Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 617-769-9 | CAS number: 858956-08-8
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
Developmental toxicity / teratogenicity
Administrative data
- Endpoint:
- developmental toxicity
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 09 September - 31 October 2007
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 011
- Report date:
- 2011
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 414 (Prenatal Developmental Toxicity Study)
- Version / remarks:
- adopted 22 January 2001
- Deviations:
- no
- GLP compliance:
- yes
- Limit test:
- no
Test material
- Reference substance name:
- 6-amino-5-chloro-2-cyclopropylpyrimidine-4-carboxylic acid
- EC Number:
- 617-769-9
- Cas Number:
- 858956-08-8
- Molecular formula:
- C8H8ClN3O2
- IUPAC Name:
- 6-amino-5-chloro-2-cyclopropylpyrimidine-4-carboxylic acid
1
Test animals
- Species:
- rat
- Strain:
- other: Crl:CD(SD)
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Laboratories, Inc., Raleigh, North Carolina, USA
- Age at study initiation: approximately 67 days
- Weight at study initiation: 222 - 270 g
- Housing: individually in stainless steel, wire-mesh cages suspended above cage boards
- Diet: PMI Nutrition International, LLC Certified Rodent Lab Diet 5002 (pellets), ad libitum
- Water: tap water (United water Delaware), ad libitum
- Acclimation period: approximately 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 - 26
- Humidity (%): 30 -70
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Route of administration:
- oral: gavage
- Details on exposure:
- PREPARATION OF DOSING SOLUTIONS: The formulations of the test substance in the vehicle were prepared daily. To achieve the respective test concentrations of active ingredient, the formulations were adjusted for sample purity (92.2%).
VEHICLE
- Other: Volume administered: 5 mL/kg bw - Analytical verification of doses or concentrations:
- yes
- Details on analytical verification of doses or concentrations:
- Samples of each formulation were taken 2 times near the beginning and the end of the study. Analyses addressed uniformity of mixing, concentration and stability. One vehicle sample and 3 samples (top,middle,and bottom samplings) of each concentrations were analysed to verify concentration and uniformity of mixing near study beginning and one vehicle sample and one sample of each concentration was analysed to verify concentration near end of the study. A fourth sample of each concentration was held for 5 h at room temperature and was then analysed for stability of the test substance in the formulation. Sample analyses were perfomed by Critical Path Services (CPS) and were shipped frozen. Data from the analysis of the formulation samples, including the 5-h stability sample, indicated that the test substance was uniformly mixed in the vehicle at the targeted concentrations and was stable in the vehicle under the conditions of the study. Test substance was not found in the control sample.
The COA included in the original finalised report listed a purity of 92.2% which did not fully account for all the inorganic impurities associated with this sample. Follow-up analysis of DPX-MAT28-009 was conducted after the final report had issued. The revised COA, included in this revised report, presents the purity as 90.5% and now accounts for the full impurity profile as determined in GLP analytical study. This reduction in determined purity of 1.7% had minimal impact on the reported doses determined by chemical analyses and on the values utilized for risk assessments. Therefore, the reported doses or dietary intake values have not been adjusted. - Details on mating procedure:
- - Impregnation procedure: purchased timed pregnant
- Duration of treatment / exposure:
- Gestation Days 6 -20
- Frequency of treatment:
- daily
- Duration of test:
- 21 Days
Doses / concentrationsopen allclose all
- Dose / conc.:
- 30 mg/kg bw/day
- Dose / conc.:
- 100 mg/kg bw/day
- Dose / conc.:
- 300 mg/kg bw/day
- Dose / conc.:
- 1 000 mg/kg bw/day
- No. of animals per sex per dose:
- 25
- Control animals:
- yes, concurrent vehicle
- Details on study design:
- - Dose selection rationale: In a pilot developmental toxicity study in rats with a similar compound (methyl ester of the test substance), the test substance was administered to time-mated female Crl:CD(SD) rats (8/group) once daily on GD 6 - 20 at dosages of 25, 300, or 1000 mg/kg/day. During the in-life portion of the study, maternal body weights, food consumption, and clinical signs were collected. On GD 21, all dams were euthanized and examined grossly. Gravid uterine weight was recorded to permit calculation of the adjusted maternal final body weight. The uterine contents were examined and described (number and status of implantation sites, and fetal assessment (viable, non-viable, location, sex, fetal weights, external alterations). There were no test substance-related maternal or developmental effects noted for any endpoint analyzed at any dose level. Based on these data, the dose levels selected for the current study were 30, 100, 300, and 1000 mg/kg/day.
Examinations
- Maternal examinations:
- CAGE SIDE OBSERVATIONS: Yes
- Time schedule: twice daily
DETAILED CLINICAL OBSERVATIONS: Yes
- Time schedule: twice daily (GD 6 - 20), once daily on GD 21
BODY WEIGHT: Yes
- Time schedule for examinations: once daily on GD 6 -21
FOOD CONSUMPTION AND COMPOUND INTAKE: Yes
- Food consumption for each animal determined: Yes
- Compound intake calculated as time-weighted averages from the consumption and body weight gain data: No
- Time schedule for examinations: GD 6, 8, 10, 12, 14, 16, 18, 20 and 21
WATER CONSUMPTION AND COMPOUND INTAKE: No
POST-MORTEM EXAMINATIONS: Yes
- Sacrifice on gestation day # 21
- Organs examined: livers were weighed and saved for histopathological examination
OTHER: Gross external and a visceral examinations were performed. In the absence of any demonstrated test substance-related effects on either the gross findings or liver weights, microscopic examination of the livers and gross lesions was not considered necessary. - 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: number of pregnant (%) - Fetal examinations:
- - External examinations: Yes: all per litter
- Soft tissue examinations: Yes: half per litter
- Skeletal examinations: Yes: all per litter
- Head examinations: Yes: half per litter
- Remarks: In addition, all live fetuses with malformations visible at external examination were examined for soft tissue alterations; decapitation of these fetuses for head examination was performed at the discretion of the study director or designee. The frozen heads of decapitated fetuses (fetuses that were decapitated prior to visceral examination, approximately half of the fetuses) were examined by a serial sectioning technique. The skeletal bodies of all the fetuses and the skulls of half the fetuses (fetuses that were not designated for head examination) were examined for alterations. - Statistics:
- The level of significance selected was p < 0.05.
For an detailed overiew on statistics, please refer to table 1 in the "Any other information on materials and methods incl. tables" section.
Results and discussion
Results: maternal animals
General toxicity (maternal animals)
- Clinical signs:
- effects observed, non-treatment-related
- Description (incidence and severity):
- 1000 mg/kg bw/day: stained skin/fur - brown was observed in a single animal
100 mg/kg bw/day: wet fur was observed in a single animal
control, 30, 100 and 300 mg/kg bw/day: hair loss was observed in single animals at different time points.
All observations that were recorded were unremarkable and occurred infrequently and were thus not considered adverse.
For details please refer to table 2 in the “Any other information on results incl. tables” section. - Dermal irritation (if dermal study):
- not examined
- 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 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:
- no effects observed
- Description (incidence and severity):
- For details please refer to table 3 in the “Any other information on results incl. tables” section.
- Gross pathological findings:
- effects observed, non-treatment-related
- Description (incidence and severity):
- 100 mg/kg bw/day: liver discoloration was observed in one animal. This single event was considered incidental and non-adverse.
For details please refer to table 4 in the “Any other information on results incl. tables” section. - Neuropathological findings:
- not examined
- Histopathological findings: non-neoplastic:
- not examined
- Histopathological findings: neoplastic:
- not examined
- Other effects:
- not examined
Maternal developmental toxicity
- Number of abortions:
- no effects observed
- Description (incidence and severity):
- For details please refer to table 5 in the “Any other information on results incl. tables” section.
- Pre- and post-implantation loss:
- no effects observed
- Description (incidence and severity):
- For details please refer to table 5 in the “Any other information on results incl. tables” section.
- Total litter losses by resorption:
- no effects observed
- Description (incidence and severity):
- For details please refer to table 5 in the “Any other information on results incl. tables” section.
- Early or late resorptions:
- no effects observed
- Description (incidence and severity):
- For details please refer to table 5 in the “Any other information on results incl. tables” section.
- Dead fetuses:
- no effects observed
- Description (incidence and severity):
- For details please refer to table 5 in the “Any other information on results incl. tables” section.
- Changes in pregnancy duration:
- not examined
- Changes in number of pregnant:
- no effects observed
- Description (incidence and severity):
- For details please refer to table 5 in the “Any other information on results incl. tables” section.
- Other effects:
- not examined
- Details on maternal toxic effects:
- There were no test substance-related effects on reproductive outcome. The number of pregnant, the mean number of corpora lutea, implantation sites, resorptions (total, early and late), live/dead fetuses were comparable across all groups tested.
Effect levels (maternal animals)
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- 1 000 mg/kg bw/day
- Based on:
- test mat.
- Basis for effect level:
- other: no adverse effects observed
Maternal abnormalities
- Abnormalities:
- no effects observed
Results (fetuses)
- Fetal body weight changes:
- no effects observed
- Description (incidence and severity):
- For details please refer to table 5 in the “Any other information on results incl. tables” section.
- Reduction in number of live offspring:
- no effects observed
- Description (incidence and severity):
- For details please refer to table 5 in the “Any other information on results incl. tables” section.
- Changes in sex ratio:
- no effects observed
- Description (incidence and severity):
- For details please refer to table 5 in the “Any other information on results incl. tables” section.
- Changes in litter size and weights:
- no effects observed
- Changes in postnatal survival:
- not examined
- External malformations:
- effects observed, non-treatment-related
- Description (incidence and severity):
- 300 mg/kg bw/day: single incidences of protruding tongue (malformation), anopthalmia (malformation) and small eye bulge (gross finding) were observed, but considered an incidental finding and not considered adverse.
For details please refer to table 6 in the “Any other information on results incl. tables” section. - Skeletal malformations:
- effects observed, non-treatment-related
- Description (incidence and severity):
- 300 mg/kg bw/day: single incidence of fused cervical arch (malformation) was observed, but considered an incidental finding and not considered adverse.
control, 30, 100, 300 and 1000 mg/kg bw/day: in all dose groups variations of the thoracic centrum and ribs were observed. In addition variations of the sternebrae were observed in all groups, exluding the 30 mg/kg bw/day dose group.
All observed variations were either incidental findings, not dose-related or occurrence did not differ significantly between dose groups and were thus not considered adverse.
For details please refer to table 6 in the “Any other information on results incl. tables” section. - Visceral malformations:
- effects observed, non-treatment-related
- Description (incidence and severity):
- 100 mg/kg bw/day: single incidence of discolored intestine (gross finding) was observed, but considered an incidental finding and thus not adverse.
30 mg/kg bw/day: single incidence of discolored liver (variation) was observed, but considered an incidental finding and thus not adverse.
For details please refer to table 6 in the “Any other information on results incl. tables” section. - Other effects:
- not examined
- Details on embryotoxic / teratogenic effects:
- There were no test substance-related effects on quantitative litter data. The number of live/dead fetuses, mean fetal weight and sex ratio were comparable across all groups tested. There were no test substance-related fetal malformations or variations observed at any dose level tested. The fetal alterations that were observed were unremarkable and occurred with low frequency across the dose levels tested.
Effect levels (fetuses)
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- 1 000 mg/kg bw/day
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: no adverse effects observed
Fetal abnormalities
- Abnormalities:
- no effects observed
Overall developmental toxicity
- Developmental effects observed:
- no
Any other information on results incl. tables
Table 2: Summary of Maternal Clinical Observations
Dose group (mg/kg bw/day) |
|
0 |
|
30 |
|
100 |
|
300 |
1000 |
|
Number of animals |
|
25 |
|
25 |
|
25 |
|
25 |
25 |
|
Hair loss Number of Observations Number of animals
|
|
4 1 |
|
17 3 |
|
16 3 |
|
3 3 |
|
|
Days from - to |
16 |
19 |
12 |
21 |
15 |
21 |
19 |
21 |
|
|
Scheduled sacrifice Number of Observations Number of Animals |
25 |
25 |
25 |
25 |
25 |
|||||
25 |
25 |
25 |
25 |
25 |
||||||
Days from - to |
21 |
21 |
21 |
21 |
21 |
21 |
21 |
21 |
21 |
21 |
Stained skin/fur - brown – chin Number of Observations Number of Animals |
|
|
|
|
1 1 |
|||||
Days from - to |
|
|
|
|
19 |
19 |
||||
Wet fur – chin/perinasal Number of Observations Number of Animals |
|
|
1 1 |
|
|
|||||
Days from - to |
|
|
18 |
18 |
|
|
Table 3: Mean Final Body Weights, Absolute and Relative Organ Weights for Maternal Rats
Dose group (mg/kg bw/day) |
0 |
30 |
100 |
300 |
1000 |
Final body weight |
392.6 |
394.6 |
397.8 |
393.5 |
386.6 |
|
19.9(25) |
21.8(25) |
23.3(25) |
24.2(25) |
25.7(25) |
Liver Mean |
15.40 |
15.04 |
15.49 |
15.71 |
14.72 |
Standard deviation (n) |
1.70(24) |
1.31(25) |
1.66(25) |
2.00(25) |
1.38(24) |
Liver/Final body weight x 100 |
3.922 |
3.816 |
3.891 |
3.994 |
3.813 |
Standard deviation (n) |
0.350(24) |
0.315(25) |
0.294(25) |
0.439(25) |
0.345(24) |
Table 4: Summary of Maternal Gross Observations
Dose group (mg/kg bw/day) |
0 |
30 |
100 |
300 |
1000 |
Number of animals |
25 |
25 |
25 |
25 |
25 |
Liver No visible lesions Discoloration
|
25 0 |
24a 0 |
23 1 |
23b 0 |
25 0
|
Whole Body No visible lesions |
25
|
24a
|
24
|
23b
|
25
|
a Maternal gross observations were inadvertently not recorded for Animal #204.
b Maternal gross observations were inadvertently not recorded for Animal #401 and #409.
Table 5: Reproductive Outcome
Dose group (mg/kg bw/day) |
0 |
30 |
100 |
300 |
1000 |
Number of animals in group |
25 |
25 |
25 |
25 |
25 |
Not Pregnant (%) |
0 (0.0) |
0 (0.0) |
0 (0.0) |
0 (0.0) |
0 (0.0) |
Died/Killed |
0 |
0 |
0 |
0 |
0 |
Survived to scheduled kill |
0 |
0 |
0 |
0 |
0 |
Pregnant (%) |
25(100.0) |
25(100.0) |
25(100.0) |
25(100.0) |
25(100.0) |
Died/Killed/Aborted |
0 |
0 |
0 |
0 |
0 |
with total resorption |
0 |
0 |
0 |
0 |
0 |
with live fetus at scheduled kill |
25 |
25 |
25 |
25 |
25 |
Corpora Lutea (Mean) |
13.5 |
13.3 |
13.6 |
13.7 |
13.7 |
Standard Deviation (n) |
3.1(25) |
2.6(24) |
3.0(25) |
2.0(25) |
2.2(25) |
Implants (Mean) |
11.7 |
12.2 |
11.9 |
12.3 |
12.3 |
Standard Deviation (n) |
1.3(25) |
2.2(25) |
1.9(25) |
1.7(25) |
2.1(25) |
Total Resorptions (Mean) |
0.08 |
0.08 |
0.20 |
0.56 |
0.40 |
Standard Deviation (n) |
0.28(25) |
0.28(25) |
0.50(25) |
2.02(25) |
0.65(25) |
Early Resorptions (Mean) |
0.08 |
0.08 |
0.20 |
0.56 |
0.40 |
Standard Deviation (n) |
0.28(25) |
0.28(25) |
0.50(25) |
2.02(25) |
0.65(25) |
Late Resorptions (Mean) |
0.00~ |
0.00 |
0.00 |
0.00 |
0.00 |
Standard Deviation (n) |
0.00(25) |
0.00(25) |
0.00(25) |
0.00(25) |
0.00(25) |
Dead Fetuses (Mean) |
0.0~ |
0.0 |
0.0 |
0.0 |
0.0 |
Standard Deviation (n) |
0.0(25) |
0.0(25) |
0.0(25) |
0.0(25) |
0.0(25) |
Live Fetuses (Mean) |
11.6 |
12.2 |
11.7 |
11.7 |
11.9 |
Standard Deviation (n) |
1.3(25) |
2.2(25) |
2.0(25) |
2.7(25) |
2.1(25) |
Male Fetuses (Mean) |
5.5 |
5.6 |
5.6 |
6.2 |
6.0 |
Standard Deviation (n) |
1.8(25) |
2.0(25) |
2.3(25) |
1.9(25) |
2.1(25) |
Female Fetuses (Mean) |
6.1 |
6.6 |
6.2 |
5.6 |
5.8 |
Standard Deviation (n) |
1.7(25) |
2.1(25) |
2.0(25) |
2.0(25) |
2.1(25) |
Fetal Weight (Mean) |
5.70 |
5.53 |
5.64 |
5.50 |
5.53 |
Standard Deviation (n) |
0.24(25) |
0.30(25) |
0.25(25) |
0.45(25) |
0.27(25) |
Male Weight (Mean) |
5.89 |
5.70 |
5.77 |
5.67 |
5.66 |
Standard Deviation (n) |
0.28(25) |
0.30(25) |
0.26(25) |
0.41(25) |
0.27(25) |
Female Weight (Mean) |
5.55 |
5.38 |
5.52 |
5.28 |
5.44 |
Standard Deviation (n) |
0.26(25) |
0.31(25) |
0.28(25) |
0.48(24) |
0.32(25) |
Sex Ratio (Mean) |
0.47 |
0.47 |
0.47 |
0.54 |
0.51 |
Standard Deviation (n) |
0.14(25) |
0.15(25) |
0.17(25) |
0.16(25) |
0.15(25) |
~ next to control mean indicates no analyses were performed. Statistical analyses are only conducted on the total mean fetal weight; the means for males and females are presented for information only. Remarks: The incidence of pregnancy, maternal mortality, the total resorptions, and early deliveries/abortions were statistically analyzed using the Cochran-Armitage test. Live fetuses, dead fetuses, resorptions, corpora lutea, and implantations were analyzed by One-Way Analysis of Variance and Dunnett’s test. Fetal weight and sex ratio were analyzed using Analysis of Covariance and Dunnett-Hsu.
Table 6: Incidence of Fetal Malformations and Variations
Dose group (mg/kg bw/day) |
0 |
30 |
100 |
300 |
1000 |
Total number of foetuses examined |
290 |
304 |
293 |
293 |
297 |
External Defects: Number of Fetuses Examined
|
290 |
304 |
293 |
293 |
297 |
External Defects: Number of Litters Examined |
25 |
25 |
25 |
25 |
25 |
Head Tongue, Protruding (Malformation) |
|
|
|
1 (0.3) 1 (4.0) |
|
Head Eye bulge, Small (Gross finding) |
|
|
|
1 (0.3) 1 (4.0) |
|
Head Defects: Number of fetuses examined |
140 |
145 |
140 |
142 |
143 |
Head Defects: Number of litters examined |
25 |
25 |
25 |
25 |
25 |
Head Eye, Anophthalmia (Malformation) |
|
|
|
1 (0.7) 1 (4.0) |
|
Visceral Defects: Number of fetuses examined |
140 |
145 |
140 |
142 |
143 |
Visceral Defects: Number of litters examined |
25 |
25 |
25 |
25 |
25 |
Abdomen Intestines, discolored (Gross finding) |
|
|
1 (0.7) 1 (4.0) |
|
|
Abdomen Liver, discolored (Variation) |
|
1 (0.7) 1 (4.0) |
|
|
|
Skeletal - Head Defects: Number of fetuses examined |
150 |
159 |
153 |
151 |
154 |
Skeletal - Head Defects: Number of litters examined |
25 |
25 |
25 |
25 |
25 |
Skull Frontal, Incomplete ossification (Variation) |
|
|
5 (3.3) 1 (4.0) |
|
|
Skull Zygomatic, Incomplete ossification (Variation) |
|
1 (0.7) 1 (4.0) |
|
|
|
Skull Interparietal, Incomplete ossification (Variation) |
|
|
|
1 (0.7) 1 (4.0) |
|
Skull Supraoccipital, Incomplete ossification (Variation) |
3 (2.0) 2 (8.0) |
2 (1.3) 2 (8.0) |
1 (0.7) 1 (4.0) |
3 (2.0) 2 (8.0) |
|
Skull Parietal, Incomplete ossification (Variation) |
|
1 (0.6) 1 (4.0) |
1 (0.7) 1 (4.0) |
2 (1.3) 2 (8.0) |
|
Skeletal - Body Defects: Number of fetuses examined |
290 |
304 |
293 |
293 |
297 |
Skeletal - Body Defects: Number of litters examined |
25 |
25 |
25 |
25 |
25 |
Vertebrae Cervical arch, Fused (Malformation) |
|
|
|
1 (0.3) 1 (4.0) |
|
Vertebrae Thoracic centrum, Unossified (Variation) |
|
|
|
1 (0.3) 1 (4.0) |
|
Vertebrae Thoracic centrum, Bipartite ossification (Variation) |
6 (2.1) 6 (14.0) |
1 (0.3) 1 (4.0) |
2 (0.7) 2 (8.0) |
1 (0.3) 1 (4.0) |
8 (2.7) 6 (24.0) |
Ribs Rib, Short (Variation) |
2 (0.7) 2 (8.0) |
1 (0.3) 1 (4.0) |
5 (1.7) 2 (8.0) |
1 (0.3) 1 (4.0) |
2 (0.7) 1 (4.0) |
Ribs Rib, Cervical rib (Variation) |
3 (1.0) 2 (8.0) |
3 (1.0) 1 (4.0) |
4 (1.4) 2 (8.0) |
1 (0.3) 1 (4.0) |
|
Ribs Rib, Full supernumerary rib (Variation) |
3 (1.0) 1 (4.0) |
|
|
|
|
Ribs Rib, Thickened (Variation) |
3 (1.0) 1 (4.0) |
|
|
|
|
Ribs Rib, Wavy (Variation) |
4 (1.4) 1 (4.0) |
|
1 (0.3) 1 (4.0) |
|
|
Ribs Rib, Short supernumerary (Variation) |
2 (0.7) 2 (8.0) |
2 (0.7) 2 (8.0) |
2 (0.7) 2 (8.0) |
|
2 (0.7) 1 (4.0) |
Ribs Rib, Extra ossification site (Variation) |
19 (6.6) 10 (40.0) |
13 (4.3) 6 (24.0) |
10 (3.4) 9 (36.0)
|
9 (3.1) 4 (16.0) |
5 (1.7) 5 (20.0) |
Sternebrae Unossified (Variation) |
|
|
|
4 (1.4) 2 (8.0) |
|
Sternebrae Misaligned (Variation) |
|
|
2 (0.7) 2 (8.0) |
|
1 (0.3) 1 (4.0) |
Sternebrae Fused (Variation) |
1 (0.3) 1 (4.0) |
|
|
1 (0.3) 1 (4.0) |
|
Upper line denotes number of affected fetuses
Lower line denotes number of affected litters
Figures in parenthesis denote percentage incidence
Calculated values do not include animals which either, were not pregnant, did not survive to the scheduled kill, had a total litter loss, aborted or are marked for exclusion
Applicant's summary and conclusion
- Conclusions:
- CLP: not classified
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.