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EC number: 944-675-8 | 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
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 30 Jan - 08 Mar 2017
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Remarks:
- Study was conducted in acordance with international guidelines and in accordance with GLP. All guideline validity criteria were met.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 017
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.1100 (Acute Oral Toxicity)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: JMAFF Guidelines (2000)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- acute toxic class method
- Limit test:
- no
Test material
- Reference substance name:
- Reaction products of 3-methyl-5-[(1S,4aS,8aS)-5,5,8a-trimethyl-2-methylenedecahydro-1-naphthalenyl]-1-penten-3-ol, cyclized
- Molecular formula:
- Not applicable (a generic molecular formula cannot be provided for this specific UVCB substance)
- IUPAC Name:
- Reaction products of 3-methyl-5-[(1S,4aS,8aS)-5,5,8a-trimethyl-2-methylenedecahydro-1-naphthalenyl]-1-penten-3-ol, cyclized
- Test material form:
- liquid: viscous
- Details on test material:
- Appearance: Off white paste
1
Test animals
- Species:
- rat
- Strain:
- other: Wistar Han
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Recognised supplier
- Females (if applicable) nulliparous and non-pregnant: Yes
- Age at study initiation: Approx. 8 weeks old
- Weight at study initiation: 143 - 171 g
- Fasting period before study: 20 h prior to dosing and 3-4 after dosing.
- Housing: Up to 5 animals (of the same sex and dose group) housed together in polycarbonate cages (Makrolon Miv type; height 18 cm) containing sterlised sawdust bedding (Lignocel S 8-15, JRS - J.Rettenmaier & Söhne GmbH + CO. KG, Rosenberg, Germany).
- Diet (e.g. ad libitum): ad libitum (except during designated procedures)
- Water (e.g. ad libitum): ad libitum
- Acclimation period: minimum of 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 - 24 ºC
- Humidity (%): 40 - 70 %
- Air changes (per hr): 10 or greater
- Photoperiod (hrs dark / hrs light): 12 / 12
IN-LIFE DATES: From: 01 Feb 2017 To: 08 Mar 2017
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- corn oil
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle:
- Amount of vehicle (if gavage): 10 mL/kg b.w.
- Justification for choice of vehicle: Trial preparations were performed at the Test Facility to select the suitable vehicle and to establish a suitable formulation procedure.
- Lot/batch no. (if required): Not reported
- Purity: Not reported
MAXIMUM DOSE VOLUME APPLIED: 2000 mg/kg bw
DOSAGE PREPARATION (if unusual): N/A
CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: The starting dose level should be the one that is likely to produce mortality in at least some of the animals and was selected based on available toxicity data of the test item. - Doses:
- Test substance was administered by oral gavage to three female Wistar rats at 300 mg/kg body weight. In a stepwise procedure two additional groups of three females were dosed at 2000 mg/kg body weight.
- No. of animals per sex per dose:
- 3 females at 300 mg/kg bw and 6 females at 2000 mg/kg bw.
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing (time after dosing): 0, 2, 4 h and twice daily thereafter (clinical signs). Day 1, 8 and 15 (weight).
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, histopathology - Statistics:
- Not required.
Results and discussion
Effect levels
- Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- not determinable due to absence of adverse toxic effects
- Mortality:
- None
- Clinical signs:
- At 300 mg/kg, piloerection was noted for all animals on Day 1 only.
At 2000 mg/kg, piloerection, uncoordinated movements, abnormal gait, quick breathing, shallow respiration, hunched posture and/or ptosis were noted for all animals on Day 1 only. - Body weight:
- The mean body weight gain shown by the animals over the study period was considered to be similar to that expected for normal untreated animals of the same age and strain.
- Gross pathology:
- No abnormalities were found at macroscopic post mortem examination of the animals.
- Other findings:
- - Organ weights: N/A
- Histopathology: No abnormalities in any of the animals.
- Potential target organs: N/A
- Other observations: N/A
Any other information on results incl. tables
Table 1: Mortality Data
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FEMALES 300 MG/KG |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
FEMALES 2000 MG/KG |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
FEMALES 2000 MG/KG |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
Table 2: Clinical Signs
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||||||||||||||||||
ANIMAL 1 |
||||||||||||||||||
Skin / fur |
||||||||||||||||||
Piloerection |
(1) |
1 |
1 |
1 |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
ANIMAL 2 |
||||||||||||||||||
Skin / fur |
||||||||||||||||||
Piloerection |
(1) |
1 |
1 |
1 |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
ANIMAL 3 |
||||||||||||||||||
Skin / fur |
||||||||||||||||||
Piloerection |
(1) |
1 |
1 |
1 |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
|
||||||||||||||||||
ANIMAL 4 |
||||||||||||||||||
Gait / motility |
||||||||||||||||||
Uncoordinated movements |
(3) |
- |
1 |
1 |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
Abnormal gait |
(3) |
- |
1 |
1 |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
Breathing |
||||||||||||||||||
Quick breathing |
(1) |
- |
1 |
1 |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
Shallow respiration |
(3) |
- |
1 |
1 |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
Skin / fur |
||||||||||||||||||
Piloerection |
(1) |
1 |
1 |
1 |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
ANIMAL 5 |
||||||||||||||||||
Gait / motility |
||||||||||||||||||
Uncoordinated movements |
(3) |
- |
1 |
1 |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
Abnormal gait |
(3) |
- |
1 |
1 |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
Breathing |
||||||||||||||||||
Quick breathing |
(1) |
- |
1 |
1 |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
Shallow respiration |
(3) |
- |
1 |
1 |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
Skin / fur |
||||||||||||||||||
Piloerection |
(1) |
1 |
1 |
1 |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
ANIMAL 6 |
||||||||||||||||||
Gait / motility |
||||||||||||||||||
Uncoordinated movements |
(3) |
- |
1 |
1 |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
Abnormal gait |
(3) |
- |
1 |
1 |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
Breathing |
||||||||||||||||||
Quick breathing |
(1) |
- |
1 |
1 |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
Shallow respiration |
(3) |
- |
1 |
1 |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
Skin / fur |
||||||||||||||||||
Piloerection |
(1) |
1 |
1 |
1 |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
ANIMAL 7 |
||||||||||||||||||
Posture |
||||||||||||||||||
Hunched posture |
(1) |
- |
1 |
1 |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
Breathing |
||||||||||||||||||
Quick breathing |
(1) |
- |
1 |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
Skin / fur |
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Piloerection |
(1) |
1 |
1 |
1 |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
Various |
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Ptosis |
(3) |
- |
1 |
1 |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
ANIMAL 8 |
||||||||||||||||||
Posture |
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Hunched posture |
(1) |
- |
1 |
1 |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
Breathing |
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Quick breathing |
(1) |
- |
1 |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
Skin / fur |
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Piloerection |
(1) |
1 |
1 |
1 |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
ANIMAL 9 |
||||||||||||||||||
Posture |
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Hunched posture |
(1) |
- |
1 |
1 |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
Breathing |
|
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|
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Quick breathing |
(1) |
- |
1 |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
Skin / fur |
|
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|
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Piloerection |
(1) |
1 |
1 |
1 |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
Table 3: Body weights (g)
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||||
|
1 |
161 |
194 |
205 |
2 |
143 |
175 |
195 |
|
3 |
169 |
208 |
220 |
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||||
MEAN |
158 |
192 |
207 |
|
ST.DEV. |
13 |
17 |
13 |
|
N |
3 |
3 |
3 |
|
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||||
|
4 |
156 |
188 |
210 |
5 |
159 |
195 |
206 |
|
6 |
149 |
186 |
190 |
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||||
MEAN |
155 |
190 |
202 |
|
ST.DEV. |
5 |
5 |
11 |
|
N |
3 |
3 |
3 |
|
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||||
|
7 |
147 |
185 |
201 |
8 |
171 |
187 |
215 |
|
9 |
143 |
182 |
198 |
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||||
MEAN |
154 |
185 |
205 |
|
ST.DEV. |
15 |
3 |
9 |
|
N |
3 |
3 |
3 |
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The oral LD50 value of the test substance in Wistar rats was established to exceed 2000 mg/kg body weight.
Based on these results, the test substance ndoes not have to be classified for acute oral toxicity according to GHS. - Executive summary:
The potential toxicity of the test item, when given by oral gavage at a single dose to rats of a single sex at one or more defined doses, was evaluated in accordance with OECD Guideline 423 and GLP.
Initially, the test item was administered by oral gavage to three female Wistar rats at 300 mg/kg body weight. In a stepwise procedure two additional groups of three females were dosed at 2000 mg/kg bw. All animals were subjected to daily observations and weekly determination of bodyweight. Macroscopic examination was performed after terminal sacrifice (Day 15).
No mortality occurred.
At 300 mg/kg, piloerection was noted for all animals on Day 1 only. At 2000 mg/kg, piloerection, uncoordinated movements, abnormal gait, quick breathing, shallow respiration, hunched posture and/or ptosis were noted for all animals on Day 1 only.
The mean body weight gain shown by the animals over the study period was considered to be normal.
No abnormalities were found at macroscopic post mortem examination of the animals.
The oral LD50 value of the test item in Wistar rats was established to exceed 2000 mg/kg body weight.
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.