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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
![](https://poisoncentres.echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
Toxicity to reproduction
Administrative data
- Endpoint:
- two-generation reproductive toxicity
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- data from handbook or collection of data
- Justification for type of information:
- Data from secondary literature
Data source
Referenceopen allclose all
- Reference Type:
- review article or handbook
- Title:
- Reasoned opinion on the setting of an import tolerance for test material
- Author:
- European Food Safety Authority (EFSA)
- Year:
- 2 013
- Bibliographic source:
- EFSA Journal 2013
- Reference Type:
- secondary source
- Title:
- Draft Assessment Report (DAR): Didecyldimethylammonium Chloride
- Author:
- European Food Safety Authority (EFSA)
- Year:
- 2 008
- Bibliographic source:
- Draft Assessment Report (DAR): Didecyldimethylammonium Chloride, Volume 3, Annex B, part 2, B.6 April 2008
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 416 (Two-Generation Reproduction Toxicity Study)
- Principles of method if other than guideline:
- Two generation reproduction study of test material was performed on Sprague Dawley rats orally by gavage.
- GLP compliance:
- not specified
- Limit test:
- no
- Justification for study design:
- No data available
Test material
- Reference substance name:
- Didecyldimethylammonium chloride
- EC Number:
- 230-525-2
- EC Name:
- Didecyldimethylammonium chloride
- Cas Number:
- 7173-51-5
- Molecular formula:
- C22H48N.Cl
- IUPAC Name:
- Didecyldimethylammonium chloride
- Test material form:
- solid
- Details on test material:
- - Name of test material (as cited in study report):Didecyldimethylammonium Chloride
- Molecular formula : C22H48N.Cl
- Molecular weight : 362.081g/mol
- Substance type: Organic
- Physical state: Solid
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Remarks:
- CD®
- Details on species / strain selection:
- No data available
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- No data available
Administration / exposure
- Route of administration:
- oral: feed
- Vehicle:
- unchanged (no vehicle)
- Details on exposure:
- Details on exposure
PREPARATION OF DOSING SOLUTIONS:
Undiluted test material given by oral route in food
DIET PREPARATION
- Rate of preparation of diet (frequency):No data available
- Mixing appropriate amounts with (Type of food )
- Storage temperature of food: No data available
VEHICLE
- Justification for use and choice of vehicle (if other than water): none
- Concentration in vehicle: 0, 20, 50 and 100 mg /kg bw/day
- Amount of vehicle (if gavage): No data available
- Lot/batch no. (if required): No data available
- Purity: No data available - Details on mating procedure:
- - M/F ratio per cage: No data available
- Length of cohabitation: 21 days
- Proof of pregnancy: [vaginal plug / sperm in vaginal smear] referred to as [day 0 / day 1] of pregnancy No data available
- After ... days of unsuccessful pairing replacement of first male by another male with proven fertility.
- Further matings after two unsuccessful attempts: [no / yes (explain)] No data available
- After successful mating each pregnant female was caged (how): No data available
- Any other deviations from standard protocol: No data available - Analytical verification of doses or concentrations:
- not specified
- Duration of treatment / exposure:
- starting 10 weeks before mating (F0) or at weaning (F1), throughout mating, gestation and lactation periods until scheduled necropsy
- Frequency of treatment:
- daily
- Details on study schedule:
- F0 rats were mated twice to produce F1a and F1b litters. Twenty-eight parents/sex of the F2 generation were selected from the F1b litters. They were mated twice to produce F2a and F2b litters. Mating was allowed for up to 21 days. Necropsy was performed on 10 pups/sex/dose from the F1a and F1b generation
Doses / concentrations
- Remarks:
- 0, 20, 50 and 100 mg /kg bw/day
- No. of animals per sex per dose:
- Total:448
For F0 generation
0 mg/kg bw/day:28 male and 28 female
20mg/kg bw/day:28 male and 28 female
50mg/kg bw/day:28 male and 28 female
100 mg/kg bw/day:28 male and 28 female
For F1 generation
0 mg/kg bw/day:28 male and 28 female
20mg/kg bw/day:28 male and 28 female
50mg/kg bw/day:28 male and 28 female
100 mg/kg bw/day:28 male and 28 female - Control animals:
- yes
- Details on study design:
- No data available
- Positive control:
- No data available
Examinations
- Parental animals: Observations and examinations:
- Parental animals observation and examinations
CAGE SIDE OBSERVATIONS: yes
DETAILED CLINICAL OBSERVATIONS: Yes
Time schedule:
BODY WEIGHT: Yes
Time schedule for examinations:
FOOD CONSUMPTION AND COMPOUND INTAKE (if feeding study): Yes Food consumption was determined weekly.
Food consumption for each animal determined and mean daily diet consumption calculated as g food/kg body weight/day: Yes
Compound intake calculated as time-weighted averages from the consumption and body weight gain data: Yes / No / No data: No data available
WATER CONSUMPTION AND COMPOUND INTAKE (if drinking water study): No data
Time schedule for examinations:
OTHER: - Oestrous cyclicity (parental animals):
- No data available
- Sperm parameters (parental animals):
- No data available
- Litter observations:
- No data available
- Postmortem examinations (parental animals):
- SACRIFICE
- Male animals: All surviving animals [describe when, e.g. as soon as possible after the last litters in each generation were produced.]
- Maternal animals: All surviving animals [describe when, e.g. after the last litter of each generation was weaned.]
GROSS NECROPSY: yes
- Gross necropsy consisted of [external and internal examinations including the cervical, thoracic, and abdominal viscera.]
HISTOPATHOLOGY / ORGAN WEIGHTS: yes
The tissues indicated in Table [#] were prepared for microscopic examination and weighed, respectively. - Postmortem examinations (offspring):
- SACRIFICE
- The F1 offspring not selected as parental animals and all F2 offspring were sacrificed at [#?] days of age.
- These animals were subjected to postmortem examinations (macroscopic and/or microscopic examination) as follows:
GROSS NECROPSY:yes
- Gross necropsy consisted of [external and internal examinations including the cervical, thoracic, and abdominal viscera.]
HISTOPATHOLOGY / ORGAN WEIGTHS
The tissues indicated in Table [#] were prepared for microscopic examination and weighed, respectively. - Statistics:
- No data available
- Reproductive indices:
- No data available
- Offspring viability indices:
- No data available
Results and discussion
Results: P0 (first parental generation)
General toxicity (P0)
- Clinical signs:
- no effects observed
- Description (incidence and severity):
- No treatment-related clinical signs were observed
- Dermal irritation (if dermal study):
- not specified
- Mortality:
- no mortality observed
- Description (incidence):
- There were no treatment related deaths during the study. One male at each dosing level was killed due to trauma or caging accident or sacrificed moribund.
- Body weight and weight changes:
- effects observed, treatment-related
- Description (incidence and severity):
- Body weight gain was reduced in males and females at 100 mg/kg/day food during the premating period.
- Food consumption and compound intake (if feeding study):
- effects observed, treatment-related
- Description (incidence and severity):
- Food consumption was reduced at 100 mg/kg /day during the premating period in males and females.
- Food efficiency:
- not specified
- Water consumption and compound intake (if drinking water study):
- not specified
- Ophthalmological findings:
- not specified
- Haematological findings:
- not specified
- Clinical biochemistry findings:
- not specified
- Urinalysis findings:
- not specified
- Behaviour (functional findings):
- not specified
- Immunological findings:
- not specified
- Organ weight findings including organ / body weight ratios:
- not specified
- Histopathological findings: non-neoplastic:
- no effects observed
- Description (incidence and severity):
- No treatment-related abnormalities were observed, including histopathological examinations
- Histopathological findings: neoplastic:
- not specified
- Other effects:
- not specified
Reproductive function / performance (P0)
- Reproductive function: oestrous cycle:
- not specified
- Reproductive function: sperm measures:
- not specified
- Reproductive performance:
- no effects observed
- Description (incidence and severity):
- There were no changes detected between parental animals of the treated and control groups in mating indices and pregnancy rates. No treatment-related changes were detected in litter size, live birth index, viability index, lactation index and sex ratio of the F0 offspring
Effect levels (P0)
- Dose descriptor:
- NOAEL
- Effect level:
- 100 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- clinical signs
- mortality
- body weight and weight gain
- food consumption and compound intake
- reproductive performance
- Remarks on result:
- other: No effects on reproductive parameters
Target system / organ toxicity (P0)
- Critical effects observed:
- not specified
- System:
- other: not specified
- Organ:
- not specified
- Treatment related:
- not specified
- Dose response relationship:
- not specified
- Relevant for humans:
- not specified
Results: F1 generation
General toxicity (F1)
- Clinical signs:
- no effects observed
- Dermal irritation (if dermal study):
- not specified
- Mortality / viability:
- no mortality observed
- Body weight and weight changes:
- effects observed, treatment-related
- Description (incidence and severity):
- F1 pup weight gains were initially similar to those in the control group, but were significantly decreased on day 21 and 28 post-partum at 100 mg/kg /day (82-87% and 83-86% of control for F1a males and females, and 76-85% and 78-83% of control for F1b males and females, resp.).
- Food consumption and compound intake (if feeding study):
- not specified
- Food efficiency:
- not specified
- Water consumption and compound intake (if drinking water study):
- not specified
- Ophthalmological findings:
- not specified
- Haematological findings:
- not specified
- Clinical biochemistry findings:
- not specified
- Urinalysis findings:
- not specified
- Sexual maturation:
- not specified
- Organ weight findings including organ / body weight ratios:
- not specified
- Gross pathological findings:
- no effects observed
- Description (incidence and severity):
- F1a and F1b pups showed no treatment-related macroscopic findings.
- Histopathological findings:
- no effects observed
- Other effects:
- not specified
Developmental neurotoxicity (F1)
- Behaviour (functional findings):
- not specified
Developmental immunotoxicity (F1)
- Developmental immunotoxicity:
- not specified
Details on results (F1)
Effect levels (F1)
open allclose all
- Dose descriptor:
- NOAEL
- Generation:
- F1a
- Effect level:
- 50 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- viability
- clinical signs
- mortality
- body weight and weight gain
- gross pathology
- Remarks on result:
- other: overall no effects on developmental parameters
- Dose descriptor:
- NOAEL
- Generation:
- F1b
- Effect level:
- 50 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- viability
- mortality
- body weight and weight gain
- gross pathology
- Remarks on result:
- other: No effects on developmental parameters
Target system / organ toxicity (F1)
- Critical effects observed:
- not specified
- System:
- other: not specified
- Organ:
- not specified
- Treatment related:
- not specified
- Dose response relationship:
- not specified
- Relevant for humans:
- not specified
Results: F2 generation
General toxicity (F2)
- Clinical signs:
- not specified
- Dermal irritation (if dermal study):
- not specified
- Mortality / viability:
- not specified
- Body weight and weight changes:
- effects observed, treatment-related
- Description (incidence and severity):
- F2a pup weight gains were decreased at 100 mg/kg /day on day 21 and 28 post-partum (85-89% and 83-90% of control for males and female resp.). F2b pup weight gains were decreased at 100 mg/kg/day on day 21 and 28 post-partum (85-89% and 84-86% of control).
- Food consumption and compound intake (if feeding study):
- not specified
- Food efficiency:
- not specified
- Water consumption and compound intake (if drinking water study):
- not specified
- Ophthalmological findings:
- not specified
- Haematological findings:
- not specified
- Clinical biochemistry findings:
- not specified
- Urinalysis findings:
- not specified
- Sexual maturation:
- not specified
- Organ weight findings including organ / body weight ratios:
- not specified
- Gross pathological findings:
- no effects observed
- Description (incidence and severity):
- F2a and F2b pups showed no treatment-related macroscopic finding
- Histopathological findings:
- not specified
- Other effects:
- not specified
Developmental neurotoxicity (F2)
- Behaviour (functional findings):
- not specified
Developmental immunotoxicity (F2)
- Developmental immunotoxicity:
- not specified
Effect levels (F2)
open allclose all
- Dose descriptor:
- NOAEL
- Generation:
- F2a
- Effect level:
- 50 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- body weight and weight gain
- gross pathology
- Remarks on result:
- other: overall no effects on developmental parameters
- Dose descriptor:
- NOAEL
- Generation:
- F2b
- Effect level:
- 50 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- body weight and weight gain
- gross pathology
- Remarks on result:
- other: overall no effects on developmental parameters
Target system / organ toxicity (F2)
- Critical effects observed:
- not specified
- System:
- other: not specified
- Organ:
- not specified
- Treatment related:
- not specified
- Dose response relationship:
- not specified
- Relevant for humans:
- not specified
Overall reproductive toxicity
- Reproductive effects observed:
- not specified
- Treatment related:
- not specified
- Relation to other toxic effects:
- not specified
- Dose response relationship:
- not specified
- Relevant for humans:
- not specified
Any other information on results incl. tables
The results of the study are summarized in table
Dose (mg/kg food) |
0 |
300 |
750 |
1500 |
dr |
|||||
m |
f |
m |
f |
m |
f |
m |
f |
|||
F0animals: |
|
|
||||||||
Mortality |
no treatment-related findings |
|
||||||||
Clinical signs |
no treatment-related findings |
|
||||||||
Body weight gain |
|
|
|
dc |
dc |
|
||||
Food consumption |
|
|
|
dc |
dc |
|
||||
Mating/fertility/gestation |
no treatment-related findings |
|
||||||||
Oestrus cycle |
not evaluated |
|
||||||||
Sperm evaluation |
not evaluated |
|
||||||||
Organ weight |
not determined |
|
||||||||
Pathology |
|
|
||||||||
Macroscopy |
no treatment-related findings |
|
||||||||
Microscopy |
no treatment-related findings |
|
||||||||
F1 pups: |
|
|
||||||||
Litter size |
no treatment-related findings |
|
||||||||
Post implantation loss (%) |
not evaluated |
|
||||||||
Live birth index |
no treatment-related findings |
|
||||||||
Viability index |
no treatment-related findings |
|
||||||||
Lactation index |
no treatment-related findings |
|
||||||||
Sex ratio |
no treatment-related findings |
|
||||||||
Clinical signs |
not determined |
|
||||||||
Body weight gain (F1a + F1b) day 21+28 post-partum |
|
|
|
dc |
dc |
|
||||
Sexual maturation |
not determined |
|
||||||||
Organ weights |
not determined |
|
||||||||
Pathology |
|
|
||||||||
Macroscopy |
no treatment-related findings |
|
||||||||
F1 animals: |
|
|
||||||||
Mortality |
no treatment-related findings |
|
||||||||
Clinical signs |
no treatment-related findings |
|
||||||||
Body weight gain |
no treatment-related findings |
|
||||||||
Food consumption - premating period |
|
|
|
dc |
dc |
|
||||
Mating/fertility/gestation |
no treatment-related findings |
|
||||||||
Oestrus cycle |
not evaluated |
|
||||||||
Sperm evaluation |
not evaluated |
|
||||||||
Organ weight |
not determined |
|
||||||||
Pathology |
|
|
||||||||
Macroscopy |
no treatment-related findings |
|
||||||||
Microscopy |
no treatment-related findings |
|
||||||||
F2 pups: |
|
|
||||||||
Litter size |
no treatment-related findings |
|
||||||||
Post implantation loss (%) |
not determined |
|
||||||||
Live birth index |
no treatment-related findings |
|
||||||||
Viability index |
no treatment-related findings |
|
||||||||
Lactation index |
no treatment-related findings |
|
||||||||
Sex ratio |
no treatment-related findings |
|
||||||||
Clinical signs |
not evaluated |
|
||||||||
Body weight F2a pups day 21 post-partum day 28 post-partum F2b pups day 21+28 post-partum |
|
|
|
|
|
|
dc dc
dc |
dc dc
dc |
|
|
Organ weights |
not determined |
|
||||||||
Pathology |
|
|
||||||||
Macroscopy |
no treatment-related findings |
|
dr :dose related
dc/ic :statistically significantly decreased/increased compared to the controls
d/i :decreased/increased, but not statistically significantly compared to the controls
a/r :absolute/relative organ weight
Applicant's summary and conclusion
- Conclusions:
- No Observed Adverse Effect Level (NOAEL) for F0 generation was considered to be 100mg/kg/day, As No treatment related changes were noted in mating behaviour, conception and gestation and the NOAEL for developmental toxicity was considered to be 50 mg/kg /day, based on decreased body weight. When female Sprague Dawley rats were treated with test material orally.
- Executive summary:
Two generation reproduction study of test material was performed on male and female Sprague Dawley CD® rats in accordance with OECD guideline 416 (1983). Although oestrus cycle, sperm parameters and sexual maturation of pups was not investigated, no reproductive effects were observed indicating indirectly no effect on these parameters. The study is considered acceptable. The test material mixed with food in dose concentration0, 20, 50 and 100 mg /kg bw/day (0, 300, 750 and 1500 mg/kg food ).28 male and 28 female placed in each dose group. Diet starting 10 weeks before mating (F0) or at weaning (F1), throughout mating, gestation and lactation periods until scheduled necropsy. F0 rats were mated twice to produce F1a and F1b litters. Twenty-eight parents/sex of the F2 generation were selected from the F1b litters. They were mated twice to produce F2a and F2b litters. Mating was allowed for up to 21 days. Necropsy was performed on 10 pups/sex/dose from the F1a and F1b generation. Clinical signs, mortality, body weight and Food consumption were noted in each generation.
No treatment-related clinical signs were observed. There were no treatment related deaths during the study. One male at each dosing level was killed due to trauma or caging accident or sacrificed moribund. Body weight gain was reduced in males and females at 100 mg/kg/day food during the premating period. Food consumption was reduced at 100 mg/kg /day during the premating period in males and females. At necropsy no treatment-related abnormalities were observed, including histopathological examinations there were no changes detected between parental animals of the treated and control groups in mating indices and pregnancy rates. No treatment-related changes were detected in litter size, live birth index, viability index, lactation index and sex ratio of the F0 offspring.
F1 pup weight gains were initially similar to those in the control group, but were significantly decreased on day 21 and 28 post-partum at 100 mg/kg /day (82-87% and 83-86% of control for F1a males and females, and 76-85% and 78-83% of control for F1b males and females, resp.). F1a and F1b pups showed no treatment-related macroscopic findings. F1 parental animals showed no treatment-related mortality or clinical signs. Body weight gain was only incidentally reduced for F1 parents. Body weights of males and females at 100 mg/kg /day were already significantly reduced at the beginning of mating due to the reduced body weight gain during their lactation period. Body weights of females were still decreased during gestation and were equal to controls at the end of lactation due 10 increased body weight gains relative to controls during gestation and lactation (F28 and F2b). Food consumption was significantly reduced at 100mg/kg /day in F1 males until week 7 and F1 females during the whole pre-mating period. No changes were noted between parental animals of the treated and control groups in mating indices, pregnancy rates and male fertility. At necropsy no treatment-related abnormalities were observed, including histopathological examination. No treatment-related changes were observed in litter size, live birth index, viability index,l actation index or sex ratio of the F, offspring (F2pups). F2apup weight gains were decreased at 100 mg/kg /day on day 21 and 28 post-partum (85-89% and 83-90% of control for males and female resp.). F2bpup weight gains were decreased at 100 mg/kg/day on day 21 and 28post-partum (85-89%and 84-86% of control).F2a andF2b pups showed no treatment-related macroscopic finding. Hence No Observed Adverse Effect Level (NOAEL) for F0 generation was considered to be 100mg/kg/day, As No treatment related changes were noted in mating behaviour, conception and gestation and the NOAEL for developmental toxicity was considered to be 50 mg/kg /day, based on decreased body weight. When female Sprague Dawley rats were treated with test material orally.
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.
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