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EC number: 246-107-8 | CAS number: 24245-27-0
- 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
The structural analogue substance, was investigated following OECD 421 guideline, at dose-levels of 5, 15 or 25 mg/kg/day. Under the experimental conditions of this study, the No Observed Adverse Effect Level (NOAEL) for parental systemic toxicity was considered to be 15 mg/kg/day, the No Observed Effect Level (NOEL) for reproductive performance (mating and fertility) was considered to be 25 mg/kg/day and the NOEL for toxic effects on progeny was 15 mg/kg/day.
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:
- The test item (target substances, CAS 24245-27-0) is the salt of 1,3-diphenylguanidine and mono-hydrochloride. As read-across source substance the uncharged free base of 1,3-diphenylguanidine (CAS 102-06-7) is applied. This is considered appropriate since the target substance is expected to readily dissociate in contact with water such as surface water in the environment or the intestinal fluids or mucosal membranes of an organism. 1,3-diphenylguanidine is considered a weak base. Therefore, it is expected to be present as uncharged molecule at neutral and high pH solutions. However, acidic conditions will lead to protonation of the molecule and the charged ion is expected to be the main present form. Since transformation of the target to the source substance and vice versa is anticipated, kinetics and toxicological behaviour are well transferable from the source to the target substance. This applies for human health endpoints as well as for the aquatic environment.
Moreover, chloride ions are ubiquitously present in every-day nutrition and are part of numerous physiological processes. Therefore, this constituent does not require further assessment in regards to its toxicological behaviour. It is expected to be well regulated by endogenous physiological mechanisms of the organism.
Based on the considerations above, a read-across is considered appropriate and further tests, especially vertebrate studies, are not needed to adequately address this endpoint. Information Requirements are fulfilled according to REACH Annex XI Section 1.5. - Reason / purpose for cross-reference:
- read-across source
- Key result
- Dose descriptor:
- NOAEL
- Remarks:
- parental toxicity
- Effect level:
- 15 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: lower body weight gain in males at 25 mg/kg/day
- Key result
- Dose descriptor:
- NOEL
- Remarks:
- reproductive performance
- Effect level:
- >= 25 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male/female
- Remarks on result:
- not determinable due to absence of adverse toxic effects
- Key result
- Critical effects observed:
- no
- Key result
- Dose descriptor:
- NOEL
- Remarks:
- developmental toxicity
- Generation:
- F1
- Effect level:
- 15 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: Lower mean body weight gain over the lactation period and lower mean body weights on lactation day 5 at 25 mg/kg/day
- Key result
- Critical effects observed:
- no
- Key result
- Reproductive effects observed:
- no
Reference
Effect on fertility: via oral route
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- NOAEL
- 25 mg/kg bw/day
- Study duration:
- subacute
- Species:
- rat
- Quality of whole database:
- GLP and guideline study with a strutural analogue substance.
Effect on fertility: via inhalation route
- Endpoint conclusion:
- no study available
Effect on fertility: via dermal route
- Endpoint conclusion:
- no study available
Additional information
OECD 421 with structural analogue substance
The objective of this study was to evaluate the potential toxic effects of 1,3-Diphenylguanidine, following daily oral administration (gavage) to male and female rats from before mating, through mating and gestation and until day 4 post-partum. This study provides initial information on possible toxicological effects likely to arise from repeated exposure on male and female reproductive performance, such as gonadal function, mating behaviour, conception, development of the conceptus and parturition. The study was conducted as a reproduction/developmental screening test according to OECD 421 guideline and GLP. Three groups of 10 male and 10 female Sprague-Dawley rats received the test item, 1,3-Diphenylguanidine, daily, by oral (gavage) administration, 4 weeks before mating, through mating and gestation and until day 4 post-partum.The dose-levels were 5, 15 or 25 mg/kg/day. Another group of 10 males and 10 females received the vehicle, 0.5% aqueous methylcellulose, alone, under the same experimental conditions and acted as a control group. The dosing volume was 5 mL/kg/day. Clinical signs and mortality were checked once or twice daily, respectively. Body weight and food consumption were recorded weekly. The animals were paired for mating after 4 weeks of treatment and the dams were allowed to litter and rear their progeny until day 5 post-partum. The total litter sizes and numbers of pups of each sex were recorded after birth. Pups were observed daily for clinical signs and pup body weights were recorded on days 1 and 5 post-partum. The males were sacrificed after a total of 10 weeks of treatment (after most of the females and litters had been sacrificed). The body and selected organs were weighed and a complete macroscopic post-mortem examination was performed. Sperm samples were taken from the left epididymis and the left testis for assessment of sperm motility, morphology and/or count. A microscopic examination was performed on the reproductive organs, liver and kidneys from the males in the control and high-dose groups and on all macroscopic lesions. The dams were sacrificed on day 5 post-partum, the body and selected organs were weighed and a complete macroscopic examination was performed. A microscopic examination was performed on the ovaries, liver and kidneys of the females in the control and high-dose groups and on all macroscopic lesions. Pups were sacrificed on day 5post-partumand, including those found dead, were carefully examined for gross external abnormalities.
There were no unscheduled deaths during the study. Lateral decubitus, mydriasis and staggering gait/locomotory difficulties were observed in one male and one female treated at 25 mg/kg/day on one occasion only. Salivation was observed with a dose-related incidence at 15 and 25 mg/kg/day but was considered to be non-adverse. The male group treated at 25 mg/kg/day had a statistically significantly lower mean body weight gain over the treatment period. There were no effects on the females treated at 25 mg/kg/day nor on the groups treated at 5 or 15 mg/kg/day. There were no effects on mean male food consumption. The female group treated at 25 mg/kg/day had lower mean food consumption during gestation and lactation, achieving statistical significance for the period of the last 7 days of gestation. There were no effects on the female groups treated at 5 or 15 mg/kg/day.
There were no effects on mating, fertility, gestation or delivery at any dose-level. Male and female pups from the group treated at 25 mg/kg/day had lower mean body weight gain over the lactation period and lower mean body weights on lactation day 5. Clinical signs were considered to be unrelated to treatment with the test item. There were no effects of treatment with 1,3-diphenylguanidine on sperm analysis, organ weights, macroscopic post-mortem examination and Microscopic examination
Based on the experimental conditions of this study, the No Observed Adverse Effect Level (NOAEL) for parental toxicity was considered to be 15 mg/kg/day, the No Observed Effect Level (NOEL) for reproductive performance (mating and fertility) was considered to be 25 mg/kg/day and the NOEL for toxic effects on progeny was 15 mg/kg/day.
Effects on developmental toxicity
Effect on developmental toxicity: via oral route
- Endpoint conclusion:
- no study available
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. Based on available data on reproductive toxicity, the NOAEL for fertility was found to be the highest dose tested (i. e. 25 mg/kg bw/d) since no adverse effects on fertility were observed in the OECD 421 study. The NOAEL for developmental and systemic toxicity was determined to be 15 mg/kg bw/d. Effects seen on the progeny are considered secondarily induced by the general toxicity in the dams and not directly induced by the test item itself. Consequently, the test item is does not require classification according to Regulation (EC) No 1272/2008 (CLP), as amended for the tenth time in Regulation (EU) No 2017/776.
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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