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EC number: 449-360-4 | CAS number: 647828-16-8
- 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
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 15 May 2003 and 11 June 2003
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 003
- Report date:
- 2003
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- acute toxic class method
- Limit test:
- yes
Test material
- Reference substance name:
- -
- EC Number:
- 449-360-4
- EC Name:
- -
- Cas Number:
- 647828-16-8
- Molecular formula:
- C18H32O
- IUPAC Name:
- decahydro-2,2,6,6,7,8,8-heptamethyl-2H-Indeno[4,5-b] furan
- Test material form:
- liquid
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS:
- Source: Charles River (UK) Ltd, Margate, Kent, UK
- Age at study initiation: 8-12 weeks
- Weight at study initiation: Body weights fell within an interval of ± 20% of the mean initial body weight of the first treated group
- Fasting period before study: Overnight fast and for approximately 3 to 4 hours after dosing
- Housing: Groups of 3 in suspended solid-floor polypropylene cages furnished with woodflakes
- Diet: Ad libitum
- Water: Ad libitum
- Acclimation period: At least 5 days
ENVIRONMENTAL CONDITIONS:
- Temperature (°C): 19 to 25
- Humidity (%): 30 to 70
- Air changes (per hr): at least 15 changes per hour
- Photoperiod (hrs dark / hrs light): 12 hrs continuous light (06:00 to 18:00) and 12 hrs darkness
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Details on oral exposure:
- MAXIMUM DOSE VOLUME APPLIED:
2.15 mL/kg
DOSAGE PREPARATION:
For the purpose of the study the test substance was used as supplied. The specific gravity was determined and used to calculate the appropriate dose volume for the required dose level.
CLASS METHOD:
- Rationale for the selection of the starting dose: In absence of data suggesting test substance is toxic, 2000 mg/kg was chosen as the starting dose. - Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 6
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days.
- Frequency of observations and weighing: 1/2, 1, 2, 4 hours after dosing and subsequently once daily for 14 days. Weighing: prior to dosing and 7 and 14 days after treatment.
- Necropsy of survivors performed: yes.
- Other examinations performed: clinical signs, body weight and gross pathological examination. - Statistics:
- None recorded.
Results and discussion
Effect levels
- Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 500 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: Confidence intervals are not applicable in view of the absence of effects.
- Mortality:
- There were no deaths.
- Clinical signs:
- other: There were no signs of systemic toxicity.
- Gross pathology:
- No abnormalities were noted at necropsy.
- Other findings:
- None
Any other information on results incl. tables
Table 1. Mortality.
Dose Level mg/kg |
Sex |
Number of Animals Treated |
Deaths During Day of Dosing (Hour) |
Deaths During Period After Dosing (Days) |
Deaths |
||||||||||
½ |
1 |
2 |
4 |
1 |
2 |
3 |
4 |
5 |
6 |
7 |
8-14 |
||||
2000 |
Female |
3 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0/3 |
Female |
3 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0/3 |
Table 2. Individual Clinical Observations.
Dose Level mg/kg |
Animal Number and Sex |
Effects Noted After Dosing (Hours) |
Effects Noted During Period After Dosing (Days) |
||||||||||||||||
½ |
1 |
2 |
4 |
1 |
2 |
3 |
4 |
5 |
6 |
7 |
8 |
9 |
10 |
11 |
12 |
13 |
14 |
||
2000 |
1-0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1-1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
1-2 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
2-0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
2-1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
2-2 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Table 3. Individual Body weights and Weekly Body weight Changes.
Dose Level |
Animal Number and Sex |
Body weight (g) at Day |
Body weight Gain (g) During Week |
|||
0 |
7 |
14 |
1 |
2 |
||
2000 |
1-0 Female |
223 |
248 |
273 |
25 |
25 |
1-1 Female |
222 |
263 |
283 |
41 |
20 |
|
1-2 Female |
242 |
275 |
298 |
33 |
23 |
|
2-0 Female |
213 |
258 |
278 |
45 |
20 |
|
2-1 Female |
214 |
258 |
283 |
44 |
25 |
|
2-2 Female |
236 |
259 |
291 |
23 |
32 |
Table 4. Individual Necropsy Findings.
Dose Level |
Animal Number and Sex |
Macroscopic Observations |
2000 |
1-0 Female |
No abnormalities detected |
1-1 Female |
No abnormalities detected |
|
1-2 Female |
No abnormalities detected |
|
2-0 Female |
No abnormalities detected |
|
2-1 Female |
No abnormalities detected |
|
2-2 Female |
No abnormalities detected |
Applicant's summary and conclusion
- Interpretation of results:
- other: Not acute harmful according to EU CLP (EC 1272/2008 and its amendments).
- Conclusions:
- The substance has an LD50 greater than 2500 mg/kg bw based on Annex 2d of OECD TG 423 and therefore, is not harmful according to CLP.
GHS: For GHS this substance needs to be classified as Acute Tox 5 (H303). - Executive summary:
In an acute oral toxicity study which was performed in accordance with the Acute Toxic Class method (OECD TG 423) and in compliance with GLP, a group of 3 fasted female Sprague-Dawley CD strain rats was treated with the test substance at a dose level of 2000 mg/kg bw. This was followed by a further group of 3 fasted females at the same dose level. The test substance was administered orally undiluted. Clinical signs and body weight development were monitored during the study. All animals were subjected to gross necropsy. No mortality was observed. All animals showed expected body weight gains over the study period. There were no signs of systemic toxicity and no abnormalities were noted at necropsy. The acute oral median lethal dose (LD50) of the test substance in the female Sprague-Dawley CD strain rat was estimated as being greater than 2500 mg/kg bw, based on Annex 2d of OECD TG 423.
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