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EC number: 410-510-9 | CAS number: 86753-82-4
- 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
Effects of test substance on fertility and developmental toxicity have been investigated in a One generation reproductive toxicity study (OECD 415). No treatment related effects were observed in parental animals or offspring up to the highest concentration tested (1000 mg/kg bw/day) indicating that the test substance do not affect fertility and offspring development.
Link to relevant study records
- Endpoint:
- one-generation reproductive toxicity
- Remarks:
- based on test type (migrated information)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 415 [One-Generation Reproduction Toxicity Study (before 9 October 2017)]
- Principles of method if other than guideline:
- EEC Directive 87/302/EEC, Annex V of the EEC Directive67/548/EEC, Part B: Methods for determination of Toxicology "One-Generation Reproductive Toxicity Test". Official Journal of the European Communities No. L 133, May 1988.OECD "Guidelines for Testing of Chemicals", Section 4,Health Effects, No. 415, "One-Generation Reproductive Toxicity Test", Paris Cedex, September 1983.
- GLP compliance:
- yes
- Limit test:
- no
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Route of administration:
- oral: gavage
- Vehicle:
- polyethylene glycol
- Remarks:
- PEG 400
- Details on exposure:
- Method of administration or exposure: Gavage
- Frequency of treatment:
- Dosing regime (males): 7 days/weekDosing regime (females): 7 days/week
- Details on study schedule:
- Number of litters per dose/conc.: 24 at mg/kg or mg/l
- Dose / conc.:
- 50 mg/kg bw/day (actual dose received)
- Dose / conc.:
- 200 mg/kg bw/day (actual dose received)
- Dose / conc.:
- 1 000 mg/kg bw/day (actual dose received)
- Dose / conc.:
- 0 mg/kg bw/day (actual dose received)
- Remarks:
- Control
- No. of animals per sex per dose:
- Male: 24 animals at 0 mg/kg or mg/lMale: 24 animals at 50 mg/kg or mg/lMale: 24 animals at 200 mg/kg or mg/lMale: 24 animals at 1000 mg/kg or mg/lFemale: 24 animals at 0 mg/kg or mg/lFemale: 24 animals at 50 mg/kg or mg/lFemale: 24 animals at 200 mg/kg or mg/lFemale: 24 animals at 1000 mg/kg or mg/l
- Clinical signs:
- no effects observed
- Dermal irritation (if dermal study):
- not examined
- Mortality:
- no mortality observed
- Body weight and weight changes:
- no effects observed
- Food consumption and compound intake (if feeding study):
- no effects observed
- Food efficiency:
- not examined
- Water consumption and compound intake (if drinking water study):
- not examined
- Ophthalmological findings:
- not specified
- Haematological findings:
- not examined
- Clinical biochemistry findings:
- not examined
- Urinalysis findings:
- not examined
- Behaviour (functional findings):
- no effects observed
- Immunological findings:
- not examined
- Organ weight findings including organ / body weight ratios:
- not specified
- Histopathological findings: non-neoplastic:
- not specified
- Histopathological findings: neoplastic:
- not specified
- Other effects:
- not examined
- Reproductive function: oestrous cycle:
- not specified
- Reproductive function: sperm measures:
- not examined
- Reproductive performance:
- no effects observed
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- > 1 000 mg/kg bw/day
- Based on:
- test mat.
- Sex:
- male/female
- Remarks on result:
- not determinable due to absence of adverse toxic effects
- Clinical signs:
- no effects observed
- Dermal irritation (if dermal study):
- not examined
- Mortality / viability:
- not specified
- Body weight and weight changes:
- no effects observed
- Food consumption and compound intake (if feeding study):
- not specified
- Food efficiency:
- not specified
- Water consumption and compound intake (if drinking water study):
- not examined
- Ophthalmological findings:
- not specified
- Haematological findings:
- not examined
- Clinical biochemistry findings:
- not examined
- Urinalysis findings:
- not examined
- Sexual maturation:
- no effects observed
- Organ weight findings including organ / body weight ratios:
- not specified
- Gross pathological findings:
- no effects observed
- Histopathological findings:
- not specified
- Other effects:
- no effects observed
- Behaviour (functional findings):
- not examined
- Developmental immunotoxicity:
- not examined
- Key result
- Dose descriptor:
- NOAEL
- Generation:
- F1
- Effect level:
- > 1 000 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Sex:
- male/female
- Remarks on result:
- not determinable due to absence of adverse toxic effects
- Key result
- Reproductive effects observed:
- no
- Lowest effective dose / conc.:
- 1 000 mg/kg bw/day (actual dose received)
- Treatment related:
- no
- Conclusions:
- Based on the findings in the study, the no adverse effect level (NOAEL) for parental and developmental toxicity was established as more than 1000 mg/kg/day.
- Executive summary:
Parental Data:
Adult males and females tolerated Hypersol Synergist L4722 at oral doses levels up to and including 1000 mg/kg/day without changes to appearance and behaviour, and without effect on survival, body weight or food intake.
There were no treatment-related macroscopic or microscopic lesions detected in parental animals.
Reproduction and litter data:
The result of the study indicate that mating was successful in all groups with similar mean coital times recorded for all groups. there was no indication of any treatment-related effects on fertility, since fertility and conception rates were similar for treated and control groups. Gestation times were unaffected by treatment.
The viability of the pups was not influenced by treatment. Development of pups from treated dams progressed in a similar manner to those pups from control dams i.e. no treatment-related clinical signs were observed and body weight development was similar for treated and control litters. Macroscopic examinations of the pups at necropsy did not detect any lesions that were associated with exposure of the parents to Hypersol Synergist L4722.
Based on the findings in the study, the no adverse effect level (NOAEL) for parental and developmental toxicity was established as more than 1000 mg/kg/day.
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:
- reliable with restrictions
Effect on fertility: via inhalation route
- Endpoint conclusion:
- no study available
Effect on fertility: via dermal route
- Endpoint conclusion:
- no study available
Additional information
Effects of test substance on fertility and developmental toxicity have been investigated in a One generation reproductive toxicity study (OECD 415). No treatment related effects were observed in parental animals or offspring up to the highest concentration tested (1000 mg/kg bw/day) indicating that the test substance do not affect fertility and offspring development.
Further toxicity data on the test substance support this interpretation:
- The test substance did not cause lethal effects after administration of a single oral dose of > 2000 mg/kg in rats,
- The test substance does not have to be classified as irritating to skin or eyes,
- it is unlikely that test substance become systemically bioavailable due to their extremely low solubility in water andn-octanoland due the missing bioavailability of the degradation product 3,3'-dichlorobenzidine after oral or dermal application.
Therefore it is concluded that the substances of this category will not cause effects on fertility and developmental toxicity and will not be transferred to breast milk.
Effects on developmental toxicity
Description of key information
Effects of test substance on fertility and developmental toxicity have been investigated in a One generation reproductive toxicity study (OECD 415). No treatment related effects were observed in parental animals or offspring up to the highest concentration tested (1000 mg/kg bw/day) indicating that the test substance do not affect fertility and offspring development.
Link to relevant study records
- Endpoint:
- developmental toxicity
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Qualifier:
- according to guideline
- Guideline:
- other: Directive 87/302 , Part B OECD 414
- GLP compliance:
- yes
- Limit test:
- no
- Species:
- rat
- Strain:
- Wistar
- Route of administration:
- oral: gavage
- Vehicle:
- polyethylene glycol
- Remarks:
- PEG 400
- Details on exposure:
- Method of administration or exposure: GavageMass median aerodynamic diameter:Not applicable
- Frequency of treatment:
- Dosing regime: 7 days/week
- No. of animals per sex per dose:
- Number of dams and doses24 at 0 mg/kg or mg/l24 at 50 mg/kg or mg/l24 at 200 mg/kg or mg/l24 at 1000 mg/kg or mg/l
- Details on maternal toxic effects:
- Details on maternal toxic effects:Treatment of pregnant females during day 6 to day 16 ofgestation inclusive, did not reveal any signs of maternaltoxocity.All mated females (except one) were pregnant and nodifferences were seen in the number of corpora lutea, thenumber of implantations, the pre- and post-implantation lossand the incidence of embryonic/foetal deaths.
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- > 1 000 mg/kg bw/day
- Basis for effect level:
- other: maternal toxicity
- Details on embryotoxic / teratogenic effects:
- Details on embryotoxic / teratogenic effects:Effects on fetus - Gross:No foetal deaths occurred among treated litters. Sex ratios were normal in litters of dams treated with substance.The total foetal weights and foetal weights of the sexes separately revealed no test substance-related changes.
Effects on fetus -
Soft tissue: There were no external findings that were concidered to have arisen as a result of treatment of dams with the substance. There were no morphological changes detected at visceral examination of the foetuses.
Skeletal: Skeletal examinations revealed no changes in the ossification of the foetal skeleton at dose up to 1000 mg/kg body weight/day. Treatment of dams at 1000 mg/kg/day slightly increased the incidences of supernumerary ribs and wavy ribs. - Key result
- Dose descriptor:
- NOEL
- Effect level:
- 200 mg/kg bw/day
- Basis for effect level:
- other: embryotoxicity
- 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 dose dependent effects except for slightly increased incidence of spontaneous variations at the highest dose.
- Abnormalities:
- effects observed, non-treatment-related
- Localisation:
- skeletal: supernumerary rib
- Description (incidence and severity):
- slight increase in incidence (frequent spontaneous variation)
- Abnormalities:
- effects observed, non-treatment-related
- Localisation:
- other: wavy rib
- Description (incidence and severity):
- silght increase in incidence (frequent spontaneous variation)
- Developmental effects observed:
- yes
- Lowest effective dose / conc.:
- 1 000 mg/kg bw/day (nominal)
- Treatment related:
- no
- Relation to maternal toxicity:
- not specified
- Dose response relationship:
- no
- Relevant for humans:
- no
- Conclusions:
- Based on the results in this embryotoxicity and teratogenicy study, the definitive No Observed Effect Level (NOEL) was established as being 200 mg/kg bw/day. The NOAEL was considered as 1000 mg/kg bw/ day.
- Executive summary:
Oral dosing of pregnant female Wistar rats with Hypersol synergist L 4722 at dose levels of 50, 200 or 1000 mg/kg bw/day during day 6 to 16 of gestation inclusive, was associated with a very slight increase in the total number of foetuses with supernumerary rib(s) or with wavy ribs, but there were no other indications of adverse effects upon in utero development of foetuses.
Based on the results in this embryotoxicity and teratogenicy study, the definitive No Observed Effect Level (NOEL) was established as being 200 mg/kg bw/day. The NOAEL was considered as 1000 mg/kg bw/ day.
Reference
Effect on developmental toxicity: via oral route
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- NOAEL
- 200 mg/kg bw/day
Additional information
Developmental toxicity / teratogenicity have been investigated in an Embryotoxicity and teratogenicity study with the test substance by oral gavage in Wistar Rats. The definitive No Obesrved Effect Level (NOEL) was established as being 200 kg/kg bw/day.
Justification for classification or non-classification
In the absence of any relevant local or systemic toxicity of the test substance after acute or repeated exposure and because they do not show any relevant bioavailability it is concluded that the test substance have not to be classified for reproductive toxicity and effects on or via lactation accordingto Regulation (EC) No 1272/2008 and Council Directive 67/548/EEC.
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.