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EC number: 209-141-4 | CAS number: 556-82-1
- 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
Toxicity to reproduction
Administrative data
- Endpoint:
- toxicity to reproduction
- Remarks:
- other: sub-chronic
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: GLP - Guideline study according to OECD 408 for repeated dose including reproductive parameters.
Cross-reference
- Reason / purpose for cross-reference:
- reference to same study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 002
- Report date:
- 2002
Materials and methods
Test guideline
- Guideline:
- other: OECD 408 including reproductive parameters
- GLP compliance:
- yes
Test material
- Reference substance name:
- 3-methylbut-2-en-1-ol
- EC Number:
- 209-141-4
- EC Name:
- 3-methylbut-2-en-1-ol
- Cas Number:
- 556-82-1
- Molecular formula:
- C5H10O
- IUPAC Name:
- 3-methylbut-2-en-1-ol
- Details on test material:
- - Name of test material (as cited in study report): 3-Methylbut-2-en-1-ol (Prenol)
- Test substance No.: 00/0274-1
- Date of production: 10 Apr 2000
- Physical state / color: Liquid / colorless, clear
- Analytical purity: 99.1 % (method: gas chromatography)
- Homogeneity: Homogeneous
- Lot/batch No.: Ch. 00/18, Abl. Nr. 56-1706
- Stability under test conditions: Proven by reanalysis after the in life phase of the study.
- Storage condition of test material: Room temperature
- Other: The analyses were carried out at the Analytical Department of BASF Aktiengesellschaft.
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River, Germany, (Strain: CRL:WI (GlX/BRL/HAN) IGS BR)
- Age at study initiation: 34 - 36 days
- Age at the start of the administration period: 41 - 43 days
- Range of weight at study initiation: males: 148.7 - 171.1 g (group mean: 159.2 g); females: 111.1 - 136.4 g (group mean: 123.5 g).
- Fasting period before study: No data
- Housing: singly
- Diet: Provimi KLIBA SA, Kaiseraugst / Switzerland, ad libitum
- Water: ad libitum
- Acclimation period: yes, 7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 24°C
- Humidity (%): 30 - 70%
- Air changes (per hr): fully air-conditioned room
- Photoperiod (hrs dark / hrs light): 12 hours/12 hours
Administration / exposure
- Route of administration:
- oral: drinking water
- Vehicle:
- water
- Details on exposure:
- PREPARATION OF DOSING SOLUTIONS:
The test substance was administered as a solution in drinking water. The appropriate amount of test substance was weighed, then drinking water was filled up to the desired volume and subsequently mixed using a magnetic stirrer. The test substance solutions were prepared twice a week.
VEHICLE
- Concentration in vehicle: 200, 1000 and 5000 ppm
STABILITY OF TEST SUBSTANCE IN VEHICLE: determined over a period of 4 days at room temperature at the start of the study. As the preparations were solutions in water, no homogeneity analyses were carried out. Concentration control analyses of the test substance preparations were performed in all concentrations at the start and the end of the administration period. - Details on mating procedure:
- No mating performed
- Analytical verification of doses or concentrations:
- yes
- Details on analytical verification of doses or concentrations:
- The stability of the test substance in drinking water over a period of 4 up to 7 days at room temperature was determined before the start of the study.
Concentration control analyses of the test substance preparations were performed in all concentrations at the start and the end of the administration period. The recovery rates were within a range of 92.1 % - 101.1 % of the target concentrations. - Duration of treatment / exposure:
- 90 days
- Frequency of treatment:
- continuously
- Details on study schedule:
- No mating performed.
Doses / concentrations
- Remarks:
- Doses / Concentrations:
5000 ppm (calculated as 243.8 mg/kg bw/d in males, 307.2 mg/kg bw/d in females) 1000 ppm (calculated as 65.4 mg/kg bw/d in males, 82.1 mg/kg bw/d in females) 200 ppm (calculated as 14.4 mg/kg bw/d in males, 21.0 mg/kg bw/d in females).
Basis:
nominal in water
- No. of animals per sex per dose:
- 10
- Control animals:
- yes, concurrent vehicle
- Details on study design:
- Post-exposure period: none
- Dose selection rationale: 5000 ppm as high concentration with expected toxic effects; 1000 ppm as mid concentration; 200 ppm as low concentration with no expected toxic effects. - Positive control:
- No data
Examinations
- Parental animals: Observations and examinations:
- See chapter 7.5.1
- Oestrous cyclicity (parental animals):
- Not examined
- Sperm parameters (parental animals):
- At necropsy specimen were sampled from fasted anesthetized male animals in a randomized sequence for sperm analyses. Thereby, sperm analyses were performed towards the end of the administration period. Immediately after necropsy and organ weight determination the right testis and cauda epididymis were taken from all male animals.
The following parameters were determined. Thereby sperm motility examinations were carried out in a randomized sequence.
• sperm motility;
• sperm morphology;
• sperm head count (cauda epididymis);
• sperm head count (testis); - Litter observations:
- Not examined
- Postmortem examinations (parental animals):
-
GROSS NECROPSY
- The animals were sacrificed by decapitation under CO2 anesthesia. The exsanguinated animals were necropsied and assessed by gross pathology.
- Gross necropsy consisted of external and internal examinations including the cervical, thoracic, and abdominal viscera.
HISTOPATHOLOGY / ORGAN WEIGHTS
ORGAN WEIGHT: Yes
Primary and secondary reproductive organ weights:
- testes,
- epididymides,
- ovaries,
- uterus,
- prostate gland.
For further information, see Chapter 7.5.1
HISTOPATHOLOGY: Yes
Primary and secondary reproductive organs:
Left testis, left epididymis and both ovaries (fixed in Bouin' solution; after fixation, the organs were embedded in paraplast).
The following organs were fixed in 4% formaldehyde solution:
- pituitary gland
- oviducts/uterus/vagina
- prostate gland, seminal vesicles
- female mammary gland
Organs were examinated in all animals of the control and the high dose group.
For further information, see Chapter 7.5.1 - Postmortem examinations (offspring):
- Not examined
- Statistics:
- For further information, see Chapter 7.5.1
- Reproductive indices:
- Not examined
- Offspring viability indices:
- Not examined
Results and discussion
Results: P0 (first parental generation)
Details on results (P0)
The estrous cycle was not examined in this study, therefore no data were available concerning this special reproductive function.
REPRODUCTIVE FUNCTION: SPERM MEASURES (PARENTAL ANIMALS)
No effects on reproductive organs (see organ weights below) and no treatment-related changes in sperm parameters were observed, up to the highest dose group (5000 ppm).
• Total spermatids/g testis
control: 123 ± 21.3;
200 ppm: 121 ± 15.0;
1000 ppm: 141 ± 15.1;
5000 ppm: 132 ± 19.4
• Total sperm/g cauda epididymis as listed below:
control: 519 ± 66.4;
200 ppm: 543 ± 92.8;
1000 ppm: 549 ± 84.1;
5000 ppm: 573 ± 105.5
• % normal sperm:
control: 98.4 ± 0.88;
200 ppm: 97.7 ± 1.01;
1000 ppm: 97.8 ± 0.89;
5000 ppm: 98.3 ± 1.32
• % abnormal sperm:
control: 1.6 ± 0.88;
200 ppm: 2.3 ± 1.01;
1000 ppm: 2.2 ± 0.89;
5000 ppm: 1.7 ± 1.32
• % mortility:
control: 89 ± 4.1;
200 ppm: 81 ± 6.3, p ≤ 0.01;
1000 ppm: 84 ± 6.9;
5000 ppm: 90 ± 4.8
The statistically significant changes in the dose group of 200 ppm were not dose dependent and are therefore assumed as not treatment related.
REPRODUCTIVE PERFORMANCE (PARENTAL ANIMALS)
The reproductive performance was not examined in this study.
ORGAN WEIGHTS (PARENTAL ANIMALS)
ORGAN WEIGHTS
5000 ppm (243.8 mg/kg bw/d in males, 307.2 mg/kg bw/d in females)
Concerning reproductive organs
• In female rats of the high dose group, the absolute mean weight of the ovaries was slightly although significantly decreased compared to controls (-13.6 %, p ≤ 0.05). The absolute mean ovary weights are tabulated in table 1 (see remarks on results).
• The relative ovary weights of the high dose females did not show statistically significant changes compared to the controls (see table 1).
• The mean relative weights of testes (+13 .7 %) and epididymides (+12 .7%) was increased compared to controls. This was regarded to be the secondary consequence of the decrease of the mean terminal body weight (-11 .7%).
Pathology (see below) did not indicate treatment-related gross lesions or microscopic findings in any of the organs investigated, thus providing no histopathological correlate to the observed changes in organ weights.
GROSS PATHOLOGY (PARENTAL ANIMALS)
- Concerning the reproductive organs of both sexes, there were no gross lesions noted.
HISTOPATHOLOGY (PARENTAL ANIMALS)
All microscopic findings recorded were either single observations, or they were recorded at a low incidence, or they occurred in control animals only, or at comparable incidence and graded severity in control and high dose animals.
Accordingly, no hisopathological correlate was obtained for the significantly increased mean relative weights of the testes and epididymides in male high dose group. No microscopic finding was obtained that may account for the significant decreased mean absolute weight of the ovaries.
For further information, see Chapter 7.5.1
Effect levels (P0)
open allclose all
- Dose descriptor:
- NOAEL
- Effect level:
- 243.2 mg/kg bw/day
- Sex:
- male
- Basis for effect level:
- other: No effects on reproductive organs or sperm parameters observed in the highest dose which was examined. The NOAEL of 243.2 mg/kg bw corresponds to 5000 ppm.
- Dose descriptor:
- NOAEL
- Effect level:
- 307.2 mg/kg bw/day (nominal)
- Sex:
- female
- Basis for effect level:
- other: No effects on reproductive organs observed in the highest dose which was examined. The NOAEL of 307.2 mg/kg bw corresponds to 5000 ppm.
Results: F1 generation
Details on results (F1)
Overall reproductive toxicity
- Reproductive effects observed:
- not specified
Any other information on results incl. tables
Table 1: Absolute and Relative Mean Ovary Weights
Dose Group |
Mean Absolute Ovary Weights (mg ± SD) |
Mean Relative Ovary Weights (mg ± SD) |
Controls |
94.9 ± 10.5 |
0.045 ± 0.005 |
200 ppm |
91.5 ± 23.2 |
0.043 ± 0.012 |
1000 ppm |
100.5 ± 16.1 |
0.050 ± 0.009 |
5000 ppm |
82.0 ± 9.4 (p ≤ 0.05) |
0.042 ± 0.004 |
Applicant's summary and conclusion
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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