Registration Dossier
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EC number: 237-600-9 | CAS number: 13863-31-5
- 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

Developmental toxicity / teratogenicity
Administrative data
- Endpoint:
- developmental toxicity
- Type of information:
- other: read-across based on grouping of substances (category approach)
- Adequacy of study:
- supporting study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: The study was conducted on the free acid form of the CAS 16090-02-1. Justification for Read Across is reported in the endpoint summary and in the Category Justification Report attached to the Section 13.
Data source
Referenceopen allclose all
- Reference Type:
- other: original reference
- Title:
- Unnamed
- Year:
- 1 998
- Report date:
- 1998
- Reference Type:
- secondary source
- Title:
- Substance: Fluorescent Brightener FWA-1 (CAS 16090-02-1).
- Author:
- HERA
- Year:
- 2 004
- Bibliographic source:
- HERA - Human & Environmental Risk Assessment on ingredients of European household cleaning products. - Draft - Version October 2004
Materials and methods
- Principles of method if other than guideline:
- Pilot developmental toxicity study in rats..
- GLP compliance:
- not specified
Test material
- Reference substance name:
- OB 2A free acid
- Cas Number:
- 32466-46-9
- IUPAC Name:
- OB 2A free acid
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
Administration / exposure
- Route of administration:
- oral: gavage
- Duration of treatment / exposure:
- Dosing was initiated on Day 6 of gestation and continued to and included Day 19 of gestation.
- Frequency of treatment:
- Once per day.
Doses / concentrations
- Remarks:
- Doses / Concentrations:
30, 300, or 1000 mg/kg bw/day.
Basis:
nominal conc.
- No. of animals per sex per dose:
- 7 groups each of 10 mated female.
- Control animals:
- yes, concurrent vehicle
Examinations
- Maternal examinations:
- The following observations of does were recorded: clinical signs, gestational body weight, and food consumption.
Gross pathology analysis was performed after necropsy. - Ovaries and uterine content:
- Gravid uterine weights were recorded.
Total number of corpora lutea, implantations, early and late resorptions, and live and dad fetuses were recorded. - Fetal examinations:
- Litters were delivered by laparohysterectomy on Day 20 of gestation.
Results and discussion
Results: maternal animals
Maternal developmental toxicity
- Details on maternal toxic effects:
- Maternal toxic effects:no effects
Details on maternal toxic effects:
All animals survived to the scheduled necropsy, and no treatment-related clinical observations were seen at any dose level.
No gross pathological alterations were noted at necropsy from any animal on test.
No significant treatment-related effects on body weight, body weight development, food consumption, number of corpora lutea, implantations, live fetuses, preimplantation, postimplantation or resorption rates were observed at any dose level.
Effect levels (maternal animals)
open allclose all
- Dose descriptor:
- NOAEL
- Effect level:
- 1 000 mg/kg bw/day
- Based on:
- test mat.
- Basis for effect level:
- other: maternal toxicity
- Dose descriptor:
- NOAEL
- Effect level:
- 1 000 mg/kg bw/day
- Based on:
- test mat.
- Basis for effect level:
- other: developmental toxicity
Results (fetuses)
- Details on embryotoxic / teratogenic effects:
- Embryotoxic / teratogenic effects:no effects
Details on embryotoxic / teratogenic effects:
No treatment-related effects on gravid uterus or adjusted body weight were observed at any dose level.
Fetal abnormalities
- Abnormalities:
- not specified
Overall developmental toxicity
- Developmental effects observed:
- not specified
Applicant's summary and conclusion
- Conclusions:
- The maternal and developmental rat NOAEL was 1000 mg/kg bw/day for test substance.
- Executive summary:
Method
A pilot prenatal developmental toxicity study was performed in rats with OB 2A free acid, administered via oral gavage. 7 groups each of 10 mated female Sprague-Dawley rats per group were treated once per day via oral gavage either with the vehicle alone (one control group) at the dose levels of 30, 300, or 1000 mg/kg bw/day. Dosing was initiated on Day 6 of gestation and continued to and included Day 19 of gestation. Clinical signs, gestational body weight, and food consumption were recorded. Litters were delivered by laparohysterectomy on Day 20 of gestation. Gravid uterine weights were recorded. Total number of corpora lutea, implantations, early and late resorptions, and live and dad fetuses were recorded.
Results
No adverse treatment-related maternal or developmental effects were observed at any dose level.
NOAEL maternal and developmental: 1000 mg/kg bw/day.
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