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EC number: 263-174-9 | CAS number: 61791-42-2
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- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
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- Long-term toxicity to aquatic invertebrates
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- Additional toxicological data

Developmental toxicity / teratogenicity
Administrative data
- Endpoint:
- developmental toxicity
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 15 Jul 2020 - 17 Aug 2021
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 020
- Report date:
- 2021
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 414 (Prenatal Developmental Toxicity Study)
- Version / remarks:
- adopted in 2018
- Deviations:
- yes
- Remarks:
- criteria used for categorising fetal external, soft tissue and skeletal examination not specified, only a limit set of historical control data provided, short acclimatisation period as time-mated females were purchased for the study
- GLP compliance:
- yes
- Limit test:
- no
Test material
- Reference substance name:
- Ethanesulfonic acid, 2-(methylamino)-, N-coco acyl derivs., sodium salts
- EC Number:
- 263-174-9
- EC Name:
- Ethanesulfonic acid, 2-(methylamino)-, N-coco acyl derivs., sodium salts
- Cas Number:
- 61791-42-2
- Molecular formula:
- UVCB
- IUPAC Name:
- Ethanesulfonic acid, 2-(methylamino)-, N-coco acyl derivs., sodium salts
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: Crl:WI(Han
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Laboratories, Margate, United Kingdom
- Age at the time of mating: 9 – 11 weeks
- Weight at dosing: 180.6 – 258.2 g
- Housing: Individually in cages that conform to the Code of Practice for the Housing and Care of Animals Bred, Supplied or Used for Scientific Purposes. Aspen wood chips were used as bedding.
- Diet: VRF1 diet (Special Diets Services Ltd., Witham, United Kingdom), ad libitum
- Water: Main tap supply water, ad libitum
- Acclimation period: The animals were delivered to the testing laboratory by gestation Day (GD) 3. Acclimatisation was limited by mated status, but all animals were given a clinical inspection for ill health upon arrival and before the start of dosing to ensure suitability for the study.
DETAILS OF FOOD AND WATER QUALITY:
Each batch of diet and the water was periodically analysed for specific constituents and contaminants. No contaminants were present in the diet and in the water at levels that might have interfered with achieving the objective of the study.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 - 25
- Humidity (%): 40 - 70
- Air changes (per hr): at least 15
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: 24 Jul 2020 To: 17 Aug 2020
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on exposure:
- PREPARATION OF DOSING SOLUTIONS:
The test article was formulated as a solution in purified water. The test article was slowly added to purified water whilst stirring for approximately 10 minutes. Formulations were prepared weekly and stored at room temperature (15 - 25°C) in a sealed container.
VEHICLE
- Concentration in vehicle: 10, 30 and 100 mg/mL
- Amount of vehicle: 10 mL/kg bw - Analytical verification of doses or concentrations:
- yes
- Details on analytical verification of doses or concentrations:
- Stability and homogeneity of the test item in the vehicle were confirmed in a previous study and found to be stable over a period of 14 days for formulations of 1 and 250 mg/mL at 15 - 25°C (Covance study no. 8422999). In the present study, formulations prepared for use at the beginning (gestation Day (GD) 6 and end of dosing (GD 20) were analysed to determine the achieved concentration. Triplicate samples were taken from the middle of the test article formulations and were analysed.
The mean achieved concentrations were 110% (GD 6) and 100 - 104% (GD 20) of the nominal concentration with relative standard deviations ranging from 0.33 – 0.53% (GD 6) and 0.28 – 0.60% (GD 20). The values fell into the accepted range of 90 – 110% of the nominal concentration with a relative standard deviation of ≤ 5.0% and were therefore considered acceptable. - Details on mating procedure:
- The females were mated prior to arrival in the testing facility.
- Duration of treatment / exposure:
- Days 6 - 21 of gestation.
- Frequency of treatment:
- daily, 7 days/week
- Duration of test:
- Day 21 of gestation
Doses / concentrationsopen allclose all
- Dose / conc.:
- 100 mg/kg bw/day (actual dose received)
- Dose / conc.:
- 300 mg/kg bw/day (actual dose received)
- Dose / conc.:
- 1 000 mg/kg bw/day (actual dose received)
- No. of animals per sex per dose:
- 20 time-mated females
- Control animals:
- yes, concurrent vehicle
- Details on study design:
- - Dose selection rationale: Dose levels for the main developmental toxicity study were selected based on the results of a preliminary dose-finding study (Covance study no. 8417090). Pregnant rats were administered dose levels of 100, 300 and 1000 mg/kg bw/day. The test article was well tolerated at all dose levels, with only transiently lower food consumption observed following administration of 1000 mg/kg bw/day during early pregnancy. No fetal variations or malformations were noted; as such, the limit dose of 1000 mg/kg bw/day was considered suitable as the high-dose level for use in the present study.
Examinations
- Maternal examinations:
- CAGE SIDE OBSERVATIONS: Yes
- Time schedule: Twice daily (at the beginning and end of each working day)
- Cage side observations included: mortality, clinical signs of toxicity
DETAILED CLINICAL OBSERVATIONS: Yes
- Time schedule: Each animal was given a detailed physical examination on gestation Days (GD) 3, 6, 7, 8, 9, 12, 15, 17, 19, 20, and 21.
BODY WEIGHT: Yes
- Time schedule for examinations: Body weights were recorded on GD 6, 7, 8, 9, 12, 15, 17,19, 20, and 21. An additional, unscheduled body weight was recorded on GD 20 for 1/20 females at 100 mg/kg bw/day.
FOOD CONSUMPTION: Yes
- Food consumption for each animal determined and mean daily diet consumption calculated as g food/kg body weight/day: Yes. The amount of food consumed was determined from GD 6 - 7, 7 - 8, 8 - 9, 9 - 12, 12 - 15, 15 - 17, 17 - 19, 19 - 20, and 20 – 21.
WATER CONSUMPTION: No
- Time schedule for examinations:
POST-MORTEM EXAMINATIONS: Yes
- Sacrifice on gestation Day 21
- Organs examined: Ovaries and uteri
OTHER:
Thyroid Hormone analysis:
- Time schedule for collection of blood: Blood samples were collected from the abdominal aorta at scheduled necropsy on gestation Day 21.
- Anaesthetic used for blood collection: Yes (isoflurane)
- How many animals: all animals in all groups
- Parameters examined: triiodothyronine (T3), thyroxin (T4) and thyroid stimulating hormone (TSH)
Thyroid weights were recorded from the parental females of all groups at scheduled caesarian section. - Ovaries and uterine content:
- The ovaries and uterine content was examined after termination: Yes
Examinations included:
- Gravid uterus weight: Yes
- Number of corpora lutea: Yes
- Number of implantations: Yes
- Number of early resorptions: Yes
- Number of late resorptions: Yes
- Other: Pregnancy status, terminal body weight and number of dead fetuses. - Fetal examinations:
- - External examinations: Yes: all per litter
- Soft tissue examinations: Yes: half per litter
- Skeletal examinations: Yes: half per litter
- Head examinations: No
- Other: Anogenital distance and sex ratio - Statistics:
- For details on statistical analysis please refer to the document "Statistical analysis_OECD 414" under "Attached background material".
- Indices:
- Maternal parameters:
Pre-implantation loss (%) = ((Number of corpora lutea – Number of implantations)/Number of corpora lutea) x 100
Post-implantation loss (%) = ((Number of implantations – Number of live embryos)/Number of implantations) x 100
Corrected body weight (Carcasse weight) = Terminal body weight – uterine weight
Corrected weight change = Carcasse weight – gestation Day 6 body weight
Total weight change = Gestation Day 21 body weight – gestation Day 6 body weight
Litter data:
Male fetuses (%) = (Number of male fetuses/Number of fetuses of determined sex) x 100 - Historical control data:
- Historical data was provided for fetal skeletal variations only to allow comparison with concurrent controls.
Results and discussion
Results: maternal animals
General toxicity (maternal animals)
- Clinical signs:
- effects observed, treatment-related
- Description (incidence and severity):
- Excessive salivation was noted in the animals at 100 mg/kg bw/day and above (in 4/20, 6/20 and 10/20 at 100, 300 and 1000 mg/kg bw/day). In addition, mouth rubbing was observed in animals of the mid (7/20) and high dose groups (20/20). The observations were made immediately after dosing, but were also observed in some animals at the end of the day observations of gestation Day (GD) 20. Isolated incidences of paddling behaviour was noted for 1/20 and 2/20 animals on GD 13 or 15 at 300 and 1000 mg/kg bw/day. The findings were attributed to unpalatability or the unpleasant taste of the test article and therefore considered non-adverse. For details please refer to Table 1 under “Any other information on results incl. tables”.
- Dermal irritation (if dermal study):
- not examined
- Mortality:
- no mortality observed
- Body weight and weight changes:
- effects observed, treatment-related
- Description (incidence and severity):
- At 1000 mg/kg bw/day there was a statistically significant reduction in body weight gain observed for gestation Days (GD) 9 – 12, 20 – 21 and over the entire treatment period (GD 6 – 21). Initial body weight losses were also observed for the animals of this group, but did not reach statistical significance. The findings were consistent with a reduced food consumption in the animals of this group and attributed to treatment. However, in absence of a detrimental effect on pregnancy or the developing fetus, these findings were considered non-adverse.
No effect on body weight or body weight change was noted following administration of 100 or 300 mg/kg bw/day. For details please refer to Table 2 under “Any other information on results incl. tables”. - Food consumption and compound intake (if feeding study):
- effects observed, treatment-related
- Description (incidence and severity):
- At 1000 mg/kg bw/day there was a statistically significant reduction in food consumption observed from the start of dosing up to gestation Day (GD) 15 and on the last day of dosing (GD 21). Overall mean food consumption was -15% when compared to control animals. The findings were in line with a reduced body weight development in these animals and related to treatment. However, in the absence of a detrimental effect on pregnancy or the developing fetus, the findings were considered not to represent an adverse effect of the test article.
- Food efficiency:
- not examined
- Water consumption and compound intake (if drinking water study):
- not examined
- Ophthalmological findings:
- not examined
- Haematological findings:
- not examined
- Clinical biochemistry findings:
- not examined
- Endocrine findings:
- not specified
- Description (incidence and severity):
- The following ED-related parameters were investigated in the study: T4 and TSH level, anogenital distance, genital abnormalities, thyroid weight and histopathology, gravid uterus weight, foetal development, litter size, litter/pup weight, number of implantations/ corpora lutea, number of embryonic or foetal deaths and viable foetuses, post-implantation losses, pre-implantation losses, presence of foetal anomalies (external, visceral and skeletal) and sex ratio.
For details, please refer to the respective result fields and the endpoint summary. - Urinalysis findings:
- not examined
- Behaviour (functional findings):
- not examined
- Immunological findings:
- not examined
- Organ weight findings including organ / body weight ratios:
- no effects observed
- Gross pathological findings:
- no effects observed
- Description (incidence and severity):
- No test article-related macroscopic findings were recorded for the thyroid of animals administered 100, 300, or 1000 mg/kg bw/day. All tissues were macroscopically unremarkable, or the findings observed were generally consistent with the usual pattern of findings in rat of this strain and age.
- Neuropathological findings:
- not examined
- Histopathological findings: non-neoplastic:
- no effects observed
- Description (incidence and severity):
- No test article-related microscopic findings were recorded for the thyroid of animals administered 100, 300, or 1000 mg/kg bw/day. All tissues were microscopically unremarkable, or the findings observed were generally consistent with the usual pattern of findings in rat of this strain and age.
- Histopathological findings: neoplastic:
- not examined
- Other effects:
- no effects observed
- Description (incidence and severity):
- Thyriod hormone levels were not affected by treatment.
Maternal developmental toxicity
- Number of abortions:
- no effects observed
- Pre- and post-implantation loss:
- no effects observed
- Total litter losses by resorption:
- effects observed, non-treatment-related
- Description (incidence and severity):
- A total in utero litter loss was noted for 1/20 females at 100 mg/kg bw/day and for 1/20 females at 1000 mg/kg bw/day. The observations were within the laboratories historical control range, occurred without any dose response relationship and, in the absence of any pre- or post-implantation losses, was considered unrelated to treatment.
- Early or late resorptions:
- no effects observed
- Dead fetuses:
- no effects observed
- Changes in pregnancy duration:
- effects observed, non-treatment-related
- Description (incidence and severity):
- 1/20 females administered 100 mg/kg bw/day and 1/20 females administered 1000 mg/kg bw/day started parturition prior to the terminal sacrifice. An increased incidence of early parturition was recently observed in this strain of animal from the animal supplier; therefore, this finding was unrelated to the test article.
- Changes in number of pregnant:
- no effects observed
- Description (incidence and severity):
- 1/20 females of the control group and 1/20 females administered 100 mg/kg bw/day were not pregnant. These animals were supplied non-pregnant, and, as such, the lack of pregnancy for these animals was unrelated to the test article.
Effect levels (maternal animals)
- Key result
- Dose descriptor:
- NOAEL
- Remarks:
- systemic
- Effect level:
- 1 000 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Basis for effect level:
- other: no adverse effects observed
Maternal abnormalities
- Key result
- Abnormalities:
- no effects observed
Results (fetuses)
- Fetal body weight changes:
- no effects observed
- Reduction in number of live offspring:
- no effects observed
- Changes in sex ratio:
- no effects observed
- Changes in litter size and weights:
- no effects observed
- Anogenital distance of all rodent fetuses:
- no effects observed
- Changes in postnatal survival:
- no effects observed
- External malformations:
- no effects observed
- Skeletal malformations:
- effects observed, non-treatment-related
- Description (incidence and severity):
- Skeletal malformations were observed in 2 fetuses of the control group and in 1 fetus of the 1000 mg/kg bw/day group. Abnormal findings in the control group comprised a shortened 13th rib on the right in a female fetus and a male fetus showing a malrotated hindlimb on the right ankle joint, a malpositioned talus of the right hindlimb and hyperextention of the hindlimb on the right ankle joint. At 1000 mg/kg bw/day, a malrotated hindlimb of the ankle joint was observed bilaterally in 1 male fetus. The findings were considered to be incidental.
At 1000 mg/kg bw/day, reduced incidences of incomplete interparietal ossification of the skull was noted in the fetuses (1.93% of the fetuses) when compared to control animals (16.4% of the fetuses). In addition, incomplete metatarsal ossification of the hindlimbs was occasionally observed in animals of the control and test item-treated groups. The findings were within the range of the laboratories historical control data and thus considered to have arisen incidentally. For details please refer to Table 4 under “Any other information on results incl. tables”. - Visceral malformations:
- effects observed, non-treatment-related
- Description (incidence and severity):
- At 100 mg/kg bw/day, diaphragmatic hernia in the muscular region, protruding from the liver was noted in 1 male fetus. At 1000 mg/kg bw/day, 1 male fetus showed edema. The latter finding was considered a congenital abnormality. The fetus was also recorded with adrenal variations, abnormal blood vessels, and dilated brain ventricles, which was associated with the severe edema. The weight of this fetus was also greater than other fetuses maternally exposed at this dose (7.28 g), and the higher fetal weight was most likely due to increased fluid retention. This is an unusual finding; however, as this was a single finding, it was considered congenital and unrelated to the test article.
Effect levels (fetuses)
- Key result
- Dose descriptor:
- NOAEL
- Remarks:
- developmental
- Effect level:
- 1 000 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: no adverse effects observed
Fetal abnormalities
- Key result
- Abnormalities:
- no effects observed
Overall developmental toxicity
- Key result
- Developmental effects observed:
- no
Any other information on results incl. tables
Table 1: Summary of clinical signs of toxicity
Dose group (mg/kg bw/day) | 0 | 100 | 300 | 1000 |
Mouth rubbing | 0/20 | 0/20 | 7/20 | 20/20 |
Paddling | 0/20 | 0/20 | 1/20 | 2/20 |
Excessive salivation, mild, clear | 0/20 | 1/20 | 3/20 | 4/20 |
Excessive salivation, mild, colorless | 0/20 | 0/20 | 3/20 | 4/20 |
Excessive salivation, moderate, clear | 0/20 | 0/20 | 0/20 | 1/20 |
Excessive salivation, moderate, colorless | 0/20 | 1/20 | 0/20 | 1/20 |
Table 2: Body weight and body weight gain
Dose group (mg/kg bw/day) | 0 | 100 | 300 | 1000 |
Body weight (g) | ||||
BW GD 6 | 214.5 ± 19.66 | 211.4 ± 14.10 | 211.7 ± 14.17 | 211.4 ± 10.84 |
% control | 100 | 99 | 99 | 99 |
BW GD 12 | 235.0 ± 23.15 | 234.8 ± 15.16 | 234.3 ± 14.23 | 226.8 ± 11.08 |
% control | 100 | 100 | 100 | 97 |
BW GD 21 | 314.8 ± 32.94 | 313.0 ± 25.63 | 312.0 ± 23.41 | 295.9 ± 19.63 |
% control | 100 | 99 | 99 | 94 |
Body weight gain (g) | ||||
GD 6-7 | 2.9 ± 4.27 | 2.9 ± 3.39 | 2.7 ± 4.49 | 1.4 ± 3.68 |
% control | 100 | 100 | 93 | 48 |
GD 9-12 | 14.4 ± 4.15 | 16.0 ± 2.93 | 13.9 ± 4.30 | 10.6 ± 3.42** |
% control | 100 | 111 | 97 | 74 |
GD 17-19 | 22.9 ± 5.32 | 22.8 ± 6.00 | 21.8 ± 5.34 | 19.6 ± 6.74 |
% control | 100 | 100 | 95 | 86 |
GD 20-21 | 15.8 ± 4.42 | 14.3 ± 4.20 | 15.0 ± 4.47 | 7.0 ± 11.93** |
% control | 100 | 91 | 95 | 44 |
GD 6-21 | 100.3 ± 16.89 | 101.2 ± 14.57 | 100.3 ± 19.81 | 83.5 ± 12.74** |
% control | 100 | 101 | 100 | 83 |
**: statistically significant at p < 0.01; BW: body weight; GD: gestation day |
Table 3: Food consumption
Dose group (mg/kg bw/day) | 0 | 100 | 300 | 1000 |
GD 6-7 | 20.3 ± 3.65 | 19.2 ± 3.15 | 19.4 ± 3.17 | 15.6 ± 3.14*** |
% control | 100 | 94 | 96 | 77 |
GD 9-12 | 19.1 ± 2.60 | 19.9 ± 2.23 | 19.4 ± 2.41 | 14.9 ± 2.13*** |
% control | 100 | 104 | 102 | 78 |
GD 15-17 | 21.5 ± 3.24 | 22.3 ± 2.39 | 22.2 ± 2.51 | 20.1 ± 2.12 |
% control | 100 | 104 | 103 | 79 |
GD 20-21 | 20.6 ± 3.94 | 19.2 ± 3.17 | 18.8 ± 3.31 | 14.2 ± 5.98*** |
% control | 100 | 93 | 91 | 69 |
GD 6-21 | 20.8 ± 2.33 | 21.0 ± 1.91 | 20.6 ± 1.78 | 17.6 ± 1.63*** |
% control | 100 | 101 | 99 | 85 |
*, ** and ***: statistically significant at p < 0.05, p < 0.01 and p < 0.001; GD: gestation day |
Table 4: Skeletal malformations in fetuses
Dose group (mg/kg bw/day) | 0 | 100 | 300 | 1000 | HCD | |
Skull | ||||||
Interparietal: incomplete ossification |
Litter (%) | 47 | 39 | 47 | 11 | 5 - 75 |
Fetal (%) | 16.4 | 12.22 | 13.73 | 1.93** | 0.76 - 49.17 | |
Hindlimb | ||||||
metatarsal: incomplete ossification | Litter (%) | 21 | 0 | 11 | 26 | 0 - 43 |
Fetal (%) | 5.44 | 0 | 1.93 | 10.33 | 0 - 14.74 | |
**: statistically significant at p< 0.01; HCD: historical control data generated in the testing facility (time frame for data generation not specified) |
Applicant's summary and conclusion
- Conclusions:
- The test item had no effect on intrauterine development. The NOAEL for maternal and developmental toxicity were both 1000 mg/kg bw/day.
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