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EC number: 221-326-1 | CAS number: 3068-39-1
- 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
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- Not reported
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 978
- Report date:
- 1978
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Deviations:
- no
- GLP compliance:
- no
- Remarks:
- Study pre-dates GLP
- Test type:
- standard acute method
- Limit test:
- no
Test material
- Reference substance name:
- 3,6-bis(ethylamino)-9-[2-(methoxycarbonyl)phenyl]-2,7-dimethylxanthylium chloride
- EC Number:
- 221-326-1
- EC Name:
- 3,6-bis(ethylamino)-9-[2-(methoxycarbonyl)phenyl]-2,7-dimethylxanthylium chloride
- Cas Number:
- 3068-39-1
- Molecular formula:
- C27H29N2O3.Cl
- IUPAC Name:
- 3,6-bis(ethylamino)-9-[2-(methoxycarbonyl)phenyl]-2,7-dimethylxanthylium chloride
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Remarks:
- Albino (SPF)
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Body weight prior to test material application: Males: group averages were 162 g for all groups; females: group averages were 147 g for 2 groups and 162 g for the two highest dose groups.
- Fasting period before study: Animals were deprived of food and water for 16 hours prior to test material application.
- Housing: The rats were housed in MAKROLON type III (max. 5 rats) cages consisting of a wire grid with vermiculite beneath.
- Diet: Standardised pellets for rat and mice ad libitum
- Water: ad libitum
- Acclimation period: Minimum of 3 days and maximum of 7 days
ENVIRONMENTAL CONDITIONS
- Temperature: 22 ± 1 °C
- Humidity: 55 ±1 0 % (relative)
- Photoperiod: 12 hour light/dark cycle. Light hours were from 07:00 to 19:00
IN-LIFE DATES: Not reported
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- other: Bi-distilled water, 0.5 % CMC-preparation olive oil (DAB7), polyethylene glycol 400
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 10, 31.6, 100 and 316 mg/mL
MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg bw
DOSAGE PREPARATION: Doses were prepared immediately before application. Emulsions and suspensions were stirred with a magnetic stirrer over the whole application period. - Doses:
- 100, 316, 1000 and 3160 mg/kg
- No. of animals per sex per dose:
- 5 animals per sex per dose
- Control animals:
- not specified
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Observations were performed <15, 15 and 30 minutes and 1, 2, 4, 5 and 24 h after application and afterwards once daily for 14 days after application. Determination of body weight was carried out immediately before dosing as well as 7 and 14 days after application. Single weighing and the body weight related to classes of the WL24-system.
- Necropsy of survivors performed: yes - Statistics:
- Probit analysis following Finney was carried out (both separately and for males and females combined).
Results and discussion
Effect levelsopen allclose all
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- 449 mg/kg bw
- Based on:
- test mat.
- 95% CL:
- >= 322 - <= 626
- Key result
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- 410 mg/kg bw
- Based on:
- test mat.
- 95% CL:
- >= 265 - <= 636
- Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- 453 mg/kg bw
- Based on:
- test mat.
- 95% CL:
- >= 266 - <= 771
- Mortality:
- No mortalities were observed for the animals dosed at 100 mg/kg. At 316 mg/kg 2 females and 1 male died. In the 1000 mg/kg dose group 5 males and 4 females died and in the high dose group all rats died.
- Clinical signs:
- Clinical signs observed were apathy, diminished response to external stimulus, narrow eyelids, bristled fur, soft stools and reduced quantity of stools.
- Body weight:
- All surviving rats gained weight over the observation period, though at the 7 day evaluation 1 female in each of the 316 and 1000 mg/kg dose groups were considered to be highly emaciated.
- Gross pathology:
- The following findings were observed for rats that spontaneously died during the observation period. One rat was found with a lentil sized bleaching in the left side of the cardiac septum, 1 rat was observed with dark red focal region in the left pulmonary lobe, 1 rat had developed atelectasis across the whole lung, 2 rats had developed atelectasis in the apex of the lung and the whole gastro-intestinal tract was coloured red-violet, 3 rats had developed dark brown livers with light brown sprinklings, liver coloured yellowish, 3 rats were found to have red colourisation of all the internal tissues systemically, 1 rat was observed to be grey-red colourised and lastly 3 rats had one or double sided abdominal cryptorchism.
There were no findings from rats sacrificed at the end of the test.
Any other information on results incl. tables
Table 1: Summary of Mortalities
Dose rate (mg/kg) |
Application volume (mL/kg) |
Concentration (mg/mL) |
n/5 Cumulative number of dead rats (timeframe) |
|||||||||
1 h |
24 h |
48 h |
7 d |
14 d |
||||||||
M |
F |
M |
F |
M |
F |
M |
F |
M |
F |
|||
100 |
10.0 |
10 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
316 |
10.0 |
31.6 |
0 |
0 |
0 |
1 |
1 |
1 |
1 |
1 |
1 |
2 |
1000 |
10.0 |
100 |
0 |
0 |
1 |
1 |
3 |
2 |
5 |
3 |
5 |
4 |
3160 |
10.0 |
316 |
0 |
0 |
3 |
3 |
3 |
3 |
5 |
5 |
5 |
5 |
Table 2: Summary of Body Weight
Dose rate |
Gender |
Body weight of rats alive (g, geometric mean) |
Mean factor for increase of body weight of surviving rats |
|||||||
Pre appl. |
7 d |
14 d |
n |
0 - 7 d |
n |
7 - 14 d |
n |
0 - 14 d |
||
100 |
M |
162 |
196 |
237 |
5 |
1.21 |
5 |
1.21 |
5 |
1.47 |
F |
147 |
178 |
196 |
5 |
1.21 |
5 |
1.10 |
5 |
1.33 |
|
316 |
M |
162 |
196 |
237 |
4 |
1.21 |
4 |
1.21 |
4 |
1.47 |
F |
147 |
162* |
196 |
4 |
1.10 |
3 |
1.21 |
3 |
1.33 |
|
1000 |
M |
162 |
— |
— |
— |
— |
— |
— |
— |
— |
F |
162 |
162* |
215 |
2 |
1.00 |
1 |
1.33 |
1 |
1.33 |
|
3160 |
M |
162 |
— |
— |
— |
— |
— |
— |
— |
— |
F |
162 |
— |
— |
— |
— |
— |
— |
— |
— |
*Rat highly emaciated
Applicant's summary and conclusion
- Interpretation of results:
- other: Classified as Category 4 in accordance with EU criteria
- Conclusions:
- Under the conditions of the study, the LD50 of the test material was found to be 449 mg/kg bw for males and females combined (95 % confidence limit 322 to 626 mg/kg bw). The LD50 for males was 410 mg/kg bw (95 % CL 265 to 636 mg/kg bw) and for females was 453 mg/kg bw (95 % CL 266 to 771 mg/kg bw).
- Executive summary:
A study was conducted to assess the acute oral toxicity potential of the test material in the rat using methodology equivalent to the standardised guideline OECD 401.
Groups of 5 female and 5 male rats were exposed the test material by gavage at dose levels of 100, 316, 1000 and 3160 mg/kg using a vehicle of bi-distilled water, 0.5 % CMC-preparation olive oil (DAB7) and polyethylene glycol 400. The animals were observed for a 14 day period for mortality and clinical signs. Necropsies were performed for animals that died spontaneously and for animals that were euthanised at the end of the study.
No mortalities were observed for the animals dosed at 100 mg/kg. At 316 mg/kg 2 females and 1 male died. In the 1000 mg/kg dose group 5 males and 4 females died and in the high dose group all rats died. Clinical signs observed were apathy, diminished response to external stimulus, narrow eyelids, bristled fur, soft stools and reduced quantity of stools. All surviving rats gained weight over the observation period, though at the 7 day evaluation 1 female in each of the 316 and 1000 mg/kg dose groups were considered to be highly emaciated.
The following findings were observed for rats that spontaneously died during the observation period. One rat was found with a lentil sized bleaching in the left side of the cardiac septum, 1 rat was observed with dark red focal region in the left pulmonary lobe, 1 rat had developed atelectasis across the whole lung, 2 rats had developed atelectasis in the apex of the lung and the whole gastro-intestinal tract was coloured red-violet, 3 rats had developed dark brown livers with light brown sprinklings, liver coloured yellowish, 3 rats were found to have red colourisation of all the internal tissues systemically, 1 rat was observed to be grey-red colourised and lastly 3 rats had one or double sided abdominal cryptorchism. There were no findings from rats sacrificed at the end of the test.
Under the conditions of the study, the LD50 of the test material was found to be 449 mg/kg bw for males and females combined (95 % confidence limit 322 to 626 mg/kg bw). The LD50 for males was 410 mg/kg bw (95 % CL 265 to 636 mg/kg bw) and for females was 453 mg/kg bw (95 % CL 266 to 771 mg/kg bw).
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