Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 700-316-5 | CAS number: 1155405-88-1
- 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
Developmental toxicity / teratogenicity
Administrative data
- Endpoint:
- developmental toxicity
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- weight of evidence
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Published study conducted to GLP and a recognised guideline
Data source
Reference
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 2 002
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 414 (Prenatal Developmental Toxicity Study)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: ICH Harmonised Tripartite Guidelines for Detection of Toxicity to Reproduction for Medicinal Products
- GLP compliance:
- yes
- Limit test:
- no
Test material
- Reference substance name:
- Behenyl alcohol
- IUPAC Name:
- Behenyl alcohol
- Details on test material:
- Behenyl alcohol is a saturated 22-carbon, long-chain aliphatic alcohol. The composition and stability of behenyl alcohol was documented throughout the study, no further information is provided.
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- The test animals were sexually mature female New Zealand White rabbits, approximately 18 to 26 weeks of age, obtained from Froxfield SPF Rabbits Ltd. (England). Approximately 2 weeks prior to arrival at the test facility, oestrus was synchronised by the supplier by an intravenous injection of 25 IU lutenizing hormone. Upon arrival, rabbits were allowed to acclimatise for a minimum of 1 week prior to the initiation of dosing. The rabbits weighed 3.29-4.98 kg at study initiation. The rabbits were housed individually in suspended stainless-steel cages equipped with an undertray lined with absorbent paper. The housing room was maintained at 18°C and 55% relative humidity with a 12 hour light-dark cycle. Rabbits were provided with a standard rabbit diet (Special Diet Services Ltd., England) and tap water, ad libitum.
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- other: 1% w/w Tween 80
- Details on exposure:
- The test substance was administered by gavage in 1% w/w Tween 80 at 0, 125, 500 or 2000 mg/kg bw/d. The preparation was administered at volume-dosages of 10, 0.625, 2.5 or 10 ml/kg bw/d corresponding to doses of 0. 125, 500 and 2000 mg/kg bw/d, respectively. The volume administered to each animal was calculated from bodyweights measured on the same day that dosing took place.
- Analytical verification of doses or concentrations:
- no
- Details on analytical verification of doses or concentrations:
- No information available.
- Details on mating procedure:
- Females were mated with New Zealand White males of proven fertility. Following insemination, each female was injected i.v. with 25 IU of lutenizing hormone to ensure successful ovulation. The day of insemination was designated as Day 0 of gestation. All animals were examined on Day 6 of gestation and determined to be suitable for use in the study.
- Duration of treatment / exposure:
- 16 days - Day 6 to Day 19 of gestation
- Frequency of treatment:
- Once daily between Day 6 to 19 of gestation
- Duration of test:
- 16 days - Day 6 to Day 19 of gestation
Doses / concentrations
- Remarks:
- Doses / Concentrations:
0, 125, 500 and 2000 mg/kg bw/d
Basis:
nominal conc.
- No. of animals per sex per dose:
- 22 females/group
- Control animals:
- yes, concurrent vehicle
- Details on study design:
- The dose levels chosen for the study were selected based on a previous range-finding study providing a maximum dose of 2000 mg/kg bw/d. Following mating, females were randomly allocated to the 4 treatment groups in order of mating to evenly distribute the mated females among the groups.
Examinations
- Maternal examinations:
- Cage-side observations were made daily for signs of toxicity and moribundity. Food consumption was recorded during the following time points: Day 1 to 5, 6 to 12, 13 to 19, 20 to 23 and 24 to 28, inclusive. Bodyweight gains and water consumption were measured daily. Any animal that delivered prematurely was killed by an i.v. injection of pentobarbitone sodium B Vet C. on the same day that the premature delivery was detected.
Following euthanasia on Day 28 of gestation, the rabbits were examined macroscopically for evidence of disease and signs of toxicity. - Ovaries and uterine content:
- The rabbits were killed on Day 28 of gestation by an i.v. injection of pentobarbitone sodium and the uterine contents examined. The number of corpora lutea were recorded, and the reproductive tract, including the ovaries was dissected out. For each animal, the number of pre- and post-implantation sites, early and late resorptions, and viable foetuses, as well as the distribution of foetuses in the uterine horn were examined. The uterus of any female presumed to be non-pregnant was stained using a 10% aq (v/v) ammonium sulphide solution and examined for implantation sites.
- Fetal examinations:
- Each foetus was weighed and examined externally. The foetuses were killed by an s.c. injection of pentobarbitone sodium, and uniquely identified within the litter with respect to their uterine position. Placental weights were recorded and examined macroscopically for any abnormalities. The neck, thoracic and abdominal cavities from each foetus were dissected and the contents examined microscopically. One third of the foetuses were decapitated and the heads fixed in Bouin's fluid for examination using a modification of the Wilson free-hand serial sectioning technique. All foetuses were subsequently eviscerated, fixed in methylated spirit and processed and stained with Alizarin Red for skeletal examination.
- Statistics:
- One way ANOVA was performed on bodyweights, bodyweight changes, and food and water consumption. Organ weights were evaluated by Dunnett's or Behren's-Fisher's tests. Nested ANOVA and weighed t-test were conducted on foetal and placental weights.
- Indices:
- Not determined.
- Historical control data:
- No information available.
Results and discussion
Results: maternal animals
Maternal developmental toxicity
- Details on maternal toxic effects:
- Maternal toxic effects:no effects
Details on maternal toxic effects:
All females survived until study termination. There were no clinical signs of toxicity, with the exception of pale faeces observed in the majority of 2000 mg/kg bw/d females. There were no effects of treatment on bodyweight gain and food and water consumption. There were no treatment related findings at necropsy. A total of 3 females, treated with 0, 125 and 500 mg/kg bw/d, respectively, were observed to have total litter loss at necropsy. The uterus of each of these females revealed early resorptions.
Effect levels (maternal animals)
open allclose all
- Dose descriptor:
- NOAEL
- Effect level:
- 2 000 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Basis for effect level:
- other: maternal toxicity
- Dose descriptor:
- NOAEL
- Effect level:
- 2 000 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Basis for effect level:
- other: developmental toxicity
Results (fetuses)
- Details on embryotoxic / teratogenic effects:
- Embryotoxic / teratogenic effects:no effects
Details on embryotoxic / teratogenic effects:
There were no effects of treatment on the number of corpora lutea, pre- and post-implantation sites, early and late resorptions, and viable foetuses. Foetal and placental weights were not affected by treatment. Sex ratios were comparable across groups. No macroscopic, skeletal or visceral variations were observed that were not comparable to historical control values previously reported for the laboratory.
Fetal abnormalities
- Abnormalities:
- not specified
Overall developmental toxicity
- Developmental effects observed:
- not specified
Any other information on results incl. tables
Parameter |
Dose (mg behenyl alcohol/kg bw/d) |
|||
0 |
125 |
500 |
2000 |
|
No. pregnant animals |
20 |
19 |
19 |
20 |
Premature delivery and total litter loss (%) |
10.0 |
5.3 |
5.3 |
0.0 |
Corpora lutea count |
12.8 ± 3.1 |
12.9 ± 2.2 |
12.6 ± 3.0 |
12.2 ± 3.9 |
Implantations |
11.4 ± 3.9 |
11.1 ± 2.6 |
11.0 ± 3.3 |
10.6 ± 4.3 |
Viable young |
||||
Male |
4.6 ± 2.6 |
4.8 ± 1.5 |
3.8 ± 1.5 |
4.7 ± 2.2 |
Female |
5.5 ± 2.4 |
4.9 ± 1.7 |
5.5 ± 2.1 |
4.3 ± 2.5 |
Total |
10.1 ± 3.7 |
9.8 ± 2.1 |
9.3 ± 2.6a |
9.0 ± 3.8 |
Resorptions |
||||
Early |
0.4 ± 0.6 |
0.3 ± 0.5 |
0.4 ± 0.6 |
0.7 ± 0.8 |
Late |
1.0 ± 1.0 |
1.1 ± 1.0 |
1.2 ± 1.1 |
0.9 ± 0.9 |
Total |
1.4 ± 1.2 |
1.3 ± 1.2 |
1.7 ± 1.3 |
1.6 ± 1.2 |
Implantation loss (%) |
||||
Pre |
10.4 |
14.2 |
13.9 |
13.5 |
Post |
12.1 |
12.0 |
15.2 |
14.7 |
Data represent mean ± standard deviation
aIncludes one foetus not sexed at necropsy
Applicant's summary and conclusion
- Conclusions:
- The NOAEL is considered to be 2000 mg/kg bw/d for both maternal toxicity and developmental toxicity.
- Executive summary:
A developmental toxicity study was conducted with behenyl alcohol. The test substance was administered to mated female New Zealand White rabbits daily by gavage at doses of 0, 125, 500 and 2000 mg/kg bw/d on Day 6 through to Day 19 of gestation. The dams were sacrificed at Day 28 of gestation for examination of the uterine contents.
There were no maternal deaths, and no clinical signs of toxicity, with the exception of pale faeces observed in the majority of 2000 mg/kg bw/d females. There were no effects of treatment on bodyweight gain and food and water consumption. There were no treatment related findings at necropsy. A total of 3 females, treated with 0, 125 and 500 mg/kg bw/d, respectively, were observed to have total litter loss at necropsy. The uterus of each of these females revealed early resorptions. There were no effects of treatment on the number of corpora lutea, pre- and post-implantation sites, early and late resorptions, and viable foetuses. Foetal and placental weights were not affected by treatment. Foetal sex ratios were comparable across groups. No macroscopic, skeletal or visceral variations were observed.
There was no evidence that behenyl alcohol is teratogenic or embryotoxic. The NOAEL is considered to be 2000 mg/kg bw/d for both maternal toxicity and developmental toxicity.
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.