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EC number: 208-932-1 | CAS number: 547-66-0
- 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
Endpoint summary
Administrative data
Key value for chemical safety assessment
Effects on fertility
Description of key information
A study was carried according to a protocol developed by the National Toxicology Program. This guideline is very similar to the two-generations study described by the OECD (OECD 416). The parameters checked are also in line with OECD 416. Not all raw data are present in the study report. The study has been perfomed in accordance with GLP. No reproductive effect related to the tet item was observed. These results are considered relevant and are used in a read across approach.
Link to relevant study records
- Endpoint:
- two-generation reproductive toxicity
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other:
- Remarks:
- The study was carried according to a protocol developed by the National Toxicology Program. This guideline is very similar to the two-generations study described by the OECD (OECD 416). The parameters checked are also in line with OECD 416. Not all raw data are present in the study report. The study has been perfomed in accordance with GLP.
- Justification for type of information:
- REPORTING FORMAT FOR THE ANALOGUE APPROACH
Further information in a detailed justification report is included as attachment to the same record.
1. HYPOTHESIS FOR THE ANALOGUE APPROACH
For the determination of analogue in this read-across approach, the following points have been considered:
- Chemical speciation and valency (common magnesium cation: Mg2+).
- The water solubility, as it provides a first indication of the availability of the metal ion in the different compartments of interest. The most simplistic approach to hazard evaluation is to assume that the specific metal-containing compound to be evaluated shows the same hazards as the most water-soluble compounds.
- In fluids of organisms and in aqueous media, dissociation of magnesium oxalate takes place immediately, resulting in formation of magnesium cations (Mg2+) and oxalate anions. Thus, any ingestion or absorption of magnesium oxalate by living organisms, in case of systemic consideration, will inevitably result of exposure to the dissociation products.
- Magnesium is an abundant mineral naturally present in the body. It is a cofactor in more than 300 enzyme systems that regulate diverse biochemical reactions in the body, including protein synthesis, muscle and nerve function, blood glucose control, and blood pressure regulation (IOM 1997, Rude 2010, Rude 2012). Magnesium is required for the normal functioning of several biochemical and physiological reactions and pay an essential role in the human body (Rude 2012). An adult body contains approximately 25 g magnesium, with 50% to 60% present in the bones and most of the rest in soft tissues (Volpe 2012). Human Recommended Dietary Allowances (RDA) for magnesium is up to 420mg per day (IOM 1997). For the same reasons (involvement in biochemical and physiological functions), magnesium is also naturally present in various organisms of the environment such as fish, crustacea or vegetables. Besides they are identified as food sources of magnesium (US 2012). Consequently, it can be concluded that magnesium is of low (eco)toxicological relevance when ingested and taken up systemically. Thus, any possible toxicological or ecotoxicological effect triggered by magnesium oxalate exposure can be attributed to oxalate anion.
- Counter ions: the assumption that the oxalate ion is responsible for the common property or effect implies that the toxicity or ecotoxicity of the counter ion present in the compound will be largely irrelevant in producing the effects to be assessed.
- Likely common breakdown products via physical and/or biological processes for the targeted substance (magnesium oxalate) and the analogues identified cannot present strong differences since the structures are very simple and very similar (formation of Mg2+ or oxalate ion).
2. SOURCE AND TARGET CHEMICAL(S) (INCLUDING INFORMATION ON PURITY AND IMPURITIES)
Source chemical information is provided in the “source” endpoint. No impurity affecting the classification is reported for the source chemical.
Information on the impurities of the target chemical are detailed in the attached report.
3. ANALOGUE APPROACH JUSTIFICATION
The main hypothesis for the analogue approach are verified. They are presented in the detailed report attached. The experimental data performed on the substance (tests performed in this REACH registration dossier on strontium peroxide) confirms the analogue approach performed (same results on analogues).
4. DATA MATRIX
A data matrix is presented in the detailed report attached. - Reason / purpose for cross-reference:
- read-across source
- Vehicle:
- water
- Clinical signs:
- no effects observed
- Body weight and weight changes:
- no effects observed
- Food consumption and compound intake (if feeding study):
- no effects observed
- Water consumption and compound intake (if drinking water study):
- no effects observed
- Organ weight findings including organ / body weight ratios:
- effects observed, treatment-related
- Histopathological findings: non-neoplastic:
- no effects observed
- Histopathological findings: neoplastic:
- no effects observed
- Reproductive function: oestrous cycle:
- no effects observed
- Reproductive function: sperm measures:
- no effects observed
- Reproductive performance:
- no effects observed
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- <= 0.1 other: %
- Sex:
- male/female
- Basis for effect level:
- other: Fertility
- Clinical signs:
- no effects observed
- Body weight and weight changes:
- no effects observed
- Sexual maturation:
- no effects observed
- Organ weight findings including organ / body weight ratios:
- effects observed, treatment-related
- Gross pathological findings:
- no effects observed
- Histopathological findings:
- no effects observed
- Key result
- Dose descriptor:
- NOAEL
- Generation:
- F1
- Effect level:
- <= 1 000 ppm
- Sex:
- male/female
- Basis for effect level:
- other: Fertility
- Key result
- Reproductive effects observed:
- no
- Conclusions:
- In conclusion, oxalic acid administered in drinking water at up to the 0.1% dose level does not affect the fertility in adult or second generation CD-1 mice. Significant reduction (p<0.05) was noted with respect to the number of litters per pair and adjusted live pup weights during Task 2-at the 0.2% dose level. During Task 4, the total number of live pups and the number of live female pups delivered by second generation breeding pairs were significantly less (p<0.05) than the corresponding control values. The prostate gland in animals exposed to 0.2% oxalic acid was smaller as evidenced by significantly reduced absolute and adjusted weights at necropsy. For second generation mice, adjusted kidney weight for female animals and absolute kidney weight for male mice were significantly increased (p<0.05). SMVCE studies indicated that prolonged oxalic acid treatment may interfere with the relative frequency of estrus as evidenced by the data from first generation mice. The incidence of abnormal sperm was almost doubled in second generation mice receiving 0.2% oxalic acid in drinking water. Since the increase in the percentage of abnormal sperm was noted in both treated second generation animals (Task 4) and adult mice (Task 2), it is possible that oxalic acid interferes with spermiogenesis.
In a read across approach, this conclusion is used in the assessment of magnesium oxalate properties. - Executive summary:
The National Toxicology Program (NTP) has developed a reproductive toxicity system designated "Fertility Assessment by Continuous Breeding" (FACB). Caesarean originated Barrier-sustained (COBS) CD-1 (ICR)BR outbred albino mice are used for the FACB study. It consists of four related tasks, not all of which are necessarily performed for a given compound.
The study consisted of three successive tasks designed to determine the effects of oxalic acid on reproduction and fertility in CD-1 mice. The chemical was administered in the drinking water.Task 1, which is not analyzed statistically, was performed in order to select the doses for Task 2.In the second task,40males and 40females were randomly paired and received a vehicle control dose,19pairs received a low dose of 0.05%, 19 pairs received a mid range dose of 0.10%, and20 pairs received a high dose of 0.20%.The pairs were housed together for 98 days, followed by a 21 day segregation period to allow for delivery of the final litters. Because the overall response (affected fertility) during Task 2 wasnegative, Task 3 was not performed and Task 4was performed using second generation animals from the control and high dose groups only.
In Task 4, the reproductive performance of the control and high dose offspring from the final Task 2litters was evaluated. Group A consisted of 20 pairs of control males and females, and Group B consisted of 20 pairs of high dose level males and females. After a seven day cohabitation period, the pairs were separated and the females were allowed to deliver their litters.
At the conclusion of Tasks 1,2 and 4, experimental animals were necropsied: the liver, kidneys, testes, epididymis, prostate, and seminal vesicles with coagulating glands are weighed and fixed for histopathologic evaluation. In addition, vaginal smears are prepared for 7 consecutive days prior to necropsy to check the effect on the estrous cycle. For male mice, sperm-are studied in detail to evaluate the effect on sperm density, sperm motility, and sperm head morphology.
Exposure to oxalic acid produced no adverse effects on mating or fertility.In Task 2, treatment with 0.20% oxalic acid resulted in significant decreases in the average number of litters per fertile pair, unadjusted pup weight(males only) and adjusted pup weight. Adjusted prostate weight was significantly decreased(by21%)in high dose males, and adjusted kidney weight was increased (by 9%) in high dose females.
In Task 4, the only significant result found in the litter analysis was a decrease at the high dose level in the average number of live pups per litter. At necropsy, kidney weight was significantly increased in high dose males (by11%)and females(by9 %) .
In conclusion, oxalic acid administered in drinking water at up to the 0.1% dose level does not affect the fertility in adult or second generation CD-1 mice.
Reference
2 females died during cohabition of task 2 (1 in the 0,05% and 1 in the 0,1% dose group)
A dose relate decrease in water consumption was noted at 0,1% and 0,2% dose levels. However this did not result in any significant clinical toxicity
BODY WEIGHT AND FOOD CONSUMPTION (PARENTAL ANIMALS)
No significant effect
TEST SUBSTANCE INTAKE (PARENTAL ANIMALS)
no significant effects
REPRODUCTIVE FUNCTION: ESTROUS CYCLE (PARENTAL ANIMALS)
No significant effects. No effect on the relative frequency of different estrous stages exept for percent estrus (11% vs 21% in the treatment group). Additional experiments are needed to confirm the adverse effects of oxalic acid on the estrus phase.
REPRODUCTIVE FUNCTION: SPERM MEASURES (PARENTAL ANIMALS)
No significant effects
REPRODUCTIVE PERFORMANCE (PARENTAL ANIMALS)
No significant effects
ORGAN WEIGHTS (PARENTAL ANIMALS)
Prostate gland in animals exposed to 0,2% oxalic acid was smaller as evidenced by significantly reduced absolute and adjusted weights at necropsy
GROSS PATHOLOGY (PARENTAL ANIMALS)
No significant effects
HISTOPATHOLOGY (PARENTAL ANIMALS)
no significant effects
OTHER FINDINGS (PARENTAL ANIMALS)
Significant increase in the percentage of abnormal sperm
Task 2: At the highest dose level tested a small but significant drop in the number of litters (4,7 vs 4,92) was noted.
Task 4: The total number of live pups and the number of live female pups delivered by second generation breeding pairs were significantly less than the corresponding control values
CLINICAL SIGNS (OFFSPRING)
No significant effects
BODY WEIGHT (OFFSPRING)
No significant effects
SEXUAL MATURATION (OFFSPRING)
No significant effects
ORGAN WEIGHTS (OFFSPRING)
The kidney weight of treated animals was significantly higher than the control group. When the organ weights were adjusted for body weight at necropsy, the observed differences with differences with respect to kidney weight were no longer significant.
GROSS PATHOLOGY (OFFSPRING)
No data
HISTOPATHOLOGY (OFFSPRING)
No data
OTHER FINDINGS (OFFSPRING)
Incidence of abnormal sperm was significantly higher than the control value.
Blood-serum calcium levels in treated animals and controls were essentially the same.
Table 3. Male Body and Organ Weights at Necropsy (Task 2) Oxalic Acid | ||
Treatment Group | ||
Variable (a | Control | 0,20% |
Body (g) | 40.270± 1.797(10) (b,c | 44.840± 2.098 ( 10) |
Liver. (g) | 1.837 ± 0.082 ( 10) | 2.015 ± 0.087 (10) |
Kidneys (g) d | 0.700± 0.025 ( 10) | 0.729± 0.033 (°10) |
Seminal Vesicles (g) | 0.663± 0.047 ( 10) | 0.688± 0.042 ( 10) |
R. Testis (g) | 0.134 ± 0.007 (10) | 0.14'1 ± 0.012 (10) |
R. Cauda (mg) | 16.980± 0.778 (10) | 17.750± 0.725(10) |
R. Epididymis (mg) | 51.250± 1.912(10) | 50.770± 1.778 (10) |
Prostate Gland (mg) | 23.670 ± 1 .627 (10) | 19.356 ± 0.51 3 ( 09) (e, f) |
a: Mean ± SE. | ||
b: Number of animals providing the data indicated in parenthesis. | ||
c: Ten representative animals were necropsied in the control and 0.2% groups. | ||
d: The kidneys were weighed with the adrenal glands attached. | ||
e: Significantly different (p0.05) from the control group | ||
f: One prostate was lost due to technical error. |
Table 4 | Summary of Data from Sperm Studies (Task 2) Oxalic Acid | ||||||
Weight | |||||||
Treatment | Body | R. Caudal | R. Epididymal | R. Testicular | Sperm Motility | Sperm Density | Abnormal Sperm |
Group | (g) | (mg) | (mg) | (g) | (%) | x 10^6 a | (%) |
Control | 40.271 1.80 (10)b,c | 16.980 10.778(10) | 51.25011.912 (10) | 0.1341 0.007 (10) | 95.2 10.61 (10) | 787 t 82(09)d | 5.33 t 0.98(09)d |
0,20% | 44.841 2.10 (10) | 17.750 10.725 (10) | 50.77011.778 (10) | 0.141 t 0.012 (10) | 94.3 1 0.87 (10) | 987 1103 (09) | 7.20t 0.96(091 |
a: Per g caudal tissue. | |||||||
b: Number of animals providing the data indicated In parenthesis. | |||||||
c: Mean t SE. | |||||||
d: Sperm suspensions from 2 animals (1 control and 1 treated) were accidentally mixed; the suspensions were discarded |
Table 5. | Summary of Pup Survival and Body Weight Data (Task 2 - Final Litter) Oxalic Acid | |||
Treatment Oroup | ||||
Parameter | ||||
Control | 0,10% | 0,20% | ||
NUMBER OF BREEDING PAIRS | 40 | 19 | 20 | |
NUMBER OF LITTERS BORN | 38 | 19 | 18 | |
TOTAL LIVE PUPS PER LITTER | ||||
Age | 0 | 12.47 ± 0.60 (38)a.b | 12.47 ± 1.10 (19) | 11.78! 0.61 (18) |
(Days) | 4 | 11.37 ± 0.71 (38) | 11.32 ± 1.21 ( 19) | 10.78t 0.83 (18) |
14 | 11.09 ± 0.76(38) | 11.26 ± 1.20 (19) | 10.78± 0.83 (18) | |
LIVE MALE PUPS PER LITTER | ||||
Age | 0 | 6.29± 0.36(38) | 5.37 ± 0.61 ( 19) | 5.56± 0.37 (18) |
(Days) | 4 | 5.58 ± 0.41 (38) | 4.84 ± 0.64 (19) | 5.17± 0.46 (18) |
14 | 5.47 ± 0.4308) | 5.00 ± 0.69 (19) | 5.11± 0.44 (18) | |
LIVE FEMALE PUPS PER LITTER | ||||
Age | 0 | 6.18± 0.42 (38) | 7.11 ± 0.70(19) | 6.22± 0.50 (18) |
(Days) | 4 | 5.79± 0.46 (38) | 6.47 ± 0.78 (19) | 5.61± 0.51 (18) |
14 | 5.55± 0.47 (38) | 6.26 ± 0.76 (19) | 5.67± 0.52 (18) | |
LIVE MALE PUP WEIGHT (g) | ||||
Age | 0 | 1.64± 0.03 (38) | 1.64± 0.04 (18) | 1.58± 0.03 ( 18) |
(Days) | 4 | 3.11± 0.09 (37) | 3.17 ± 0.13 ( 17) | 3.03± 0.09 (17) |
14 | 8.03± 0.26 (35) | 7.64± 0.42 ( 17) | 7.49± 0.31 ( 17) | |
LIVE FEMALE PUP WEIGHT (g) | ||||
Age | 0 | 1.55± 0.02 (38) | 1.58± 0.04 (18) | 1.55± 0.02 (18) |
(Days) | 4 | 2.92± 0.11 (38) | 3.09± 0.14 ( 17) | 2.96± 0.08 (17) |
14 | 7.83± 0.27 (35) | 7.55± 0.44 ( 17) | 7.46± 0.27 ( 17) | |
LIVE COMBINED PUP WEIGHT (g) | ||||
Age | 0 | 1.60± 0.02 ( 38) | 1.60± 0.04 ( 18) | 1.56± 0.02 ( 18) |
(Days) | 4 | 2.98± 0.10 (38) | 3.12± 0.14 ( 17) | 2.99± 0.08 ( 17) |
14 | 7.93± 0.26 (35) | 7.56± 0.43 ( 17) | 7.46± 0.29 ( 17) | |
a: Mean +/- SE. | ||||
b:Number of fertile pairs providing the data indicated in parenthesis. |
Table 6. Reproductive Performance of Second Generation Fertile Pairs (Task 4) Oxalic Acid | ||
Treatment Group | ||
Reproductive Parameter | Control Male X | 0.20% Male X |
Control Female | 0.20% Female | |
LIVE PUPS PER LITTER | ||
Male | 6.07± 0.50(15)b | 5.39 ± 0.58 (18) |
Female | 6.13 ±0.70(15) | 4.33 ± 0.57 (18) c |
Combined | 12 .20 ±0.61(15) | 9.72 ± 0.65(18) c |
PROPORTION OF PUPS BORN ALIVE | 0.99 ±0.01(15) | 0.98 ±0.01(18) |
SEX OF PUPS BORN ALIVE | ||
(MALES/TOTAL) | 0.51 ± 0.04 ( 15) | 0.56 ±0.04(18) |
LIVE PUP WEIGHT (g) | ||
Male | 1.54 t 0.03(15) | 1.62±0.04(18) |
Female | 1.50 ± 0.04,(15) | 1.55 ± 0.05 (18) |
Combined | 1.52 ± 0.03 (15) | 1.60 ±0.04(18) |
ADJUSTED LIVE PUP WEIGHT (g)d | ||
Male | 1.59 ± 0.04(15) | 1.59 ± 0.04(18) |
Female | 1.54 ± 0.04(15) | 1.52 ± 0.04 ( 18) |
Combined | 1.56 ± 0.04(15) | 1.56 ± 0.04 ( 18) |
a: Mean ±SE. | ||
b: Number of fertile pairs providing the data indicated in parenthesis. | ||
c: Significantly different (p0.05) from the control group. | ||
d: Means adjusted for total number of live and dead pups per litter by analysis of covariance. |
Justification for classification or non-classification
No reproductive effect related to the tet item was observed. These results are considered relevant and are used in a read across approach.
Additional information
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