Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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.
Diss Factsheets
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: 203-232-2 | CAS number: 104-74-5
- 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: oral
Administrative data
- 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.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 017
- Report date:
- 2017
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Principles of method if other than guideline:
- The purpose of this study was to access the toxicological profile of the test item to a single administration via oral route to Sprague-Dawley rats.
- GLP compliance:
- yes
- Test type:
- acute toxic class method
- Limit test:
- no
Test material
- Reference substance name:
- 1-dodecylpyridinium chloride
- EC Number:
- 203-232-2
- EC Name:
- 1-dodecylpyridinium chloride
- Cas Number:
- 104-74-5
- Molecular formula:
- C17H30N.Cl
- IUPAC Name:
- 1-dodecylpyridin-1-ium chloride
- Details on test material:
- - Name of test material : 1-dodecylpyridinium chloride
- Molecular formula : C17H30N.Cl
- Molecular weight : 283.884 g/mol
- Physical state : Solid
- Substance type : Organic
- Smiles notation : [n+]1(ccccc1)CCCCCCCCCCCC.[ClH-]
- InChl : GKQHIYSTBXDYNQ-UHFFFAOYSA-M
SOURCE OF TEST MATERIAL
- Test Item: 1-dodecylpyridinium chloride (CAS No. 104-74-5)
- Source of test material: Sustainability Support Services (Europe) AB, Sweden
- Batch No. of test material: 6KBDG
- Manufacturing Date: May; 2017
- Expiration date of the lot/batch: April; 2018
- Consistency: Solid, powder
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: Test Item and prepared formulation(s) were stored at ambient temperature.
OTHER SPECIFICS:
Safety Precautions: Safety precautions included use of protective clothing, gloves, masks and eye protection (glasses).
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: National Institute of Biosciences, Pune.
- Females nulliparous and non-pregnant: yes
- Age at study initiation: Female rats of the age of approximately 8 to 12 weeks old were used at the commencement of its dosing.
- Weight at study initiation: Body weight range was 192.2 to 207.1 grams.
Body weights at the start : Female Mean: 199.74 g (= 100 %); Minimum : 192.2 g (- 3.78 %); Maximum : 207.1 g (+ 3.68 %)
- Identification: Each female rat was individually identified by the picric acid marking.
- Fasting period before study: Approximately 16 hours or more.
- Housing: The rats were housed in polycarbonate cages.
- Diet (e.g. ad libitum): Rodent feed supplied by the Nutrivet Life Sciences, Pune, was provided ad libitum from individual feeders.
- Water (e.g. ad libitum): Water was provided ad libitum from individual bottles attached to the cages. All water was from a local source and passed through the reverse osmosis membrane before use.
- Acclimation period: 5 days.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20.0 to 22.0 degree centigrade.
- Humidity (%): 54.4% to 59.3%
- Air changes (per hr): Ten to fifteen air changes per hour.
- Photoperiod (hrs dark / hrs light): An artificial light and dark cycle of 12 hours each was provided to the room.
IN-LIFE DATES:13-10-2017 to 31-10-2017
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Remarks:
- Distilled water
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle:300 mg/kg, 50 mg/kg and 50 mg/kg
MAXIMUM DOSE VOLUME APPLIED: 10 ml/kg body weight.
DOSAGE PREPARATION (if unusual): The test item was dissolved in distilled water. The formulation was prepared fresh. The test item was administered in the dose volume of 10 ml/kg bw. - Doses:
- Dose Group I : 300 mg/kg
Dose Group II : 50 mg/kg
Dose Group II : 50 mg/kg - No. of animals per sex per dose:
- Three females were used at each step.
- Control animals:
- not specified
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Twice daily
- Necropsy of survivors performed: Yes
- Other examinations performed: Clinical Observations and General Appearance: Animals were observed for clinical signs, mortality and morbidity, until sacrifice.
Onset, duration and severity of any sign were recorded. The clinical signs and mortality observations were conducted at immediately (0 to 5 minutes), 5, 10, 30, 60 minutes, 2, 4 and 6 hours on the day of dosing and once daily thereafter for 14 day. Daily observation was done as far as possible at the same time.
The observations were included general clinical signs, observations of eyes, mucous membranes, respiratory, circulatory system and behavior pattern.
Body weights: Individual animal body weights were recorded, before fasting, prior to administration of the test item (fasting body weights), weekly thereafter and at termination on day 14. Weight changes were calculated and recorded.
Gross Pathology: Necropsy was performed on all animals, found dead and sacrificed at the end of the study. Macroscopic examination of all the orifices, cavities and tissues were made and the findings were recorded. All animals surviving the study period were sacrificed by the carbon dioxide asphyxiation technique (day 15).
Histopathology: No gross abnormalities were observed in animals sacrificed terminally hence, no histopathology was performed. - Statistics:
- not specified
Results and discussion
- Preliminary study:
- not specified
Effect levels
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 50 - 300 mg/kg bw
- Based on:
- test mat.
- Mortality:
- Group I Step I : Two animals died at 6 hours and one animal died on day 1 after the dosing.
Group II Step I : All animals survived through the study period of 14 days.
Group II Step II : All animals survived through the study period of 14 days. - Clinical signs:
- other: Group I Step I : Animals treated at the dose level of 300 mg/kg body weight resulted in diarrhoea and reduced locomotor activity with onset at 30 minutes to 1 hour after the dosing. Group II Step I : Animals treated at the dose level of 50 mg/kg body wei
- Gross pathology:
- Gross pathological examination did not reveal any abnormalities in all animals from 300 mg/kg and 50 mg/kg dose groups.
- Other findings:
- not specified
Any other information on results incl. tables
Table No. I
Summary of Clinical Signs of Toxicity and Mortality
Laboratory Test Item Code :TAS/122/054
Test System : Sprague Dawley Rat
Sex : Female
Group I :
Step No. |
Dose mg/kg |
Observed Signs |
Total Number of Animals |
Animal Nos. |
Period of signs in days From - to |
Mortality |
I |
300 |
Diarrhoea |
3 |
1 2 3 |
1 hr. - 4 hrs. 30 min. - 4 hrs. 1 hr. - 6 hrs. |
3/3 |
Reduced locomotor activity |
3 |
1 2 3 |
1 hr. - 4 hrs. 30 min. - 4 hrs. 1 hr. - 6 hrs. |
Group II :
Step No. |
Dose mg/kg |
Observed Signs |
Total Number of Animals |
Animal Nos. |
Period of signs in days From - to |
Mortality |
I |
50 |
Diarrhoea |
3 |
4,5 6 |
1 hr. - 4 hrs. 1 hr. - 6 hrs. |
0/3 |
Group II :
Step No. |
Dose mg/kg |
Observed Signs |
Total Number of Animals |
Animal Nos. |
Period of signs in days From - to |
Mortality |
II |
50 |
Diarrhoea |
3 |
7 8,9 |
1 hr. - 6 hrs. 1 hr. - 4 hrs. |
0/3 |
Table No.II
Mean Body Weight and Percent Body Weight Gain (g)
Laboratory Test Item Code :TAS/122/054
Test System : Sprague Dawley Rat
Sex : Female
Group I :
Step No. |
Dose (mg/kg body weight) |
|
Before Fasting Body weight |
Body weight Day 7 |
% body weight gain day 0-7 |
Body weight Day 14 |
% body weight gain day 7- 14 |
% body weight gain day 0- 14 |
I |
300 |
Mean |
195.23 |
- |
- |
- |
- |
- |
± SD |
2.87 |
- |
- |
- |
- |
- |
Group II :
Step No. |
Dose (mg/kg body weight) |
|
Before Fasting Body weight |
Body weight Day 7 |
% body weight gain day 0-7 |
Body weight Day 14 |
% body weight gain day 7- 14 |
% body weight gain day 0- 14 |
I |
50 |
Mean |
201.77 |
214.87 |
6.49 |
232.20 |
8.07 |
15.09 |
± SD |
3.40 |
4.15 |
0.30 |
5.14 |
1.78 |
1.98 |
Group II :
Step No. |
Dose (mg/kg body weight) |
|
Before Fasting Body weight |
Body weight Day 7 |
% body weight gain day 0-7 |
Body weight Day 14 |
% body weight gain day 7- 14 |
% body weight gain day 0- 14 |
II |
50 |
Mean |
202.23 |
215.20 |
6.41 |
232.37 |
7.97 |
14.89 |
± SD |
4.54 |
5.58 |
0.58 |
6.80 |
0.93 |
0.85 |
Table No.III
Summary of Gross Pathological Findings
Laboratory Test Item Code :TAS/122/054
Test System : Sprague Dawley Rat
Sex : Female Group I :
Step No. |
Dose mg/kg |
Animal Numbers |
Animal Fate |
Gross Pathological Findings |
I |
300 |
1 - 3 |
FD |
No abnormality detected |
Group II :
Step No. |
Dose mg/kg |
Animal Numbers |
Animal Fate |
Gross Pathological Findings |
I |
50 |
4 - 6 |
TS |
No abnormality detected |
Group II :
Step No. |
Dose mg/kg |
Animal Numbers |
Animal Fate |
Gross Pathological Findings |
II |
50 |
7 - 9 |
TS |
No abnormality detected |
FD = Found dead
TS = Terminal sacrifice
Applicant's summary and conclusion
- Interpretation of results:
- Category 3 based on GHS criteria
- Conclusions:
- Under the condition of the study, the acute oral LD50 value of the given test chemical was considered in between 50 – 300 mg/kg body weight. Thus, it was concluded that the acute toxicity study of test chemical, when administered via oral route in Sprague Dawley rats falls into the “Category 3” according to criteria of CLP.
- Executive summary:
The reported study was designed and conducted to determine the acute oral toxicity profile of the given test chemical as per OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method) in Sprague Dawley rats.
Initially, three female animals were treated at the dose level of 300 mg/kg body weight of the test item (Step - I). Administration of the test item at 300 mg/kg resulted in diarrhoea and reduced locomotor activity with onset at 30 minutes to 1 hour after the dosing. Two animals died at 6 hours and one animal died on day 1 after the dosing.
As mortality was observed at 300 mg/kg dose group, additional three female animals were treated with the lower dose of 50 mg/kg of the test item (Step - I).
Administration of the test item at 50 mg/kg resulted in diarrhoea with onset at 1 hour after the dosing and no mortality at 24 hours after the dosing. As no mortality was observed at 24 hours after the dosing, three additional female animals were added to the study and treated with the dose of 50 mg/kg of the test item (Step - II). Administration of the test item at 50 mg/kg resulted in diarrhoea with onset at 1 hour after the dosing and no mortality at 24 hours after the dosing.
All animals from 50 mg/kg dose group survived through the study period of 14 days. Gross pathological examination did not reveal any abnormalities in all animals from 300 mg/kg and 50 mg/kg dose groups.
Under the condition of the study, the acute oral LD50 value of the given test chemical was considered in between 50 – 300 mg/kg body weight. Thus, it was concluded that the acute toxicity study of test chemical, when administered via oral route in Sprague Dawley rats falls into the “Category 3” according to criteria of CLP.
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.