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EC number: 484-460-1 | CAS number: 37859-55-5
- 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
![](https://chesar.echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
Endpoint summary
Administrative data
Key value for chemical safety assessment
Effects on fertility
Description of key information
Weight of evidence: Test method OECD 415. GLP study. Based on the read-across approach from the analogue substance MIBKO, the NOAEL for OS1600 was determined to be > 99 mg/kg-bw/day since no adverse effects were observed in any of the reproductive or developmental parameters or in the F1 pups.
Weight of evidence. Test method OECD 422. GLP study. Based on the read-across approach from the analogue substance MPKO, The NOEL of OS1600 was determined to be 170 mg/kg bw/day since no effects were observed on reprotox parameters at the hightes dose tested.
Weight of evidence. Test method OECD 408. GLP study. Based on the read-across approach from the analogue substance OS2200, the NOAEL of OS1600 for effects on reproductive organs was estimated to be >43 mg/kg bw/day since no effects were observed on the reproductive organs at the highest tested dose.
Link to relevant study records
- Endpoint:
- one-generation reproductive toxicity
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Read-across from an analogue substance for which a guideline study (Klimish =1) is available.
- Justification for type of information:
- REPORTING FORMAT FOR THE ANALOGUE APPROACH
See attached reporting format and read-across rationale. - Reason / purpose for cross-reference:
- read-across source
- Key result
- Dose descriptor:
- NOAEL
- Remarks:
- (parental toxicity)
- Effect level:
- 30 mg/kg bw/day
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- histopathology: non-neoplastic
- Remarks on result:
- other: Based on a read-across form an analogue subdtance for which the NOAEL was 30 mg/kg-bw/day.
- Key result
- Dose descriptor:
- NOAEL
- Remarks:
- (reproductive toxicity)
- Effect level:
- > 99 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: Based on no effects at the highest dose tested
- Remarks on result:
- other: Based on a read-across from analogue substance for which the NOAEL was 100 mg/kg-bw/day.
- Key result
- Critical effects observed:
- yes
- Lowest effective dose / conc.:
- 99 mg/kg bw/day (nominal)
- System:
- haematopoietic
- Organ:
- spleen
- Treatment related:
- yes
- Dose response relationship:
- no
- Relevant for humans:
- not specified
- Key result
- Dose descriptor:
- NOAEL
- Remarks:
- (F1 toxicity)
- Generation:
- F1
- Effect level:
- > 99 mg/kg bw/day
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: No effects at the highest dose tested.
- Remarks on result:
- other: Based on a read-across form an analogue substance for which the NOAEL was 100 mg/kg-bw/day.
- Key result
- Dose descriptor:
- NOAEL
- Remarks:
- (developmental and sexual maturation)
- Generation:
- F1
- Effect level:
- > 99 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: No effects at the highest dose tested.
- Remarks on result:
- other: Based on a read-across form an analogue substance for which the NOAEL was 100 mg/kg-bw/day.
- Key result
- Critical effects observed:
- no
- Key result
- Reproductive effects observed:
- no
- Conclusions:
- Based on the read-across approach from experimental data on the analogue substance MIBKO (a one-generation reproduction study in, OECD 415, no data on GLP), the NOAEL of OS1600 for parental toxicity was estimated to be 30 mg/kg bw/day (based on histological effects on the spleen) and the NOAEL for the F1 generation and reproductive toxicity was estimated to be >99 mg/kg bw/day (based on no effects on reproduction or developmental parameters or in the F1 pups).
- Executive summary:
Based on the experimental data from the one-generation reproduction study on the analogue substance MIBKO in rats, where the NOAEL for parental toxicity was determined to be 30 mg/kg bw/day based on histological effects on the spleen and where the NOAEL for F1 and toxicity to reproduction was > 100 mg/kg bw/day based on no effects on reproductive or developmental parameters or in the F1 pups at the highest dose, the read-across was applied and the NOAEL of OS1600 for parental toxicity, and F1 and toxicity to reproduction were estimated to be 30 and >99 mg/kg-bw/day respectively.
- Endpoint:
- reproductive toxicity, other
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Read-across from an analogue substance for which a guideline study (Klimish =1) is available.
- Justification for type of information:
- REPORTING FORMAT FOR THE ANALOGUE APPROACH
See attached reporting format and read-across rationale. - Reason / purpose for cross-reference:
- read-across source
- Key result
- Dose descriptor:
- NOAEL
- Remarks:
- (reproductive organs)
- Effect level:
- > 43 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: Based on no effects observed in reproductive organs or tissues (testes, seminal vesicles, ovaries, epididymes, uterus with cervix)
- Remarks on result:
- other: Based on a read-across from an analogue for which NOAEL > 50 mg/kg bw/day
- Key result
- Dose descriptor:
- NOAEL
- Remarks:
- (systemic toxicity)
- Effect level:
- 13 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: Based on red blood cell rate of turnover resulting in associated changes in the spleen.
- Remarks on result:
- other: Read-across from an analogue for which NOAEL = 15 mg/kg bw/day.
- Key result
- Critical effects observed:
- yes
- Lowest effective dose / conc.:
- 43 mg/kg bw/day (nominal)
- System:
- haematopoietic
- Organ:
- erythrocyte development
- spleen
- Treatment related:
- yes
- Dose response relationship:
- not specified
- Relevant for humans:
- not specified
- Key result
- Remarks on result:
- not determinable
- Remarks:
- Repeated dose toxicity study. It provides information on the lack of effects on reproductive organs and tissues, however, the design does not include F1.
- Key result
- Reproductive effects observed:
- no
- Conclusions:
- Based on the read-across approach, the 90day-NOAEL of the target substance in rats by oral route was 13 mg/kg bw/day in both sexes. No effects were observed in the reproductive organs or tissues up to the highest dose tested (estimated dose of 43 mg/kg bw/day).
- Executive summary:
A 13 week repeated dose toxicity test followed by a 4 week recovery period was performed to assess the systemic toxicity of the analogue substance OS 2200 (GLP study). The test was performed in rats by oral gavage, three groups, each comprising then male and ten female rats received OS2200 at dosages of 5, 15 or 50 mg/kg bodyweight/day. It was concluded that the principal action of OS2200 was to affect the red blood cell rate of turnover occurring mainly among animals receiving 50 mg/kg/day, resulting in associated changes in the spleen. A dosage level of 15 mg/kg/day, was considered to be the highest NOAEL for OS 2200 as the changes observed at 5 and 15 mg/kg/day were considered to be minor in nature and had shown full recovery after 4 weeks without treatment. Based on these results, the read-across approach was applied and the 90 days-NOAEL for the target substance OS1600 by oral route in rats was determined to be 13 mg/kg bw/day. No effects were observed in the reproductive organs or tissues up to the highest dose tested (50 mg/kg bw/day). Based on these results, the read-across approach was applied and the 90 days-NOAEL for OS1600 by oral route in rats was determined to be 13 mg/kg bw/day for systemic toxicity and >43 mg/kg bw/day for toxicity in reproductive organs.
- Endpoint:
- screening for reproductive / developmental toxicity
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Read-across from an analogue substance for which a guideline study (Klimish =1) is available.
- Justification for type of information:
- REPORTING FORMAT FOR THE ANALOGUE APPROACH
See attached reporting format and read-across rationale. - Reason / purpose for cross-reference:
- read-across source
- Key result
- Dose descriptor:
- NOAEL
- Remarks:
- (toxicity to reproduction)
- Effect level:
- 170 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: No adverse effects obrserved at the highest dose tested.
- Remarks on result:
- other: Based on a read-across from an analogue for which NOAEL = 150 mg/kg bw/day.
- Key result
- Dose descriptor:
- NOAEL
- Remarks:
- (systemic toxicity)
- Effect level:
- 17 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: Basis for effect: red blood cell destruction with associated findings in the spleen, liver or kidneys at an estimated dose levels of 58 mg/kg bw/day and above.
- Remarks on result:
- other: Based on a read-across from an analogue for which NOAEL = 15 mg/kg bw/day.
- Key result
- Critical effects observed:
- yes
- Lowest effective dose / conc.:
- 57 mg/kg bw/day (nominal)
- System:
- haematopoietic
- Organ:
- erythrocyte development
- kidney
- liver
- spleen
- Treatment related:
- yes
- Dose response relationship:
- yes
- Relevant for humans:
- not specified
- Key result
- Dose descriptor:
- NOEL
- Remarks:
- (toxicity to reproduction)
- Generation:
- F1
- Effect level:
- 170 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: There were no effects on any of the reproductive parameters or developmental endpoints evaluated.
- Remarks on result:
- other: Read-across from an analogue for which NOEL = 150 mg/kg bw/day.
- Key result
- Critical effects observed:
- no
- Key result
- Reproductive effects observed:
- no
- Conclusions:
- Based on the read-across approach from the analogue substance MPKO, the NOEL for OS1600 was considered to be 170 mg/kg bw/day since no effects were observed on reproductive screening parameters up to 170 mg/kg bw/day, the highest dose tested.
- Executive summary:
The systemic toxic potential and effects on reproduction were assessed in rats following oral administration of the analogue substance MPKO for at least five weeks in accordance with OECD Guideline 422. The results observed in this study showed effects of MPKO assessed by haematology, organ weights and macroscopic appearance at dose levels of 50 mg/kg bw/day and above and microscopic tissue appearance were observed at dose levels of 15 mg/kg bw/day and above. After two weeks off dose complete recovery was seen in many clinical pathology parameters and recovery was in progress but not complete in males for high mean cell haemoglobin level, low mean cell haemoglobin concentration and high mean cell volume and in females low red blood cell counts, high mean cell haemoglobin level and high mean cell volume, organ weights, macroscopic and microscopic appearance. There were no adverse effects of treatment on the reproductive/developmental screening parameters assessed at least 150 mg/kg/day. The NOAEL for MPKO was considered to be 15 mg/kg bw/day for general systemic toxicity. The NOEL for reproductive and developmental screening parameters was considered to be 150 mg/kg bw/day. Based on these results, the read-across approach was applied, and the NOAEL for OS1600 was determined to be 17 mg/kg bw/day for systemic toxicity and the NOEL was 170 mg/kg bw/day for toxicity to reproduction.
Referenceopen allclose all
See "Data Matrix" and "Reporting Format" attached.
The read-across approach from experimental results with the supporting substance MIBKO are expressed (calculated) as the estimated toxicity based on molecular weights and the estimated amount of oxime generated from the hydrolysis reaction. The amount of oxime generated was estimated using the assumption that 1 mole of test material (OS1600) produces 3 moles of MPKO, and thus, an estimated quantity of 3 moles of MIBKO.
No effects were observed in the reproductive organs at the highest dose tested (50 mg/kg bw/day): epididymides, ovaries, prostate, seminal vesicles, testes and uterus and cervix.
The data matrix is included in the reporting format attached.
The results from the read-across approach are expressed on the basis of the amount of MPKO generated from the hydrolysis reaction of OS1600 and their molecular weights. The amount of MPKO was estimated using the assumption that 1 mole of the target substance OS1600 produces 3 moles of MPKO. No other adaptions are necessary.
Effect on fertility: via oral route
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- NOAEL
- 99 mg/kg bw/day
- Study duration:
- subchronic
- Species:
- rat
- Quality of whole database:
- The studies available are a screening study, a one-generation study and a subchronic repeated dose toxicity. The screening study has Klimisch score=2 (read-across from a Klimish 1 study), the one-generation study has Klimisch score=2 (read-across from a Klimish 1 study) and the subchronic repeated dose study has Klimish score =2 (read-across from a Klimish 1 study). The overall quality of the database is therefore high.
Effect on fertility: via inhalation route
- Endpoint conclusion:
- no study available
Effect on fertility: via dermal route
- Endpoint conclusion:
- no study available
Additional information
Weight of evidence:
1. Test method OECD 415. GLP Study: Read-across from experimental data on the analogue substance methyl isobutyl ketoxime (MIBKO): A one-generation study was performed on the analogue substance MIBKO on Sprague-Dawley rats according to OECD guideline 415. No adverse effects were observed in any of the reproductive or developmental parameters or in the F1 pups. The toxicity profile included symptoms of minimal to moderate hemosiderosis and minimal congestion in the spleens at 100 mg/kg bw/day males and females. The NOAEL for parental toxicity in the F0 generation was considered to be 30 mg/kg bw/day based on histological effects on the spleen. The NOAEL for the F1 generation and reproductive toxicity was considered to be >100 mg/kg bw/day based on no effects observed at the highest dose. Based on these results the read-across was applied and the NOAEL of OS1600 for parental toxicity, and F1 and toxicity to reproduction were estimated to be 30 and >99 mg/kg-bw/day respectively.
2.Test method OECD 422. GLP study: Read-across from experimental data on the analogue substance MPKO: The systemic toxic potential and effects on reproduction of the analogue MPKO were assessed in rats following oral administration for at least five weeks in accordance with OECD Guideline 422 (GLP study). Based on the read-across approach from the analogue substance MPKO, the hydrolysis product of OS1600 (NOEL = 150 mg/kg bw/day since no adverse effects observed on the reproductive screening parameters at the highest dose level), the NOEL for OS1600 was determined to be 170 mg/kg bw/day for reproductive toxicity in rats.
3. Test method OECD 408. GLP study: Read-across from experimental data on analogue substance OS2200: A 90 days oral repeated dose toxicity test was performed on the analogue substance OS2200 according to OECD Guideline 408 and GLP. The NOAEL was determined to be 15 mg/kg bw/day in rats since effects on red blood cells, resulting in associated changes in the spleen were observed. Based on these results, the read-across was applied and the 90 days NOAEL (oral) for OS1600 in rats was estimated to be 13 mg/kg- bw/day under the test conditions. No effects were observed in the reproductive organs or tissues (testes, seminal vesicles, ovaries, epididymides, uterus with cervix) up to the highest dose tested (an estimated dose of 43 mg/kg-bw/day).
Effects on developmental toxicity
Description of key information
Data waiving: The pre-natal developmental toxicity study does not need to be conducted since no effects were observed on F1 generation regarding both developmental parameters and sexual maturation in the one-generation toxicity study. Moreover, no developmental toxicity was observed in the "Combined Repeated Dose Toxicity Study with the Reproduction/Developmental Toxicity Screening Test" up to the highest tested dose.
Link to relevant study records
- Endpoint:
- developmental toxicity
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- other:
- Reason / purpose for cross-reference:
- data waiving: supporting information
- Reason / purpose for cross-reference:
- data waiving: supporting information
- Abnormalities:
- not specified
- Developmental effects observed:
- not specified
- Endpoint:
- developmental toxicity
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Read-across from an analogue substance for which a guideline study (Klimish =1) is available.
- Justification for type of information:
- REPORTING FORMAT FOR THE ANALOGUE APPROACH
See attached reporting format. - Reason / purpose for cross-reference:
- read-across source
- Key result
- Dose descriptor:
- NOAEL
- Remarks:
- (parental systemic toxicity)
- Effect level:
- 17 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Basis for effect level:
- other: Red blood cell destruction with associated findings in the spleen, liver or kidneys at an estimated dose levels of 58 mg/kg bw/day and above.
- Remarks on result:
- other: Read-across from an analogue for which NOAEL = 15 mg/kg bw/day.
- Key result
- Abnormalities:
- no effects observed
- Key result
- Dose descriptor:
- NOEL
- Effect level:
- 170 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Sex:
- not specified
- Basis for effect level:
- other: There were no effects on any of the developmental endpoints assessed.
- Remarks on result:
- other: Read-across from an analogue for which NOEL = 150 mg/kg bw /day.
- Key result
- Abnormalities:
- no effects observed
- Key result
- Developmental effects observed:
- no
- Conclusions:
- Based on the read-across approach from the analogue substance MPKO, the NOEL for OS1600 was considered to be 170 mg/kg bw/day since no effects were observed on the developmental screening parameters up to 170 mg/kg bw/day, the highest dose tested.
- Executive summary:
The systemic toxic potential and effects on reproduction were assessed in rats following oral administration of the analogue substance MPKO for at least five weeks in accordance with OECD Guideline 422. The results observed in this study showed effects of MPKO assessed by haematology, organ weights and macroscopic appearance at dose levels of 50 mg/kg bw/day and above and microscopic tissue appearance were observed at dose levels of 15 mg/kg bw/day and above. After two weeks off dose complete recovery was seen in many clinical pathology parameters and recovery was in progress but not complete in males for high mean cell haemoglobin level, low mean cell haemoglobin concentration and high mean cell volume and in females low red blood cell counts, high mean cell haemoglobin level and high mean cell volume, organ weights, macroscopic and microscopic appearance. There were no adverse effects of treatment on the reproductive/developmental screening parameters assessed at least 150 mg/kg/day. The NOAEL for MPKO was considered to be 15 mg/kg bw/day for general systemic toxicity. The NOEL for reproductive and developmental screening parameters was considered to be 150 mg/kg bw/day. Based on these results, the read-across approach was applied, and the NOAEL for OS1600 was determined to be 17 mg/kg bw/day for systemic toxicity and 170 mg/kg bw/day for toxicity to reproduction.
Referenceopen allclose all
The data matrix is included in the reporting format attached.
The results from the read-across approach are expressed on the basis of the amount of MPKO generated from the hydrolysis reaction of OS1600 and their molecular weights. The amount of MPKO was estimated using the assumption that 1 mole of the target substance OS1600 produces 3 moles of MPKO. No other adaptions are necessary.
Effect on developmental toxicity: via oral route
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- NOAEL
- 99 mg/kg bw/day
- Study duration:
- subchronic
- Species:
- rat
- Quality of whole database:
- The studies available (screening study and one generation toxicity study), of which screening study has Klimisch score=2 (read-across) and the one generation study has Klimish score=2. The overall quality of the database is therefore high.
Effect on developmental toxicity: via inhalation route
- Endpoint conclusion:
- no study available
Effect on developmental toxicity: via dermal route
- Endpoint conclusion:
- no study available
Additional information
Weight of evidence:
1. Test method OECD 415. GLP Study: Read-across from experimental data on the analogue substance methyl isobutyl ketoxime (MIBKO): A one-generation study was performed on the analogue substance MIBKO on Sprague-Dawley rats according to OECD guideline 415. No adverse effects were observed in any of the reproductive or developmental parameters or in the F1 pups. The NOAEL for the F1 generation and reproductive toxicity was considered to be >100 mg/kg bw/day based on no effects observed at the highest dose. Based on these results the read-across was applied and the NOAEL of OS1600 for developmental effects was estimated to be > 99 mg/kg-bw/day.
2. Test method OECD 422. GLP study: Based on the read-across approach from the analogue substance MPKO, the NOEL for OS1600 was determined to be 170 mg/kg bw/day since no effects were observed on screening developmental parameters at the highest dose tested.
Justification for classification or non-classification
Based on the available results, the substance OS1600 is not classified in accordance with CLP Regulation (EC) no. 1272/2008 since no adverse effects were observed on reproductive and/or developmental parameters.
Additional information
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.
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