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EC number: - | CAS number: -
- 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
Description of key information
Acute oral toxicity
Acute oral toxicity was experimentally determined for Fe(Na)EDDHA in rats according to OECD TG 401 . The LD50 values derived from the acute oral toxicity studies with the source substance Fe(Na)EDDHA were > 2000 mg/kg bw (Ciba-Geigy, 1993, Hempstock, 1996).
To address the acute oral toxicity of the zinc ion in the target substance the key value for chemical safety assessment was derived based on a study with zinc sulfate and zinc chloride in rats and mice (Domingo, 1988). Zinc sulfate revealed LD50 values of 1710 and 926 mg/kg bw in rats and mice, respectively. The LD50 values for zinc dichloride were 1100 mg/kg bw and 1260 mg/kg bw in rats and mice, respectively. The majority of deaths for both species were observed within the first 24 hours. No deaths occurred after 3 days. The physical and clinical signs appeared within the first 48 hours. These signs were decreasing or disappearing with time. The principal findings included miosis, conjunctivitis, erythema and necrosis in nose, exophthalmos, and necrosis in tail.
Converted to the target substance under consideration of the maximum zinc concentration of 7.5 % the lowest hazard value found for zinc sulfate in mice of 926 mg/kg bw corresponds to 4500 mg/kg bw.
For more information on the selection of this study please refer to 'Additional information'.
Acute dermal toxicity
Acute dermal toxicity was experimentally determined for Fe(Na)EDDHA in rats according to OECD TG 402. The LD50 values derived from the acute dermal toxicity studies with the source substance Fe(Na)EDDHA were > 2000 mg/kg bw (Ciba-Geigy, 1993, Hempstock, 1996).
Key value for chemical safety assessment
Acute toxicity: via oral route
Link to relevant study records
- Endpoint:
- acute toxicity: oral
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Justification for type of information:
- Please refer to Read Across Statement attached in Section 13
- Reason / purpose for cross-reference:
- read-across source
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortalities occured in this study.
- Clinical signs:
- other: other: Piloerection, hunched posture, and dyspnea were seen, being common symptoms in acute tests. Additionally, diarrhea was observed in all animals. The animals recovered within 5 to 6 days.
- Gross pathology:
- At necropsy no deviations from normal morphology were found in all animals.
- Other findings:
- No other findings were noted
- Interpretation of results:
- GHS criteria not met
- Remarks:
- according to EU GHS
- Conclusions:
- The acute oral median LD50 of the source substance Fe(Na)EDDHA in albino rats was found to be greater than 2000 mg/kg bodyweight. The same result is expected for the organic constituents of target substance since it has the same composition as the source substance.
- Executive summary:
The acute oral toxicity of the source substance FeNaEDDHA in albino rats was determined acoording to the OECD Guideline 401 (Acute Oral Toxicity) and the EU Method B.1 (Acute Toxicity Oral). Upon an acute oral administration and a 14 day post-treatment observation period, the LD50 of the test material in albino rats was found to be greater than 2000 mg/kg bw. No mortalities occurred in this study. At necropsy no deviations from normal morphology were found in all animals. Piloerection, hunched posture, and dyspnea were seen, being common symptoms in acute tests. Additionally, diarrhea was observed in all animals. The animals recovered within 5 to 6 days.
- Endpoint:
- acute toxicity: oral
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Justification for type of information:
- Please refer to Read Across Statement attached in Section 13
- Reason / purpose for cross-reference:
- read-across source
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- no deaths
- Clinical signs:
- other: other: no signs of systemic toxicity
- Gross pathology:
- no abnormalities were noted at necropsy
- Interpretation of results:
- GHS criteria not met
- Remarks:
- according to EU GHS
- Conclusions:
- The acute oral median LD50 of the test material in the Sprague-Dawley CD strain rat was found to be greater than 2000 mg/kg bodyweight. The same result is expected for the organic constituents of target substance since it has the same composition as the source substance.
- Executive summary:
The acute oral toxicity of the source substance FeNaEDDHA in Sprague Dawley rats was determined according to the OECD Guideline 401 (Acute Oral Toxicity). Upon an acute oral administration, the LD50 of the test material in rats was found to be greater than 2000 mg/kg bw. No mortalities and signs of systemic toxicity occurred in this study. The animals gained in body weight. At necropsy no abnormalities were noted in all animals.
- Endpoint:
- acute toxicity: oral
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- weight of evidence
- Justification for type of information:
- Please refer to Read Across Statement attached in Section 13
- Reason / purpose for cross-reference:
- read-across source
- Preliminary study:
- A preliminary screening with small groups of three animals of each sex was carried out. The LD50 values were then calculated according to the Litchfield and Wilcoxon method.
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- ca. 8 060.15 mg/kg bw
- Based on:
- test mat.
- Remarks:
- converted to target substance
- 95% CL:
- >= 4 957.63 - <= 14 712.98
- Mortality:
- Mostly, deaths occurred during the first 48 h of test compound administration. No deaths occurred after three days.
- Clinical signs:
- other: other: Conjunctivitis, piloerection, asthenia, decreased food and water consumption and hemorrhages and hematomas in the tail For details see Table 1 in "Remark on results including tables and figures" field.
- Gross pathology:
- No data
- Other findings:
- No data
- Conclusions:
- Under the test conditions, the acute oral LD50 of ZnCl2 in mice was calculated to be 1,260 mg/kg (equivalent to 605 mg of Zn/kg). Considering the Zn concentration of max. 7.5 % in the target substance, the LD50 corresponds to 8060.15 mg/kg.
- Executive summary:
A study was conducted to evaluate the acute oral toxicity of the test material in mice according to the OECD Guideline 401 (Acute Oral Toxicity).
Initially a preliminary screening study with small groups of three mice of each sex was carried out and the LD50 values were then calculated according to the Litchfield and Wilcoxon method. The main study was conducted with ten mice. Conjunctivitis, piloerection, asthenia, decreased food and water consumption and severe hemorrhages and hematomas in the tail vein were observed in mice.
Under the test conditions, the acute oral LD50 of ZnCl2 in mice was calculated to be 1,260 mg/kg (equivalent to 605 mg of Zn/kg). Considering the Zn concentration of max. 7.5 % in the target substance, the LD50 corresponds to 8060.15 mg/kg.
- Endpoint:
- acute toxicity: oral
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- weight of evidence
- Justification for type of information:
- Please refer to Read Across Statement attached in Section 13
- Reason / purpose for cross-reference:
- read-across source
- Preliminary study:
- A preliminary screening with small groups of three animals of each sex was carried out. The LD50 values were then calculated according to the Litchfield and Wilcoxon method.
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- 7 036.64 mg/kg bw
- Based on:
- test mat.
- Remarks:
- converted to target substance
- 95% CL:
- >= 4 228.38 - <= 11 706.42
- Mortality:
- Mortality observed mostly during the first 48 h of test material administration. No deaths occurred after three days.
- Clinical signs:
- other: other: Miosis, conjunctivitis and hemorrhages and hematomas in the tail. For details see Table 1 in "Remark on results including tables and figures" field
- Gross pathology:
- No data
- Other findings:
- No data
- Conclusions:
- Under the test conditions, the acute oral LD50 of ZnCl2 in Sprague-Dawley rats was calculated to be 1,100 mg/kg (equivalent to 528 mg of Zn/kg). Considering the Zn concentration of max. 7.5 % in the target substance, the LD50 corresponds to 7036.64 mg/kg.
- Executive summary:
A study was conducted to evaluate the acute oral toxicity of the test material in Sprague-Dawley rats according to the OECD Guideline 401 (Acute Oral Toxicity).
Initially a preliminary screening with small groups of three rats of each kind was carried out and the LD50 values were then calculated according to the Litchfield and Wilcoxon method. The main study was conducted with ten rats.
Miosis, conjunctivitis, decreased consumption of food and water and hemorrhages and hematomas in the tail were observed in the rats.
Under the test conditions, the acute oral LD50 of ZnCl2 in Sprague-Dawley rats was calculated to be 1,100 mg/kg (equivalent to 528 mg of Zn/kg). Considering the Zn concentration of max. 7.5 % in the target substance, the LD50 corresponds to 7036.64 mg/kg.
- Endpoint:
- acute toxicity: oral
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- weight of evidence
- Justification for type of information:
- Please refer to Read Across Statement attached in Section 13
- Reason / purpose for cross-reference:
- read-across source
- Preliminary study:
- A preliminary screening with small groups of three animals of each sex was carried out. The LD50 values were then calculated according to the Litchfield and Wilcoxon method.
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- ca. 4 499.96 mg/kg bw
- Based on:
- test mat.
- Remarks:
- converted to target substance
- 95% CL:
- >= 3 090.68 - <= 6 560.41
- Mortality:
- Mostly, deaths occurred during the first 48 h of test compound administration. No deaths occurred after three days.
- Clinical signs:
- other: other: Conjunctivitis, piloerection, asthenia, decreased food and water consumption and hemorrhages and hematomas in the tail For details see Table 1 in "Remark on results including tables and figures" field.
- Gross pathology:
- No data
- Other findings:
- No data
- Conclusions:
- Under the test conditions, the acute oral LD50 of ZnSO4 in mice was calculated to be 926 mg/kg (equivalent to 337 mg of Zn/kg). Considering the Zn concentration of max. 7.5 % in the target substance, the LD50 corresponds to 4499.96 mg/kg.
- Executive summary:
A study was conducted to evaluate the acute oral toxicity of the test material in mice according to the OECD Guideline 401 (Acute Oral Toxicity).
Initially a preliminary screening study with small groups of three mice of each sex was carried out and the LD50 values were then calculated according to the Litchfield and Wilcoxon method. The main study was conducted with ten mice. Conjunctivitis, piloerection, asthenia, decreased food and water consumption and severe hemorrhages and hematomas in the tail vein were observed in mice.
Under the test conditions,the acute oral LD50 of ZnSO4 in mice was calculated to be 926 mg/kg (equivalent to 337 mg of Zn/kg). Considering the Zn concentration of max. 7.5 % in the target substance, the LD50 corresponds to 4499.96 mg/kg.
- Endpoint:
- acute toxicity: oral
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- weight of evidence
- Justification for type of information:
- Please refer to Read Across Statement attached in Section 13
- Reason / purpose for cross-reference:
- read-across source
- Preliminary study:
- A preliminary screening with small groups of three animals of each sex was carried out. The LD50 values were then calculated according to the Litchfield and Wilcoxon method.
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- 8 309.85 mg/kg bw
- Based on:
- test mat.
- Remarks:
- converted to target substance
- 95% CL:
- >= 6 123.05 - <= 11 177
- Mortality:
- Mortality observed mostly during the first 48 h of test material administration. No deaths occurred after three days.
- Clinical signs:
- other: other: Miosis, conjunctivitis and hemorrhages and hematomas in the tail. For details see Table 1 in "Remark on results including tables and figures" field
- Gross pathology:
- No data
- Other findings:
- No data
- Conclusions:
- Under the test conditions, the acute oral LD50 of ZnSO4 in Sprague-Dawley rats was calculated to be 1,710 mg/kg (equivalent to 623 mg of Zn/kg). Considering the Zn concentration of max. 7.5 % in the target substance, the LD50 corresponds to 8309.85 mg/kg.
- Executive summary:
A study was conducted to evaluate the acute oral toxicity of the test material in Sprague-Dawley rats according to the OECD Guideline 401 (Acute Oral Toxicity).
Initially a preliminary screening with small groups of three rats of each sex was carried out and the LD50 values were then calculated according to the Litchfield and Wilcoxon method. The main study was conducted with ten rats.
Miosis, conjunctivitis, decreased consumption of food and water and hemorrhages and hematomas in the tail were observed in the rats.
Under the test conditions, the acute oral LD50 of ZnSO4 in Sprague-Dawley rats was calculated to be 1,710 mg/kg (equivalent to 623 mg of Zn/kg). Considering the Zn concentration of max. 7.5 % in the target substance, the LD50 corresponds to 8309.85 mg/kg.
Referenceopen allclose all
No other information
Table 1. Severity of physical and clinical signs in mice after zinc intoxication in a single dose
|
Number of days after zinc administration |
|||
1 |
2-3 |
4-7 |
8-14 |
|
Mortality rates on oral administration |
90% |
10% |
0% |
0% |
Conjunctivitis |
None |
+ |
+ |
None |
Piloerection |
None |
+ |
+ |
+ |
Hemorrhages and hematomas in the tail |
None |
+ |
+++ |
+++ |
Asthenia |
++ |
++ |
+ |
None |
Decreased food and water consumption, weight loss |
None |
+ |
+ |
None |
Mortality rates and physical and observational examination of rats are average for all zinc compounds.
+Light; ++Moderate; +++Severe
Table 1. Severity of physical and clinical signs in rats after zinc intoxication in a single dose
|
Number of days after zinc administration |
|||
1 |
2-3 |
4-7 |
8-14 |
|
Mortality rates on oral administration |
90% |
10% |
0% |
0% |
Miosis |
+ |
++ |
++ |
+ |
Conjunctivitis |
+ |
++ |
+ |
None |
Erythema, necrosis in nose |
None |
++ |
++ |
++ |
Exophthalmos |
None |
None |
None |
None |
Decreased food and water consumption, weight loss |
None |
+ |
+ |
None |
Hemorrhages and hematomas in the tail |
None |
++ |
++ |
+ |
Mortality rates and physical and observational examination of rats are average for all zinc compounds.
+Light; ++Moderate
Table 1. Severity of physical and clinical signs in mice after zinc intoxication in a single dose
|
Number of days after zinc administration |
|||
1 |
2-3 |
4-7 |
8-14 |
|
Mortality rates on oral administration |
90% |
10% |
0% |
0% |
Conjunctivitis |
None |
+ |
+ |
None |
Piloerection |
None |
+ |
+ |
+ |
Hemorrhages and hematomas in the tail |
None |
+ |
+++ |
+++ |
Asthenia |
++ |
++ |
+ |
None |
Decreased food and water consumption, weight loss |
None |
+ |
+ |
None |
Mortality rates and physical and observational examination of rats are average for all zinc compounds.
+Light; ++Moderate; +++Severe
Table 1. Severity of physical and clinical signs in rats after zinc intoxication in a single dose
|
Number of days after zinc administration |
|||
1 |
2-3 |
4-7 |
8-14 |
|
Mortality rates on oral administration |
90% |
10% |
0% |
0% |
Miosis |
+ |
++ |
++ |
+ |
Conjunctivitis |
+ |
++ |
+ |
None |
Erythema, necrosis in nose |
None |
++ |
++ |
++ |
Exophthalmos |
None |
None |
None |
None |
Decreased food and water consumption, weight loss |
None |
+ |
+ |
None |
Hemorrhages and hematomas in the tail |
None |
++ |
++ |
+ |
Mortality rates and physical and observational examination of rats are average for all zinc compounds.
+Light; ++Moderate
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 2 000 mg/kg bw
- Quality of whole database:
- Good overall quality, studies well documented and meet generally accepted scientific principles.
Acute toxicity: via inhalation route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Acute toxicity: via dermal route
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 2 000 mg/kg bw
- Quality of whole database:
- Good overall quality, studies well documented and meet generally accepted scientific principles.
Additional information
Acute toxicity (oral)
Zinc compounds
To address the hazard of zinc ion, the most conservative value for the source substance zinc sulfate was selected from public reports (EU Risk Assessment Report. ZINC SULFATE CAS No: 7733-02-0, EINECS No: 231-793-3. Final Report, 2008.). The lowest hazard value cited in this report is an LD50 for mice from a publication of Domingo et al. (1988). In this study zinc sulfate and zinc chloride was administered to rats and mice via gavage. The doses were selected based on a preliminary screening. In the main study ten rats and mice were treated with the test item and observed for 14 days. As a result, zinc sulfate revealed LD50 values of 1710 and 926 mg/kg bw in rats and mice, respectively. The LD50 values for zinc dichloride were 1100 mg/kg bw/d and 1260 mg/kg bw/d in rats and mice, respectively. The majority of deaths for both species were observed within the first 24 hours. No deaths occurred after 3 days. The physical and clinical signs appeared within the first 48 hours. These signs were decreasing or disappearing with time. The principal findings included miosis, conjunctivitis, erythema and necrosis in nose, exophthalmos, and necrosis in tail.
Converted to the target substance under consideration of the maximum zinc concentration of 7.5 % the lowest hazard value found for zinc sulfate in mice of 926 mg/kg bw/d corresponds to 4500 mg/kg bw/d.
Justification for classification or non-classification
Based on the available data the substance does not meet the criteria for classification and labelling for acute toxicity in accordance with European Regulation (EC) No 1272/2008.
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.
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