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Diss Factsheets
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EC number: 216-133-4 | CAS number: 1506-02-1
- 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://echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 9 August 1985 - 23 August 1985
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study conducted in accordance with GLP requirements and OECD 401 method.
Cross-reference
- Reason / purpose for cross-reference:
- reference to other study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 985
- Report date:
- 1985
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Deviations:
- yes
- Remarks:
- The variation in volume of dosing; that recommendation was not part of that guideline.
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- no
Test material
- Reference substance name:
- 1-(5,6,7,8-tetrahydro-3,5,5,6,8,8-hexamethyl-2-naphthyl)ethan-1-one
- EC Number:
- 216-133-4
- EC Name:
- 1-(5,6,7,8-tetrahydro-3,5,5,6,8,8-hexamethyl-2-naphthyl)ethan-1-one
- Cas Number:
- 1506-02-1
- Molecular formula:
- C18H26O
- IUPAC Name:
- 1-(5,6,7,8-tetrahydro-3,5,5,6,8,8-hexamethyl-2-naphthyl)ethan-1-one
- Details on test material:
- - Name of test material (as cited in study report): AHTN (Tonalid)
- Substance type: pure active substance
- Physical state:pure active substance dissolved in isopropyl myristate
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: Cpb:Wu;Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- Young adult, SPF—bred albino rats (Cpb:Wu;Wistar random) were used. They were obtained from the Central Institute for the Breeding of Laboratory Animals TNO, Zeist, the Netherlands. The body weights of the males varied from 245 to 283 g, those of the females from 162 to 187 g. The rats were kept under the environmental conditions of the Institute’s animal house for 1 week prior to the test.
Species: albino ratis, male: weight 245-283 g and female: weight 162-187 g.Test conditions: temperature: 22 =/-2 degreesCelsius. Relative humidity; 40-60 % 12 hours light/12 hours dark. Food: cereal-based diet.
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- other: isopropyl myristate (IPM)
- Doses:
- 17.5% Tonalid in IPM. Dose: 4.00, 4.80, 5.76, 6.91, 8.29 ml/kg body weight euivalent to 700, 840, 1008, 1209, 1451 g/kg body weight.
- No. of animals per sex per dose:
- 10 (5 male and 5 female)
- Control animals:
- no
- Statistics:
- The LD5O was calculated according to the method of Weil, C.W., Biometrics 8 (1952) 249-263
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- 920 mg/kg bw
- 95% CL:
- > 795 - < 1 066
- Mortality:
- Deaths occurred between 6 hours and 8 days after dosing.
- Clinical signs:
- other: Within a few hours after dosing the rats showed sluggishness and piloerection. - Later on haematuria was observed until 2 days after treatment. After a few days, moreover, encrustations around eyes and nostrils, and signs of’ emaciation were observed. The
- Gross pathology:
- Macroscopic examination at autopsy of the rats that died in the first few post—treatment days revealed blood—stained urine in the bladder of all rats. In the rats that died thereafter and in those that survived the observation period no treatment—related gross alterations were found.
Any other information on results incl. tables
Table 1 Body weight and mortality rate in rats after a single oral dose administration in rats
Bodyweights on day (g) | Mortality | |||||||
Dose | Males | Females | Males | Females | ||||
mg/kg bw | 0 days | 7 days | 14 days | 0 days | 7 days | 14 days | ||
700 | 268 | 280 | 315 | 172 | 171 | 191 | 1/5 | 0/5 |
840 | 254 | 212 | 273 | 170 | 157 | 170 | 4/5 | 0/5 |
1008 | 266 | 235 | 287 | 178 | 150 | 196 | 3/5 | 4/5 |
1209 | 257 | 250 | 304 | 174 | 152 | 175 | 4/5 | 3/5 |
1451 | 260 | - | - | 173 | - | - | 5/5 | 5/5 |
Applicant's summary and conclusion
- Interpretation of results:
- Category 4 based on GHS criteria
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- After treatment, the rats showed sluggishness, piloerection, haematuria, encrustations around eyes and nostrils & signs of emaciation. Deaths occurred between 6 hours and 8 days after treatment. The oral LD50 of Tonalid was found to be 920 mg per kg body weight with 795 and 1066 as the 95% confidence limits.
- Executive summary:
Groups of five male and five female young adult albino rats were administered by gavage 4.00, 4.80, 5.76, 6.91 or 8.29 ml/kg bw of a 17.5% (w/v) solution of AHTN (Tonalid®; purity =98%; equivalent to doses of 700, 840, 1008, 1209 and 1451 mg/kg bw AHTN) in isopropyl myristate and observed for 14 days. Within a few hours, signs of sluggishness and piloerection were seen. Later on haematuria, encrustrations around eyes and nostrils and signs of emaciation were observed. Death occurred between 6 hours and 8 days of dosing at which time survivors recovered gradually looking healthy at the end of the observation period. Macroscopic examination at autopsy of the rats that died in the first few days revealed blood stained urine in the bladder. No other treatment-related gross alterations were seen in these or other animals. An LD50 of 920 mg/kg bw was calculated.
Source: EU Risk Asssessment Report AHTN, Luxembourg, Office for Official Publications of the European Communities, ECB (May 2008)
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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