Registration Dossier
Registration Dossier
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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.
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: 278-248-6 | CAS number: 75535-16-9
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1982
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Justification for type of information:
- REPORTING FORMAT FOR THE ANALOGUE APPROACH
1. HYPOTHESIS FOR THE ANALOGUE APPROACH
Target and source differ only in the salt form
2. SOURCE AND TARGET CHEMICAL(S) (INCLUDING INFORMATION ON PURITY AND IMPURITIES)
Source: 2-[2-[4-(diethylamino)phenyl]vinyl]-1,3,3-trimethyl-3H-indolium chloride
CAS Registry Number 6359-45-1
EC No.: 228-799-3
Target: 2-[2-[4-(diethylamino)phenyl]vinyl]-1,3,3-trimethyl-3H-indolium dihydrogen phosphate
CAS Registry Number 75535-16-9
EC No.: 278-248-6
3. ANALOGUE APPROACH JUSTIFICATION
[see attachment section 13
Cross-reference
- Reason / purpose for cross-reference:
- read-across source
Reference
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1982
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- GLP compliance:
- no
- Remarks:
- pre-dates GLP-regulation
- Test type:
- standard acute method
- Limit test:
- no
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Dr K Thomae Biberach Germany
- Age at study initiation: ca. 12 weeks
- Fasting period before study: 16 h
- Housing: in groups of 5
- Diet (e.g. ad libitum): Ssniff R ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 26
- Humidity (%): 45 - 75
- Air changes (per hr): 15 - 20
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: 4. March To: 24. March 1982 - Route of administration:
- oral: gavage
- Vehicle:
- CMC (carboxymethyl cellulose)
- Remarks:
- 0.5%
- Details on oral exposure:
- VEHICLE: suspension in 0.5% CMC in water
- Concentration in vehicle: 3.16, 2.15, 1.47, 1% (w/v)
- Amount of vehicle (if gavage): 10 mL/kg bw - Doses:
- 316, 215, 147, 100 mg/kg bw
- No. of animals per sex per dose:
- 5
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: several observation on the day of treatment , at least once daily afterwards
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, - Sex:
- male/female
- Dose descriptor:
- LD0
- Effect level:
- ca. 150 mg/kg bw
- Based on:
- act. ingr.
- Key result
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- ca. 215 mg/kg bw
- Based on:
- act. ingr.
- Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 100 - < 147 mg/kg bw
- Based on:
- act. ingr.
- Mortality:
- 316 mg/kg: all animals within 2 days
215 mg/kg: 2 males within 3 days, 3 females withinf 2 days
147 mg/kg: 1 male within 2 days; all females within 2 days
100 mg/kg: no deaths - Clinical signs:
- dyspnea, apathia, prone position, ataxia, piloerection, exsiccosis, bad general condition, diarrhea;
females in addition: atony, tremor, convulions, cyanosis, paresis - Body weight:
- no effects in surviving animals
- Gross pathology:
- no adverse effects
- Other findings:
- red skin, red faeces, red urine
- Interpretation of results:
- Category 3 based on GHS criteria
- Conclusions:
- The LD50 for the test material was approximately 150 mg/kg after single oral gavage in aqueous suspension.
- Executive summary:
The test material was administered to male and female rats as single oral gavage at dose levels of 316, 215, 147, and 100 mg/kg bw. Animals were observed for 14 days. Clinical findings consisted in dyspnea, apathia, prone position, ataxia, piloerection, exsiccosis, bad general condition, and diarrhea; females showed in addition: atony, tremor, convulions, cyanosis, and paresis. Red discolored faeces, urine and skin were observed during the first two days after treatment.
The following mortality was observed:
316 mg/kg: all animals within 2 days
215 mg/kg: 2 males within 3 days, 3 females withinf 2 days
147 mg/kg: 1 male within 2 days; all females within 2 days
100 mg/kg: no deaths
The bodyweight in surviving animals developed normally. No abnormal findings were detected at necropsy.
The LD50 for the test material was about 150 mg/kg bw after single oral gavage in aqueous CMC suspension.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 982
- Report date:
- 1982
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- GLP compliance:
- no
- Remarks:
- pre-dates GLP-regulation
- Test type:
- standard acute method
- Limit test:
- no
Test material
- Reference substance name:
- 2-[2-[4-(diethylamino)phenyl]vinyl]-1,3,3-trimethyl-3H-indolium dihydrogen phosphate
- EC Number:
- 278-248-6
- EC Name:
- 2-[2-[4-(diethylamino)phenyl]vinyl]-1,3,3-trimethyl-3H-indolium dihydrogen phosphate
- Cas Number:
- 75535-16-9
- Molecular formula:
- C23H29N2.H2O4P
- IUPAC Name:
- 2-[2-[4-(diethylamino)phenyl]vinyl]-1,3,3-trimethyl-3H-indolium dihydrogen phosphate
- Test material form:
- solid: particulate/powder
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Dr K Thomae Biberach Germany
- Age at study initiation: ca. 12 weeks
- Fasting period before study: 16 h
- Housing: in groups of 5
- Diet (e.g. ad libitum): Ssniff R ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 26
- Humidity (%): 45 - 75
- Air changes (per hr): 15 - 20
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: 4. March To: 24. March 1982
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- CMC (carboxymethyl cellulose)
- Remarks:
- 0.5%
- Details on oral exposure:
- VEHICLE: suspension in 0.5% CMC in water
- Concentration in vehicle: 3.16, 2.15, 1.47, 1% (w/v)
- Amount of vehicle (if gavage): 10 mL/kg bw - Doses:
- 316, 215, 147, 100 mg/kg bw
- No. of animals per sex per dose:
- 5
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: several observation on the day of treatment , at least once daily afterwards
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight,
Results and discussion
Effect levelsopen allclose all
- Sex:
- male/female
- Dose descriptor:
- LD0
- Effect level:
- ca. 150 mg/kg bw
- Based on:
- act. ingr.
- Key result
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- ca. 215 mg/kg bw
- Based on:
- act. ingr.
- Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 100 - < 147 mg/kg bw
- Based on:
- act. ingr.
- Mortality:
- 316 mg/kg: all animals within 2 days
215 mg/kg: 2 males within 3 days, 3 females withinf 2 days
147 mg/kg: 1 male within 2 days; all females within 2 days
100 mg/kg: no deaths - Clinical signs:
- dyspnea, apathia, prone position, ataxia, piloerection, exsiccosis, bad general condition, diarrhea;
females in addition: atony, tremor, convulions, cyanosis, paresis - Body weight:
- no effects in surviving animals
- Gross pathology:
- no adverse effects
- Other findings:
- red skin, red faeces, red urine
Applicant's summary and conclusion
- Interpretation of results:
- Category 3 based on GHS criteria
- Conclusions:
- The LD50 for the test material was approximately 150 mg/kg after single oral gavage in aqueous suspension.
- Executive summary:
The test material was administered to male and female rats as single oral gavage at dose levels of 316, 215, 147, and 100 mg/kg bw. Animals were observed for 14 days. Clinical findings consisted in dyspnea, apathia, prone position, ataxia, piloerection, exsiccosis, bad general condition, and diarrhea; females showed in addition: atony, tremor, convulions, cyanosis, and paresis. Red discolored faeces, urine and skin were observed during the first two days after treatment.
The following mortality was observed:
316 mg/kg: all animals within 2 days
215 mg/kg: 2 males within 3 days, 3 females withinf 2 days
147 mg/kg: 1 male within 2 days; all females within 2 days
100 mg/kg: no deaths
The bodyweight in surviving animals developed normally. No abnormal findings were detected at necropsy.
The LD50 for the test material was about 150 mg/kg bw after single oral gavage in aqueous CMC suspension.
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.
