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EC number: 258-380-0 | CAS number: 53126-67-3
- 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
Key value for chemical safety assessment
Effects on fertility
Description of key information
Adverse effects regarding development were observed with the read across-substance (CAS 107-66-4) at 1000 mg/kg bw in combination with systemic adverse effects. It was concluded that the NOAEL regarding reproduction was 1000 mg/kg bw/d and the NOAEL regarding development was found to be 300 mg/kg bw/d.
Link to relevant study records
- Endpoint:
- screening for reproductive / developmental toxicity
- 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
Please refer to the attached read-across justification in section 13. - Reason / purpose for cross-reference:
- read-across source
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 422 (Combined Repeated Dose Toxicity Study with the Reproduction / Developmental Toxicity Screening Test)
- Version / remarks:
- 1996
- Deviations:
- no
- Sex:
- male/female
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- 1 000 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: no statistically significant changes regarding reproductive performance
- Key result
- Critical effects observed:
- no
- Key result
- Dose descriptor:
- NOAEL
- Generation:
- F1
- Effect level:
- 300 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- viability
- mortality
- Key result
- Critical effects observed:
- no
- Key result
- Reproductive effects observed:
- yes
- Lowest effective dose / conc.:
- 1 000 mg/kg bw/day (actual dose received)
- Treatment related:
- yes
- Relation to other toxic effects:
- reproductive effects as a secondary non-specific consequence of other toxic effects
- Dose response relationship:
- yes
- Conclusions:
- Adverse effects regarding development were observed with the read across-substance (CAS 107-66-4) at 1000 mg/kg bw in combination with systemic adverse effects. It was concluded that the NOAEL regarding reproduction was 1000 mg/kg bw/d and the NOAEL regarding development was found to be 300 mg/kg bw/d.
- Executive summary:
In order to investigate the toxicity of the read across substance (CAS 107-66-4) after repeated administration a combined repeated dose toxicity and reproductive toxicity study was undertaken using SD (Crj:CD(SD)) rats. There were 10 male and 10 female rats per group, and the test item doses were 0 (control: solvent administered), 30, 100, 300 and 1000 mg/kg bw/day, administered by forced oral administration every day from 14 days prior to the start of mating, until day 3 of lactation after delivery for the females (40-51 days), and for 44 days for the males. The results obtained were as follows: For the parental animals, no adverse effects due to test item administration were observed in the 30 mg/kg bw/day group (=NOAEL for systemic toxicity). With regard to reproduction of the parental males and parental females, no significant difference to the control group was observed for any of the indicators, even in the 1000 mg/kg bw/d group. One animal in the 1000 mg/kg bw/d group had a difficult delivery where all the pups died, and therefore the gestation index tended to be slightly low, but there were no significant changes. Regarding development of the pups, also in the 100 mg/kg bw/d and higher dose groups there were parental females whose pups all died: in the 1000 mg/kg bw/d group the incidence was high in that there were 3 such parental females, and so the number of live pups, the number of live pups on day 4 of lactation and the viability decreased or tended to be low. Although the only statistically significant difference observed was in the number of live female pups on day 4 of lactation, there was a decrease in the number of live pups, including males, on day 4 of lactation, and the viability was low. In the parental females whose pups all died, erosion and ulceration of the stomach were observed and severe pathological changes were confirmed, but no abnormalities of the pituitary or reproductive organs were observed. The changes in these developmental toxicity indicators in the parental females are therefore deemed to have been secondary general toxicological effects. It was concluded that the NOAEL regarding reproduction was 1000 mg/kg bw/d and the NOAEL regarding development was found to be 300 mg/kg bw/d.
Reference
Effect on fertility: via oral route
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- NOAEL
- 1 000 mg/kg bw/day
- Study duration:
- subacute
- Species:
- rat
- Quality of whole database:
- GLP and guideline study
Effect on fertility: via inhalation route
- Endpoint conclusion:
- no study available
Effect on fertility: via dermal route
- Endpoint conclusion:
- no study available
Additional information
In order to investigate the toxicity of the read across-substance (CAS 107 -66 -4) after repeated administration a combined repeated dose toxicity and reproductive toxicity study was undertaken using SD (Crj:CD(SD)) rats. There were 10 male and 10 female rats per group, and the test item doses were 0 (control: solvent administered), 30, 100, 300 and 1000 mg/kg bw/day, administered by forced oral administration every day from 14 days prior to the start of mating, until day 3 of lactation after delivery for the females (40-51 days), and for 44 days for the males. The results obtained were as follows: For the parental animals, no adverse effects due to test item administration were observed in the 30 mg/kg bw/day group (=NOAEL for systemic toxicity). With regard to reproduction of the parental males and parental females, no significant difference to the control group was observed for any of the indicators, even in the 1000 mg/kg bw/d group. One animal in the 1000 mg/kg bw/d group had a difficult delivery where all the pups died, and therefore the gestation index tended to be slightly low, but there were no significant changes. Regarding development of the pups, also in the 100 mg/kg bw/d and higher dose groups there were parental females whose pups all died: in the 1000 mg/kg bw/d group the incidence was high in that there were 3 such parental females, and so the number of live pups, the number of live pups on day 4 of lactation and the viability decreased or tended to be low. Although the only statistically significant difference observed was in the number of live female pups on day 4 of lactation, there was a decrease in the number of live pups, including males, on day 4 of lactation, and the viability was low. In the parental females whose pups all died, erosion and ulceration of the stomach were observed and severe pathological changes were confirmed, but no abnormalities of the pituitary or reproductive organs were observed. The changes in these developmental toxicity indicators in the parental females are therefore deemed to have been secondary general toxicological effects. It was concluded that the NOAEL regarding reproduction was 1000 mg/kg bw/d and the NOAEL regarding development was found to be 300 mg/kg bw/d.
Effects on developmental toxicity
Description of key information
In the above mentioned study conduicted with the read across-substance (CAS 107-66-4) the changes in developmental toxicity indicators (decreased pup viability, increased number of stillborn pups) in the parental females are deemed to have been secondary general toxicological effects. It was concluded that the NOAEL regarding reproduction was 1000 mg/kg bw/d and the NOAEL regarding development was found to be 300 mg/kg bw/d.
Effect on developmental toxicity: via oral route
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- NOAEL
- 300 mg/kg bw/day
- Study duration:
- subacute
- Species:
- rat
- Quality of whole database:
- GLP and Guideline study
Effect on developmental toxicity: via inhalation route
- Endpoint conclusion:
- no study available
Effect on developmental toxicity: via dermal route
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
Classification,
Labelling, and Packaging Regulation (EC) No 1272/2008
The
available experimental test data are reliable and suitable for
classification purposes under Regulation (EC) No 1272/2008. Available
data on toxicity to reproduction and developmental toxicity indicate
adverse effects on reproduction/development only together with general
toxicity, thus not fulfilling requirements for classification under
Regulation (EC) No 1272/2008 (CLP). Therefore, the
test item is not classified according
to Regulation (EC) No 1272/2008 (CLP), as amended for the twelth
time in Regulation (EU) No 2019/521.
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.
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