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EC number: 947-567-9 | 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
Endpoint summary
Administrative data
Description of key information
Acute toxicity, oral in rats: LD50 = 1656 mg/kg bw (equivalent or similar to OECD 401, non-GLP, K, Rel.2)
Key value for chemical safety assessment
Acute toxicity: via oral route
Link to relevant study records
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2001
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Deviations:
- no
- GLP compliance:
- no
- Test type:
- standard acute method
- Limit test:
- no
- Specific details on test material used for the study:
- Fessoukh, bought from a herbalist in Rabat, was dissolved in absolute ethanol, then filtered and evaporated to dryness to obtain the resinous gum or fessoukh extract
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- Bodyweight: 200-250 g
- Route of administration:
- oral: gavage
- Vehicle:
- peanut oil
- Details on oral exposure:
- The total volume administered to each animal did not exceed 0.5 mL/100 g bw
- Doses:
- 500, 1000, 1500, 2000, or 3000 mg/kg bw
- No. of animals per sex per dose:
- 5
- Control animals:
- yes
- Details on study design:
- All animals were observed daily for 15 days, and deaths or any other toxic effect were noted
- Statistics:
- The probit method for LD50 calculation was used.
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- 1 656.1 mg/kg bw
- Based on:
- test mat.
- 95% CL:
- >= 1 576 - <= 1 740.4
- Mortality:
- See results table; at 3000 mg/kg, deaths occurred within 24 h after administration. At lower doses, deaths of rats began after 4 days.
- Clinical signs:
- other: Rats that survived more than 4 days had bleeding from nose, eyes, and anal and genital organs. The affected rats first had diarrhea on the 1st and 2nd day after dosing and then bleeding on days 2 and 3. The animals then had anemia and ataxia, and the last
- Gross pathology:
- No bleeding evidence was detected at necropsy.
- Other findings:
- The toxicity of the test item would be mainly due to its 4-hydroxicoumarins.
- Interpretation of results:
- Category 4 based on GHS criteria
- Conclusions:
- The LD50 of Fessoukh extract with absolute ethanol in rats is 1656 mg/kg bw therefore it is classified as category 4, "H302: Harmful if swallowed" according to Regulation EC No. 1272/2008.
- Executive summary:
Six groups of 10 albino rats each (5 males and 5 females) were administrated Fessoukh extract with absolute ethanol at doses of 500, 1000, 1500, 2000, or 3000 mg/kg bw. The control group was given peanut oil only, which was used as the vehicle. All animals were observed daily for 15 days, and deaths or any other toxic effect were noted.
At 3000 mg/kg, deaths occurred within 24 h after administration. At lower doses, deaths of rats began after 4 days. Rats that survived more than 4 days had bleeding from nose, eyes, and anal and genital organs. The affected rats first had diarrhea on the 1st and 2nd day after dosing and then bleeding on days 2 and 3. The animals then had anemia and ataxia, and the last died the 7th day after dosing.
The calculated LD50 was 1656.1 mg/kg bw, with a 95% confidence limit of 1576.0 to 1740.4 mg/kg therefore the test item is classified as category 4, "H302: Harmful if swallowed" according to Regulation EC No. 1272/2008.
Reference
Table 1: Oral acute toxicity of fessoukh extract in rats:
Dose (mg/kg bw) | 500 | 1000 | 1500 | 2000 | 3000 |
Mortality (%) |
0 |
10 |
30 |
70 |
100 |
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 1 656 mg/kg bw
- Quality of whole database:
- Some details of the experimental conditions are missing (animal conditions, bodyweights) but the main useful data are described for appropriate hasard assessment.
Acute toxicity: via inhalation route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Acute toxicity: via dermal route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Acute toxicity: via oral route
Six groups of 10 albino rats each (5 males and 5 females) were administrated Fessoukh ethanol extract at doses of 500, 1000, 1500, 2000, or 3000 mg/kg bw. The control group was given peanut oil only, which was used as the vehicle. All animals were observed daily for 15 days, and deaths or any other toxic effect were noted.
At 3000 mg/kg, deaths occurred within 24 h after administration. At lower doses, deaths of rats began after 4 days. Rats that survived more than 4 days had bleeding from nose, eyes, and anal and genital organs. The affected rats first had diarrhea on the 1st and 2nd day after dosing and then bleeding on days 2 and 3. The animals then had anemia and ataxia, and the last died the 7th day after dosing.
The calculated LD50 was 1656.1 mg/kg bw, with a 95% confidence limit of 1576.0 to 1740.4 mg/kg therefore the test item is classified as category 4, "H302: Harmful if swallowed" according to Regulation EC No. 1272/2008.
Justification for classification or non-classification
Harmonized classification:
The registered substance has no harmonized classification according to the Regulation (EC) No. 1272/2008.
Self-classification:
Acute toxicity via Oral route:
Based on the available information, the registered substance is:
- classified as category 4, "H302: Harmful if swallowed" according to Regulation EC No. 1272/2008 because the LD50 = 1656 mg/kg bw in rats
Acute toxicity via Dermal route:This information is not available
Acute toxicity via Inhalation:This information is not available.
Specific target organ toxicity: single exposure (Oral):
The classification criteria according to the Annex VI of the Regulation (EC) No. 1272/2008 as specific target organ toxicant (STOT) – single exposure, oral are not met since no reversible or irreversible adverse health effects were observed immediately or delayed after exposure and no effects were observed at the guidance value (oral) for a Category 1 classification (C ≤ 300 mg/kg bw) and at the guidance value (oral) for a Category 2 classification (2000 mg/kg bw ≥ C > 300 mg/kg bw). No classification is required.
Specific target organ toxicity: single exposure (Dermal): This information is not available
Specific target organ toxicity: single exposure (Inhalation): This information is not available.
Based on its composition (> 10% of aspiration toxicants or hydrocarbons), the registered substance is classified for aspiration hazard category 1, H304 according to CLP Regulation and GHS.
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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