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EC number: 701-215-9 | CAS number: -
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Endpoint summary
Administrative data
Key value for chemical safety assessment
Effects on fertility
Description of key information
In line with ECHA Final Decision number CCH-D-2114495769-22-01/F an extended one-generation reproductive toxicity study in rats, according to OECD Test Guideline 443, has been planned for the Category member DTPMP (5-7Na), which will be read across to DTPMP (1-3Na). The deadline for submitting the requested information is 22 May 2023.
Effect on fertility: via oral route
- Endpoint conclusion:
- no study available
Effect on fertility: via inhalation route
- Endpoint conclusion:
- no study available
Effect on fertility: via dermal route
- Endpoint conclusion:
- no study available
Additional information
In line with ECHA Final Decision number CCH-D-2114495769-22-01/F an extended one-generation reproductive toxicity study in rats, according to OECD Test Guideline 443, has been planned for the Category member DTPMP (5-7Na), which will be read across to DTPMP (1-3Na). The deadline for submitting the requested information is 22 May 2023.
In a supporting one-generation reproductive study (BioDynamics Inc., 1979), conducted prior to OECD Test Guidelines and GLP, DTPMP-H was administered continuously via the diet to Long-Evans rats at concentrations of 300, 1000 and 3000 ppm through one complete generation. Test substance administration to the F0 generation females (20/group) was initiated at the onset of gestation and continued throughout the ensuing gestation and lactation periods. Administration then continued to the F1 generation animals (10 males and 20 females/group) through a growth period and mating, gestation and lactation period for two successive litters. In the F0 generation, no treatment-related effects in the low and mid dose groups were evident. In the high dose group, females delivered litters containing fewer live pups and more dead pups (not statistically significant) resulting in a lower live birth index. Pups also had a lower weight at birth (not statistically significant). No other treatment-related effects were observed. In the F1 generation, no treatment-related effects were evident in the low dose group. No such effects were observed in the second litters and no other treatment-related effects were observed during the remainder of the study. Gross pathological examination of five adult F1 generation males and females of the control and high dose groups did not reveal any abnormal findings. The NOAEL was concluded to be 3000 ppm, equivalent to 294 mg/kg bw/day for males and 312 mg/kg bw/day for females.
Effects on developmental toxicity
Description of key information
There are no prenatal developmental toxicity data for DTPMP(1-3Na), therefore data are read-across from other DTPMP Category members.
In the prenatal developmental toxicity study with DTPMP-7Na (Monsanto, 1982), conducted according to a protocol similar to OECD Test Guideline 414 and in compliance with GLP, clear maternal toxicity (approx. 30% decrease in body weight gain, soft stools) was noted in pregnant Sprague-Dawley rats given 2000 mg/kg bw/day DTPMP-7Na (expressed as active acid) on gestation days 6-19, therefore the NOAEL for maternal toxicity was concluded to be 1000 mg/kg bw/day. The NOAEL for developmental toxicity was concluded to be 2000 mg/kg bw/day (active acid) based on no adverse developmental effects at the highest dose level tested.
In line with ECHA Final Decision number CCH-D-2114495769-22-01/F a prenatal developmental toxicity study in second species (rabbit), according to OECD Test Guideline 414, has been planned for the Category member DTPMP (5-7Na), which will be read across to DTPMP (1-3Na). The deadline for submitting the requested information is 22 May 2023.
Link to relevant study records
- Endpoint:
- developmental toxicity
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 21.05.1980 to 09.06.1980
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 414 (Prenatal Developmental Toxicity Study)
- Deviations:
- yes
- Remarks:
- No record of gravid uterine weight, number of corpora lutea not recorded, no analytical confirmation of dosing solutions.
- GLP compliance:
- yes
- Limit test:
- no
- Species:
- rat
- Strain:
- Sprague-Dawley
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River
- Age at study initiation: No data
- Weight at study initiation: 180-200 g
- Fasting period before study: No data
- Housing: Individually in suspended stainless steel mesh cages.
- Diet (e.g. ad libitum): Ad libitum
- Water (e.g. ad libitum): Ad libitum
- Acclimation period: None, animals were received mated and allocated to cages.
ENVIRONMENTAL CONDITIONS
- Temperature (°F): 72 ±2
- Humidity (%): 40-60
- Air changes (per hr): No data
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: 26.05.1980 To: 09.06.1980 - Route of administration:
- oral: gavage
- Vehicle:
- other: Aqueous solution
- Details on exposure:
- No data
- Analytical verification of doses or concentrations:
- no
- Details on mating procedure:
- No data. Animals were received on gestational day 1, having already been mated.
- Duration of treatment / exposure:
- GD 6 - 19
- Frequency of treatment:
- daily
- Duration of test:
- 20 days
- Dose / conc.:
- 500 mg/kg bw/day
- Dose / conc.:
- 1 000 mg/kg bw/day
- Dose / conc.:
- 2 000 mg/kg bw/day
- No. of animals per sex per dose:
- 25
- Control animals:
- other: 0.9% (w/v) aqueous NaCl
- Details on study design:
- - Dose selection rationale: No data
- Maternal examinations:
- CAGE SIDE OBSERVATIONS: Yes
- Time schedule: Twice daily for visible toxic effects.
DETAILED CLINICAL OBSERVATIONS: No
BODY WEIGHT: Yes
- Time schedule for examinations: Gestational days 3, 6, 8, 10, 13, 15, 17 and 20.
FOOD CONSUMPTION: No
WATER CONSUMPTION: No
POST-MORTEM EXAMINATIONS: Yes
- Sacrifice on gestation day 20
- Organs examined: Gross examination of all animals that included examination of external surfaces and thoracic and abdominal cavities. - Ovaries and uterine content:
- The ovaries and uterine content was examined after termination: yes
Examinations included:
- Gravid uterus weight: No
- Number of corpora lutea: Yes
- Number of implantations: Yes
- Number of early resorptions: Yes
- Number of late resorptions: Yes - Fetal examinations:
- - External examinations: Yes: all per litter
- Soft tissue examinations: Yes: half per litter
- Skeletal examinations: Yes: half per litter
- Head examinations: No data - Statistics:
- Comparison of body weights between treatment and control groups was performed using Dunnett's test. Counted data (corpora lutea, implants, resorptions, live and dead fetuses) and data expressed as percentage were analysed, when appropriate with the Mann-Whitney U test. Response data (pregnancy rates, number of litters with post-implantation loss, and fetuses or litters with abnormalities and variants) were analysed, when appropriate, with Fisher's exact test and the chi-square test.
- Indices:
- None
- Historical control data:
- No data
- Clinical signs:
- effects observed, treatment-related
- Description (incidence and severity):
- 9/25 dams had soft stools in the 2000 mg/kg bw/day group beginning on gestation day 14 (9th day of the treatment) and persisted through to gestation day 17. This finding was not observed in the other treated groups or the controls.
- Mortality:
- no mortality observed
- Description (incidence):
- No deaths occurred prior to the scheduled sacrifice.
- Body weight and weight changes:
- effects observed, treatment-related
- Description (incidence and severity):
- The only statistically significant (P<0.01) effect observed was lower body weight gain (mean value approximately 68% of the control mean) between gestation day 6 and 20 for dams in the 2000 mg/kg bw/day group (33.6/27.6/27.5/22.9). However, terminal body weights were not statistically significantly affected (mean terminal body weights with uterine contents by dose: 360.1/368.1/357.0/346.1 and mean terminal body weights without uterine contents: 265.8/264.5/260.1/257.2).
- Food consumption and compound intake (if feeding study):
- no effects observed
- 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
- Gross pathological findings:
- no effects observed
- Description (incidence and severity):
- There were no treatment-related findings in the gross necropsy.
- Neuropathological findings:
- not examined
- Histopathological findings: non-neoplastic:
- no effects observed
- Histopathological findings: neoplastic:
- no effects observed
- Number of abortions:
- no effects observed
- Pre- and post-implantation loss:
- no effects observed
- Description (incidence and severity):
- There were no significant differences between any of the treatment groups and the control group in the number of pre- or postimplantation losses.
- Total litter losses by resorption:
- no effects observed
- Description (incidence and severity):
- There were no significant differences between any of the treatment groups and the control group in the resorptions.
- Early or late resorptions:
- no effects observed
- Description (incidence and severity):
- There were no significant differences between any of the treatment groups and the control group in the resorptions.
- Dead fetuses:
- no effects observed
- Description (incidence and severity):
- There were no significant differences between any of the treatment groups and the control group in the mean number of live fetuses.
- Changes in pregnancy duration:
- no effects observed
- Changes in number of pregnant:
- no effects observed
- Description (incidence and severity):
- There was no effect on pregnancy rate.
- Other effects:
- no effects observed
- Description (incidence and severity):
- There was no effect on the mean number of corpora lutea.
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- 1 000 mg/kg bw/day
- Based on:
- act. ingr.
- Remarks:
- active acid
- Basis for effect level:
- body weight and weight gain
- Abnormalities:
- effects observed, treatment-related
- Localisation:
- other: body weight gain
- Fetal body weight changes:
- no effects observed
- Description (incidence and severity):
- There were no effects on fetal body weight.
- Reduction in number of live offspring:
- no effects observed
- Description (incidence and severity):
- There were no significant differences between any of the treatment groups and the control group in the mean number of live fetuses.
- Changes in sex ratio:
- no effects observed
- Description (incidence and severity):
- There were no effects on sex ratios (males/litter: 5.6/5.8/5.9/4.8. Females/litter: 5.9/6.5/5.4/6.4).
- 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):
- There were no treatment-related gross external malformations present.
Subcutaneous haematomas were present in controls and all treated groups, however the incidence increased at 500 mg/kg bw/day (P<0.05) and was considered unrelated to treatment by the study authors (no dose relationship was present). The occurrence of one female fetus that was hydrocephalic and one female with gastroschisis in the 1000 mg/kg bw/day group was considered by the study authors to be spontaneous. The hydrocephalic female also exhibited a developmental variation (underdeveloped renal papilla) that was not considered to be related to treatment. - Skeletal malformations:
- effects observed, non-treatment-related
- Description (incidence and severity):
- Skeletal examination revealed single incidences of dwarfism (one female fetus of 500 mg/kg bw/day group) and fused sternebrae (one female fetus of the 2000 mg/kg bw/day group), which were considered spontaneous. Two fetuses from different litters in the 2000 mg/kg bw/day group and one fetus of the 1000 mg/kg bw/day group had vertebral anomalies (missing, reduced or fused vertebral arches). Although the incidence of these anomalies was not statistically significant compared with the control group, the rare spontaneous occurrence of such anomalies and the pattern of incidence indicated that they might have been treatment-related. Various skeletal variations occurred, but none showed a clear dose-response and so were considered spontaneous. Review of these results for the REACH assessment concluded that the effects should not be considered adverse as they were not statistically significant and were only observed in the presence of maternal toxicity. The limit dose for a prenatal developmental toxicity study conducted to OECD 414 is 1000 mg/kg bw/day, therefore the high dose used in this old study was double the limit dose. When findings up to the limit dose are considered, vertebral anomalies were observed in only one fetus. Therefore, this finding is not considered adverse.
- Visceral malformations:
- no effects observed
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- >= 2 000 mg/kg bw/day
- Based on:
- act. ingr.
- Remarks:
- active acid
- Sex:
- male/female
- Basis for effect level:
- other: No adverse developmental effects observed.
- Abnormalities:
- no effects observed
- Developmental effects observed:
- no
- Conclusions:
- In the prenatal developmental toxicity study with DTPMP-7Na, conducted according to a protocol similar to OECD Test Guideline 414 and in compliance with GLP, clear maternal toxicity (approx. 30% decrease in body weight gain, soft stools) was noted in pregnant Sprague-Dawley rats given 2000 mg/kg bw/day DTPMP-7Na (expressed as active acid) on gestation days 6-19, therefore the NOAEL for maternal toxicity was concluded to be 1000 mg/kg bw/day. The NOAEL for developmental toxicity was concluded to be 2000 mg/kg bw/day (active acid) based on no adverse developmental effects.
Reference
Effect on developmental toxicity: via oral route
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- NOAEL
- 2 000 mg/kg bw/day
- Study duration:
- subacute
- Species:
- rat
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
There are no prenatal developmental toxicity data for DTPMP(1-3Na), therefore data are read-across from other DTPMP Category members. See attachment to Section 13 for justification of read-across.
In the prenatal developmental toxicity study with DTPMP-7Na (Monsanto, 1982), conducted according to a protocol similar to OECD Test Guideline and in compliance with GLP, mated female Sprague-Dawley rats (25/dose) were given daily oral gavage doses of 500, 1000, 2000 mg/kg bw/day DTPMP-7Na (expressed as active acid) during gestation days 6 to 19. Control animals were given 0.9% sodium chloride solution. On day 20 all surviving animals were sacrificed and foetuses were examined. There were no deaths prior to scheduled sacrifice. The highest dose produced marginal toxic effects in the dams, as evidenced by lower mean body weight gain between gestational days 6 and 20, and soft stools in some animals. No treatment-related lesions were detected at gross necropsy of the dams of any treatment group. There were no statistically significant treatment-related effects on post-implantation loss or foetal weight at any dose. Vertebral anomalies were observed in single foetuses in two litters of the 2000 mg/kg bw/day group and one of the 1000 mg/kg bw/day group. The incidence was not statistically significant and the effect was only observed in the presence of maternal toxicity. In addition, the limit dose for a prenatal developmental toxicity study conducted to OECD 414 is 1000 mg/kg bw/day, therefore the high dose used in this old study was double the limit dose. When findings up to the limit dose are considered, vertebral anomalies were observed in only one fetus. Therefore, this finding is concluded not to be adverse. The NOAEL for maternal toxicity was concluded to be 1000 mg/kg bw/day based on the lower body weight gain, while the NOAEL for developmental toxicity was concluded to be 2000 mg/kg bw/day (active acid) based on no adverse developmental effects.
Information is also available on DTPMP-H from a one-generation reproductive toxicity study (Biodynamics, 1979b), conducted prior to OECD Test Guidelines and GLP, in which DTPMP-H was administered continuously via the diet to Long-Evans rats at concentrations of 300, 1000 and 3000 ppm through one complete generation. Test substance administration to the F0 generation females (20/group) was initiated at the onset of gestation and continued throughout the ensuing gestation and lactation periods. Administration then continued to the F1 generation animals (10 males and 20 females/group) through a growth period and mating, gestation and lactation period for two successive litters. In the F0 generation, no treatment-related effects in the low and mid dose groups were evident. In the high dose group, females delivered litters containing fewer live pups and more dead pups (not statistically significant) resulting in a lower live birth index. Pups also had a lower weight at birth (not statistically significant). No other treatment-related effects were observed. In the F1 generation, no treatment-related effects were evident in the low dose group. No such effects were observed in the second litters and no other treatment-related effects were observed during the remainder of the study. Gross pathological examination of five adult F1 generation males and females of the control and high dose groups did not reveal any abnormal findings. The NOAEL was concluded to be 3000 ppm, equivalent to 294 mg/kg bw/day for males and 312 mg/kg bw/day for females.
Justification for classification or non-classification
Based on the available data, no classification for reproductive and developmental toxicity is required for DTPMP (1-3Na) according to Regulation (EC) No 1272/2008.
Additional information
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.

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