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Diss Factsheets
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EC number: 201-004-7 | CAS number: 77-09-8
- 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
![](https://chesar.echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
Endpoint summary
Administrative data
Description of key information
The test item does not possess any acute toxic potential below 2000 mg/kg bw (reference 7.2.1 -1).
Key value for chemical safety assessment
Acute toxicity: via oral route
Link to relevant study records
- Endpoint:
- acute toxicity: oral
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- other:
- Justification for type of information:
- JUSTIFICATION FOR DATA WAIVING
In early studies, the test substance given intravenously in dogs was found to be relatively non-toxic. Moderate toxicity after intraperitoneal injection in rats is reported in SAX’s with an LD50 of 500 mg/kg body weight. Information on oral toxicity of test substance in rodents have been found through several studies undertaken during the National Toxicology Program (NTP), including 14 day, 13 week, and 2 year feeding studies in rats and mice. These studies were published in November 1996 as NTP’s Technical Report Series, No. 465 (TR-465): Toxicology and Carcinogenesis Studies of Phenolphthalein (CAS no. 77 -09 -8) in F344/N Rats and B6C3F1 Mice (Feed Studies).1 In these studies, the dose range applied in oral feed exceeds the limit dose for acute toxicity studies according to the OECD Guideline for the Testing of Chemicals No. 423 throughout the protocols. For example, in the 13 -week study in rats groups of 10 male and 10 or 9 female F344/N rats were given 0, 3000, 6000, 12000, 25000, or 50000 ppm test item equivalent to average daily doses of approximately 200, 400, 800 , 1600, or 3500 mg/kg body weight. All study rats survived the end of the study and no mortality was observed. The final mean body weight of the 50000 ppm females and the mean body weight gains of the females were significantly lower compared to those data of the controls. The final mean body weight and mean body weight gains of all other exposed groups were similar to those of the controls. Thus, in can be concluded that the test substance does not possess any acute toxic potential below 2000 mg/kg bw. These findings suggest that further acute oral toxicity studies for the test substance are scientifically unjustified and should thus not be performed due to animal welfare reasons.
References: Repeated dose toxicity studies: (1) NTP 1996, 14-day oral feed rats (2) NTP 1996, 13-weeks oral feed rats - Reason / purpose for cross-reference:
- data waiving: supporting information
- Reason / purpose for cross-reference:
- data waiving: supporting information
Reference
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- discriminating dose
- Value:
- 2 000 mg/kg bw
Additional information
Information on oral toxicity of the test substance in rodents have been observed through several studies undertaken through the National Toxicology Program (NTP), including 14 day, 13 week, and 2 year feeding studies in rats and mice. These studies were published in November 1996 as NTP’s Technical Report Series, No. 465 (TR-465): Toxicology and Carcinogenesis Studies of Phenolphthalein (CAS no. 77 -09 -8) in F344/N Rats and B6C3F1 Mice (Feed Studies)(1). In these studies, the dose range applied in oral feed exceeds the limit dose for acute toxicity studies according to the OECD Guideline for the Testing of Chemicals No. 423 throughout the protocols. For example, in the 13 -week study in rats groups of 10 male and 10 or 9 female F344/N rats were given 0, 3000, 6000, 12000, 25000, or 50000 ppm test item equivalent to average daily doses of approximately 200, 400, 800 , 1600, or 3500 mg/kg body weight. All study rats survived the end of the study and no mortality was observed. The final mean body weight of the 50000 ppm females and the mean body weight gains of the females were significantly lower compared to those data of the controls. The final mean body weight and mean body weight gains of all other exposed groups were similar to those of the controls. Thus, in can be concluded that the test item does not possess any acute toxic potential below 2000 mg/kg bw. These findings suggest that further acute oral toxicity studies for the test substance are scientifically unjustified and should thus not be performed due to animal welfare reasons.
References: Repeated dose toxicity studies: (1) NTP 1996, 14-day oral feed rats (2) NTP 1996, 13-weeks oral feed rats
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, the test item is not classified as acute toxicity
according to Regulation (EC) No 1272/2008 (CLP), as amended for
the fourteenth time in Regulation (EU) 2020/217.
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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