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EC number: 252-156-6 | CAS number: 34690-00-1
- 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
Toxicity to reproduction
Administrative data
- Endpoint:
- one-generation reproductive toxicity
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 12.09. 1977 to 19.06.1978
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 979
- Report date:
- 1979
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 415 [One-Generation Reproduction Toxicity Study (before 9 October 2017)]
- Version / remarks:
- Conducted prior to adoption of OECD test guideline.
- Deviations:
- yes
- Remarks:
- No analytical confirmation of exposure, no pre-mating exposure, no assessment of oestrus cycle or sperm analyses, no evaluation of sexual milestones in pup. Males treated only as F1 and F2 generation.
- GLP compliance:
- no
- Limit test:
- no
Test material
- Reference substance name:
- [[(phosphonomethyl)imino]bis[ethane-2,1-diylnitrilobis(methylene)]]tetrakisphosphonic acid
- EC Number:
- 239-931-4
- EC Name:
- [[(phosphonomethyl)imino]bis[ethane-2,1-diylnitrilobis(methylene)]]tetrakisphosphonic acid
- Cas Number:
- 15827-60-8
- Molecular formula:
- C9H28N3O15P5
- IUPAC Name:
- [(bis{2-[bis(phosphonomethyl)amino]ethyl}amino)methyl]phosphonic acid
- Reference substance name:
- [[(phosphonomethyl)imino]bis[ethane-2,1-diylnitrilobis(methylene)]]tetraki sphosphonic acid
- IUPAC Name:
- [[(phosphonomethyl)imino]bis[ethane-2,1-diylnitrilobis(methylene)]]tetraki sphosphonic acid
- Test material form:
- liquid
Constituent 1
Constituent 2
Test animals
- Species:
- rat
- Strain:
- Long-Evans
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Females: Blue Spruce Farms. Males: BioDynamics Inc. in-house Long Evans breeding colony.
- Age at study initiation: (P) x 15-16 wks; (F1) x 3 wks
- Weight at study initiation (means): Females approximately 240 g. Males not weighed.
- Fasting period before study: No
- Housing: Individually in elevated stainless steel cages.
- Diet (e.g. ad libitum): Ad libitum
- Water (e.g. ad libitum): Ad libitum
- Acclimation period: No data
ENVIRONMENTAL CONDITIONS
- Temperature (°C): No data
- Humidity (%): No data
- Air changes (per hr): No data
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: 12.09. 1977 to 19.06.1978
Administration / exposure
- Route of administration:
- oral: feed
- Vehicle:
- unchanged (no vehicle)
- Details on exposure:
- DIET PREPARATION
- Rate of preparation of diet (frequency): Weekly
- Mixing appropriate amounts with (Type of food): Purina Laboratory Chow
- Storage temperature of food: No data - Details on mating procedure:
- - M/F ratio per cage: 1:2
- Length of cohabitation: nightly until signs of mating.
- Proof of pregnancy: vaginal plug or sperm in vaginal smear referred to as day 0 of pregnancy.
- After successful mating each pregnant female was caged (how): Individually in elevated stainless steel cages.
- Any other deviations from standard protocol: Dosing not started until Day 0 of gestation. - Analytical verification of doses or concentrations:
- no
- Duration of treatment / exposure:
- Test substance administration to F0 females was initiated on gestation Day 0 and continued throughout gestation and lactation, and for F1males and females through the F2a and f2b litters.
- Frequency of treatment:
- Daily
- Details on study schedule:
- - F1 parental animals not mated until one week after selection from the F1 litters.
- Selection of parents from F1 generation when pups had reached maturity.
Doses / concentrationsopen allclose all
- Dose / conc.:
- 300 ppm (nominal)
- Remarks:
- in diet
- Dose / conc.:
- 1 000 ppm (nominal)
- Remarks:
- in diet
- Dose / conc.:
- 3 000 ppm (nominal)
- Remarks:
- in diet
- No. of animals per sex per dose:
- F0 females: 20.
F1 Parents: females - 20; males - 10. - Control animals:
- yes, concurrent vehicle
- Details on study design:
- - Dose selection rationale: No data
- Rationale for animal assignment (if not random): Random.
- F1 offspring were separated from siblings seven days after weaning of the last litter and were randomly selected to continue as future parents (f1). More offspring than needed were selected (12 males and 24 females) for the growth period to insure the required number of adults (10 males and 20 females) necessary for mating. Following pup selection, remaining offspring and F0 females were sacrificed and discarded after gross external and internal examinations.
F1 animals were raised to maturity and mated to produce the F2a litters. F2a pups were sacrificed, necropsied and discarded at weaning. All F1 females were remated after a rest period of at least 14 days to produce the F2b litters. F2b pups were sacrificed and necropsied at weaning. Following completion of the F2b sacrifice, all F1 parents were sacrificed, necropsied and selected tissues preserved. - Positive control:
- None
Examinations
- Parental animals: Observations and examinations:
- CAGE SIDE OBSERVATIONS: Yes
- Time schedule: mortality and gross signs of toxicity in F0 and F1: twice daily.
DETAILED CLINICAL OBSERVATIONS: Yes
- Time schedule: Weekly (F0 and F1)
BODY WEIGHT: Yes
- Time schedule for examinations: Males and nonpregnant females (F1): weekly in growth and rest periods of F1 generation. Pregnant females (F0 and F1): Days 0, 6, 15 and 20 of gestation. Lactation females (F0 and F1): Days 0, 4, 14 and 21 of lactation.
FOOD CONSUMPTION AND COMPOUND INTAKE (if feeding study):
-Males and nonpregnant females: weekly for growth and rest periods of F1 generation.
-Test substance consumption was calculated from body weight and food consumption values: Males and nonpregnant females: weekly during growth and rest periods of F1 generation.
WATER CONSUMPTION AND COMPOUND INTAKE (if drinking water study): No - Oestrous cyclicity (parental animals):
- Not examined as dosing in F0 dams started on Day 0 gestation, F0 males not dosed.
- Sperm parameters (parental animals):
- Parameters examined in [all/P/F1/F2] male parental generations: No data
- Litter observations:
- STANDARDISATION OF LITTERS
- Performed on day 4 postpartum: yes
PARAMETERS EXAMINED:
Gestation period: On day 19 of gestation, dams were provided with nesting material and were examined daily for signs of parturition.
Lactation period (Day 0 is day on which all pups had been delivered): General appearance of pups and presence of dead pups examined daily in all litters (F1, F2a and F2b). Live, dead and missing pups were recorded on Days 0, 1, 4 (pre-cull and post-cull), 14 and 21 of lactation in all litters (F1, F2a and F2b). Live pups were weighed as a litter on Days 0, 4 (pre-cull) and 21 (calculated from individual weights) of lactation for all litters, and individually on Day 21 of lactation for all litters.
Litter Data and Observations: The number of each sex per litter was determined on Days 0 and 4 (pre- and post-cull) of lactation for all litters. Individual sex determination on Day 21 of lactation for all litters.
GROSS EXAMINATION OF DEAD PUPS:
Yes, for external and internal abnormalities. - Postmortem examinations (parental animals):
- SACRIFICE
F0 generation: All females sacrificed after weaning of F1 offspring, and necropsy performed.
F1 generation: All surviving males and females sacrificed after weaning and necropsy of the last F2b litter. Necropsy performed, and selected organs weighed and tissues preserved.
Extra F1 males and females: sacrifice at initiation of mating, necropsy performed and discarded.
Dead and moribund dams: Necropsy performed. Uterine contents examined and presence of implantation sites and/or scars recorded.
GROSS NECROPSY
- Gross necropsy consisted of external and internal examinations including the cervical, thoracic, and abdominal viscera.
HISTOPATHOLOGY / ORGAN WEIGHTS
The tissues indicated in Table 1 were weighed and/or prepared for microscopic examination. - Postmortem examinations (offspring):
- SACRIFICE
- The F1 offspring not selected as parental animals and all F2 offspring were sacrificed after weaning. Necropsy performed including internal sex determination performed, then carcass discarded.
- F2a: necrospy included internal sex determination performed. All offspring where then discarded.
- F2b: necrospy included internal sex determination performed. Selected tissues were preserved from ten randomly chosen males and females from all groups.
F2b found dead after Day 14 of lactation: necropsy including internal sex determination performed and discarded.
Culled F1, F2a and F2b: sacrifice on Day 4 of lactation. Necropsy including internal sex determination performed and discarded.
GROSS NECROPSY
- Gross necropsy consisted of external and internal examinations including the cervical, thoracic, and abdominal viscera.
- Dead pups: sex was determined and pups checked for presence of milk in their stomach and discarded.
HISTOPATHOLOGY / ORGAN WEIGTHS
The tissues indicated in Table 1 were preserved for F2b offspring. - Statistics:
- Body weight, body weight gain, food consumption and litter examination data, organ weights, organ/body weight and organ/brain weight ratios were analysed. Group I and Group II (control groups) were compared to each other. If no statistically significant differences, the control groups were combined and compared against test groups. If controls differed, individual control/test comparisons conducted - continuous and discrete data (body weight, food intake, organ weight): Dunnett's test. - gestation length: F-test and Student's T-test (Cochran's approximation). - offspring data: Chi-square. Incidence data for control Group II was compared to control Group I and incidence data for each test substance treated group was compared to each control group.
- Reproductive indices:
- F0 females: Pregnancy rates, gestation length, percentage of mothers that weaned litters.
F1 females: Mating and fertility indices, pregnancy rates, parturition indices, gestation length, percentage of mothers that weaned litters. - Offspring viability indices:
- F1 litters: Mean numbers of live and dead pups at birth, pup survival (at representative intervals through lactation), body weight, sex distribution.
F2 litters: Mean numbers of live and dead pups at birth, pup survival (at representative intervals through lactation), body weight, sex distribution.
Results and discussion
Results: P0 (first parental generation)
General toxicity (P0)
- Clinical signs:
- no effects observed
- Description (incidence and severity):
- No parental animals died or showed clinical signs of toxicity.
- Mortality:
- no mortality observed
- Description (incidence):
- No parental animals died or showed clinical signs of toxicity.
- Body weight and weight changes:
- no effects observed
- Description (incidence and severity):
- There were no effects on body weight/body weight gain.
- Food consumption and compound intake (if feeding study):
- no effects observed
- Description (incidence and severity):
- There are no comments on this, but as food consumption was not affected, test substance intake should also have not been affected.
- Food efficiency:
- 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
- Histopathological findings: non-neoplastic:
- no effects observed
- Description (incidence and severity):
- No abnormal findings.
- Other effects:
- no effects observed
Reproductive function / performance (P0)
- Reproductive function: oestrous cycle:
- not examined
- Reproductive function: sperm measures:
- not examined
- Reproductive performance:
- no effects observed
- Description (incidence and severity):
- Pregnancy rates and mean gestation length were comparable between the control and treated groups.
The mean number of live and dead pups at birth were considered comparable between the control and low- and mid-dose group. In high-dose group a decrease in the mean number of live pups with a corresponding increase in the mean number of dead pups was observed at birth; however neither of these values differet statistically from the combined control values.
The percentage of females that weaned litters was comparable between the control and treated groups.
Effect levels (P0)
- Dose descriptor:
- NOAEL
- Effect level:
- 3 000 ppm
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: No adverse effects observed
Target system / organ toxicity (P0)
- Critical effects observed:
- no
Results: P1 (second parental generation)
General toxicity (P1)
- Clinical signs:
- no effects observed
- Description (incidence and severity):
- No clinical signs were noted.
- Mortality:
- no mortality observed
- Description (incidence):
- No mortality was observed.
- Body weight and weight changes:
- no effects observed
- Description (incidence and severity):
- No effects on mean body weight data during growth and rest periods.
During the gestation and lactation intervals for the first litters (F2a) mean weight data were comparable between the control and treated groups. During the gestation and lactation interval for the second litters (F2b) mean weights were comparable between the control and low-dose group and slightly lower than the control data in treated mid- and high-dose groups. These differences were not statistically significant. Mean body weight gain data during these same intervals were considered comparable between control and treated group. - Food consumption and compound intake (if feeding study):
- no effects observed
- Description (incidence and severity):
- The food consumption was comparable between the control and treated groups.
- Food efficiency:
- 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):
- No effects were observed.
- Gross pathological findings:
- no effects observed
- Description (incidence and severity):
- No effects were observed.
- Neuropathological findings:
- not examined
- Histopathological findings: non-neoplastic:
- no effects observed
- Description (incidence and severity):
- No effects were observed.
- Histopathological findings: neoplastic:
- not examined
Reproductive function / performance (P1)
- Reproductive function: oestrous cycle:
- not examined
- Reproductive function: sperm measures:
- not examined
- Reproductive performance:
- no effects observed
- Description (incidence and severity):
- Mating indices for both males and females were comparable between the control and treated groups during both the first and second mating intervals.
Likewise, fertility indices were comparable between these same groups. Pregnancy rates were comparable between the control and treated low- and mid-dose groups for both mating intervals. In high dose group a slight decrease in pregnancy rate was observed during the first mating interval; this difference from the control data was not statistically significant. During the mating interval to produce the second litter (F2b), pregnancy rate for high-dose group was comparable to the control data. Parturition indices were comparable.
Mean gestation length was considered comparable between the control and treated groups for both pregnancy intervals. A statistically significant reduction in mean gestation length in mid-dose group from the pooled control data for the first pregnancy interval (F2a) was considered spurious and not related to treatment.
The mean numbers of live and dead pups at birth were considered comparable between the control and treated groups for both the first and second litters (F2a and F2b, respectively). A slight increase in the mean number of dead pups at birth in high-dose group for the first litters (F2a) was attributed to one high-dose female that had five dead pups. The percentage of females that weaned litters was comparable between the control and treated groups for both the first and second lactation intervals.
Effect levels (P1)
- Dose descriptor:
- NOAEL
- Effect level:
- >= 3 000 ppm
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: No adverse effects observed
Target system / organ toxicity (P1)
- Critical effects observed:
- no
Results: F1 generation
General toxicity (F1)
- Clinical signs:
- no effects observed
- Description (incidence and severity):
- There were no clinical signs of toxicity.
- Mortality / viability:
- mortality observed, non-treatment-related
- Description (incidence and severity):
- The mean numbers of live and dead pups at birth (F1) were considered comparable between the controls and 300 and 1000 ppm groups. In the high dose group the live birth index was significantly lower (p<0.01) than incidence data for the control group. The 24-hour and 4-day survival indices for the treated groups were slightly lower than the control values and some statistically significant differences from the control group were observed. No obvious dose-response relationship was apparent in the 24-hour and 4-day survival indices and no treatment-related effects were indicated. Pup survival indices for the 14-day and 21-day intervals were comparable to the control values.
- Body weight and weight changes:
- no effects observed
- Description (incidence and severity):
- In the highest dose group (F1) there was a non-statistically significant reduction in mean pup weights at days 0, 4, 14 and 21 of lactation. There was no difference at other time points. Mean pup weight was comparable to the control group for all the other treatment groups.
- Food consumption and compound intake (if feeding study):
- not examined
- Food efficiency:
- not examined
- Ophthalmological findings:
- not examined
- Haematological findings:
- not examined
- Clinical biochemistry findings:
- not examined
- Urinalysis findings:
- not examined
- Sexual maturation:
- not examined
- Anogenital distance (AGD):
- not examined
- Nipple retention in male pups:
- not examined
- Organ weight findings including organ / body weight ratios:
- not examined
- Gross pathological findings:
- no effects observed
- Description (incidence and severity):
- No abnormal findings.
- Histopathological findings:
- not examined
- Other effects:
- no effects observed
- Description (incidence and severity):
- Sex distribution data between the treated and control groups were comparable.
Developmental neurotoxicity (F1)
- Behaviour (functional findings):
- not examined
Developmental immunotoxicity (F1)
- Developmental immunotoxicity:
- not examined
Effect levels (F1)
- Dose descriptor:
- NOAEL
- Generation:
- F1
- Effect level:
- >= 3 000 ppm
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: No adverse effects observed
Target system / organ toxicity (F1)
- Critical effects observed:
- no
Results: F2 generation
General toxicity (F2)
- Clinical signs:
- not examined
- Mortality / viability:
- no mortality observed
- Description (incidence and severity):
- Pup survival for F2a and F2b was comparable with the control group.
- Body weight and weight changes:
- effects observed, non-treatment-related
- Description (incidence and severity):
- (F2a) mean pup weight at birth was slightly lower than control values in treated mid- and high-dose groups. Only in high-dose group was this difference statistically significant from the pooled control data. Mean pup weight at Days 4, 14 and 21 were considered comparable between the control and treated groups.
In the second litters (F2b) mean pup weights were considered comparable between the control and treated groups throughout lactation.
In the males, mean terminal body weights were slightly lower than the pooled control value in treated mid- and high-dose groups and higher than control in low dose group. None of these differences were statistically significant. In the females, mean terminal body weights were comparable between the control and treated groups. - Food consumption and compound intake (if feeding study):
- not examined
- Food efficiency:
- not examined
- Ophthalmological findings:
- not examined
- Haematological findings:
- not examined
- Clinical biochemistry findings:
- not examined
- Urinalysis findings:
- not examined
- Sexual maturation:
- not examined
- Anogenital distance (AGD):
- not examined
- Nipple retention in male pups:
- not examined
- Organ weight findings including organ / body weight ratios:
- no effects observed
- Description (incidence and severity):
- No effects seen at necropsy of F2a and F2b.
- Gross pathological findings:
- no effects observed
- Description (incidence and severity):
- No effects seen at necropsy of F2a and F2b.
- Histopathological findings:
- not examined
- Other effects:
- no effects observed
- Description (incidence and severity):
- Sex distribution ratios for the treated groups both at birth, day 4 (post-cull) and weaning revealed no treatment effects during either the first or second litters.
Developmental neurotoxicity (F2)
- Behaviour (functional findings):
- not examined
Developmental immunotoxicity (F2)
- Developmental immunotoxicity:
- not examined
Effect levels (F2)
open allclose all
- Dose descriptor:
- NOAEL
- Generation:
- F2a
- Effect level:
- >= 3 000 ppm
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: No adverse effects observed
- Dose descriptor:
- NOAEL
- Generation:
- F2b
- Effect level:
- >= 3 000 ppm
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: No adverse effects observed
Target system / organ toxicity (F2)
- Critical effects observed:
- no
Overall reproductive toxicity
- Reproductive effects observed:
- no
Any other information on results incl. tables
Table 2 Summary of Gestation length, litter survival, growth of offspring and weaning sex ratio data.
Group (ppm) | Mean gestation period (days) | Mean No. | Mean No. weaned/litter | Litters weaned | Mean live offspring weights (g) | Day 21 sex ratio (M/F) | ||||||
Live | Dead | No | % | Day 0 | Day 4a | Day 14 | Day 21 | No. | Ratiob | |||
F0 to F1 | ||||||||||||
I/0 | 22.1 | 12.3 | 0.1 | 9.8 | 18/18 | 100 | 5.9 | 9.4 | 27.3 | 40.8 | 86/90 | 0.96 |
II/0 | 22.1 | 11 | 0.6 | 8.9 | 17/18 | 94.4 | 5.9 | 9.3 | 27.0 | 41.5 | 71/81 | 0.88 |
I+II | 22.1 | 11.6 | 0.3 | 9.4 | 5.9 | 9.3 | 27.2 | 41.1 | ||||
III/300 | 21.9 | 11.3 | 0.8 | 9.5 | 17/18 | 94.4 | 5.9 | 9.6 | 27.9 | 41.3 | 81/81 | 1.00 |
IV/1000 | 21.9 | 10.9 | 0.6 | 8.7 | 17/17 | 100 | 6.1 | 9.8 | 27.3 | 40.4 | 65/83 | 0.78 |
V/3000 | 22.3 | 9.2 | 1.9 | 7.9 | 17/19 | 89.5 | 5.7 | 8.5 | 26.6 | 40.8 | 64/70 | 0.91 |
F1 to F2a | ||||||||||||
I/0 | 22.4 | 10.9 | 0.1 | 8.7 | 13/14 | 92.9 | 6.3 | 9.7 | 26.6 | 35.4 | 55/58 | 0.95 |
II/0 | 22.4 | 10.5 | 0.3 | 9.1 | 14/15 | 93.3 | 6.1 | 10.1 | 25.5 | 35.3 | 64/63 | 1.02 |
I+II | 22.4 | 10.7 | 0.2 | 8.9 | 6.2 | 9.9 | 26.0 | 35.3 | ||||
III/300 | 22.3 | 12.4# | 0.1 | 9.3 | 17/18 | 94.4 | 6.2 | 9.3 | 26.0 | 36.4 | 83/75 | 1.11 |
IV/1000 | 22.1# | 11.1 | 0.0 | 8.8 | 19/19 | 100 | 5.8 | 9.2 | 24.8 | 34.7 | 84/84 | 1.00 |
V/3000 | 22.2 | 11.7 | 0.8 | 9.5 | 13/13 | 100 | 5.8# | 9.2 | 25.6 | 34.6 | 60/63 | 0.95 |
F1 to F2b | ||||||||||||
I/0 | 22.3 | 12.3 | 0.1 | 8.9 | 14/15 | 93.3 | 6.0 | 8.8 | 26.1 | 39.2+ | 59/66 | 0.89 |
II/0 | 22.1 | 9.4 | 0.9 | 7.8 | 15/17 | 88.2 | 6.1 | 9.7 | 29.5 | 45.0* | 61/56 | 1.09 |
I+II | 22.2 | 10.8 | 0.6 | 8.3 | 6.0 | 9.3 | 27.8 | |||||
III/300 | 22.1 | 12.5 | 0.3 | 9.3 | 19/19 | 100 | 6.1 | 9.5 | 27.6 | 41.3 | 83/93 | 0.89 |
IV/1000 | 22.1 | 11.4 | 0.9 | 9.3 | 15/17 | 88.2 | 5.8 | 9.0 | 26.5 | 39.5 ++ | 75/73 | 1.03 |
V/3000 | 22.2 | 11.1 | 0.5 | 9.2 | 14/15 | 93.3 | 5.9 | 9.3 | 27.2 | 40.1 | 63/66 | 0.95 |
Significantly different from control Group I: *p≤0.05; **p≤0.01.
Significantly different from control Group II: +p ≤0.05; ++p ≤0.01.
Significantly different from pooled values of control Groups I and II: #p ≤0.05; ##p ≤0.01.
a Pre-cull weight only.
b Data not analysed statistically.
Applicant's summary and conclusion
- Conclusions:
- In a well conducted and documented, pre-GLP one generation reproductive toxicity study (reliability score 2), CP 66257 (DTPMP) administered via the diet caused no clear treatment-related or statistically significant effects in rats. Pregnancy rate and pup body weight were lower for F2a litters from dams fed diets containing 3000 ppm DTPMP, but this was not replicated in the F1 or F2b litters. A NOAEL of 294 mg/kg bw/d for males and 312 mg/kg bw/d in females was therefore concluded.
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