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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 246-515-6 | CAS number: 24887-06-7
- 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
Effects on skin and eye irritation were tested according to standard OECD in vitro assays.
The OECD 439 in vitro skin irritation assay concluded that the test substances has to be considered as non-irritant to skin.
Both the OECD 438 and 492 in vitro eye irritation assays did identify effects, but were not conclusive in the final classification. Based on the weight of evidence, a classification as eye irritant cat. 2 was assigned to zinc formaldehyde sulfoxylate.
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- Endpoint:
- skin irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 6-14 June 2018
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.46 (In Vitro Skin Irritation: Reconstructed Human Epidermis Model Test)
- GLP compliance:
- yes (incl. QA statement)
- Specific details on test material used for the study:
- Batch no: 515
- Test system:
- human skin model
- Source species:
- human
- Cell type:
- non-transformed keratinocytes
- Cell source:
- foreskin from a single donor
- Vehicle:
- unchanged (no vehicle)
- Details on test system:
- RECONSTRUCTED HUMAN EPIDERMIS (RHE) TISSUE
- Model used: Reconstructed Human epidermis (SkinEthic RHE® model, Episkin SA, RHE/S/17)
- Tissue batch number(s): 18-RHE-064
- Production date: not reported
- Shipping date: not reported
- Delivery date: 12 June 2018
- Date of initiation of testing: 12 June 2018
TEMPERATURE USED FOR TEST SYSTEM
- Temperature used during treatment / exposure: not reported
- Temperature of post-treatment incubation (if applicable): 37°C
REMOVAL OF TEST MATERIAL AND CONTROLS
-Volume and number of washing steps: 42 minutes after the test item application, the human epidermis were washed with 25 x 1 mL of DPBS (Dutscher - Batch No. 9120318).
- Observable damage in the tissue due to washing: none
- Modifications to validated SOP: none
MTT DYE USED TO MEASURE TISSUE VIABILITY AFTER TREATMENT / EXPOSURE
- MTT concentration: 1.0 mg/mL
- Incubation time: 3 hours
- Spectrophotometer: ELx800 absorbance microplate reader
- Wavelength: 570 nm
NUMBER OF REPLICATE TISSUES: 3
CONTROL TISSUES USED IN CASE OF MTT DIRECT INTERFERENCE
There is no direct interaction between the test item and MTT and there is no need to add non- specific coloration controls to the study.
PREDICTION MODEL / DECISION CRITERIA (choose relevant statement)
- The test item is considered as non-irritant to skin in accordance with UN GHS No Category: if the mean percent viability after 42 minutes exposure and 42 hours of post-treatment incubation is > 50%.
- The test item is identified as requiring classification and labelling according to UN GHS (Category 2): if the mean percent tissue viability after 42 minutes exposure and 42 hours of post-treatment incubation is ≤ 50% and the result of a skin corrosion test is “non corrosive”.
- The test item is identified as requiring classification and labelling according to UN GHS (Category 2 or Category 1): if the mean percent tissue viability after 42 minutes exposure and 42 hours of post-treatment incubation is ≤ 50% and in absence of information on a skin corrosion test. - Control samples:
- yes, concurrent negative control
- yes, concurrent positive control
- Amount/concentration applied:
- 16 mg/0.5 cm2
- Duration of treatment / exposure:
- 42 minutes
- Duration of post-treatment incubation (if applicable):
- 42 hours
- Number of replicates:
- 3
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- 1
- Value:
- 81.3
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- 2
- Value:
- 85.5
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- 3
- Value:
- 87
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Other effects / acceptance of results:
- Mean tissue viability test item: 84.6 %
Mean tissue viability negative control: 100%
Mean tissue viability positive control (5% sodium dodecyl sulfate): 1.3% - Interpretation of results:
- GHS criteria not met
- Conclusions:
- In accordance with the Regulation EC No. 1272/2008, the test item ZINC FORMALDEHYDE SULFOXYLATE has to be considered as Non-irritant to skin. It corresponds to UN GHS No Category.
- Executive summary:
The aim was to evaluate the possible irritating effects of the test item ZINC FORMALDEHYDE SULFOXYLATE after topical application on in vitro human reconstructed epidermis (SkinEthic RHE model) in accordance with OECD 439 and Test Method B.46 of Council regulation No 761/2009).
The test item was applied as supplied, at the dose of 16 mg to 3 living Reconstructed Human epidermis during 42 minutes. The application was followed by a rinse with 25 mL of DPBS and a 42 hours post-incubation period at 37°C, 5% CO2. Cell viability was then measuered by enzymatc conversion of the vital dye MTT into a blue formazan salt that was quantitatively meausured after extraction from tissues.The mean percent viability of the treated tissues was 84.6%, versus 1.3% in the positive control (5% SDS).
In accordance with the Regulation EC No. 1272/2008, the test item ZINC FORMALDEHYDE SULFOXYLATE has to be considered as Non-irritant to skin. It corresponds to UN GHS No Category.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Eye irritation
Link to relevant study records
- Endpoint:
- eye irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 9 July 2018
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 438 (Isolated Chicken Eye Test Method for Identifying i) Chemicals Inducing Serious Eye Damage and ii) Chemicals Not Requiring Classification for Eye Irritation or Serious Eye Damage)
- Qualifier:
- according to guideline
- Guideline:
- EU method B.48 (Isolated chicken eye test method for identifying occular corrosives and severe irritants)
- GLP compliance:
- yes (incl. QA statement)
- Specific details on test material used for the study:
- Batch no 515
- Species:
- chicken
- Details on test animals or tissues and environmental conditions:
- Eyes collected from chickens obtained from a slaughterhouse (Etablissement Brun, 33820 Etauliers, France) where they were killed for human consumption have been used for this assay. Heads have been removed immediately after sedation of the chickens by electric shock, and incision of the neck for bleeding. The intact heads were transported from the slaughterhouse at ambient temperature in plastic boxes humidified with towels moistened with physiological saline. The eyes were enucleated at Phycher afterwards.
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent positive control
- yes, concurrent negative control
- Amount / concentration applied:
- 30 mg per eye
- Duration of treatment / exposure:
- 10 seconds
- Duration of post- treatment incubation (in vitro):
- 240 minutes
- Number of animals or in vitro replicates:
- 3 eyes for the test item, 1 eye for negative control, 3 eyes for positive controls
- Details on study design:
- Damages by the test item were assessed by determination of corneal swelling, opacity, and fluorescein retention at 30, 75, 120 180 and 240 minutes post-dose.
- Irritation parameter:
- cornea opacity score
- Run / experiment:
- Mean
- Value:
- 0
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- other: ICE Class I
- Irritation parameter:
- fluorescein retention score
- Run / experiment:
- Mean
- Value:
- 1.7
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- other: ICE Class III
- Irritation parameter:
- percent corneal swelling
- Run / experiment:
- Mean
- Value:
- 3
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- other: ICE Class I
- Other effects / acceptance of results:
- The combination the three endpoints for the test item was 1 x III, 2 x I.
The combination of the three endpoints for the positive control, Sodium hydroxide, was 3 x IV. Therefore, the positive control is classified as "Corrosive/Severe Irritant", as expected.
The combination of the three endpoints for the negative control, physiological saline, was 3 x I. Therefore, the negative control is classified as "No Category", as expected. - Interpretation of results:
- other: no prediction can be made
- Conclusions:
- In accordance with the Regulation (EC) No. 1272/2008, the results obtained under these experimental conditions lead to the category "no prediction can be made", as defined by the OECD Guideline No 438. Therefore the test item is not predicted as causing serious eye damage (Category 1) or as not classified for eye irritation/serieous eye damage (No category) with the Isolated Chicken eye test method.
- Executive summary:
The aim of the study was to evaluate the possible ocular corrosive or severe irritating effects of the test item after administration on enucleated chicken eyes.
The test item ZINC FORMALDEHYDE SULFOXYLATE was applied, after being reduced in fine powder, at the dose of 30 mg, to 3 enucleated chicken eyes, during 10 seconds. Then the eyes were rinsed twice with 10 mL of physiological saline. Three eyes were treated in the same manner with a positive control and one eye with a negative control. Damages by the test item were assessed by determination of corneal swelling, opacity, and fluorescein retention at 30, 75, 120 180 and 240 minutes post-dose. The test experimental protocol was established in accordance with OECD 438 and test method B.48.
The ocular reactions observed in eyes treated with the test item were:
- maximal mean score of corneal opacity: 0.0, corresponding to ICE Class I;
- mean score of fluorescein retention: 1.7, corresponding to ICE Class III;
- maximal mean corneal swelling: 3%, corresponding to ICE Class I.
The combination the three endpoints for the test item was 1 x III, 2 x I.
The combination of the three endpoints for the positive control, Sodium hydroxide, was 3 x IV. Therefore, the positive control is classified as "Corrosive/Severe Irritant", as expected.
The combination of the three endpoints for the negative control, physiological saline, was 3 x I. Therefore, the negative control is classified as "No Category", as expected.
In accordance with the Regulation (EC) No. 1272/2008, the results obtained under these experimental conditions lead to the category "no prediction can be made", as defined by the OECD Guideline No 438. Therefore the test item is not predicted as causing serious eye damage (Category 1) or as not classified for eye irritation/serieous eye damage (No category) with the Isolated Chicken Eye test method.
- Endpoint:
- eye irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 11 September 2018 - 11 October 2018
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 492 (Reconstructed Human Cornea-like Epithelium (RhCE) Test Method for Identifying Chemicals Not Requiring Classification and Labelling for Eye Irritation or Serious Eye Damage)
- GLP compliance:
- yes (incl. QA statement)
- Specific details on test material used for the study:
- Batch no 515
- Species:
- human
- Details on test animals or tissues and environmental conditions:
- EpiOcular OCL-212-ver2.0, supplied by MatTEK Corporation, Reconstructed human Cornea-like Epithelia
Lot number: 27073
Keratinocyte strain: 4F1188 - Vehicle:
- unchanged (no vehicle)
- Remarks:
- The test item was used after being reduced in fine powder in the study.
- Controls:
- yes, concurrent positive control
- yes, concurrent negative control
- Amount / concentration applied:
- 50 mg per DBPS pre-treated RhCE or killed RhCE (0.60 cm2)
- Duration of treatment / exposure:
- 6 hours at 37°C, 5% CO2, 95% humidity
- Duration of post- treatment incubation (in vitro):
- 18 hours
- Number of animals or in vitro replicates:
- 2 DPBS pre-treated RhCE and 2 killed RhCE
- Details on study design:
- The test item was identified as a direct MTT reducer and two killed control tissue models were added to the study which underwent the entire testing procedure to generate a non- specific MTT reduction control.
After the overnight incubation, the tissues were pre-wetted with 20 μL of Ca2+Mg2+Free-DPBS (Dutscher - Batch No. 4080718). The tissues were incubated at standard culture conditions for 30 minutes.
The test item was applied, after being reduced in fine powder, during 6 hours at standard culture conditions, at the dose of 50 mg to the entire surface of 2 living RhCE tissue replicates and 2 killed RhCE (EpiOcularTM tissue model) (NSC control)
In the same experimental conditions, a positive control (Methyl acetate - MatTek Corporation, batch No. 022118ISA), and a negative control (distilled water - VWR - Batch No.1007127) were carried out. The controls were applied, as supplied, at the dose of 50 μL, to the surface of 2 RhCE tissue replicates during 6 hours at standard culture conditions.
After the treatment, the test item and control substances were carefully washed from the RhCE tissues by extensive rinsing with Ca2+Mg2+Free-DPBS (Dutscher - Batch No. 4080718). The rinsed tissues were checked for any coloration and noted to be of comparable colour with the negative control treated tissues (whitish).
This rinsing step was followed by a 25-minute post-exposure immersion period at room temperature in 5 mL of fresh medium to remove any test item absorbed into the tissue. The RhCE constructs were then incubated for an 18 hours post-exposure incubation at standard culture conditions in 1 mL of fresh medium at 37°C, 5% CO2.
Following the exposure to the test item, viability measurements are performed immediately after the post-exposure incubation period of the rinsed tissues in fresh medium. This period allows both for recovery from weak cytotoxic effects and for appearance of clear cytotoxic effects.
The RhCE tissue viability was measured by enzymatic conversion of the vital dye MTT [3-(4,5- Dimethylthiazol-2-yl)-2,5-diphenyltetrazolium bromide; Thiazolyl blue tetrazolium bromide; CAS No. 298-93-1] by the viable cells of the tissue into a blue MTT formazan salt that is quantitatively measured after extraction from tissues.
The RhCE constructs were placed in 300 μL of a MTT solution at 1.0 mg/mL for 3 hours at standard culture conditions.
The precipitated blue formazan product was then extracted from the tissues by placing each insert in 2 mL of isopropanol during 2 hours at room temperature in the dark.
The concentration of formazan was measured by determining the OD at 570 nm, just after dilution of the extractions in isopropanol (1:2).
The OD at 570 nm was measured in triplicate samples of formazan extracts. The measured OD are proportional to the number of living cells.
The measurement of OD was performed using the ELx800 absorbance microplate reader (controlled every year and calibrated if necessary) supplied by BioTek and the validated software Gen5 ELISA V1.05.11 supplied by BioTek. - Irritation parameter:
- other: % viability
- Run / experiment:
- second run
- Value:
- 2.67
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Other effects / acceptance of results:
- mean tissue viability of postitive control: 42.03%
- Interpretation of results:
- other: potentially requiring classification and labelling according to UN GHS Category 2 or Category 1
- Conclusions:
- In accordance with the Regulation EC No. 1272/2008, the test item ZINC FORMALDEHYDE SULFOXYLATE has to be identified as potentially requiring classification and labelling according to UN GHS Category 2 or Category 1.
- Executive summary:
The aim of the study was to evaluate the eye hazard potential of the test item ZINC FORMALDEHYDE SULFOXYLATE after topical administration on in vitro reconstructed human cornea-like epithelium tissues (EpiOcular tissue model).
The test item was applied, after being reduced in fine powder, during 6 hours at 37°C, 5% CO2, 95% humidity (standard culture conditions), at the dose of 50 mg to 2 DPBS pre-treated RhCE (EpiOcular tissue model) and 2 killed RhCE (EpiOcular tissue model). The exposure perioed was followed by extensive rinsing with DPBS at room temperature, a 25 minutes post-exposure immersion period at room temperature and 18 hours post-exposure incubation at standard culture conditions. The tissue viability was measured by performing an MTT assay. The experimental protocol was established in accordance with OECD Test Guideline No 492 adopted 09 October 2017.
As the acceptability criteria defined in OECD 492 were not met for the negative control during the 1st run, it was not possible to conclude. A second test was therefore performed under the same experimental conditions to conclude.
Fot the second run, the mean corrected percent tissue viability of the RhCE replicates treated with the test item was 2.67%, versus 42.03% in the positive control (Methyl acetate).
In accordance with the Regulation EC No. 1272/2008, the test item ZINC FORMALDEHYDE SULFOXYLATE has to be identified as potentially requiring classification and labelling according to UN GHS Category 2 or Category 1.
Referenceopen allclose all
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Justification for classification or non-classification
Skin irritation/corrosion:
The substance is not classified a skin irritant because in the selected test it does not meet the classification criteria of the CLP regulation n. 1272/2008.
Eye irritation:
The substance is classified a eye irritant (cat. 2) based on 2 in vitro tests. The isolated chicken eye (ICE, OECD 438) test results in the category "no prediction can be made", as defined by the OECD Guideline No 438 and the test item is not predicted as causing serious eye damage (Category 1) or as not classified for eye irritation/serieous eye damage (No category). The reconstructed human cornea-like epithelium (RhCE, OECD 492) test method identified the substance as potentially requiring classification and labelling according to UN GHS Category 2 or Category 1. Combining the results of both non-conclusive tests (clear identification of effects but not predicted as eye damage), the substance is classified as eye irritant cat. 2.
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.