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EC number: 229-764-5 | CAS number: 6712-98-7
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- Appearance / physical state / colour
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- Endpoint summary
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- Environmental data
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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
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- Toxicological Summary
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- Exposure related observations in humans
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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:
- 13 October 2020 - 04 January 2021.
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 021
- Report date:
- 2021
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 414 (Prenatal Developmental Toxicity Study)
- Version / remarks:
- July 2018
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Limit test:
- no
Test material
- Reference substance name:
- 1-(N,N-bis(2-hydroxyethyl)amino)propan-2-ol
- EC Number:
- 229-764-5
- EC Name:
- 1-(N,N-bis(2-hydroxyethyl)amino)propan-2-ol
- Cas Number:
- 6712-98-7
- Molecular formula:
- C7H17NO3
- IUPAC Name:
- 1-[bis(2-hydroxyethyl)amino]propan-2-ol
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source: Sasol, Marl, Germany; Batch no. 200162527.
- Purity: 99.6%.
- Appearance: clear liquid.
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: At ambient temperature, in the dark.
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Envigo RMS, UK.
- Age at study initiation: 17 - 22 weeks.
- Weight at study initiation: 2.30 - 4.17 kg.
- Fasting period before study: No.
- Housing: One animal (female) per cage.
- Diet: Commercial diet, 200 g/animal/day. "A small supplement of autoclaved hay was given on a daily basis to promote gastric motility and a small amount of chopped fresh vegetables were given twice weekly."
- Water: Tap water ad libitum.
- Acclimation period: Five days before commencement of treatment (days 1 - 5 after mating).
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 15 - 21 °C.
- Humidity (%): 45 - 70%.
- Air changes (per hr): Not specified. Filtered fresh air which was passed to atmosphere and not recirculated.
- Photoperiod: 14 hours light / 10 hours dark.
IN-LIFE DATES:
From: Approx. July 2020 (based on age on arrival at testing facility).
To: 24 - 27 November 2020.
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on exposure:
- PREPARATION OF DOSING SOLUTIONS: Water was added to pre-weighed test material and mixed (for at least 40 minutes) to obtain a homogenous solution at the highest concentration. Lower concentrations were prepared by serial dilution.
VEHICLE
- Concentration in vehicle: 25, 75 and 250 mg/mL
- Amount of vehicle (if gavage): 4 mL/kg bw. - Analytical verification of doses or concentrations:
- yes
- Details on analytical verification of doses or concentrations:
- Samples of each formulation prepared for administration in the first and last preparation were analyzed for achieved concentration of the test item.
- Details on mating procedure:
- Animals were received at the test facility having already been successfully mated. Natural mating with New Zealand white bucks of established fertility at the supplier’s facility. Males and females were not closely related.
- Duration of treatment / exposure:
- Days 6 - 28 (inclusive) after mating (i.e. 23 days total).
- Frequency of treatment:
- Once daily.
Doses / concentrationsopen allclose all
- Dose / conc.:
- 100 mg/kg bw/day (nominal)
- Dose / conc.:
- 300 mg/kg bw/day (nominal)
- Dose / conc.:
- 1 000 mg/kg bw/day (nominal)
- No. of animals per sex per dose:
- 24
- Control animals:
- yes, concurrent vehicle
- Details on study design:
- - Dose selection rationale: Dose levels selected for this study, were based on the results from a Combined Pilot and Preliminary Study.
Examinations
- Maternal examinations:
- CAGE SIDE OBSERVATIONS: Yes.
- Time schedule: At least twice daily.
- Specific cage side observations not listed in study report.
DETAILED CLINICAL OBSERVATIONS: Yes.
- Time schedule: At least twice daily.
BODY WEIGHT: Yes.
- Time schedule for examinations: On arrival (day 1 after mating), day 3 after mating, and daily on days 6 - 29 after mating.
POST-MORTEM EXAMINATIONS: Yes
- Sacrifice on day 29 after mating.
- Organs examined: A full macroscopic examination of the tissues was performed. All external features and orifices were examined visually. Any abnormality in the appearance or size of any organ and tissue (external and cut surface) was recorded and the required tissue samples preserved in appropriate fixative. - Ovaries and uterine content:
- The ovaries and uterine content was examined after termination: Yes.
Examinations included:
- Gravid uterus weight: Yes (including cervix and ovaries).
- Number of corpora lutea: Yes.
- Number of implantations: Yes.
- Number of early resorptions: Yes.
- Number of late resorptions: Yes.
- Other: Number of foetuses (live and dead). - Fetal examinations:
- - External examinations: Yes [all per litter].
- Soft tissue examinations: Yes [all per litter].
- Skeletal examinations: Yes [all per litter].
- Head examinations: Yes [50% per litter].
- Anogenital distance of all live rodent pups: Not applicable. - Statistics:
- The following data types were analyzed at each timepoint separately:
Body weight, using absolute weights and gains over appropriate study periods
Gravid uterine weight and adjusted body weight
Food consumption, over appropriate study periods
C-section litter data (corpora lutea, implantations, pre/post implantation loss, live young and sex ratio - percentage male)
Placental, litter and fetal weights
A parametric analysis, using the t-test or F1 approximate test, was performed if Bartlett's test was not significant at the 1% level.
A non-parametric analysis, using Kruskal-Wallis' test, Wilcoxon rank sum tests, or the H1 approximate test, was performed if Bartlett's test was still significant at the 1% level following both logarithmic and square-root transformations. - Historical control data:
- Historical control data from 14 studies conducted from January 2020 are included, using New Zealand white rabbits from the same supplier (Envigo RMS) as used in the present study.
Results and discussion
Results: maternal animals
General toxicity (maternal animals)
- Clinical signs:
- no effects observed
- Mortality:
- mortality observed, non-treatment-related
- Description (incidence):
- One animal in each of the vehicle control, mid-dose and high-dose groups was killed early for welfare reasons.
In the case of the control and mid-dose animals, the litters had resorbed. "The poor clinical condition of [the mid-dose animal] was attributed to the loss of the litter and not attributable to treatment with DEIPA."
The high-dose animal was killed for welfare reasons on suspicion that the pregnancy had resorbed or aborted. Upon examination, the death of the animal was due to a twisted caecum, and not attributable to treatment with DEIPA. - Body weight and weight changes:
- no effects observed
- Description (incidence and severity):
- See Table 4.
- Food consumption and compound intake (if feeding study):
- effects observed, treatment-related
- Description (incidence and severity):
- Food consumption was 18% lower than control in the high-dose group. See Table 1.
- 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
- Urinalysis findings:
- not examined
- Behaviour (functional findings):
- not examined
- Immunological findings:
- not examined
- Organ weight findings including organ / body weight ratios:
- not specified
- Gross pathological findings:
- no effects observed
- Neuropathological findings:
- not examined
- Histopathological findings: non-neoplastic:
- not examined
- Histopathological findings: neoplastic:
- not examined
Maternal developmental toxicity
- Number of abortions:
- not specified
- Description (incidence and severity):
- Data not available in study report.
- Pre- and post-implantation loss:
- no effects observed
- Description (incidence and severity):
- See Table 3.
- Total litter losses by resorption:
- no effects observed
- Early or late resorptions:
- no effects observed
- Dead fetuses:
- not specified
- Description (incidence and severity):
- Data on stillbirths and/or dead foetuses not available in study report.
- Changes in pregnancy duration:
- not specified
- Description (incidence and severity):
- Data, including on early deliveries, not available in study report.
- Changes in number of pregnant:
- no effects observed
- Description (incidence and severity):
- 11 animals were not pregnant: 3 in the control group, 2 in the low-dose group, 4 in the mid-dose group and 2 in the high-dose group. See Table 2.
Effect levels (maternal animals)
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- 1 000 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Remarks on result:
- not determinable due to absence of adverse toxic effects
Results (fetuses)
- Fetal body weight changes:
- effects observed, non-treatment-related
- Description (incidence and severity):
- Total litter weight was marginally reduced in the high-dose group, attributed to the marginally smaller litter size.
- Reduction in number of live offspring:
- effects observed, non-treatment-related
- Description (incidence and severity):
- "Marginally smaller" litter size at the high dose. See Table 5.
- Changes in sex ratio:
- no effects observed
- Description (incidence and severity):
- See Table 5.
- Changes in litter size and weights:
- no effects observed
- Description (incidence and severity):
- See Table 6.
- Changes in postnatal survival:
- not examined
- External malformations:
- no effects observed
- Description (incidence and severity):
- See Table 7.
- Skeletal malformations:
- effects observed, non-treatment-related
- Description (incidence and severity):
- There was 1 incidence each of lumbar scoliosis, lumbar hemivertebra, bent clavicle and pointing backwards hindpaw(s). See Table 7.
- Visceral malformations:
- effects observed, non-treatment-related
- Description (incidence and severity):
- There were 2 incidences each of dilated ascending aorta and narrow pulmonary trunk, and 1 each of acephalostomia, truncus arteriosus and septal defect. See Table 7.
- Other effects:
- effects observed, non-treatment-related
- Description (incidence and severity):
- The incidence of incompletely ossified/unossified epiphyses and metacarpals/phalanges at all treated doses exceeded the concurrent and historical controls ranges. These are a transient stage in foetal development and indicative of foetal immaturity, and therefore non-adverse. See Table 8.
Effect levels (fetuses)
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- 1 000 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male/female
- Remarks on result:
- not determinable due to absence of adverse toxic effects
Overall developmental toxicity
- Key result
- Developmental effects observed:
- no
Any other information on results incl. tables
Table 1 - Food consumption during gestation days 6-29
Group | Nominal dose (mg/kg bw/day) | Mean food consumption (g/animal/day) | Standard Deviation |
1 | 0 | 102 | 14.6 |
2 | 100 | 100 | 11.7 |
3 | 300 | 97 | 14.0 |
4 | 1000 | 84** | 14.7 |
** p < 0.01
Table 2 - Number of pregnancies
Group | Nominal dose (mg/kg bw/day) | Number of treated animals | Number of animals that died during study | Number of non-pregnant dams | Number of pregnant dams |
1 | 0 | 24 | 1 | 3 | 20 |
2 | 100 | 24 | 0 | 2 | 22 |
3 | 300 | 24 | 1 | 4 | 19 |
4 | 1000 | 24 | 1 | 2 | 21 |
Table 3 - Pre- and post-implantation loss - litter data
Group | Nominal dose (mg/kg bw/day) | Number of pregnant dams | Resorptions | Pre-implantation loss (%) | Post-implantation loss (%) | ||
Early | Late | Total | |||||
1 | 0 | 20 | 0.6 | 0.1 | 0.7 | 10.0 | 8.7 |
SD 0.94 | SD 0.31 | SD 0.92 | SD 12.08 | SD 11.87 | |||
2 | 100 | 22 | 0.7 | 0.4 | 1.0 | 15.3 | 12.9 |
SD 1.36 | SD 0.49 | SD 1.36 | SD 22.51 | SD 15.66 | |||
3 | 300 | 19 | 0.6 | 0.4 | 0.9 | 8.8 | 10.3 |
SD 1.02 | SD 0.76 | SD 1.18 | SD 12.23 | SD 12.05 | |||
4 | 1000 | 21 | 0.5 | 0.3 | 0.8 | 13.3 | 10.8 |
SD 0.98 | SD 0.64 | SD 1.21 | SD 18.31 | SD 16.00 |
Table 4 - Body and gravid uterine weights
Group mean values (kg) | |||||||
Group | Nominal dose (mg/kg bw/day) | Body weight, day 6 | Terminal body weight | Body weight change | Gravid uterine weight | Adjusted terminal body weight | Adjusted body weight change |
1 | 0 | 3.13 | 3.42 | 0.29 | 0.420 | 3.00 | -0.13 |
SD 0.415 | SD 0.343 | SD 0.133 | SD 0.0997 | SD 0.343 | SD 0.154 | ||
2 | 100 | 3.19 | 3.45 | 0.25 | 0.396 | 3.05 | -0.14 |
SD 0.374 | SD 0.318 | SD 0.145 | SD 0.1325 | SD 0.222 | SD 0.175 | ||
3 | 300 | 3.13 | 3.41 | 0.28 | 0.408 | 3.00 | -0.13 |
SD 0.321 | SD 0.301 | SD 0.115 | SD 0.0718 | SD 0.278 | SD 0.102 | ||
4 | 1000 | 3.08 | 3.36 | 0.28 | 0.366 | 2.99 | -0.08 |
SD 0.323 | SD 0.307 | SD 0.174 | SD 0.0990 | SD 0.274 | SD 0.132 |
Table 5 - Live offspring
Group | Nominal dose (mg/kg bw/day) | Mean number of live young | Sex ratio (% male) | ||
Male | Female | Total | |||
1 | 0 | 3.9 | 3.6 | 7.5 | 50.3 |
SD 2.13 | SD 1.27 | SD 2.37 | SD 14.27 | ||
2 | 100 | 4.2 | 2.8 | 7.0 | 62.8 |
SD 2.18 | SD 2.14 | SD 2.60 | SD 25.75 | ||
3 | 300 | 3.1 | 4.2 | 7.3 | 41.5 |
SD 1.66 | SD 1.65 | SD 1.53 | SD 21.33 | ||
4 | 1000 | 3.0 | 3.7 | 6.7 | 43.7 |
SD 1.70 | SD 1.76 | SD 2.19 | SD 19.50 |
Table 6 - Litter and foetal weights
Group | Nominal dose (mg/kg bw/day) | Mean total litter weight (g) | Mean foetal weights (g) | ||
Male | Female | Combined | |||
1 | 0 | 279.5 | 39.2 | 37.5 | 38.4 |
SD 71.98 | SD 6.26 | SD 5.97 | SD 5.68 | ||
2 | 100 | 260.6 | 38.0 | 36.7 | 38.0 |
SD 96.02 | SD 6.86 | SD 6.03 | SD 5.99 | ||
3 | 300 | 268.4 | 36.6 | 37.3 | 37.2 |
SD 55.61 | SD 4.93 | SD 4.68 | SD 4.71 | ||
4 | 1000 | 242.9 | 36.2 | 36.2 | 36.6 |
SD 74.07 | SD 6.06 | SD 4.80 | SD 4.40 |
Table 7 - Foetal examinations - major abnormality findings
Group | 1 | 2 | 3 | 4 | ||
Nominal dose (mg/kg bw/day) | 0 | 100 | 300 | 1000 | ||
Litters examined | 20 | 22 | 19 | 21 | ||
Total number of litters affected | 1 | 0 | 0 | 2 | ||
Foetuses examined | 150 | 154 | 139 | 141 | ||
Total number of foetuses affected | 3 | 0 | 0 | 4 | ||
Number of foetuses with major abnormalities | ||||||
Skeletal | Head | Acephalostomia | 0 | 0 | 0 | 1 |
Cervical/Thoracic | Thoracic scoliosis | 1 | 0 | 0 | 0 | |
Dorsoventral distortion of sternum | 1 | 0 | 0 | 0 | ||
Lubmar (and abdominal)/ sacral/ caudal | Sacral/caudal spina bifida | 1 | 0 | 0 | 0 | |
Lumbar scoliosis | 0 | 0 | 0 | 1 | ||
Lumbar hemivertebra | 0 | 0 | 0 | 1 | ||
Appendicular | Bent clavicle | 0 | 0 | 0 | 1 | |
Pointing backwards hindpaw | 0 | 0 | 0 | 1 | ||
Visceral | Cervical/Thoracic | Dilated ascending aorta/aortic arch | 0 | 0 | 0 | 2 |
Dorsally displaced pulmonary trunk | 1 | 0 | 0 | 0 | ||
Truncus arteriosus | 0 | 0 | 0 | 1 | ||
Membranous ventricular septal defect | 1 | 0 | 0 | 1 | ||
Muscular ventricular septal defect | 0 | 0 | 0 | 1 | ||
Fistula ascending aorta/pulmonary trunk | 1 | 0 | 0 | 0 | ||
Narrow/marked pulmonary trunk | 0 | 0 | 0 | 2 |
Table 8 - Foetal examinations - minor abnormality findings
Group | 1 | 2 | 3 | 4 | |
Nominal dose (mg/kg bw/day) | 0 | 100 | 300 | 1000 | |
Litters examined | 20 | 22 | 19 | 21 | |
Foetuses examined | 150 | 154 | 139 | 141 | |
Number of foetuses with minor abnormalities | |||||
Skeletal | Cranial abnormality - unossified area(s) | 0 | 0 | 1 | 0 |
Cranial abnormality - sutural bone(s) | 1 | 0 | 0 | 0 | |
Cranial abnormality - bent cornu(a) of hyoid | 0 | 8 | 3 | 3 | |
Vertebral abnormality - thoracic | 1 | 0 | 0 | 1 | |
Vertebral abnormality - lumbar | 1 | 0 | 0 | 1 | |
Rib abnormality - short without costal cartilage | 1 | 0 | 0 | 0 | |
Rib abnormality - misaligned | 1 | 0 | 0 | 0 | |
Rib abnormality - partially fused | 1 | 0 | 0 | 0 | |
Rib abnormality - distally thickened | 1 | 0 | 0 | 0 | |
Rib abnormality - branched with additional costal cartilage | 1 | 0 | 0 | 0 | |
Sternebrae - fused/partially fused | 3 | 3 | 1 | 4 | |
Sternebrae - misaligned hemicentres | 0 | 2 | 1 | 0 | |
Sternebrae - supernumerary site | 0 | 1 | 0 | 0 | |
Sternebrae - wide | 1 | 0 | 0 | 0 | |
Sternebrae - misshapen | 2 | 0 | 0 | 0 | |
Sternebrae - branched 6th | 0 | 1 | 0 | 0 | |
Costal cartilage - partially fused | 2 | 0 | 0 | 0 | |
Costal cartilage - misaligned | 0 | 3 | 1 | 2 | |
Costal cartilage - branched | 1 | 1 | 0 | 0 | |
Costal cartilage - additional | 1 | 0 | 0 | 0 | |
Costal cartilage - 7th not connected to sternum | 0 | 2 | 0 | 0 | |
Appendicular abnormality - absent 1st digit forepaw(s) | 0 | 0 | 0 | 1 | |
Cervical rib abnormality - short supernumerary | 1 | 9 | 7 | 2 | |
Cervical rib abnormality - full supernumerary | 1 | 0 | 0 | 0 | |
Number of 13th ribs - short supernumerary | 44 | 34 | 37 | 45 | |
Number of 13th ribs - full supernumerary | 35 | 32 | 22 | 57 | |
Number of 13th ribs - total | 67 | 61 | 54 | 89 | |
Thoracolumbar vertebrae - 18 | 1 | 0 | 1 | 0 | |
Thoracolumbar vertebrae - 20 | 7 | 12 | 4 | 19 | |
Pelvic girdle - unilateral cranial shift | 2 | 0 | 0 | 0 | |
Pelvic girdle - unilateral caudal shift | 6 | 2 | 0 | 4 | |
Delayed/incomplete ossification | Cranial - large posterior fontanelle | 1 | 0 | 0 | 1 |
Sternebrae - 5th | 20 | 23 | 39 | 24 | |
Sternebrae - 1st-4th, 6th | 9 | 5 | 11 | 13 | |
Sternebrae - total | 28 | 26 | 46 | 32 | |
Vertebrae - cervical | 3 | 0 | 0 | 2 | |
Vertebrae - thoracic | 1 | 0 | 0 | 0 | |
Appendicular - pubes | 0 | 2 | 0 | 1 | |
Appendicular - epiphyses | 11 | 20 | 10 | 14 | |
Appendicular - talus | 1 | 1 | 0 | 0 | |
Appendicular - metacarpals/phalanges | 9 | 16 | 15 | 17 | |
Appendicular - metatarsals/phalanges | 2 | 7 | 1 | 4 | |
Increased ossification | Cranial - partially fused jugal to maxilla | 1 | 1 | 0 | 0 |
Vertebrae - long lumbar transverse processes | 1 | 0 | 0 | 0 | |
Visceral | Eyes - folded retina | 3 | 2 | 0 | 0 |
Brain - dilated interventricular foramen | 1 | 0 | 0 | 0 | |
Head - supernumerary minor upper incisor | 0 | 1 | 0 | 0 | |
Lungs - abnormal lobation | 1 | 0 | 0 | 0 | |
Gall bladder - bilobed | 0 | 0 | 1 | 0 | |
Ovary - cyst(s) | 0 | 0 | 1 | 0 | |
Head - tongue present | 0 | 0 | 0 | 1 | |
Limb(s) - flexure forepaw(s) | 1 | 1 | 0 | 3 | |
Tail - curled | 0 | 0 | 0 | 1 | |
Tail - kinked | 0 | 2 | 0 | 0 |
Applicant's summary and conclusion
- Conclusions:
- In a good-quality guideline study to GLP, gavage administration of DEIPA at doses up to 1000 mg/kg bw/day (nominal) to time-mated rabbits on GD 6-28 (inclusive) did not produce any clinical signs of toxicity. Reproductive parameters were not altered and no signs of treatment-related malformations were seen. On this basis, the study NOAELs for both maternal and developmental toxicity were 1000 mg/kg bw/day (nominal), the highest dose tested.
- Executive summary:
In a good quality guideline study, conducted to GLP, groups of 24 time-mated female New Zealand white rabbits were administered DEIPA by gavage at dose levels of 0, 100, 300, or 1000 mg/kg bw/day (nominal) on days 6-28 of gestation. Animals were killed on gestation day 29 and examined for gross pathological alterations. Gravid uterine weights were recorded, along with the number of corpora lutea, implantations, resorptions, and live/dead foetuses. All foetuses were weighed and sexed, and examined for external, visceral and (in 50%) skeletal alterations.
No clinical signs of toxicity were seen, reproductive parameters were not altered, and there were no treatment-related malformations or other developmental toxicity observed in the foetuses at any dose of DEIPA. On this basis, the no-observed-adverse-effect levels (NOAELs) for maternal toxicity and developmental toxicity were 1000 mg/kg bw/day (nominal), the highest dose tested.
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