Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
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
Zinc monoglycinate sulfate is not expected to be a skin sensitiser.
Key value for chemical safety assessment
Skin sensitisation
Link to relevant study records
- Endpoint:
- skin sensitisation: in vivo (LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- Version / remarks:
- adopted 22 July, 2010
- Principles of method if other than guideline:
- - Principle of test:
Test conducted similar to OECD guideline 429
- Short description of test conditions:
Groups of 4 CBAKa mice were treated with 25 µL of test material, or with an equal volume of the vehicle alone, on the dorsum of both ears. Treatment was performed once daily for 3 consecutive days. Five days after the initiation of exposure, all mice were injected by the tail vein with 250 µL of phosphate buffered saline (PBS) containing 20 µCi of tritiated thymidine. Mice were killed 5 hours later and the draining lymph nodes excised and pooled for each experimental group. A single-cell suspension of lymph node cells was prepared by mechanical disaggregation. The lymph node cell suspension was washed twice in an excess of PBS and then precipitated with 5% trichloroacetic acid (TCA) at 4°C for 18 hours. Pellets were resuspended in TCA and the incorporation of tritiated thymidine measured by β-scintillation counting.
- Parameters analysed / observed: cell proliferation measured by incorporation of tritiated thymidine - GLP compliance:
- not specified
- Type of study:
- mouse local lymph node assay (LLNA)
- Specific details on test material used for the study:
- Source: Sigma, Poole, UK.
Purity: 99 % - Species:
- mouse
- Strain:
- CBA/Ca
- Sex:
- not specified
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Harlan Olac, Bicester, United Kingdom)
- Age at study initiation: 7- 12 weeks
- Housing: in groups of four animals
- Vehicle:
- dimethyl sulphoxide
- Concentration:
- 5, 10, 25%
- No. of animals per dose:
- 4
- Details on study design:
- MAIN STUDY
Groups of 4 CBA/Ca mice were treated with 25 µL of test material, or with an equal volume of the vehicle alone, on the dorsum of both ears. Treatment was performed once daily for 3 consecutive days. Five days after the initiation of exposure, all mice were injected by the tail vein with 250 µL of phosphate buffered saline (PBS) containing 20 µCi of tritiated thymidine (2 Ci mmol/L; Amersham International, Amersham, UK). Mice were killed 5 hours later and the draining lymph nodes excised and pooled for each experimental group. A single-cell suspension of lymph node cells was prepared by mechanical disaggregation. The lymph node cell suspension was washed twice in an excess of PBS and then precipitated with 5% trichloroacetic acid (TCA) at 4°C for 18 hours. Pellets were resuspended in TCA and the incorporation of tritiated thymidine measured by B-scintillation counting.
- Criteria used to consider a positive response:
A substance was regarded as a skin sensitizer if, at any test concentration, the proliferation in treated lymph nodes was threefold or greater than that in the concurrent vehicle treated controls.
- Positive control substance(s):
- other: see 'Remarks'
- Statistics:
- Not reported
- Positive control results:
- From the positive control substances, mercury and cobalt resulted in a SI value of over 3 at least in two of three concentrations and were thus considered as dermal sensitisers.
- Key result
- Parameter:
- SI
- Value:
- 1.3
- Test group / Remarks:
- at 5 % zinc sulfate
- Key result
- Parameter:
- SI
- Value:
- 2
- Test group / Remarks:
- at 10% zinc sulfate
- Key result
- Parameter:
- SI
- Value:
- 2.3
- Test group / Remarks:
- at 25 % zinc sulfate
- Cellular proliferation data / Observations:
- CLINICAL OBSERVATIONS: none reported
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- In this study similar to OECD guideline 429 (LLNA), zinc sulfate is not considered to be a dermal sensitiser.
- Executive summary:
In a dermal sensitization study similar to OECD guideline 429 (22 July, 2010) with zinc sulfate in DMSO, young adult CBA/CA mice (4/group) were tested in an LLNA. Additionally, besides zinc sulfate, other metal salts were investigated in the LLNA which are known dermal sensitizers and these metal salts are considered to be the positive controls.
No adverse clinical signs or mortality was observed during the study. Stimulation Indices (S.I.) of 1.3, 2.0 and 2.3 were determined with the test item at concentrations of 5, 10 and 25 % in DMSO, respectively. These results indicate that the test substance could not elicit an SI ≥ 3 and is therefore not regarded as skin sensitizer under the conditions of this study.
Proliferation of the treated lymph nodes was in no concentration increased to over 3-fold of that of the vehicle control lymph nodes. Thus, in this study, zinc sulfate is not a dermal sensitizer and does not need to be classified as dermal sensitizer according to Regulation (EC) No 1272/2008 (CLP) and the Globally Harmonized System for Classification and Labelling of Chemicals (GHS).
- Endpoint:
- skin sensitisation: in vivo (LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- GLP compliance:
- no
- Type of study:
- mouse local lymph node assay (LLNA)
- Specific details on test material used for the study:
- Source: Wako Pure Chemical Industries, Ltd., Osaka, Japan.
- Species:
- mouse
- Strain:
- Balb/c
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Females nulliparous and non-pregnant: not specified
- Age at study initiation: 6-8 weeks - Vehicle:
- other: ethanol (20 %)
- Concentration:
- 10%
- No. of animals per dose:
- 3
- Details on study design:
- TREATMENT PREPARATION AND ADMINISTRATION:
The mice (n = 3) received 25 µL of test chemical solution, or vehicle alone, on the dorsum of each ear. The application was repeated for three consecutive days. In some experiments, the dorsal surface of each ear was gently abraded by lightly dragging a 19-g needle across the dorsal surface of each ear five times (without causing bleeding) just prior to the application of test chemicals. Four days following the initial application, mice were killed and the draining lymph nodes (auricular and axillary) were excised and pooled per animal. A single cell suspension of LNC was prepared by mechanical disaggregation through sterile 200-mesh steel gauge. Lymphocyte suspensions were washed twice in phosphate-buffered saline (PBS) and resuspended in RPMI-1640 culture medium supplemented with 10% fetal calf serum (FCS), 25 mM N-2-hydroxyethylpiperazine-N’-2-ethanesulfonic acid (Hepes), 100 µg/ml penicillin and 100 U/ml streptomycin. The cell concentration was adjusted to give 5 E+06 cells/mL. Lymphocyte suspensions were seeded into 96-well microtiter plates at a concentration of 1 E+06 cells/well (5 wells per animal), and cultured with 0.5 µCi [3H]methyl thymidine ([3H]TdR) for 18 h at 37°C in a humidified atmosphere of 5% CO2 in air.
Culture was terminated by automatic cell harvesting. The incorporation of [3H]TdR was measured using a liquid scintillation counter and expressed as mean counts per min (cpm) ± standard deviation per node of three animals for each test group. Increases in [3H]TdR incorporation relative to vehicle-treated controls were calculated for each test group, and expressed as stimulation indices (SI). - Positive control substance(s):
- other:
- Positive control results:
- The SI values observed with CoCl2 and K2Cr2O7 were 4.3 and 3.1, respectively.
- Key result
- Parameter:
- SI
- Value:
- 1.41
- Test group / Remarks:
- zinc sulfate, 10 %, in 20 % ethanol solution
- Parameter:
- SI
- Value:
- 4.33
- Test group / Remarks:
- positive control CoCl2
- Parameter:
- SI
- Value:
- 0
- Test group / Remarks:
- negative control, 20 % ethanol solution
- Parameter:
- SI
- Value:
- 3.16
- Test group / Remarks:
- positive control K2Cr2O7
- Cellular proliferation data / Observations:
- In the present study only the results from one treatment group were reported.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- In the present study conducted by Ikarashi et al. (1992), zinc sulfate is not considered to be a sensitizer in the LLNA.
- Executive summary:
In the present study conducted by Ikarashi et al. (1992), zinc sulfate was dissolved in 20% ethanol and applied to the dorsal surface of the ear on three consecutive days. After four days after initial application the mice were killed and the draining lymph nodes were dissected and incubated for 18 hours at 37°C in humidified air with [3H]TdR. After the incubation period the [3H]TdR incorporation was detected and the SI was determined.
Incubation with 10% ZnSO4 in 20% ethanol resulted in a SI value of 1.41. Thus, under the conditions of the present test, the substance was not considered a skin sensitizer.
- Endpoint:
- skin sensitisation: in vivo (LLNA)
- Type of information:
- other: Information from the QSAR Toolbox database
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study without detailed documentation
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- mouse local lymph node assay (LLNA)
- Species:
- mouse
- Strain:
- not specified
- Sex:
- not specified
- Details on test animals and environmental conditions:
- not specified
- Vehicle:
- not specified
- Key result
- Parameter:
- EC3
- Remarks on result:
- other: Value not reported in QSAR Toolbox
- Key result
- Parameter:
- SI
- Value:
- < 3
- Test group / Remarks:
- mean of all tested groups
- Remarks on result:
- other:
- Remarks:
- Result as reported by the OECD QSAR Toolbox
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The OECD QSAR Toolbox was used in order to gather all available information about the skin sensitizing potential of glycine. The QSAR Toolbox revealed two identical entries exhibiting the same result from a test conducted accoding to OECD guideline 429 (LLNA). Glycine does not meet the classification criteria of Regulation (EC) No 1272/2008 (CLP) and the Globally Harmonized System for Classification and Labelling of Chemcials (GHS) and is therefore no classified as dermal sensitizer.
- Executive summary:
No data are available regarding the skin sensitizing potential of glycine. Beside the QSAR prediction of skin sensitization using the VEGA-Module data was also gathered from the OECD QSAR Toolbox. The QSAR Toolbox revealed two identical entries exhibiting the same result from a test conducted accoding to OECD guideline 429 (LLNA). In both cases glycine was niot classified as skin sensitizer because there was no SI value above 3 in the mentioned study reports, thus, glycine is not considered to be a skin sensitizer according to Regulation (EC) No 1272/2008 (CLP) and the Globally Harmonized System for Classification and Labelling of Chemcials (GHS).
- Endpoint:
- skin sensitisation: in vivo (LLNA)
- Type of information:
- (Q)SAR
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- results derived from a valid (Q)SAR model and falling into its applicability domain, with adequate and reliable documentation / justification
- Justification for type of information:
- 1. SOFTWARE
VEGA-QSAR:AI inside a platform for predictive toxicology
2. MODEL (incl. version number)
1.1.5
3. SMILES OR OTHER IDENTIFIERS USED AS INPUT FOR THE MODEL
O=C(O)CN
4. SCIENTIFIC VALIDITY OF THE (Q)SAR MODEL
For more detailed information please refer to the 'attached justification' section
5. APPLICABILITY DOMAIN
For more detailed information please refer to the 'attached justification' section
6. ADEQUACY OF THE RESULT
For more detailed information please refer to the 'attached justification' section - Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- Result of a QSAR prediction using VEGA-QSAR platform Skin Sensitization model (CAESAR) 2.1.6.
- GLP compliance:
- no
- Justification for non-LLNA method:
- No data are available for the source substance glycine, thus, based on a weight of evidence approach i.a. the results of a QSAR prediction were used to determine the skin sensitizing potential of glycine.
- Species:
- other: not applicable for an in silico system
- Strain:
- other: not applicable for an in silico system
- Details on test animals and environmental conditions:
- not applicable for an in silico system
- Vehicle:
- other: not applicable for an in silico system
- Concentration:
- not applicable for an in silico system
- No. of animals per dose:
- not applicable for an in silico system
- Details on study design:
- not applicable for an in silico system
- Key result
- Parameter:
- other: not applicable for an in silico system
- Remarks on result:
- no indication of skin sensitisation based on QSAR/QSPR prediction
- Interpretation of results:
- study cannot be used for classification
- Conclusions:
- In the present QSAR calculation using VEGA-QSAR platform and its Skin Sensitization model (CAESAR) 2.1.6. the skin sensitizing potential of Glycine was estimated. There are no indications for skin sensitisation by appliying this QSAR prediction method. The results are considered to be reliable because the substance falls in the applicability domain of the used model. Glycine is not a sensitizier according to this prediction.
- Executive summary:
No data are available for the soure substance glycine with regard to its skin sensitizing potential. Thus, a QSAR prediction with the VEGA module was performed. It predicts the skin sensitizing potential based on atom-centered fragments of a set of structural similar molecules. Based on the evaluation summary contained in the prediction results the QSAR estimation can be regarded as reliable. The accuracy of the prediction for similar structures is considered to be good, the concordance for similar structures is good, the Atom Centered Fragments similarity is good. Thus, there are no inconclusive predictions to be discussed and Glycine is predicted as NOT SENSITIZING TO THE SKIN.
- Endpoint:
- skin sensitisation: in vivo (LLNA)
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Justification for type of information:
- REPORTING FORMAT FOR THE ANALOGUE APPROACH
1. HYPOTHESIS FOR THE ANALOGUE APPROACH
This read-across hypothesis is based on transformation of the target and source substances to common compounds (scenario 1 of the RAAF). The target substance zinc monoglycinate sulfate and the source substances zinc sulfate and zinc bisglycinate consist of the Zn2+ cation and the respective anion. The amino acid glycine is constituent of both the target substance zinc monoglycinate sulfate and the source substance zinc bisglycinate.
It is generally accepted that the Zn2+ cation (as measure for dissolved zinc species) is the determining factor for toxicity and ecotoxicity, but not sulfate or glycine.
2. SOURCE AND TARGET CHEMICAL(S) (INCLUDING INFORMATION ON PURITY AND IMPURITIES)
The target substance zinc monoglycinate sulfate is a chelate-complex which consists of the divalent zinc ion as centre-ion and glycine as ligand. The remaining sulfate group stabilizes the center ion within the complex.
Zinc monoglycinate sulfate and the source substance zinc sulfate are ionic and consist of the Zn2+ cation and the respective anions. It is generally accepted that the zinc cation is the determining factor for toxicity and ecotoxicity. Therefore, this read-across approach is based on the assumption that the metal cation of both the target and the source substance, zinc, is the relevant component for assessment of toxicity and ecotoxicity.
The anion of the target substance is the essential amino acid glycine and the sulfate anion. In the source substance, it is the sulfate anion. These anions are not considered as (eco)toxicologically relevant at the given concentrations.
Please refer to the justification for read-across analogue approach in Chapter 13.2 for more detailed information.
3. ANALOGUE APPROACH JUSTIFICATION
Please refer to the justification for read-across analogue approach in Chapter 13.2 for more detailed information.
4. DATA MATRIX
Please refer to the justification for read-across analogue approach in Chapter 13.2 for more detailed information. - Reason / purpose for cross-reference:
- read-across source
- Reason / purpose for cross-reference:
- read-across source
- Reason / purpose for cross-reference:
- read-across source
- Reason / purpose for cross-reference:
- read-across source
- Parameter:
- SI
- Value:
- 1.41
- Test group / Remarks:
- zinc sulfate, 10 %, in 20 % ethanol solution
- Remarks on result:
- other: Ikarashi et al., 1992
- Parameter:
- SI
- Value:
- 2.3
- Test group / Remarks:
- at 25 % zinc sulfate
- Remarks on result:
- other: Basketter et al., 1999
- Parameter:
- SI
- Value:
- 2
- Test group / Remarks:
- at 10 % zinc sulfate
- Remarks on result:
- other: Basketter et al., 1999
- Parameter:
- SI
- Value:
- 1.3
- Test group / Remarks:
- at 5 % zinc sulfate
- Remarks on result:
- other: Basketter et al., 1999
- Parameter:
- SI
- Value:
- < 3
- Test group / Remarks:
- Glycine: mean of all tested groups
- Remarks on result:
- other: Result as reported by the OECD QSAR Toolbox
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Zinc monoglycinate sulfate is not considered to be a skin sensitiser.
- Executive summary:
The potential of zinc monoglycinate sulfate to elicit skin sensitisation was examined in a read-across approach since the in chemico test (DPRA) is not designed to accommodate the spectrum of reaction mechanisms considered to be associated with sensitising metals. Metal compounds can be readily excluded from testing (EURL ECVAM RECOMMENDATION on the Direct Peptide Reactivity Assay (DPRA) for Skin Sensitisation Testing, November 2013). Furthermore, Zn2+ has been shown to be cytotoxic to in vitro cultured cell lines (Borovanský and Riley, 1989). Thus, it is unlikely to yield 2 valid results out of 3 tests according to IATA with zinc monoglycinate. The endpoint is therefore covered with data on zinc sulfate, while glycine is not considered relevant for skin sensitisation.
In the dermal sensitization study by Basketter et al. (1999) similar to OECD guideline 429 (22 July, 2010) with zinc sulfate in DMSO, young adult CBA/CA mice (4/group) were tested in an LLNA. No adverse clinical signs or mortality was observed during the study. Stimulation Indices (S.I.) of 1.3, 2.0 and 2.3 were determined with the test item at concentrations of 5, 10 and 25 % in DMSO, respectively. These results indicate that the test substance could not elicit an SI ≥ 3 and is therefore not regarded as skin sensitizer under the conditions of this study. Proliferation of the treated lymph nodes was in no concentration increased to over 3-fold of that of the vehicle control lymph nodes. Thus, in this study, zinc sulfate is not a dermal sensitizer and does not need to be classified as dermal sensitizer according to Regulation (EC) No 1272/2008 (CLP) and the Globally Harmonized System for Classification and Labelling of Chemicals (GHS).
In the study conducted by Ikarashi et al. (1992), zinc sulfate was dissolved in 20% ethanol and applied to the dorsal surface of the ear on three consecutive days. After four days after initial application the mice were killed and the draining lymph nodes were dissected and incubated for 18 hours at 37°C in humidified air with [3H]TdR. After the incubation period the [3H]TdR incorporation was detected and the SI was determined. Incubation with 10% ZnSO4 in 20% ethanol resulted in a SI value of 1.41. Thus, under the conditions of the present test, the substance was not considered a sensitizer.
No data are available regarding the skin sensitizing potential of glycine. Beside the QSAR prediction of skin sensitization using the VEGA-Module data was also gathered from the OECD QSAR Toolbox. The QSAR Toolbox revealed two identical entries exhibiting the same result from a test conducted according to OECD guideline 429 (LLNA). In both cases glycine was not classified as skin sensitizer because there was no SI value above 3 in the mentioned study reports and thus, glycine is not considered to be a skin sensitizer according to Regulation (EC) No 1272/2008 (CLP) and the Globally Harmonized System for Classification and Labelling of Chemcials (GHS).
In conclusion, zinc monoglycinate sulfate is not considered to be a skin sensitiser.
Referenceopen allclose all
THE LOCAL LYMPH NODE ASSAY PERFORMED WITH FIVE METAL SALTS
Chemical |
[3H]TdR incorporation (mean cpm±SD (x 10-3) |
SI |
20% EtOH |
1.52± 0.67 |
- |
10% FeSO4 |
2.03±0.63 |
1.32 |
10% MnCl2 |
1.26±0.08 |
0.82 |
10% ZnSO4 |
2.14±0.77 |
1.41 |
10% CuSO4 |
4.08±1.20 |
2.67 |
10% NiSO4 |
3.56±0.25 |
2.32 |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
The potential of zinc monoglycinate sulfate to elicit skin sensitisation was examined in a read-across approach since the in chemico test (DPRA) is not designed to accommodate the spectrum of reaction mechanisms considered to be associated with sensitising metals. Metal compounds can be readily excluded from testing (EURL ECVAM RECOMMENDATION on the Direct Peptide Reactivity Assay (DPRA) for Skin Sensitisation Testing, November 2013). Furthermore, Zn2+ has been shown to be cytotoxic to in vitro cultured cell lines (Borovanský and Riley, 1989). Thus, it is unlikely to yield 2 valid results out of 3 tests according to IATA with zinc monoglycinate. The endpoint is therefore covered with data on zinc sulfate, while glycine is not considered relevant for skin sensitisation.
In the dermal sensitization study by Basketter et al. (1999) similar to OECD guideline 429 (22 July, 2010) with zinc sulfate in DMSO, young adult CBA/CA mice (4/group) were tested in an LLNA. No adverse clinical signs or mortality was observed during the study. Stimulation Indices (S.I.) of 1.3, 2.0 and 2.3 were determined with the test item at concentrations of 5, 10 and 25 % in DMSO, respectively. These results indicate that the test substance could not elicit an SI ≥ 3 and is therefore not regarded as skin sensitizer under the conditions of this study. Proliferation of the treated lymph nodes was in no concentration increased to over 3-fold of that of the vehicle control lymph nodes. Thus, in this study, zinc sulfate is not a dermal sensitizer and does not need to be classified as dermal sensitizer according to Regulation (EC) No 1272/2008 (CLP) and the Globally Harmonized System for Classification and Labelling of Chemicals (GHS).
In the study conducted by Ikarashi et al. (1992), zinc sulfate was dissolved in 20% ethanol and applied to the dorsal surface of the ear on three consecutive days. After four days after initial application the mice were killed and the draining lymph nodes were dissected and incubated for 18 hours at 37°C in humidified air with [3H]TdR. After the incubation period the [3H]TdR incorporation was detected and the SI was determined. Incubation with 10% ZnSO4 in 20% ethanol resulted in a SI value of 1.41. Thus, under the conditions of the present test, the substance was not considered a sensitizer.
No data are available regarding the skin sensitizing potential of glycine. Beside the QSAR prediction of skin sensitization using the VEGA-Module data was also gathered from the OECD QSAR Toolbox. The QSAR Toolbox revealed two identical entries exhibiting the same result from a test conducted according to OECD guideline 429 (LLNA). In both cases glycine was not classified as skin sensitizer because there was no SI value above 3 in the mentioned study reports and thus, glycine is not considered to be a skin sensitizer according to Regulation (EC) No 1272/2008 (CLP) and the Globally Harmonized System for Classification and Labelling of Chemcials (GHS).
In conclusion, zinc monoglycinate sulfate is not expected to be a skin sensitiser.
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.