Registration Dossier
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EC number: 701-196-7 | CAS number: -
- 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

Toxicity to reproduction
Administrative data
- Endpoint:
- extended one-generation reproductive toxicity - basic test design (Cohorts 1A, and 1B without extension)
- Type of information:
- experimental study planned
- Study period:
- after ECHA's final decision, depending on laboratory capacity
- Justification for type of information:
- TESTING PROPOSAL ON VERTEBRATE ANIMALS
NON-CONFIDENTIAL NAME OF SUBSTANCE:
- Name of the substance on which testing is proposed to be carried out: Reaction products of pentaerythritol, propoxylated and 1-chloro-2,3-epoxypropane with hydrogen sulfide
CONSIDERATIONS THAT THE GENERAL ADAPTATION POSSIBILITIES OF ANNEX XI OF THE REACH REGULATION ARE NOT ADEQUATE TO GENERATE THE NECESSARY INFORMATION:
- Available GLP studies: there are no GLP studies available for the endpoint toxicity to reproduction
- Available non-GLP studies: there are no non-GLP studies available for the endpoint toxicity to reproduction
- Historical human data: there are no historical human data that can be considered acceptable for this higher tier toxicity endpoint.
- (Q)SAR: Although (Q)SAR programmes include several endpoints that are related to toxicity to reproduction, these (Q)SAR endpoints do not cover all endpoints that need to be investigated for the endpoint reproductive toxicity. In some cases (Q)SAR for this endpoint can be useful as a first indication for possible reproductive toxicity; however absence of structural alerts is considered not acceptable to replace further studies for this toxicity endpoint, neither for registration nor for classification purposes.
According to ECHA Practical Guide on alternatives to animal testing (July 2016) ECHA’s experience of using adaptations to address standard information requirements reveals that there are no simple (Q)SAR solutions for complex health endpoints such as reproductive toxicity.
- In vitro methods: there are no reliable in vitro tests available that can be considered for the endpoint reproductive toxicity that sufficiently cover the endpoint for risk assessment and classification purposes
- Weight of evidence: there is no relevant information available that can be used in a WoE to cover the endpoint reproductive toxicity for registration and classification purposes.
- Grouping and read-across: there are currently no structures known (and that also have reliable data on reproductive toxicity) that can be used for grouping or read-across, and which is acceptable for registration and classification purposes.
CONSIDERATIONS THAT THE SPECIFIC ADAPTATION POSSIBILITIES OF ANNEXES VI TO X (AND COLUMN 2 THEREOF) OF THE REACH REGULATION ARE NOT ADEQUATE TO GENERATE THE NECESSARY INFORMATION:
The specific rules for adaptation from column 1 as given in column 2 are not met, as the available data do not demonstrate that the substance is a genotoxic carcinogen or germ cell mutagen. The available data are indicative for systemic absorption, whereas data demonstrating adverse effect on fertility meeting the criteria for classification as Repr Cat 1 or 2 (with adequate data to support risk assessment). According to Column 1 and Column 2 of Regulation (EC) No 1907/2006 concerning REACH an extended one-generation toxicity study (OECD 443), basic test design (cohorts 1A and 1B without extension to include a F2 generation) needs to be performed in case the available repeated dose toxicity studies (e. g. 90- day study) indicate adverse effects on reproductive organs or tissues or reveal other concerns in relation with reproductive toxicity. No treatmentrelated effects were observed on all sexual organ weights, estrous cycle length and number, and sperm motility, count and percentage of abnormal
sperms in a reliable 90-day repeated dose toxicity study in rat. The weight of the thyroid gland was increased in females and slight/minimal follicular hypertrophy/hyperplasia was seen in males and females at 1000 mg/kg bw/day and in males at 250 mg/kg bw/day also follicular hypertrophy/hyperplasia was seen. Hormones made in the thyroid gland are involved in the regulation of T-lymphocyte development and growth. The extended one generation study is proposed to contain the developmental immunotoxicity cohort (DIT) due to the thyroid effects observed in the 90-day study. The reproduction-developmental screening study is waived, based on testing proposals for an extended one-generation toxicity study (OECD 443) and a developmental toxicity study (OECD 414) for ANNEX IX registration.
Data source
Materials and methods
Test guideline
- Qualifier:
- according to
- Guideline:
- other: OECD 443, including DIT cohort
- Justification for study design:
- SPECIFICATION OF STUDY DESIGN FOR EXTENDED ONE-GENERATION REPRODUCTION TOXICITY STUDY WITH JUSTIFICATIONS [please address all points below]:
- Premating exposure duration for parental (P0) animals; according to guideline
- Basis for dose level selection: all available information from toxicity studies and when necessary a dose range finding study
- Exclusion of extension of Cohort 1B
- Termination time for F2: according to guideline
- Exclusion of developmental neurotoxicity Cohorts 2A and 2B
- Inclusion of developmental immunotoxicity Cohort 3
- Route of administration: oral
Test material
Reference
- Name:
- Unnamed
- Type:
- Constituent
Results and discussion
Overall reproductive toxicity
- Reproductive effects observed:
- not specified
Applicant's summary and conclusion
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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