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EC number: 215-275-4 | CAS number: 1317-60-8
- 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
Repeated dose toxicity: oral
Administrative data
- Endpoint:
- short-term repeated dose toxicity: oral
- Remarks:
- combined repeated dose and reproduction / developmental screening
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- No data
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: 1d The study was well documented and meets generally accepted scientific principles, and conducted in compliance with GLP.
Cross-reference
- Reason / purpose for cross-reference:
- reference to same study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 002
- Report date:
- 2002
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 422 (Combined Repeated Dose Toxicity Study with the Reproduction / Developmental Toxicity Screening Test)
- Deviations:
- no
- GLP compliance:
- yes
- Limit test:
- no
Test material
- Reference substance name:
- ferrous sulphate heptahydrate
- IUPAC Name:
- ferrous sulphate heptahydrate
- Reference substance name:
- iron(2+);sulfate;heptahydrate
- Cas Number:
- 7782-63-0
- Molecular formula:
- FeH14O11S
- IUPAC Name:
- iron(2+);sulfate;heptahydrate
- Details on test material:
- - Name of test material (as cited in study report): Iron (II) sulfate heptahydrate
- Physical state: blue-green crystalline powder
- Analytical purity: 91.1 % (Lot No. 010628) and 90.6 % (Lot No. 010903)
- Impurities (identity and concentrations): Mg 0.3%, Mn 0.19%, Zn 75 ppm and Mg 0.28%, Mn 0.16%, Zn 84 ppm
- Storage condition of test material: room temperature under argon
- Stability under test conditions: The stability of test concentrations was confirmed for 6 hours in the dark at room temperature.
Constituent 1
Constituent 2
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Laboratories Japan, Inc., Yokohama, Japan
- Age at study initiation: 8 weeks
- Weight at study initiation: male: 341 -383 g; female: 222 -255 g
- Housing: stainless steel cage
- Diet (ad libitum): CRF-1 from Oriental Yeast Co., Ltd.
- Water (ad libitum): tap water
- Acclimation period: 12 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 26
- Humidity (%): 40 - 70
- Air changes (per hr): 12
- Photoperiod (hrs dark / hrs light): 12 / 12
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on oral exposure:
- PREPARATION OF DOSING SOLUTIONS: Test substance was prepared with water for injection purposes. Gavage solutions were prepared freshly everytime and used within 6 hours.
- Analytical verification of doses or concentrations:
- yes
- Details on analytical verification of doses or concentrations:
- The stability of test concentrations was confirmed for 6 hours in the dark at room temperature.
The concentrations were measured in samples used for males at the first teatment and at the end of administration. - Duration of treatment / exposure:
- Males: Total of 49 days beginning 14 days before mating, Females: Total of 42-47 days from 14 days before mating to day 5 of lactation
- Frequency of treatment:
- once daily
Doses / concentrations
- Remarks:
- Doses / Concentrations:
30, 100, 300, 1000 mg/kg bw/day
Basis:
other: nominal conc.
- No. of animals per sex per dose:
- 12
- Control animals:
- yes, concurrent vehicle
- Details on study design:
- Post-exposure period: none
- Dose selection rationale: Doses selected for the main studies were based on gross pathology finging observed in the 14-days preliminary studies (Study No. 100520P).
- Rationale for animal assignment (if not random): No data
- Rationale for selecting satellite groups: To study repeated dose toxicity in non-pregnant females
- Post-exposure recovery period in satellite groups: No post-exposure period
- Section schedule rationale (if not random): No data - Positive control:
- None
Examinations
- Observations and examinations performed and frequency:
- CAGE SIDE OBSERVATIONS: Yes
- Time schedule: twice daily
- Cage side observations: general condition and mortality
BODY WEIGHT: Yes
- Time schedule for examinations: male: twice weekly; female: twice weekly, during pregnancy on days 0, 7 14 and 21, during lactation on days 0 and 4
FOOD CONSUMPTION:
- Food consumption for each animal determined and mean daily diet consumption calculated as g food/kg body weight/day: Yes
HAEMATOLOGY: Yes
- Time schedule for collection of blood: on day after last application
- Anaesthetic used for blood collection: Yes (identity) Pentobarbital-Na
- Animals fasted: Yes
- How many animals: 6 of each group
- Parameters checked: RBC, Hemoglobin, Hematocrit, MCV, MCH, MCHC, Platelet, Reticulocyte, PT, APTT, Fibrinogen, WBC, Differential leukocyte: Lymphocyte, Neutrophil, Eosinophil, Basophil, Monocyte
CLINICAL CHEMISTRY: Yes
- Time schedule for collection of blood: on day after last application
- Animals fasted: Yes
- How many animals: 6 of each group
- Parameters checked: AST, ALT, ALP, gamma-GTP, T-potein, Albumin, A/G, T-bilirubin, BUN, Creatinine, Glucose, T-cholesterol, Triglyceride, Na, K, Cl, Ca, Inorganic-p, Fe
URINALYSIS: Yes
- Time schedule for collection of urine: before end of exposure
- Metabolism cages used for collection of urine: Yes
- Animals fasted: Yes
- Parameters checked: Color, pH, Protein, Glucose, Ketone body, Bilirubin, Occult blood, Urobilinogen, Urinary sediments, Epithelial cells, Erythrocytes, Leukocytes, Casts, Crystals
- Reproductive behavior od parental animals: see section 7.8.1
- Development of F1 generation: see section 7.8.1 - Sacrifice and pathology:
- GROSS PATHOLOGY: Yes: males: brain, pituitary, thyroids, thymus, heart, liver, spleen, kidneys, adrenals, testes, epididymides; females: brain, pituitary, thyroids, thymus, heart, liver, spleen, kidneys, adrenals, ovaries, uterus
HISTOPATHOLOGY: Yes: males: eyeball, thymus, heart, lung, stomach, liver, pancreas, spleen, kidney, urinary bladder, testis, epididymis, prostate,bone marrow; females: heart, lung, liver, spleen, kidney, urinary bladder, pituitary, - Other examinations:
- Estrus cycle, reproductive performance, observation of pups
- Statistics:
- Bartlett's test, Dunnett's and Chi² test
Results and discussion
Results of examinations
- Clinical signs:
- no effects observed
- Description (incidence and severity):
- No adverse systemic effects
- Mortality:
- no mortality observed
- Description (incidence):
- No adverse systemic effects
- Body weight and weight changes:
- effects observed, treatment-related
- Food consumption and compound intake (if feeding study):
- no effects observed
- Description (incidence and severity):
- No significant effects
- Food efficiency:
- not examined
- Water consumption and compound intake (if drinking water study):
- not examined
- Ophthalmological findings:
- not examined
- Haematological findings:
- effects observed, treatment-related
- Clinical biochemistry findings:
- effects observed, treatment-related
- Urinalysis findings:
- effects observed, treatment-related
- Behaviour (functional findings):
- not examined
- Organ weight findings including organ / body weight ratios:
- effects observed, treatment-related
- Gross pathological findings:
- effects observed, treatment-related
- Histopathological findings: non-neoplastic:
- effects observed, treatment-related
- Histopathological findings: neoplastic:
- not examined
- Details on results:
- CLINICAL SIGNS AND MORTALITY
male: 1000 mg/kg bw/day: 1 died on day 27 and salivation, 300 mg/kg bw/day: salivation; female: 1000 mg/kg bw/day: 1 died on day 19 and salivation, 300 mg/kg bw/day: salivation
BODY WEIGHT
male: 1000 mg/kg bw/day: reduced between days 11 and 49; female: 1000 mg/kg bw/day: reduced during pregnancy on day 21 (not significant)
FOOD CONSUMPTION
male/female: 1000 mg/kg bw/day: reduced on day 3
HAEMATOLOGY
male: 1000 mg/kg bw/day: RBC and APTT reduced; MCV, MCH and reticulocytes increased, increase at 300 mg/kg bw/day of MCH is considered to be not toxicologically relevant, because no change in RBC is observed ; female: 30 and 1000 mg/kg bw/day: MCV and MCH increased; 1000 mg/kg bw/day: hemoglobin increased, increase at 30 and 1000 mg/kg bw/day of MCH, MCV and hemoglobin is considered to be not toxicologically relevant, because no change in RBC is observed .
CLINICAL CHEMISTRY
male: 1000 mg/kg bw/day: total-protein, albumin, calcium decreased; ALT, gamma-GTP and A/G increased; T-bilirubin was increased at 30 and 100 mg/kg bw/day, but no changes at 300 and 1000 mg/kg bw/day; female: 300 mg/kg bw/day: inorganic-p increased; 1000 mg/kg bw/day: gamma-GTP and inorganic-p increased; ALP decreased at 30, 100 and 300 mg/kg bw/day, but no changes at 1000 mg/kg bw/day.
URINALYSIS
male: 1000 mg/kg bw/day: volume increased and specific gravity decreased
ORGAN WEIGHTS
male: 1000 mg/kg bw/day: absolute and relative weight of adrenals, relative weight of liver increased; absolute testes weight increased at 300 mg/kg bw/day, but not at 1000 mg/kg bw/day; absolute weights of pituitary and heart were decreased; relative weight of brain and testes increased: these changes are considered to be due to the significant body weight loss
females: 1000 mg/kg bw/day: absolute and relative weight of liver increased relative weight of uterus increased at 1000 mg/kg bw/day, but this was considered to be due to the significant body weight loss.
GROSS PATHOLOGY and HISTOPATHOLOGY: NON-NEOPLASTIC
male survivors:
1000 mg/kg bw/day: thymus: atrophy in 2 animals; stomach inflammation and ulcers in glandular stomach (1 animal); bleeding (1 case); inflammatory cell infiltration in submucosal glandular stomach (2 cases); vacuolization of the forestomach epithelium (1 case); liver: yellow-brown pigmentation of periportal hepatocytes (6 cases); pigmentation of periportal Kupffer cells (3 cases): probably due to iron; spleen: extramedullary hematopoiesis (4 cases); yellow-brown pigmentation in red pulp (6 cases); kidney: basophilic changes in tubular epithelium (4 cases); bone marrow: hematopoiesis in the femur (1 case)
300 mg/kg bw/day: spleen: yellow-brown pigmentation in the red pulp (6 cases); extramedullary hematopoiesis (5 cases)
100 mg/kg bw/day: spleen: yellow-brown pigmentation in the red pulp (6 cases); extramedullary hematopoiesis (2 cases); kidney: basophilic changes in tubular epithelium (1 case)
30 mg/kg bw/day: spleen: yellow-brown pigmentation in the red pulp (6 cases); extramedullary hematopoiesis (1 cases); kidney: basophilic changes in tubular epithelium (2 cases)
Control: yellow-brown pigmentation in the red pulp (6 cases); extramedullary hematopoiesis (2 cases)
dead males:
1000 mg/kg bw/day: mineral deposits in heart, lung congestion, pigmentation of periportal hepatocytes
The adrenal glands showed abnormalities (abnormal growth) in the autopsy.
female survivors:
1000 mg/kg bw/day: liver: yellow-brown pigmentation of periportal hepatocytes (6 cases) probably due to iron; spleen: yellow-brown pigmentation in the red pulp (6 cases); extramedullary hematopoiesis (6 cases)
300 mg/kg bw/day: spleen: yellow-brown pigmentation in the red pulp (6 cases); extramedullary hematopoiesis (6 cases)
100 mg/kg bw/day: spleen: yellow-brown pigmentation in the red pulp (6 cases); extramedullary hematopoiesis (6 cases)
30 mg/kg bw/day: spleen: yellow-brown pigmentation in the red pulp (5 cases); extramedullary hematopoiesis (6 cases)
Control: spleen: yellow-brown pigmentation in the red pulp (6 cases); extramedullary hematopoiesis (6 cases)
dead females:
Lung congestion and edema, mineral deposits in liver
Abnormalities in pituitary (mass), adrenal (enlargement) and thymus (atrophy) were found at autopsy.
OTHER FINDINGS
Parent animal reproduction:
Reproductive performance displayed no significant changes between treatment groups and controls (number of estrous cases, copulation index, number of days before copulation, fertility index, gestation length, gestation index, delivery conditions, nursing conditions, number of corpora lutea, number of implantation sites, or implantation rate).
Pups:
No significant changes between treatment groups and controls were observed (number, number of stillbriths, number of live pups on day 0 of lactation, sex ratio, delivery index, birth index, live birth index, general signs, number of live pups on day 4 of lactation, viability index on day 4 of lactation, external observation, body weight change, necropsy findings).
Effect levels
open allclose all
- Dose descriptor:
- NOAEL
- Remarks:
- repeated dose toxicity
- Effect level:
- 100 mg/kg bw/day (actual dose received)
- Based on:
- test mat. (total fraction)
- Remarks:
- FeSO4.7H2O
- Sex:
- male/female
- Basis for effect level:
- histopathology: non-neoplastic
- Dose descriptor:
- NOAEL
- Remarks:
- reproductive toxicity
- Effect level:
- >= 1 000 mg/kg bw/day (actual dose received)
- Based on:
- test mat. (total fraction)
- Remarks:
- FeSO4.7H2O
- Sex:
- male/female
- Remarks on result:
- not determinable due to absence of adverse toxic effects
- Dose descriptor:
- NOAEL
- Remarks:
- developmental toxicity
- Effect level:
- >= 1 000 mg/kg bw/day (actual dose received)
- Based on:
- test mat. (total fraction)
- Remarks:
- FeSO4.7H2O
- Sex:
- male/female
- Remarks on result:
- not determinable due to absence of adverse toxic effects
- Dose descriptor:
- NOAEL
- Remarks:
- repeated dose toxicity
- Effect level:
- 20 mg/kg bw/day (actual dose received)
- Based on:
- element (total fraction)
- Remarks:
- Fe
- Sex:
- male/female
- Basis for effect level:
- other: recalculated value from the FeSO4 level
- Dose descriptor:
- NOAEL
- Remarks:
- reproductive toxicity
- Effect level:
- >= 200 mg/kg bw/day (actual dose received)
- Based on:
- element (total fraction)
- Remarks:
- Fe
- Sex:
- male/female
- Basis for effect level:
- other: recalculated value from the FeSO4 level
- Remarks on result:
- not determinable due to absence of adverse toxic effects
- Dose descriptor:
- NOAEL
- Remarks:
- developmental toxicity
- Effect level:
- >= 200 mg/kg bw/day (actual dose received)
- Based on:
- element (total fraction)
- Remarks:
- Fe
- Sex:
- male/female
- Basis for effect level:
- other: recalculated value from the FeSO4 level
- Remarks on result:
- not determinable due to absence of adverse toxic effects
Target system / organ toxicity
- Critical effects observed:
- not specified
Any other information on results incl. tables
Table 1: Urinalysis (urine volume and specific gravity) results for males
Dose (mg/kg bw/day) |
0 |
30 |
100 |
300 |
1000 |
Number of animals |
6 |
6 |
6 |
6 |
6 |
Urine volume (mL) mean |
13.4 |
13.2 |
14.6 |
17.6 |
28.7** |
SD |
3.7 |
3.4 |
2.6 |
6.7 |
8.0 |
Specific gravity mean |
1.055 |
1.056 |
1.052 |
1.051 |
1.027** |
SD |
0.013 |
0.012 |
0.007 |
0.014 |
0.004 |
Note:**, p<0.01
Table 2: Haematology results for males
Dose (mg/kg bw/day) |
0 |
30 |
100 |
300 |
1000 |
Number of animals |
6 |
6 |
6 |
6 |
6 |
RBC (10e+4/uL) mean |
839 |
826 |
807 |
798 |
689** |
SD |
25 |
29 |
47 |
38 |
113 |
ATPP (sec.) mean |
31.6 |
32.5 |
30.7 |
30.2 |
25.6** |
SD |
1.9 |
2.0 |
2.0 |
3.8 |
2.3 |
MCV (fL) mean |
53.9 |
56.1 |
55.3 |
56.3 |
60.0** |
SD |
1.4 |
1.7 |
0.5 |
1.8 |
5.5 |
MCH (pg) mean |
18.3 |
19.1 |
18.8 |
19.3* |
20.5** |
SD |
0.3 |
0.5 |
0.3 |
0.5 |
1.4 |
Reticulocyte (0/00) mean |
26 |
28 |
27 |
29 |
65* |
SD |
4 |
5 |
3 |
4 |
68 |
Note:*, p<0.05; **, p<0.01
Table 3: Blood chemistry for males
Dose (mg/kg bw/day) |
0 |
30 |
100 |
300 |
1000 |
Number of animals |
6 |
6 |
6 |
6 |
6 |
ALT (IU/L) mean |
30.4 |
34.2 |
33.9 |
29.8 |
57.0* |
SD |
4.7 |
7.9 |
7.8 |
4.3 |
27.0 |
Gamma-GTP (IU/L) mean |
0.42 |
0.49 |
0.40 |
0.36 |
0.71* |
SD |
0.14 |
0.14 |
0.16 |
0.07 |
0.29 |
T-protein (g/dL) mean |
5.6 |
5.5 |
5.5 |
5.6 |
4.5** |
SD |
0.3 |
0.2 |
0.2 |
0.2 |
0.3 |
Albumin (g/dL) mean |
2.78 |
2.75 |
2.81 |
2.78 |
2.35** |
SD |
0.08 |
0.16 |
0.15 |
0.12 |
0.17 |
A/G mean |
0.99 |
0.99 |
1.03 |
1.00 |
1.10* |
SD |
0.06 |
0.05 |
0.07 |
0.05 |
0.08 |
Note:*, p<0.05; **, p<0.01
Table 4: Blood chemistry for females
Dose (mg/kg bw/day) |
0 |
30 |
100 |
300 |
1000 |
Number of animals |
6 |
6 |
6 |
6 |
6 |
Gamma-GTP (IU/L) mean |
0.57 |
0.70 |
0.60 |
0.70 |
1.31* |
SD |
0.17 |
0.16 |
0.12 |
0.18 |
0.85 |
Inorganic-p (mg/dL) mean |
8.9 |
9.0 |
9.1 |
10.1* |
10.3** |
SD |
0.9 |
0.7 |
0.8 |
0.4 |
0.4 |
Note :*, p<0.05; **, p<0.01
Table 5: Organ weights for males (only statistically significant changes included)
Dose (mg/kg bw/day) |
0 |
30 |
100 |
300 |
1000 |
Number of animals |
6 |
6 |
6 |
6 |
6 |
Body weight (g) mean |
485 |
483 |
474 |
478 |
426** |
SD |
32 |
38 |
31 |
32 |
47 |
Brain relative (g%) mean |
0.44 |
0.43 |
0.44 |
0.44 |
0.50** |
SD |
0.03 |
0.03 |
0.02 |
0.03 |
0.05 |
Pituitary absolute (g) mean |
14.9 |
16.4 |
15.2 |
14.0 |
13.0* |
SD |
1.7 |
2.1 |
1.7 |
1.6 |
1.6 |
Heart absolute (g) mean |
1.40 |
1.41 |
1.46 |
1.41 |
1.27* |
SD |
0.12 |
0.12 |
0.08 |
0.12 |
0.14 |
Liver relative (g%) mean |
2.53 |
2.47 |
2.56 |
2.65 |
2.96** |
SD |
0.12 |
0.19 |
0.21 |
0.16 |
0.33 |
Adrenals absolute (mg) mean |
53.3 |
57.3 |
53.4 |
55.4 |
66.6** |
SD |
7.0 |
9.0 |
7.0 |
6.5 |
9.3 |
Adrenals relative (mg%) mean |
11.0 |
11.9 |
11.3 |
11.6 |
15.9** |
SD |
1.5 |
2.0 |
1.6 |
1.6 |
3.3 |
Note: :*, p<0.05; **, p<0.01
Table 6: Organ weights for females (only statistically significant changes included)
Dose (mg/kg bw/day) |
0 |
30 |
100 |
300 |
1000 |
Number of animals |
6 |
6 |
6 |
6 |
6 |
Body weight (g) mean |
302 |
306 |
302 |
301 |
293 |
SD |
21 |
14 |
17 |
17 |
14 |
Liver absolute (g) mean |
10.62 |
10.76 |
10.76 |
10.63 |
11.89* |
SD |
1.14 |
0.65 |
1.23 |
0.83 |
1.20 |
Liver relative (g%) mean |
3.52 |
3.52 |
3.56 |
3.54 |
4.06** |
SD |
0.21 |
0.19 |
0.29 |
0.23 |
0.37 |
Uterus relative(g%) mean |
0.19 |
0.20 |
0.18 |
0.20 |
0.22* |
SD |
0.02 |
0.03 |
0.02 |
0.03 |
0.04 |
Note:*, p<0.05; **, p<0.01
Applicant's summary and conclusion
- Conclusions:
- In a good quality OECD 422 study conducted to GLP (reliability score 1) the NOAEL for repeated dose toxicity of iron sulphate heptahydrate was 100 mg/kg bw/day (equivalent to 20 mg Fe/kg bw/day for both sexes) based on the extramedullary hematopoiesis of the spleen in males and increased levels of inorganic phosphate in females at 300 mg/kg bw/day in rats.
- Executive summary:
In a good quality OECD 422 study conducted to GLP (reliability score 1) the NOAEL for repeated dose toxicity of iron sulphate heptahydrate was 100 mg/kg bw/day (equivalent to 20 mg Fe/kg bw/day for both sexes) based on the extramedullary hematopoiesis of the spleen in males and increased levels of inorganic phosphate in females at 300 mg/kg bw/d
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