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EC number: 947-995-6 | CAS number: -
- Life Cycle description
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- Endpoint summary
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- Endpoint summary
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- 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
Key value for chemical safety assessment
Effects on fertility
Description of key information
The NOAEL of Amidoaminethoxylate (REWOSOFT TE 19L) for reproductive and developmental toxicity screening on rats was 500 mg/kg bw/day.
From the findings of a two-generation reproductive study of Amidoaminethoxylate (REWOSOFT TE 19L), the NOAEL for F0 rats was 1000 mg/kg and for F1 and F2 pups was 500 mg/kg.
Link to relevant study records
- Endpoint:
- screening for reproductive / developmental toxicity
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2013/2014
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 421 (Reproduction / Developmental Toxicity Screening Test)
- Qualifier:
- according to guideline
- Guideline:
- other: Technical Guidelines for Drug Reproductive Toxicity Study, China Food and Drug Administration,
- Version / remarks:
- March 2005
- GLP compliance:
- yes
- Limit test:
- no
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: ST02697671 - Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Beijing Vital River Test Animals Technology Co., Ltd.
- Weight at study initiation:(P) 195 - 390 g
- Housing: SPF class test animal room
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 - 24°C
- Humidity (%): 50 - 65 %
- Air changes (per hr): 10-20 times/h
- Photoperiod (hrs dark / hrs light): 12/12 - Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on exposure:
- PREPARATION OF DOSING SOLUTIONS:
VEHICLE
- Concentration in vehicle: 100 mg/mL - Details on mating procedure:
- - M/F ratio per cage: 1:1
- Length of cohabitation: 14 days
- Proof of pregnancy: vaginal plug / sperm in vaginal smear referred to as day 0 of pregnancy
- After 14 days of unsuccessful pairing replacement of first male by another male with proven fertility. - Analytical verification of doses or concentrations:
- not specified
- Duration of treatment / exposure:
- Female rats were continuously treated until day 4 after birth of their offspring.
- Frequency of treatment:
- once daily
- Dose / conc.:
- 500 mg/kg bw/day
- Dose / conc.:
- 1 000 mg/kg bw/day
- Dose / conc.:
- 2 000 mg/kg bw/day
- No. of animals per sex per dose:
- 15 male + 15 female per dose
- Control animals:
- yes, concurrent vehicle
- Details on study design:
- - Dose selection rationale: based on the results of a sub-chronic oral toxicity test (90 days).
- Parental animals: Observations and examinations:
- CAGE SIDE OBSERVATIONS: Yes
- Time schedule: daily
BODY WEIGHT: Yes
- Time schedule for examinations: on first day of exposure and once a week thereafter;
during pregnancy on 0d, 4d, 7d, 10d, 14d, 17d and 20d;
after delivery 0d and 4d.
FOOD CONSUMPTION The weekly food consumption was recorded before and during the mating period, respectively. - Litter observations:
- PARAMETERS EXAMINED
The following parameters were examined in F1 offspring:
number and sex of pups, stillbirths, live births, postnatal mortality, presence of gross anomalies, weight gain, physical or behavioural abnormalities,
GROSS EXAMINATION OF DEAD PUPS:
yes, for external abnormalities; - Postmortem examinations (parental animals):
- SACRIFICE
- Male animals: All surviving animals
- Maternal animals: All surviving animals
GROSS NECROPSY
- Gross necropsy consisted of external and internal examinations including the cervical, thoracic, and abdominal viscera.
HISTOPATHOLOGY / ORGAN WEIGHTS
Following tissues were prepared for microscopic examination and weighed, respectively.: heart, liver, spleen, lungs, kidneys, thymus, ovary, testis, epididymis, other reproductive accessories and all organs showing macroscopic lesions. - Postmortem examinations (offspring):
- SACRIFICE
- The F1 offspring were sacrificed at 4 days of age.
- These animals were subjected to postmortem examinations (macroscopic and/or microscopic examination) as follows:
GROSS NECROPSY
- Gross necropsy consisted of external and internal examinations including the cervical, thoracic, and abdominal viscera.
- Statistics:
- Mean +- standard deviation, t-test.
- Clinical signs:
- no effects observed
- Mortality:
- no mortality observed
- Body weight and weight changes:
- no effects observed
- Ophthalmological findings:
- not examined
- Haematological findings:
- not examined
- Clinical biochemistry findings:
- not examined
- Urinalysis findings:
- not examined
- Behaviour (functional findings):
- not examined
- Immunological findings:
- not examined
- Organ weight findings including organ / body weight ratios:
- no effects observed
- Histopathological findings: non-neoplastic:
- effects observed, treatment-related
- Description (incidence and severity):
- Changes with respect to the uterine wall where the placenta was atteched, was reported. the tissue structure inside the uetrine wall was disordered and arrangement disorder of smooth muscle was evident. Other lesions observed were local tissue cell degeneration, necrosis, vascular dilation, congestion and hemorrhage. In terms of changes with uterus recovery after delivery such as remaining decidual cells, the recovery progress of high-dose group was worse conpared to the intermediate dose group, the low dose group and the blank control group.
- Histopathological findings: neoplastic:
- no effects observed
- Reproductive function: oestrous cycle:
- no effects observed
- Reproductive function: sperm measures:
- not examined
- Reproductive performance:
- no effects observed
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- 500 mg/kg bw/day
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- histopathology: non-neoplastic
- Clinical signs:
- no effects observed
- Mortality:
- no mortality observed
- Body weight and weight changes:
- no effects observed
- Food consumption and compound intake (if feeding study):
- no effects observed
- Food efficiency:
- not specified
- Water consumption and compound intake (if drinking water study):
- not specified
- Ophthalmological findings:
- no effects observed
- Haematological findings:
- not specified
- Clinical biochemistry findings:
- not specified
- Urinalysis findings:
- not specified
- Behaviour (functional findings):
- no effects observed
- Immunological findings:
- not examined
- Organ weight findings including organ / body weight ratios:
- no effects observed
- Gross pathological findings:
- no effects observed
- Neuropathological findings:
- no effects observed
- Histopathological findings: non-neoplastic:
- no effects observed
- Histopathological findings: neoplastic:
- no effects observed
- Reproductive function: oestrous cycle:
- not examined
- Reproductive function: sperm measures:
- not examined
- Reproductive performance:
- not examined
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- 500 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- histopathology: non-neoplastic
- Clinical signs:
- no effects observed
- Mortality / viability:
- not specified
- Body weight and weight changes:
- no effects observed
- Ophthalmological findings:
- not examined
- Haematological findings:
- not examined
- Clinical biochemistry findings:
- not examined
- Urinalysis findings:
- not examined
- Sexual maturation:
- not examined
- Organ weight findings including organ / body weight ratios:
- not examined
- Gross pathological findings:
- no effects observed
- Histopathological findings:
- not examined
- Behaviour (functional findings):
- not examined
- Developmental immunotoxicity:
- not examined
- Key result
- Dose descriptor:
- NOAEL
- Generation:
- F1
- Effect level:
- 500 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- histopathology: neoplastic
- Remarks on result:
- not measured/tested
- Key result
- Reproductive effects observed:
- yes
- Lowest effective dose / conc.:
- 500 mg/kg bw/day
- Treatment related:
- yes
- Relation to other toxic effects:
- reproductive effects in the absence of other toxic effects
- Dose response relationship:
- yes
- Relevant for humans:
- not specified
- Conclusions:
- The NOAEL of REWOSOFT TE 19L for reproductive and developmental toxicity screening on rats was 500 mg/kg bw/day.
- Endpoint:
- two-generation reproductive toxicity
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2013/2014
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 416 (Two-Generation Reproduction Toxicity Study)
- Qualifier:
- according to guideline
- Guideline:
- other: Chemicals-Test Method of Two-generation Reproduction Toxicity Study (GB 21758-2008), Guidelines for the Testing of Chemicals of China
- Version / remarks:
- March 2005
- GLP compliance:
- yes
- Limit test:
- no
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: ST02697671 - Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Beijing Vital River Experimental Rat Technology Co. Ltd., China
- Weight at study initiation: (P) Males: 120 -143 g; Females: 170 - 190 g;
- Housing: SPF experimental room
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum):ad libitum
- Acclimation period: quarantine for 5 days at least
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 - 24°C
- Humidity (%): 50 - 65 %
- Air changes (per hr): 10 - 20 times/h
- Photoperiod (hrs dark / hrs light):12/12 - Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on exposure:
- VEHICLE
- Concentration in vehicle: 100 mg/ml
- Amount of vehicle (if gavage): 0.5 - 2.0 ml/100 g - Details on mating procedure:
- - M/F ratio per cage:1/1
- Length of cohabitation: 3 weeks
- Proof of pregnancy: vaginal plug / sperm in vaginal smear referred to as day 0 of pregnancy
- After 21 days of unsuccessful pairing replacement of first male by another male with proven fertility.
- Further matings after two unsuccessful attempts: no - Analytical verification of doses or concentrations:
- not specified
- Duration of treatment / exposure:
- F0 male rats were treated 10 weeks prior to mating and continuously treated during the mating period.
F0 female rats were treated 2 weeks prior to mating and continuously treated during mating, gestation and lactation period.
F1 males were traated continuously from ablactation to mating period.
F1 female rats were treated 10 from ablactation to mating and continuously treated during mating, getsation and lactation period. - Frequency of treatment:
- once daily
- Dose / conc.:
- 500 mg/kg bw/day
- Dose / conc.:
- 1 000 mg/kg bw/day
- Dose / conc.:
- 2 000 mg/kg bw/day
- No. of animals per sex per dose:
- 15 males + 15 females
- Control animals:
- yes, concurrent vehicle
- Details on study design:
- - Dose selection rationale: basing on results of a subchronic oral toxicity studa (90 days)
- Parental animals: Observations and examinations:
- CAGE SIDE OBSERVATIONS: Yes
- Time schedule: daily
DETAILED CLINICAL OBSERVATIONS: Yes
- Time schedule: daily
BODY WEIGHT: Yes
- Time schedule for examinations: weekly
- Litter observations:
- STANDARDISATION OF LITTERS
- Performed on day 4 postpartum: yes
- If yes, maximum of 8 pups/litter (4/sex/litter as nearly as possible); excess pups were killed and discarded.
PARAMETERS EXAMINED
The following parameters were examined in F1 / F2 offspring:
number and sex of pups, stillbirths, live births, postnatal mortality, presence of gross anomalies, weight gain,
GROSS EXAMINATION OF DEAD PUPS:
yes, for external and internal abnormalities;
: - Postmortem examinations (parental animals):
- SACRIFICE
- Male animals: All surviving animals
- Maternal animals: All surviving animals
GROSS NECROPSY
- Gross necropsy consisted of external and internal examinations
HISTOPATHOLOGY / ORGAN WEIGHTS
The following tissues were prepared for microscopic examination and weighed, respectively:
The ovary, uterus, cervix, vagina, testis, epididymis seminal vesicles, prostrate and other reproductive tissues and internal organs of all dams, possible target organs like brain, heart, lung, liver, kidney, adrenal glands, spleen, stomach, duodenum, thymus, etc. - Postmortem examinations (offspring):
- SACRIFICE
- The F1 offspring not selected as parental animals and all F2 offspring were sacrificed
- These animals were subjected to postmortem examinations macroscopic
GROSS NECROPSY
- Gross necropsy consisted of external and internal examinations
HISTOPATHOLOGY / ORGAN WEIGTHS
The following tissues were prepared for microscopic examination and weighed, respectively:
The ovary, uterus, cervix, vagina, testis, epididymis seminal vesicles, prostrate and other reproductive tissues and internal organs of all dams, possible target organs like brain, heart, lung, liver, kidney, adrenal glands, spleen, stomach, duodenum, thymus, etc - Statistics:
- group means and standard deviation, t-test
- Clinical signs:
- no effects observed
- Mortality:
- no mortality observed
- Body weight and weight changes:
- no effects observed
- Ophthalmological findings:
- not examined
- Haematological findings:
- not examined
- Clinical biochemistry findings:
- not examined
- Urinalysis findings:
- not examined
- Behaviour (functional findings):
- not examined
- Immunological findings:
- not examined
- Organ weight findings including organ / body weight ratios:
- no effects observed
- Histopathological findings: non-neoplastic:
- no effects observed
- Histopathological findings: neoplastic:
- no effects observed
- Reproductive function: oestrous cycle:
- not examined
- Reproductive function: sperm measures:
- effects observed, treatment-related
- Description (incidence and severity):
- Significant difference in sperm deformity rate was obsrved in the high-dose group compared to the control group.
- Reproductive performance:
- not examined
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- 1 000 mg/kg bw/day
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- reproductive function (sperm measures)
- Clinical signs:
- no effects observed
- Mortality / viability:
- no mortality observed
- Body weight and weight changes:
- effects observed, treatment-related
- Description (incidence and severity):
- Significant difference was observed in average body weight during the period from birth to day 28 of F1 pups in the medium and high-dose group compared to the vehicle control group. The crown-rump length of the high-dose group was significantly shorter than the vehicle control group. No significant difference was observed in the body weight of day 42 male and female rats.
- Ophthalmological findings:
- not examined
- Haematological findings:
- not examined
- Clinical biochemistry findings:
- not examined
- Urinalysis findings:
- not examined
- Sexual maturation:
- not examined
- Organ weight findings including organ / body weight ratios:
- no effects observed
- Gross pathological findings:
- effects observed, treatment-related
- Description (incidence and severity):
- In F1 rats treated with the high-dose of REWOSOFT TE 19L incomplete occipital ossification was observed in 9 cases and significant difference was observed compared to the vehicle control group.
- Histopathological findings:
- no effects observed
- Behaviour (functional findings):
- not examined
- Developmental immunotoxicity:
- not examined
- Key result
- Dose descriptor:
- NOAEL
- Generation:
- F1
- Effect level:
- 500 mg/kg bw/day
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- body weight and weight gain
- gross pathology
- Clinical signs:
- no effects observed
- Mortality / viability:
- no mortality observed
- Body weight and weight changes:
- no effects observed
- Ophthalmological findings:
- not examined
- Haematological findings:
- not examined
- Clinical biochemistry findings:
- not examined
- Urinalysis findings:
- not examined
- Sexual maturation:
- not examined
- Organ weight findings including organ / body weight ratios:
- not examined
- Gross pathological findings:
- effects observed, treatment-related
- Description (incidence and severity):
- In F2 rats of the high-dose group incomplete occipital bone ossification was observed in 6 cases and significant difference was observed with the vehicle control group.
- Histopathological findings:
- not examined
- Behaviour (functional findings):
- not examined
- Developmental immunotoxicity:
- not examined
- Dose descriptor:
- NOAEL
- Generation:
- F2
- Effect level:
- 500 mg/kg bw/day
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- gross pathology
- Key result
- Reproductive effects observed:
- no
- Conclusions:
- From the findings of this two-generation reproductive study of REWOSOFT TE 19L, the NOAEL for F0 rats was 1000 mg/kg and for F1 and F2 pups was 500 mg/kg.
Referenceopen allclose all
Impact of REWOSOFT TE 19L on skeleton of F1 generation of fetal rats
Vehicle Control | Low-dose 500 mg/kg | Medium-dose 1000 mg/kg | High-dose 2000 mg/kg | |
Number of pups | 176 | 185 | 158 | 183 |
Skull | 1 | 2 | 3 | 11** |
Sternum | 0 | 0 | 0 | 0 |
Rib | 1 | 1 | 3 | 1 |
Limbs | 0 | 0 | 0 | 0 |
Vertebra | 0 | 0 | 0 | 0 |
Pelvis | 0 | 0 | 0 | 0 |
Coccyx | 0 | 0 | 0 | 0 |
compared to the vehicle control group "**" represents P<0.01
Impact of REWOSOFT TE 19L on skeleton of F2 generation of fetal rats
Vehicle Control | Low-dose 500 mg/kg | Medium-dose 1000 mg/kg | High-dose 2000 mg/kg | |
Number of pups | 168 | 157 | 165 | 142 |
Skull | 1 | 0 | 1 | 6* |
Sternum | 0 | 0 | 0 | 0 |
Rib | 0 | 0 | 0 | 0 |
Limbs | 0 | 0 | 0 | 0 |
Vertebra | 0 | 0 | 0 | 0 |
Pelvis | 0 | 0 | 0 | 0 |
Coccyx | 0 | 0 | 0 | 0 |
compared to the vehicle control group "*" represents P<0.05
Effect on fertility: via oral route
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- NOAEL
- 500 mg/kg bw/day
- Study duration:
- subacute
- Species:
- rat
Effects on developmental toxicity
Effect on developmental toxicity: via oral route
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
Additional information
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.