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EC number: 947-853-3 | CAS number: -
- 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
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- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
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- Nanomaterial radical formation potential
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- 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
Endpoint summary
Administrative data
Key value for chemical safety assessment
Effects on fertility
Description of key information
- study conducted according to OECD guideline EPA OPP 83-3 (Prenatal Developmental Toxicity Study), GLP, Sprague-Dawley rats were exposed to 100, 300, and 1000 mg/kg bw/day administered undiluted once a day for 10 days from gd6 through gd15 and observed for 22days (gd21), no teratogenic properties, NOEL = 1000 mg a.i./kg bw/d, NOEL (maternal toxicity) = 1000 mg a.i./kg bw/d, read-across, partially unsaturated IQCAs, DMS quaternised (75%)
- study conducted similar to EPA OPPTS 870.3700 (Prenatal Developmental Toxicity Study), similar to GLP, Sprague-Dawley rats were exposed to 200, 350, 610, 1075, and 1875 mg/kg bw/day (referring to 100 % active substance) for 10 days from gd6 through gd15 and observed for 22days (gd21), no maternal toxicity, embryotoxicity, or developmental toxicity up to the highest dose, read-across, partially unsaturated IQCAs, DMS quaternised (75%)
Link to relevant study records
- Endpoint:
- screening for reproductive / developmental toxicity
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- other:
- Reproductive effects observed:
- not specified
Reference
Effect on fertility: via oral route
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- NOAEL
- 1 000 mg/kg bw/day
- Study duration:
- subchronic
- Species:
- rat
- Quality of whole database:
- High quality, guideline study
Effect on fertility: via inhalation route
- Endpoint conclusion:
- no study available
Effect on fertility: via dermal route
- Endpoint conclusion:
- no study available
Additional information
No experimental data on Toxicity to reproduction are available for the target substance hydrogenated tallow/nortallow based IQACs. However, a study is available for the source substance partially unsaturated IQAC, DMS quaternised (tallow fatty acids). A detailed justification for read-across is attached to IUCLID section 13.
In the 91-days repeated dose study, Sprague-Dawley rats were treated with partially unsaturated IQAC, DMS quaternised (tallow fatty acids) by application in the feed at doses of up to 1000 mg/kg bw/d of active ingredient. No treatment related effects were observed on the reproductive organs of either gender. Fertility studies are not available and not necessary at the production volume of this substance. Also, the dossier contains either the results of, or a testing proposal for, a pre-natal developmental toxicity study.
Short description of key
information:
Concerning fertility there are no animal studies specifically
investigating this endpoint. However, no effects on organ weights of
ovary and testes and histopathology of gonads from a 91-day repeated
dose study were reported. There is no information available in humans.
Assessment of effects on fertility via inhalation is not applicable due
to the very low vapour pressure of the test substance and the absence of
aerosols.
Effects on developmental toxicity
Description of key information
- study conducted according to OECD guideline EPA OPP 83-3 (Prenatal Developmental Toxicity Study), GLP, Sprague-Dawley rats were exposed to 100, 300, and 1000 mg/kg bw/day administered undiluted once a day for 10 days from gd6 through gd15 and observed for 22days (gd21), no teratogenic properties, NOEL = 1000 mg a.i./kg bw/d, NOEL (maternal toxicity) = 1000 mg a.i./kg bw/d, read-across, partially unsaturated IQCAs, DMS quaternised (75%)
- study conducted similar to EPA OPPTS 870.3700 (Prenatal Developmental Toxicity Study), similar to GLP, Sprague-Dawley rats were exposed to200, 350, 610, 1075, and 1875 mg/kg bw/day (referring to 100 % active substance) for 10 daysfrom gd6 through gd15 and observed for 22days (gd21), no maternal toxicity, embryotoxicity, or developmental toxicity up to the highest dose, read-across, partially unsaturated IQCAs, DMS quaternised (75%)
Link to relevant study records
- Endpoint:
- developmental toxicity
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1991-05-13 to 1992-04-23
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: guideline Study
- Qualifier:
- according to guideline
- Guideline:
- EPA OPP 83-3 (Prenatal Developmental Toxicity Study)
- Deviations:
- no
- GLP compliance:
- yes
- Limit test:
- no
- Species:
- rat
- Strain:
- Sprague-Dawley
- Details on test animals or test system and environmental conditions:
- Test animals
- Age: Males approx. 63 days; Females: approx. 56 days
- Weight: Males 265 – 320 g upon arrival; Females 172 – 200 g upon arrival
- Fasting period before study: no data given
- Housing: Before mating males were housed singly, females were housed two to a cage.
- During mating 1 male and 1 female were housed individually.
- After mating copulation plug positive females and therefore considered successfully mated
- were housed singly for the duration of the study in stainless steel wire mesh cages.
- Diet: Access ad libitum; Ground Certified Rodent Chow ® (#5002, Ralston Purina Co., St. Louis, MO).
- Water: ad libitum, municipal tap water
- Acclimation period: approx. 2 wks
Environmental Conditions
- Temperature (°C): 19 – 25
- Humidity (%): relative 40 – 70
- Photoperiod: 12 hrs dark/12 hrs light; light period 5 – 17 hrs
In-Life dates: From May 27-30, 1991 to June 14 (gd 15); May 28 – 30, 1991 was gd0.
- Treatment began on gd6 (June 3-5, 1991). Dams were sacrificed on gd21 (June 18 – 20, 1991) - Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Details on exposure:
- Preparation of dosing solutions:
Control: Milli-Q ® water, volume according to highest test substance volume selected (1,42
ml / kg bw/day)
Dose levels: The dose levels referring to the active ingredient were 100, 300, and 1000
mg/kg bw/day administered undiluted once a day, based on the dam's body weight on
gestational day 6, the percent active ingredient (76,6%) and the specific gravity of the test
substance (0,92 g/cm3). Dosage volumes were not changed to account for increases in
gestational body weight after gd6. Accordingly the applied test substance volumes were
0,142, 0,426, and 1,42 mg/kg bw/day - Analytical verification of doses or concentrations:
- no
- Details on analytical verification of doses or concentrations:
- not applicable
- Details on mating procedure:
- Proof of pregnancy: Females were checked once daily for vaginal copulation plugs in the
morning and the paperboard beneath the cages was checked twice daily for dropped
copulation plugs. The observation of a vaginal or dropped copulation plug was considered
evidence of successful mating. Each male was paired only once in this study. - Duration of treatment / exposure:
- 10 days, from gd6 through gd15
- Frequency of treatment:
- once daily
- Duration of test:
- 22 days (till gd21)
- No. of animals per sex per dose:
- 25; Evaluated pregnant rats: group 1-4: 21/23/22/25 (females with viable fetuses)
Animals evaluated for maternal toxicity: group 1-4: 22/23/24/25 - Control animals:
- yes, concurrent vehicle
- Details on study design:
- Dose selection rationale: Based on a former dose range finding study
Rationale for animal assignment (if not random): The rat is a commonly used rodent species for embryotoxic studies.
Group size per dose level: 22/23/23/25 pregnant animals per dose group - Maternal examinations:
- Cage side observations: yes
Time schedule: daily
Detailed clinical observations: Yes
Time schedule: daily
Clinical signs: Yes
daily observations for behavior, external appearance and general condition
Viability: Yes
daily checks twice daily for morbidity and mortality
Body weight: yes
Time schedule for examinations: Maternal body weights were taken on gd0, gd6 (prior to the onset of dosing), gd9, 12, 15, 18, and 21
Food consumption: yes
Food consumption was measured at three-day intervals throughout the study (gd0 through 21).
Water consumption: no
Post-mortem examinations: Yes
Organs examined: Macroscopic examination of uteri, ovaries, cervix, vagina, peritoneal and thoracic cavities.
Maternal liver and Gravid Uteri weights, Number of Corpora lutea, Number and status of Implantation sites. - 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 - Fetal examinations:
- Fetal examinations
External examinations: yes: all litter
Soft tissue examinations: yes; approx. 50%
Skeletal examinations: yes, 50%
Head examinations: yes
other: Number of fetuses (live and dead), sex and viability of fetuses, variations and malformations, including cleft palate - Statistics:
- Levene's test for equality of variances, analysis of variance (ANOVA) and t-tests. The t-tests
were used when the F value from the ANOVA was significant. When Levene's test indicated
equal variances, and the ANOVA was significant, a pooled t-test was used for pair wise
comparisons. When Levene's test indicated heterogeneous variances, all groups were
compared by an ANOVA for unequal variances followed, when necessary, by a separate
variance t-test for pair wise comparisons.
Nonparametric data were statistically evaluated using the Kruskal-Wallis test, followed by the
Mann-Whiney U test when appropriate. Incidence data were compared using the Fisher's
Exact Test. With the exception of analyses for fetal malformation and variation data, all
statistical evaluations were performed using BMDP Statistical Software (Dixon, 1990). For all
statistical tests, the probability value of <0,05 (two-tailed) was used as the critical level of
significance. - Clinical signs:
- effects observed, non-treatment-related
- Description (incidence and severity):
- 300 mg/kg bw/day dose group:
2 dams exhibited audible respiration during or subsequent to the treatment period.
One dam exhibited swelling in the face, urogenital area wetness, gasping and perinasal and perioral encrustation. This animal was sacrificed due to her moribund condition on gd10. None of these signs were considered to be test substance related due to their absence in the dose range finding study up to doses of 1875 mg/kg bw/day and the lack of any dose relation in the current study.
1000 mg/kg bw/day dose group:
3 dams exhibited audible respiration during or subsequent to the treatment period.
No treatment-related differences in gestational parameters including total number of implantations, number of viable and nonviable implants in any dose group. - Dermal irritation (if dermal study):
- not examined
- Mortality:
- mortality observed, non-treatment-related
- Description (incidence):
- Mortality:
300 mg/kg bw/day dose group: One female became moribund and was sacrificed on gd10. - Body weight and weight changes:
- no effects observed
- Description (incidence and severity):
- No treatment-related effects on gestational body weights and body weight gain, corrected body weight, corrected body weight gain, absolute and relative liver weight, and gravid uterine weight .
- Food consumption and compound intake (if feeding study):
- effects observed, non-treatment-related
- Description (incidence and severity):
- Increased food consumption in the 100 mg/kg bw/day dose group was not considered to be related to treatment due to the lack of a dose-relationship.
- Food efficiency:
- not examined
- Water consumption and compound intake (if drinking water study):
- not examined
- Ophthalmological findings:
- not examined
- Haematological findings:
- no effects observed
- Clinical biochemistry findings:
- no effects observed
- 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:
- effects observed, non-treatment-related
- Description (incidence and severity):
- One female in the 300 mg/kg bw/day dose group which was sacrificed due to her moribund condition, had gas-filled intestines, mucoid fluid or material in the nose turbinates, abnormal material in the trachea and discolored and consolidated lungs. One further animal in this dose group had no implants in one uterine horn. Two females in the 1000 mg/kg bw/day dose group contained blood in the uterus (detected with Hemastix reagent strips) One further female had discolored lungs (dark red) in all lobes.
- Neuropathological findings:
- not examined
- Histopathological findings: non-neoplastic:
- no effects observed
- Histopathological findings: neoplastic:
- not examined
- Other effects:
- no effects observed
- 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):
- Resorptions: 10 (0.5 per dam), 7 (0.4 per dam), 12 (0.5 per dam), 53 (2.7 per dam)**
- Early or late resorptions:
- no effects observed
- Description (incidence and severity):
- Early resorptions:13 (0.6 per dam), 21 (0.9 per dam), 17 (0.7 per dam), 14 (0.6 per dam)
Late resorptions:0 (0 per dam), 1 (0 per dam), 2 (0.1 per dam), 0 (0 per dam) - Dead fetuses:
- no effects observed
- Description (incidence and severity):
- Live (Viable) fetuses:327 (14.9 per dam), 356 (15.5 per dam), 343 (14.3 per dam), 367 (14.7 per dam)
- Changes in pregnancy duration:
- no effects observed
- Changes in number of pregnant:
- no effects observed
- Description (incidence and severity):
- Implantation sites (Total implants): 340 (15.5 per dam), 379 (16.5 per dam)*, 363 (15.7 per dam)**, 382 (15.3 per dam)
- Other effects:
- no effects observed
- Description (incidence and severity):
- Corpora lutea:338 (16.1 per dam), 380 (16.5 per dam), 364 (15.7 per dam), 387 (15.5 per dam)
- Details on maternal toxic effects:
- Maternal toxic effects:no effects
Details on maternal toxic effects:
No substance related maternal toxicity detected up to the highest dose tested. - Key result
- Dose descriptor:
- NOEL
- Effect level:
- >= 1 000 mg/kg bw/day
- Based on:
- test mat.
- Basis for effect level:
- other: maternal toxicity
- Key result
- Abnormalities:
- no effects observed
- Fetal body weight changes:
- no effects observed
- Description (incidence and severity):
- Fetal body weights per litter were not affected by treatment.
- Reduction in number of live offspring:
- no effects observed
- Changes in sex ratio:
- no effects observed
- Changes in litter size and weights:
- effects observed, non-treatment-related
- Description (incidence and severity):
- No treatment related effects on fetal body weights (all fetuses, male or female) observed in any group. The statistically significant* differences in mean male and female body weights in litters at 100 mg/kg bw/day were not considered to be treatment-related due to the lack of a dose-response relationship.
- Changes in postnatal survival:
- not examined
- External malformations:
- no effects observed
- Description (incidence and severity):
- none significantly different from Control
- Skeletal malformations:
- effects observed, non-treatment-related
- Description (incidence and severity):
- Findings: Anterior arch of atlas poorly ossified; Statistical significance of affected litters in 1000 mg/kg bw/day dose group; % affected litters (71.4, 87.0, 86.4 96.0*)
Findings: Majority of forelimbs unossified; Statistical significance of affected litters in 300 mg/kg bw/day dose group; % affected litters (38.1, 26.1, 4.5**, 24.0) - Visceral malformations:
- no effects observed
- Other effects:
- no effects observed
- Description (incidence and severity):
- Other External variations (fetal incidence): none significantly different from control
- Details on embryotoxic / teratogenic effects:
- Embryotoxic / teratogenic effects:no effects
Details on embryotoxic / teratogenic effects:
No embryotoxicity or teratogenicity detected up to the highest dose tested - Key result
- Dose descriptor:
- NOEL
- Effect level:
- >= 1 000 mg/kg bw/day
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: embryotoxicity
- Key result
- Abnormalities:
- not specified
- Developmental effects observed:
- not specified
- Conclusions:
- In conclusion the test item partially unsaturated IQAC, DMS quaternised possessed no teratogenic properties, not even at the highest dose tested . Embryotoxicity was not observed.
Therefore the NOEL was 1000 mg active ingredient/kg bw/day. The NOEL for maternal toxicity was 1000 mg active ingredient/kg bw/day. - Executive summary:
In a developmental toxicity study according to OPP 83-3 the partially unsaturated IQAC, DMS quaternised (75%) was administered to 25 female Sprague CD rats/dose by gavage at dose levels of 0, 100, 300, and 1000 mg/kg bw/day referring to 100 % active substance from day 6 through 15 of gestation. The maternal NOEL is 1000 mg active substance/kg bw/day, based on the lack of effects indicating maternal toxicity.
Likewise, the embryotoxic NOEL is 1000 mg active substance/kg bw/day, based on the lack of embryotoxic effects up to the highest dose level.
The teratogenic NOEL is 1000 mg active substance/kg bw/day.
The partially unsaturated IQAC, DMS quaternised showed no teratogenic properties (no incidence of malformations). The observed variations were isolated without dose relation or lower than in the control group and were therefore not regarded as treatment related.
The developmental toxicity study in the rat is classified acceptable and satisfies the guideline requirement for a developmental toxicity study (OPPTS 870.3700) in rats.
These findings are further backed by the lack of adverse effects in a dose range finding study which was conducted up to a dose level of 1875 mg/kg bw/day.
- Endpoint:
- developmental toxicity
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- 1991-03-26 to 1993-02-17
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: study comparable to Guideline
- Qualifier:
- no guideline required
- Principles of method if other than guideline:
- similar to EPA OPPTS 870.3700 (Prenatal Developmental Toxicity Study)
- GLP compliance:
- yes
- Limit test:
- no
- Species:
- rat
- Strain:
- Sprague-Dawley
- Details on test animals or test system and environmental conditions:
- Details on test animals and environmental conditions
Test animals
- Source: Charles River Breeding Laboratories, Inc. (Partage, MT)
- Age: Males approx. 64 days; Females: approx. 57 days
- Weight: Males 260 – 325 g upon arrival; Females 172 – 210 g upon arrival
- Fasting period before study: no data given
- During mating 1 male and 1 female were housed individually.
- After mating copulation plug positive females and therefore
- considered successfully mated were housed singly for the duration of the study in stainless steel wire mesh cages.
- Each male was paired only once in this study.
- Diet: Access ad libitum; Ground Certified Rodent Chow ® (#5002, Ralston Purina Co., St. Louis, MO).
- Water: ad libitum, municipal tap water
- Acclimation period: approx. 2 wks
Environmental Conditions
- Temperature (°C): 19 – 25
- Humidity (%): relative 40 – 70
- Photoperiod: 12 hrs dark/12 hrs light; light period 5 – 17 hrs - Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Analytical verification of doses or concentrations:
- no
- Details on mating procedure:
- Details on mating procedure
Proof of pregnancy: Females were checked once daily for vaginal copulation plugs in the morning and the paperboard beneath
the cages was checked twice daily for dropped copulation plugs. The observation of a vaginal or dropped copulation plug was
considered evidence of successful mating. Each male was paired only once in this study. - Duration of treatment / exposure:
- 10 days, from gd6 through gd15
- Frequency of treatment:
- once daily
- Duration of test:
- 22 days (till gd21)
- No. of animals per sex per dose:
- 5
- Control animals:
- yes, concurrent no treatment
- Details on study design:
- The objective of this study was to obtain information from which to select dosage levels for a subsequent developmental toxicity study of the test substance.
- Maternal examinations:
- Maternal examinations
Cage side observations: yes
Time schedule: daily - Details on maternal toxic effects:
- Maternal toxic effects:no effects
- Dose descriptor:
- NOAEL
- Effect level:
- >= 1 875 mg/kg bw/day (actual dose received)
- Based on:
- act. ingr.
- Basis for effect level:
- other: maternal toxicity
- Dose descriptor:
- NOAEL
- Effect level:
- >= 1 875 mg/kg bw/day (actual dose received)
- Based on:
- act. ingr.
- Basis for effect level:
- other: developmental toxicity
- Details on embryotoxic / teratogenic effects:
- Embryotoxic / teratogenic effects:no effects
- Abnormalities:
- not specified
- Developmental effects observed:
- not specified
- Conclusions:
- Administration of the test item partially unsaturated IQAC, DMS quaternised (75%) by gavage to pregnant CD ® Sprague Dawley rats during organogenesis resulted in no maternal toxicity, embryotoxicity, or developmental toxicity at dosages up to 1875 mg a.i./kg bw/day. On the basis of this study, target doses selected for the definitive developmental toxicity study were 0, 100, 300, and 1000 mg a.i./kg bw/day.
Referenceopen allclose all
TOXIC RESPONSE/EFFECTS BY DOSE LEVEL:
Mortality:
300 mg/kg bw/day dose group:
One female became moribund and was sacrificed on gd10.
Clinical signs:
300 mg/kg bw/day dose group:
2 dams exhibited audible respiration during or subsequent to the treatment period.
One dam exhibited swelling in the face, urogenital area wetness, gasping and perinasal and perioral
encrustation. This animal was sacrificed due to her moribund condition on gd10. None of these signs
were considered to be test substance related due to their absence in the dose range finding study up
to doses of 1875 mg/kg bw/day and the lack of any dose relation in the current study.
1000 mg/kg bw/day dose group:
3 dams exhibited audible respiration during or subsequent to the treatment period.
No treatment-related differences in gestational parameters including total number of implantations,
number of viable and nonviable implants in any dose group.
Body weight:
No treatment-related effects on gestational body weights and body weight gain, corrected body
weight, corrected body weight gain, absolute and relative liver weight, and gravid uterine weight .
Fetal body weights per litter were not affected by treatment.
Increased food consumption in the 100 mg/kg bw/day dose group was not considered to be related to
treatment due to the lack of a dose-relationship.
NECROPSY FINDINGS IN DAMS AT TERMINATION:
One female in the 300 mg/kg bw/day dose group which was sacrificed due to her moribund
condition, had gas-filled intestines, mucoid fluid or material in the nose turbinates, abnormal
material in the trachea and discolored and consolidated lungs. One further animal in this
dose group had no implants in one uterine horn.
Two females in the 1000 mg/kg bw/day dose group contained blood in the uterus (detected
with Hemastix reagent strips) One further female had discolored lungs (dark red) in all lobes.
REPRODUCTION DATA OF DAMS (0, 100, 300, 1000 mg/kg bw):
- Corpora lutea:338 (16.1 per dam), 380 (16.5 per dam), 364 (15.7 per dam), 387 (15.5 per dam)
- Implantation sites (Total implants): 340 (15.5 per dam), 379 (16.5 per dam)*, 363 (15.7 per dam)**, 382 (15.3 per dam)
- Resorptions: 10 (0.5 per dam), 7 (0.4 per dam), 12 (0.5 per dam), 53 (2.7 per dam)**
- Early resorptions:13 (0.6 per dam), 21 (0.9 per dam), 17 (0.7 per dam), 14 (0.6 per dam)
- Late resorptions:0 (0 per dam), 1 (0 per dam), 2 (0.1 per dam), 0 (0 per dam)
- Live (Viable) fetuses:327 (14.9 per dam), 356 (15.5 per dam), 343 (14.3 per dam), 367 (14.7 per dam)
- Malformations (external, skeletal, soft tissue) (fetal incidence): none significantly different from Control
- Skeletal variations (fetal incidence):
- Findings: Anterior arch of atlas poorly ossified; Statistical significance of affected litters in 1000 mg/kg bw/day dose group;
% affected litters (71.4, 87.0, 86.4 96.0*)
- - Skeletal variations (fetal incidence):
- Findings: Majority of forelimbs unossified; Statistical significance of affected litters in 300 mg/kg bw/day dose group;
% affected litters (38.1, 26.1, 4.5**, 24.0)
- - Soft Tissue variations (fetal incidence):
- Findings: Excessive bleeding at umbilicus; Statistical significance of affected litters in 100 mg/kg bw/day dose group;
% affected litters (23.8, 0*, 27.3, 40.0)
- Other External variations (fetal incidence): none significantly different from control
Weight of
fetuses: No treatment related effects on fetal body weights (all
fetuses, male or female)
observed in any group. The statistically significant* differences in mean male and female body
weights in litters at 100 mg/kg bw/day were not considered to be treatment-related due to the lack
of a dose-response relationship.
* Significantly different from control, p= 0.05 using two-tailed Fisher's exact test
** Significantly different from control, p= 0.01 using two-tailed Fisher's exact test
In a developmental toxicity Range-Finding study the partially unsaturated IQAC; DMS quaternised (75%) was administered to 5 pregnant female CD rats/dose by gavage at dose levels of 200, 350, 610, 1075, and 1875 mg/kg bw/day (referring to 100 % active substance) from day 6 through 15 of gestation. An additional 5 females, assigned to the control group, received Milli ®-Q water at a dose volume equivalent to that used in the high dose group.
Clinical observations were made daily (twice daily during dosing), and maternal body weights were measured at three-day intervals throughout gestation, gd 0-21. At scheduled sacrifice on gd 21, the dams were evaluated for liver and gravid uterine weights, number of corpora lutea and number and status of implantation sites, including early and late resorptions, dead and live fetuses. All live and dead fetuses were dissected from the uterus, weighed and examined for sex determinations and external malformations, including cleft palates and variations.
There were no treatment-related effects on clinical signs of toxicity, food consumption, gestational body weight and body weight gain, corrected body weight, corrected body weight gain, and gravid uterine weight.
No treatment related differences in gestational parameters including total number of implantations, number of viable and non-viable implants, were observed in any dose group.
No females died prior to scheduled sacrifice. No females aborted, delivered early or were removed from the study.
At scheduled sacrifice, one female in the 1075 mg/kg bw/day group found to be non-pregnant and another animal from this group contained only non-viable fetuses. All other animals were pregnant and bore at least one viable fetus.
Fetal body weights per litter were not affected by treatment. No treatment-related external malformations or variations were observed in this study.
Effect on developmental toxicity: via oral route
- Dose descriptor:
- NOAEL
- 1 000 mg/kg bw/day
- Study duration:
- subchronic
- Species:
- rat
- Quality of whole database:
- high quality, guideline study
Effect on developmental toxicity: via inhalation route
- Endpoint conclusion:
- no study available
Effect on developmental toxicity: via dermal route
- Endpoint conclusion:
- no study available
Additional information
No experimental data on Toxicity to reproduction are available for the target substance hydrogenated tallow/nortallow based IQACs. However, a study is available for the source substancepartially unsaturated IQAC, DMS quaternised (tallow fatty acids). A detailed justification for read-across is attached to IUCLID section 13.
The test item partially unsaturated IQAC, DMS quaternised (tallow fatty acids, 75 %) possessed no teratogenic properties, not even at the highest dose tested. Embryotoxicity was not observed. Therefore the NOEL was 1000 mg partially unsaturated IQAC, DMS quaternised (tallow fatty acids) (75 %) active ingredient/kg bw/day. The NOEL for maternal toxicity was 1000 mg partially unsaturated IQAC, DMS quaternised (tallow fatty acids) (75 %) active ingredient/kg bw/day based on the lack of effects indicative of maternal toxicity.
Justification for classification or non-classification
There is no evidence for an intrinsic toxicity to reproduction of partially unsaturated IQAC, DMS quaternised from the results of a reliable oral developmental toxicity / teratogenicity study on rats at doses including the guideline limit dose of 1000 mg a. i./kg bw/day and reliable oral sub-chronic repeated dose toxicity data, where no treatment related effects were observed on the reproductive organs of either gender at 1000 mg/kg bw/day.
Therefore also no classification is required for toxicity to reproduction according to CLP, EU GHS (Regulation (EC) No 1272/2008) and directive 67/548/EEC for the target substance hydrogenated tallow/nortallow based IQACs.
Additional information
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