg) |
Body Weight (gram) |
Body Weight Change (%) |
||||
Day 0 |
Day 7 |
Day 14 |
Found Dead |
Day 0-7 |
Day 0-14 |
||
1 |
G1/ 2000 |
194 |
- |
- |
173 |
- |
- |
2 |
190 |
- |
- |
169 |
- |
- |
|
3 |
190 |
- |
- |
166 |
- |
- |
|
4 |
G2/ 300 |
211 |
240 |
250 |
- |
13.74 |
18.48 |
5 |
200 |
224 |
231 |
- |
12.00 |
15.50 |
|
6 |
207 |
229 |
234 |
- |
10.63 |
13.04 |
|
7 |
197 |
216 |
211 |
- |
9.64 |
7.11 |
|
8 |
182 |
189 |
202 |
- |
3.85 |
10.99 |
|
9 |
178 |
195 |
205 |
- |
9.55 |
15.17 |
Key:- = Not applicable
Table 2: Summary of Animal Body Weight (g) and Body Weight Changes (%)
Sex:Female
Group/ Dose (mg/kg) |
Rats Body Weight (g) |
Body Weight Changes (%) |
||||
Day 0 |
Day 7 |
Day 14 |
0-7 |
0-14 |
||
G1/ 2000 |
Mean |
191.33 |
- |
- |
- |
- |
SD |
2.31 |
- |
- |
- |
- |
|
n |
3 |
- |
- |
- |
- |
|
G2/ 300 |
Mean |
195.83 |
215.50 |
222.17 |
9.90 |
13.38 |
SD |
13.29 |
19.89 |
19.07 |
3.36 |
3.97 |
|
n |
6 |
6 |
6 |
6 |
6 |
Keys:- = Not applicable, SD = Standard Deviation, n = Number of Animals
Table 3: Individual Animal Clinical Signs and Symptoms
Sex:Female
Animal No. |
Group/ Dose (mg/kg) |
Hours (Day 0) |
||||
1/2 |
1 |
2 |
3 |
4 |
||
1 |
G1/ 2000 |
1 |
1 |
1 |
1 |
1 |
2 |
1 |
1 |
1 |
1 |
1 |
|
3 |
1 |
1 |
1 |
1 |
1 |
|
4 |
G1/ 300
|
1 |
1 |
1 |
1 |
1 |
5 |
1 |
1 |
1 |
1 |
1 |
|
6 |
1 |
1 |
1 |
1 |
1 |
|
7 |
1 |
1 |
1 |
1 |
1 |
|
8 |
1 |
1 |
1 |
1 |
1 |
|
9 |
1 |
1 |
1 |
1 |
1 |
Animal No. |
Group/ Dose (mg/kg) |
Days post dosing |
|||||||||||||
1 |
2 |
3 |
4 |
5 |
6 |
7 |
8 |
9 |
10 |
11 |
12 |
13 |
14 |
||
1 |
G2/ 2000 |
4+++ 155 2 |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
2 |
99+++4++ 98 2 |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
|
3 |
4+++ 155 2 |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
|
4 |
G2/ 300 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
5 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
|
6 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
|
7 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
|
8 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
|
9 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
Keys:- = Not applicable, 1 = Normal, 2 = Found dead, 4 = Abdominal breathing, 98 = Lateral recumbency, 99 = Lethargy, 155 = Sternal recumbency,++= Moderate,+++= Severe
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 1 000 mg/kg bw
- Quality of whole database:
- Data is Klimisch 1 and from study report.
Acute toxicity: via inhalation route
Link to relevant study records
- Endpoint:
- acute toxicity: inhalation
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- other:
Reference
Endpoint conclusion
- Quality of whole database:
- Waiver
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
- Justification for type of information:
- Data is from experimental study report
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Principles of method if other than guideline:
- The objective of the study was to assess the dermal toxicity of test chemical after single dose application by dermal route in rats.
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- yes
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source:In-House Bred at sa-Ford, Animal Facility.
- Age at study initiation:N/A
- Health Status:Healthy young adult animals were used for the study. Females were nulliparous and non pregnant.
- Weight (Prior to Treatment):Male:Minimum: 232 g and Maximum: 265 g , Female:Minimum: 248 g and Maximum: 261 g
- Fasting period before study:N/A
- Housing:The animals were housed individually in polycarbonate cages.
- Bedding : All cages were provided with corn cobs.
- Room Sanitation : The experimental room floor and work tops were swept and mopped with disinfectant solution every day.
- Cages and water bottle : All the cages and water bottles were changed at least twice every week.
- Diet (e.g. ad libitum):All animals were provided conventional laboratory rodent diet (Nutrivet Life Sciences, Pune) ad libitum.
- Water (e.g. ad libitum):Aqua guard filtered tap water was provided ad libitum via drinking bottles.
- Acclimation period:All animals were acclimatized to the test conditions for 6 days prior to administration of the test item.
- Randomization : Animals were selected manually. No computer generated randomization program was used.
ENVIRONMENTAL CONDITIONS
- Temperature (°C):Minimum: 20.40 °C and Maximum: 23.10 °C
- Humidity (%):Minimum: 38.40% and Maximum: 58.70%
- Air changes (per hr):More than 12 changes per hour
- Photoperiod (hrs dark / hrs light):12:12 - Type of coverage:
- semiocclusive
- Vehicle:
- other: distilled water
- Details on dermal exposure:
- TEST SITE
- Area of exposure:The test item was applied uniformly over clipped dorsal area of rat skin.
- % coverage:Approximately 10% body surface area of rat.
- Type of wrap if used:The porous gauze dressing and non-irritating tape.
REMOVAL OF TEST SUBSTANCE
- Washing (if done):The residual test item was removed by using distilled water.
- Time after start of exposure:24-hour.
TEST MATERIAL
- Amount(s) applied (volume or weight with unit):A limit dose of 2000 mg/ kg body weight of test item was applied.
- Constant volume or concentration used: yes
- For solids, paste formed: yes
VEHICLE
- Amount(s) applied (volume or weight with unit):0.2 ml distilled water
- Concentration (if solution):N/A
- Lot/batch no. (if required):N/A
- Purity:N/A - Duration of exposure:
- 24 hrs
- Doses:
- 2000 mg/kg body weight.
- No. of animals per sex per dose:
- 10 (Five per sex)
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing:Daily
- Necropsy of survivors performed: yes
At the end of 14 day observation period, all the surviving rats were euthanised by overdose of CO2 and subjected to gross pathology examination, for external and internal observations.
- Other examinations performed:
- Clinical signs : After test item administration, individual animals were frequently observed at 1, 2, 3 and 4 hours post dosing on day 0 (day of dosing). Subsequently, all animals were observed once a day during the 14 day observation period.
- Body weight: All rats were weighed on days 0 (prior to dosing), 7 and 14.
other:
- Local Signs/Skin Reactions
All animals were observed once daily during days 1-14 (in common with clinical signs).
- Mortality
Animals were observed twice daily for any mortality during the experimental period. - Statistics:
- No statistical analysis was performed since the study was terminated with limit test.
- Preliminary study:
- not specified
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: no mortality was observed
- Mortality:
- No mortality was observed at limit dose of 2000 mg/kg body weight of test item during the 14 day observation period.
- Clinical signs:
- other: No systemic or local signs of toxicity were observed at limit dose of 2000 mg/kg body weight of test item during the experimental period, except mild alopecia was observed in female animal no. 9 on day 9 and 10.
- Gross pathology:
- The external and internal gross pathological observation of all terminally sacrificed animals did not show any pathological abnormality
- Other findings:
- not specified
- Interpretation of results:
- other: not classified
- Conclusions:
- The LD50 value was considered to be >2000 mg/kg bw,when groups of 5 male and female wistar rats were semiocclusively treated with test chemical by dermal application following 14 days of observation period according to OECD Guideline 402 (Acute Dermal Toxicity).
- Executive summary:
The acute dermal toxicity profile of test chemical in groups of 5 male and female wistar rats.This study was performed as per OECD No.402. Five male and five female healthy young adult rats were randomly selected and used for conducting acute dermal toxicity study. Rats free from injury and irritation of skin were selected for the study. Twenty four hours prior to dermal application of test item, approximately 10% of body surface area of each rat was clipped. A limit dose of 2000 mg/ kg body weight of test item moistened with 0.2 ml distilled water was applied by single dermal application and observed for 14 days after treatment. On test day 0, anamount oftestitem moistened with 0.2 ml distilled water was applied directly on the intact skin of clipped area of rats; the surgical gauze patch was put on to the intact skin of clipped area.This gauze patch was covered with a semi-occlusive dressing.The dressing was wrapped around the abdomen and anchored with non-irritating adhesive tape.After the 24-hour application period, the dressings were removed and theskin was gently wiped with distilled water.The skin reactions were assessed. The animals were observed daily for mortality and clinical signs, during the acclimatization period. All animals were observed for clinical signs at approximately 1, 2, 3 and 4 hours after treatment on day 0 and once daily during test days 1‑14. Mortality was recorded after application on test day 0 and twice daily during days 1-14 (at least once on the day of sacrifice). Local signs / Skin reactions were observed daily from test days 1-14 (in common with clinical signs). Body weights were recorded on day 0 (prior to application) and on day 7 and 14. All animals were necropsied and examined macroscopically.No mortality was observed in any animal till the end of the experimental period. No systemic or local signs of toxicity were observed at limit dose of 2000 mg/kg body weight of test item during the experimental period, except mild alopecia was observed in female animal no. 9 on day 9 and 10.The mean body weight of male and female animals was observed with gain compared to day 0 throughout the experiment.The external and internal gross pathological observation of all terminally sacrificed animals did not show any pathological abnormality. Hence,The LD50 value was considered to be >2000 mg/kg bw,when male and female wistar rats were semiocclusively treated with test chemical by dermal application following 14 days of observation period according to OECD Guideline 402 (Acute Dermal Toxicity).
Reference
Table 1: Individual Animal Body Weight (g) andBody Weight Changes(%)
Dose:2000 mg/ kg bodyweight
Animal No. |
Sex |
Body Weight (gram) |
Body Weight Change (%) |
|||
Day 0 |
Day 7 |
Day 14 |
Day 0-7 |
Day 0-14 |
||
1 |
Male |
260 |
263 |
279 |
1.15 |
6.08 |
2 |
257 |
252 |
263 |
-1.95 |
4.37 |
|
3 |
265 |
260 |
277 |
-1.89 |
6.54 |
|
4 |
260 |
258 |
278 |
-0.77 |
7.75 |
|
5 |
232 |
262 |
260 |
12.93 |
-0.76 |
|
6 |
Female |
251 |
260 |
273 |
3.59 |
5.00 |
7 |
248 |
251 |
259 |
1.21 |
3.19 |
|
8 |
256 |
261 |
260 |
1.95 |
-0.38 |
|
9 |
259 |
258 |
265 |
-0.39 |
2.71 |
|
10 |
261 |
260 |
267 |
-0.38 |
2.69 |
Table 2: Individual Animal Clinical Signs and Symptoms
Dose:2000 mg/kg body weight
Animal No. |
Sex |
Hour(s) - Day 0 |
Day |
||||||||||||||||
1 |
2 |
3 |
4 |
1 |
2 |
3 |
4 |
5 |
6 |
7 |
8 |
9 |
10 |
11 |
12 |
13 |
14 |
||
1 |
Male |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
2 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
|
3 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
|
4 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
|
5 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
|
6 |
Female |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
7 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
|
8 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
|
9 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
12+ |
12+ |
1 |
1 |
1 |
1 |
|
10 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
Keys: 1 = Normal, 12 = Alopecia, + = Mild
Table 3: Individual Animal Mortality Record
Dose:2000 mg/kg body weight
Animal No. |
Sex |
Days of Observation (0 to 14) |
|
Morning Observations |
Evening Observations |
||
1 |
Male |
No mortality and morbidity |
No mortality and morbidity |
2 |
No mortality and morbidity |
No mortality and morbidity |
|
3 |
No mortality and morbidity |
No mortality and morbidity |
|
4 |
No mortality and morbidity |
No mortality and morbidity |
|
5 |
No mortality and morbidity |
No mortality and morbidity |
|
6 |
Female |
No mortality and morbidity |
No mortality and morbidity |
7 |
No mortality and morbidity |
No mortality and morbidity |
|
8 |
No mortality and morbidity |
No mortality and morbidity |
|
9 |
No mortality and morbidity |
No mortality and morbidity |
|
10 |
No mortality and morbidity |
No mortality and morbidity |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 2 000 mg/kg bw
- Quality of whole database:
- Data is Klimisch 1 and from study report.
Additional information
Acute oral toxicity:
The acute oral toxicity profile of test chemical in nine wistar rats at dose concentration of 300 mg/kg and 2000 mg/kg bw.corn oil was used as vehicle.This study was performed as per OECD No. 423. Nine female Wistar rats were selected for acute oral toxicity study. The animals were fasted for minimum 16-18 hours prior to dosing and for 3-4 hours post dosing, with food withheld but drinking water providedad libitum. The time intervals between dosing were determined by the onset, duration and severity of toxic signs.Three rats of group G1 were dosed with starting dose of 2000 mg/kg body weight, as the animals were found dead (on day 1 post dosing). Hence three animals of the group G2 were dosed with 300 mg/kg body weight and no mortality was observed, therefore another three animals of same group G2 were dose with 300 mg/kg and no mortality was observed. Hence, further dosing was stopped.Body weights were recorded on day 0 (prior to dosing) 7 and 14 and of found dead. Mean body weight of the animals treated with 300 mg/kg was observed with gain on day 7 and 14, as compared to day 0.At 2000 mg/kg, all the found dead animals were observed with decreased body weight as compared to day 0. At 2000 mg/kg, animal nos. 1 and 3 were observed normal at 30 minutes, 1, 2, 3 and 4 hours post dosing, severe abdominal breathing and sternal recumbency on day 1 followed by found dead. Animal no. 2 observed normal at 30 minutes, 1, 2, 3 and 4 hours post dosing, severe lethargy, moderate abdominal breathing and lateral recumbency on day 1 followed by found dead. At 300 mg/kg, all the six animals (animal nos. 4-9) were observed normal throughout the experimental period.At 2000 mg/kg, all three animals (animal nos. 1-3) were observed with blue colour around perineal area, whreas no external gross pathological changes were observed in the animals treated with 300 mg/kg dose.At 2000 mg/kg, animal nos. 1 and 3 were observed with moderate red discoloration of all the lobes of lungs, severe dark colour observed in all the lobes of liver, moderate dark colour observed in the kidney, blue tinched urine observed in the urinary bladder and blue discoloration of test item observed in the stomach and intestine. Animal no. 2 was observed with severe red discoloration of all the lobes of lungs, severe dark colour observed in all the lobes of liver, moderate dark colour observed in the kidney, blue tinched urine observed in the urinary bladder and blue discoloration of test item observed in the stomach and intestine, whreas no internal gross pathological changes were observed in the animals treated with 300 mg/kg dose.The acute oral LD50value of test chemical was >300 - ≤2000 mg/kg body weight.Thus by considering the CLP criteria for acute toxicity rating for the test chemicals, it infers that test chemical exhibit acute oral toxicity in “Category 4” LD50 > 300 to ≤ 2000 mg/kg body weight.
Thus, based on the above summarised study on test chemical, all rats were died at 2000 mg/kg bw, hence the LD100 was considered to be 2000 mg/kg bw. Considering this value, the LD50 value can be assumed to be 1000 mg/kg bw. Therefore, comparing this value with the criteria of CLP regulation, the given test chemical can be classified in “Category 4 (300 – ≤ 2000)” for acute oral toxicity.
Acute Inhalation Toxicity:
In accordance with column 2 of Annex VIII, this end point was considered for waiver since the vapour pressure of 4,4'-bis(dimethylamino)-4''-(methylamino)trityl alcohol is very low (0.00000000052 Pa) and thus there is no possibility of exposure by the inhalation route in this case. Also, considering that the particle size of this chemical ranges between 53 to 250 micrometer in size; there is no possibility of inhalable dust particles (size usually in nano meters) being generated during the use.
Acute Dermal Toxicity:
The acute dermal toxicity profile of test chemical in groups of 5 male and female wistar rats.This study was performed as per OECD No.402. Five male and five female healthy young adult rats were randomly selected and used for conducting acute dermal toxicity study. Rats free from injury and irritation of skin were selected for the study. Twenty four hours prior to dermal application of test item, approximately 10% of body surface area of each rat was clipped. A limit dose of 2000 mg/ kg body weight of test item moistened with 0.2 ml distilled water was applied by single dermal application and observed for 14 days after treatment. On test day 0, anamount oftestitem moistened with 0.2 ml distilled water was applied directly on the intact skin of clipped area of rats; the surgical gauze patch was put on to the intact skin of clipped area.This gauze patch was covered with a semi-occlusive dressing.The dressing was wrapped around the abdomen and anchored with non-irritating adhesive tape.After the 24-hour application period, the dressings were removed and the skin was gently wiped with distilled water.The skin reactions were assessed. The animals were observed daily for mortality and clinical signs, during the acclimatization period. All animals were observed for clinical signs at approximately 1, 2, 3 and 4 hours after treatment on day 0 and once daily during test days 1‑14. Mortality was recorded after application on testday 0 and twice daily during days 1-14 (at least once on the day of sacrifice). Local signs / Skin reactions were observed daily from test days 1-14 (in common with clinical signs). Body weights were recorded on day 0 (prior to application) and on day 7 and 14. All animals were necropsied and examined macroscopically.No mortality was observed in any animal till the end of the experimental period. No systemic or local signs of toxicity were observed at limit dose of 2000 mg/kg body weight of test item during the experimental period, except mild alopecia was observed in female animal no. 9 on day 9 and 10.The mean body weight of male and female animals was observed with gain compared to day 0 throughout the experiment.The external and internal gross pathological observation of all terminally sacrificed animals did not show any pathological abnormality. Hence,The LD50 value was considered to be >2000 mg/kg bw,when male and female wistar rats were semiocclusively treated with test chemical by dermal application following 14 days of observation period according to OECD Guideline 402 (Acute Dermal Toxicity).
It was concluded that the acute dermal median lethal dose (LD50) of the given test chemical, when administered to female wistar rats was considered to be >2000 mg/kg body weight. Thus, according to CLP criteria for acute toxicity rating for the chemicals, it infers that the given test chemical does not classify as an acute dermal toxicant. CLP Classification: “Not classified”.
Justification for classification or non-classification
Based on the above studies on test chemical, it can be concluded that LD50 value is between 300-2000 mg/kg bw for acute oral and >2000 mg/kg bw for acute dermal toxicity. Thus, comparing this value with the criteria of CLP regulation, the given test chemical can be classified as “Category IV” for acute oral toxicity and cannot be classified for acute dermal toxicity. For acute inhalation toxicity wavier was added so, not possible to classify.
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