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EC number: 203-212-3 | CAS number: 104-54-1
- 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
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Justification for type of information:
- Data is from experimental study report.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 018
- Report date:
- 2018
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Principles of method if other than guideline:
- According to OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- GLP compliance:
- yes
- Test type:
- acute toxic class method
- Limit test:
- no
Test material
- Reference substance name:
- Cinnamyl alcohol
- EC Number:
- 203-212-3
- EC Name:
- Cinnamyl alcohol
- Cas Number:
- 104-54-1
- Molecular formula:
- C9H10O
- IUPAC Name:
- 3-phenylpropan-1-ol
- Test material form:
- liquid
- Details on test material:
- - IUPAC Name: (2E)-3-phenylprop-2-en-1-ol
- InChI: 1S/C9H10O/c10-8-4-7-9-5-2-1-3-6-9/h1-7,10H,8H2/b7-4+
- Smiles: c1(ccccc1)/C=C/CO
- Molecular formula :C9H10O
- Molecular weight :134.177 g/mol
- Substance type:Organic
- Physical state: Clear colorless liquid
- Purity as per Certificate of Analysis: 98.25%
- Lot No.: 2017101201R-253
- Manufactured date:12 October 2017
- Retest date:11 September 2018
- pH:4.05 at 24°C
- Storage conditions:Ambient (+18 to +36°C)
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Geniron Biolabs Pvt. Ltd, Bengaluru
- Females (if applicable) nulliparous and non-pregnant: yes
- Age at study initiation: 10 to 11 Weeks
- Weight at study initiation: 176.30 to 193.98 g
- Identification:By rat accession number. Identification of individual rats was by cage card and turmeric colour body markings. The rat accession number was allotted during the course of the study. The temporary body marking during acclimatization period was done with crystal violet.
- Fasting period before study: rats were fasted overnight (16 to 18 hours).
- Housing:Rats were housed individually in standard polysulfone cages (Size: L 425 x B 266 x H 185 mm), with stainless steel top grill
- Diet (e.g. ad libitum): Hypro Rat & Mice pellet feed, ad libitum
- Water (e.g. ad libitum): Deep bore-well water passed through activated charcoal filter and exposed to UV rays in Aquaguard on-line water filter-cum-purifier, ad libitum
- Acclimation period: The animals were acclimatized six days for G1-FTS, eight days for G2-FTS and ten days for G2-STS before treatment. Animals were observed once daily during acclimatization period.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 to 24°C
- Humidity (%): 66 to 68%
- Air changes (per hr): air conditioned with adequate fresh air supply (12.4 to 13.0 air changes/hour).
- Photoperiod (hrs dark / hrs light): 12 hours light and 12 hours dark cycle.
IN-LIFE DATES: From: 18 April 2018 To: 28 August 2018
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Details on oral exposure:
- DOSAGE PREPARATION (if unusual): Undiluted test item as supplied by the sponsor was administered based on the density of the test item i.e., 1.01 g/cm3 at 27°C (as per TIDS) and the
dose volume was 1.98 and 0.30 mL/kg body weight to attain the doses of 2000 and 300 mg/kg body weight as a single oral gavage. - Doses:
- G1 (FTS) - 2000 mg/kg
G2 (FTS) - 300 mg/kg
G1 (STS) - 300 mg/kg - No. of animals per sex per dose:
- G1 (FTS) - 2000 mg/kg - 3
G2 (FTS) - 300 mg/kg - 3
G1 (STS) - 300 mg/kg - 3 - Control animals:
- not specified
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Clinical signs and pre-terminal deaths - At each step, the animals were observed five times on test day 1 (day of administration) i.e. at 30 minutes and four times at hourly intervals and once daily during days 2 to 15 post administration. Observations included changes in skin and fur, eyes and mucous membranes, and also respiratory, circulatory, autonomic and central nervous systems and somatomotor activity and behaviour pattern. Attention was directed to the observations of tremors, convulsions, salivation, diarrhoea, lethargy, sleep and coma and all observed clinical signs were recorded.
Body weights - The body weights were recorded on test day 1 (pre-administration), day 8 (7 days post administration) and day 15 (14 days post administration).
- Necropsy of survivors performed: yes, the rats surviving to the end of the observation period were euthanised by using isoflurane anaesthesia and subjected to detailed necropsy. Gross pathological findings were recorded and reported. Microscopic examination was not carried out as no gross pathological changes were observed. - Statistics:
- not specified
Results and discussion
- Preliminary study:
- not specified
Effect levels
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- At 2000 mg/kg body weight (G1-FTS) one rat died at 4 hours post dose and the other rat was found dead on day 2.
At G2 - [300 mg/kg body weight - Treatment (FTS & STS)]: There was no mortality. - Clinical signs:
- other: G1 - [2000 mg/kg body weight - Treatment (FTS)]: Clinical signs of recumbency and ataxia were observed in two rats at 30 minutes to 4 hours. G2 - [300 mg/kg body weight - Treatment (FTS & STS)]: There were no clinical signs observed.
- Gross pathology:
- There were no gross pathological changes at necropsy.
- Other findings:
- not specified
Any other information on results incl. tables
TABLE 1. Body weight, body weight change and pre-terminal deaths
Group and Dose (mg/kg body weight) |
Rat No. |
Sex |
Body weight (g) |
Day of Death (Time of Death) |
No. dead/ No. tested |
Pre-terminal deaths (%) |
|||||
Initial (Day 1) |
8thday |
Weight change (day 8 – Initial) |
15thday |
Weight change (day 15 – Initial) |
At Death |
||||||
G1 (FTS) 2000
|
Rm9115 |
F |
193.98 |
- |
- |
- |
- |
186.75 |
2 (8.55 AM) |
2/3 |
66.66 |
Rm9116 |
F |
182.88 |
- |
- |
- |
- |
177.78 |
1 (2.38 PM) |
|||
Rm9117 |
F |
189.56 |
216.22 |
26.66 |
220.87 |
31.31 |
- |
- |
|||
G2 (FTS) 300
|
Rm9118 |
F |
190.53 |
197.13 |
6.6 |
199.87 |
9.34 |
- |
- |
0/3 |
0 |
Rm9119 |
F |
187.80 |
191.75 |
3.95 |
198.35 |
10.55 |
- |
- |
|||
Rm9120 |
F |
189.20 |
198.65 |
9.45 |
207.10 |
17.9 |
- |
- |
G2 (STS) 300
|
Rm9121 |
F |
181.96 |
203.94 |
21.98 |
207.53 |
25.57 |
- |
- |
0/3 |
0 |
Rm9122 |
F |
176.30 |
198.66 |
22.36 |
202.16 |
25.86 |
- |
- |
|||
Rm9123 |
F |
186.62 |
188.08 |
1.46 |
191.57 |
4.95 |
- |
- |
F: Female FTS: First Treatment Step STS: Second Treatment Step - : Nil
Applicant's summary and conclusion
- Interpretation of results:
- Category 4 based on GHS criteria
- Conclusions:
- Based on the results of the present study, The LD50 of the given test chemical is 2000 mg/kg. Thus, the test item is classified “Category 4” (300 mg/kg < Acute Toxicity Estimates ≤ 2000 mg/kg) as per Globally Harmonized Classification system of Annex 2d of the Guideline, OECD 423 as there was two mortalities observed at 2000 mg/kg body weight.
- Executive summary:
The acute oral toxicity study was conducted to assess the toxicological profile of the test chemical in Wistar rats.
Undiluted test chemical was administered based on the density of the test item i.e., 1.01 g/cm3 at 27°C (as per TIDS) and the dose volume was 1.98 and 0.30 mL/kg to attain the doses of 2000 and 300 mg/kg body weight respectively.
The test item was administered as a single oral gavage to overnight fasted (16 to 18 hours) three female rats (G1-FTS) at the dose of 2000 mg/kg body weight. Clinical signs of Recumbency and ataxia were observed in two rats at 30 minutes to 4 hours, one rat died at 4 hours post dose and the other rat was found dead on day 2. The third rat was normal from day one till end of observation.
Hence as per Annex 2d, three female rats were tested at the next lower dose of 300 mg/kg body weight (G2-FTS). There were no clinical signs and there was no pre-terminal deaths observed. As per annex 2d of the guideline the treatment was continued with three additional rats at the same dose of 300 mg/kg bodyweight (0.30 mL/kg body weight) – G2-STS. There were no clinical signs and there was no pre-terminal deaths observed, as per the scheme – the Annex 2d of the guideline OECD 423, the dosing was stopped.
The rats were observed for mortality and clinical signs for 14 days post treatment. Body weights were recorded prior to dosing on day 1 and again on days 8 and 15. Necropsy was performed for all the rats at termination. All survived rats gained weight during experimental period. There were no gross pathological changes at necropsy.
Based on the results of the present study, The LD50 of the given test chemical is 2000 mg/kg. Thus, the test item is classified “Category 4” (300 mg/kg < Acute Toxicity Estimates ≤ 2000 mg/kg) as per Globally Harmonized Classification system of Annex 2d of the Guideline, OECD 423 as there was two mortalities observed at 2000 mg/kg body weight.
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