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EC number: 942-520-9 | 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
Endpoint summary
Administrative data
Key value for chemical safety assessment
Effects on fertility
Link to relevant study records
- Endpoint:
- one-generation reproductive toxicity
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Justification for type of information:
- Please see Read-across justification document in chapter 13
- Reason / purpose for cross-reference:
- read-across source
- Reason / purpose for cross-reference:
- read-across: supporting information
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- 1 000 mg/kg bw/day (actual dose received)
- Sex:
- male/female
- Basis for effect level:
- other: overall effects
- Sexual maturation:
- not examined
- Gross pathological findings:
- no effects observed
- Key result
- Dose descriptor:
- NOAEL
- Generation:
- F1
- Effect level:
- 1 000 mg/kg bw/day (actual dose received)
- Sex:
- male/female
- Basis for effect level:
- other: overall effects
- Reproductive effects observed:
- not specified
- Conclusions:
- In a reliable study, conducted to a protocol similar to OECD guideline 415, an NOAEL of 1000 mg/kg bw/day was determined in the rat for reproductive effects. The study was performed in compliance with GLP.
Reference
Effect on fertility: via oral route
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- NOAEL
- 1 000 mg/kg bw/day
- Species:
- rat
Effect on fertility: via inhalation route
- Endpoint conclusion:
- no study available
Effect on fertility: via dermal route
- Endpoint conclusion:
- no study available
Additional information
A well documented one-generation study of the structurally-related linear alcohol 1-docosanol in rats is available which was performed according to a protocol similar to OECD 415. There were no treatment related effects on reproductive parameters observed.
Furthermore in the repeated dose toxicity studies (OECD 408) of the substance Guerbet alcohols, C24-26, branched and cyclic
no effects on reproductive organs could be found.Based on these data it is concluded that the substance Guerbet alcohols, C24-26, branched and linear is not expected to impair fertility.
Effects on developmental toxicity
Link to relevant study records
- Endpoint:
- developmental toxicity
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- January to October 2020
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Justification for type of information:
- This study was performed for the notification in other regions where authorities do not accept read-across data.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 414 (Prenatal Developmental Toxicity Study)
- Version / remarks:
- June 25, 2018
- Deviations:
- no
- GLP compliance:
- yes
- Limit test:
- no
- Species:
- rat
- Strain:
- Sprague-Dawley
- Route of administration:
- oral: gavage
- Vehicle:
- corn oil
- Details on exposure:
- PREPARATION OF DOSING SOLUTIONS: The required amount of test item was suspended in the vehicle. The formulation was prepared daily or weekly according to stability data. Concentrations were calculated and expressed in terms of test item as supplied.
VEHICLE- Justification for use and choice of vehicle (if other than water):
- Concentration in vehicle: 20, 60 and 200 mg/mL
- Amount of vehicle (if gavage): 5 ml/kg - Details on analytical verification of doses or concentrations:
- Analysis were performed in a separate study in order to validate the analytical method and the formulation procedure and to verify the stability of the formulations. Samples of the formulations prepared during the current study (the first and the last week of treatment )
- Details on mating procedure:
- The females were paired with male rats. Females were paired one to one in the home cage of the male and left overnight. Vaginal smears were taken daily in themorning from the day after pairing until a positive identification of mating was made. The day of mating, as judged by the presence of spermin the vaginal smear or by the presence of a copulation plug, was considered as Day 0 of gestation (or Day 0 post coitum). Full mating records were maintained.
- Duration of treatment / exposure:
- All animals were dosed from Day 3 through Day 19 post coitum.
- Frequency of treatment:
- once a day
- Dose / conc.:
- 100 mg/kg bw/day
- Dose / conc.:
- 300 mg/kg bw/day
- Dose / conc.:
- 1 000 mg/kg bw/day
- No. of animals per sex per dose:
- 25 mated females
- Control animals:
- yes, concurrent vehicle
- Details on study design:
- - Dose selection rationale: Dose levels have been selected based on a previous GLP subchronic toxiicty study.
- Maternal examinations:
- CAGE SIDE OBSERVATIONS: Yes
- Time schedule: daily in the morning and in the afternoon (during the weekend: morning and mid-day)
DETAILED CLINICAL OBSERVATIONS: Yes
- Time schedule: daily
BODY WEIGHT: Yes
- Time schedule for examinations: on Days 0, 3, 6, 9, 12, 15, 18 and 20 post coitum.
FOOD CONSUMPTION AND COMPOUND INTAKE (if feeding study): Yes on Days 3, 6, 9, 12, 15, 18 and 20 post coitum starting
from Day 0 post coitum
- Food consumption for each animal determined and mean daily diet consumption calculated as g food/animal/day: Yes
- Compound intake calculated as time-weighted averages from the consumption and body weight gain data: No
WATER CONSUMPTION AND COMPOUND INTAKE (if drinking water study): No
POST-MORTEM EXAMINATIONS: Yes
- Sacrifice on gestation day 20 post coitum
- Organs examined: thyroid
Other: Thyroid hormone determination (T3, T4, TSH) - Ovaries and uterine content:
- The ovaries and uterine content was examined after termination: Yes
Examinations included:
- Gravid uterus weight: Yes
- Number of corpora lutea: Yes
- Number of implantations: Yes
- Number of early resorptions: Yes
- Number of late resorptions: Yes
Other:
- number, sex and weight of all live foetuses;
– number and sex of dead foetuses (foetuses at termwithout spontaneous movements
and breathing);
– number of intra-uterine deaths;
– gross evaluation of placentae. - Fetal examinations:
- - External examinations: Yes: all per litter
- Soft tissue examinations: Yes: half per litter
- Skeletal examinations: Yes: half per litter
- Head examinations: Yes: No data - Statistics:
- For continuous variables the significance of the differences amongst group means was assessed by Dunnett’s test or a modified t test, depending on the homogeneity of data. Statistical analysis of non-continuous variables was carried out by means of the Kruskal-Wallis test and intergroup differences between the control and treated groups assessed by a non-parametric version of theWilliams test. Statistical analysis of histopathological findings was carried out by means of the non-parametric Kolmogorov-Smirnov test if n was more than 5.
- Indices:
- Pre-implantation loss was calculated as a percentage from the formula:
Pre impl. Loss%= (no. of corpora lutea−no. of implantations)/no. of corpora lutea ×100
Post-implantation loss was calculated as a percentage from the formula:
Post impl. Loss%=(no. of implantations−no. of live foetuses)/no. of implantations×100
Total implantation loss was calculated as a percentage from the formula:
Total impl. Loss%=(no. of corpora lutea−no. of live foetuses)/no. of corpora lutea×100
Sex ratios of the foetuses were calculated as the percentage of males per litter. - Clinical signs:
- effects observed, non-treatment-related
- Description (incidence and severity):
- Minor signs, such as scabs, hairloss and damaged ear were sporadically recorded during the study. These findings were considered as incidental.
- Dermal irritation (if dermal study):
- effects observed, non-treatment-related
- Description (incidence and severity):
- Minor signs, such as scabs, were sporadically recorded during the study. These findings were considered as incidental.
- Mortality:
- mortality observed, non-treatment-related
- Description (incidence):
- One low dose female died on Day 20 post coitum, immediately after the blood collection. No signs were noted during the in vivo phase and no relevant changes were observed at micro- and macroscopic observations. The cause of death was considered due to the bleeding procedure.
- Body weight and weight changes:
- no effects observed
- Food consumption and compound intake (if feeding study):
- effects observed, non-treatment-related
- Description (incidence and severity):
- No relevant differences in food consumption were noted between control and treated females. A slight statistically significant increase (12%) recorded in high dose females on Day 20 post coitum was considered incidental and not adverse.
- Food efficiency:
- not examined
- Water consumption and compound intake (if drinking water study):
- not examined
- Ophthalmological findings:
- not examined
- Haematological findings:
- not examined
- Clinical biochemistry findings:
- not examined
- Urinalysis findings:
- not examined
- Behaviour (functional findings):
- not examined
- Immunological findings:
- no effects observed
- Description (incidence and severity):
- No changes were recorded between control and treated groups in thyroid stimulating hormone (TSH), triiodothyronine (T3) and thyroxine (T4) determinations.
- Organ weight findings including organ / body weight ratios:
- effects observed, non-treatment-related
- Description (incidence and severity):
- The statistically significant decrease (approximately 18%) of relative thyroid weight (% to terminal body weight) observed in the high dose group compared to controls was not explained by the evaluation of the thyroid histopathological data. Furthermore, considering that the terminal body weight of females was influenced by their state of pregnancy (pregnant, not-pregnant, different number of foetuses), no toxicological significance could be attributed to this change.
- Gross pathological findings:
- no effects observed
- Description (incidence and severity):
- No treatment-related changes were noted in the females that completed the treatment period, following gross pathology examination. All observed changes were considered spontaneous and incidental, having a comparable incidence in control and treated groups and/or are characteristically seen in untreated Sprague Dawley SD rats of the same age.
- Neuropathological findings:
- not examined
- Histopathological findings: non-neoplastic:
- no effects observed
- Histopathological findings: neoplastic:
- no effects observed
- Other effects:
- no effects observed
- Number of abortions:
- not specified
- Pre- and post-implantation loss:
- no effects observed
- Total litter losses by resorption:
- no effects observed
- Early or late resorptions:
- no effects observed
- Dead fetuses:
- no effects observed
- Changes in pregnancy duration:
- not examined
- Changes in number of pregnant:
- no effects observed
- Other effects:
- no effects observed
- Dose descriptor:
- NOAEL
- Effect level:
- >= 1 000 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Remarks on result:
- not determinable due to absence of adverse toxic effects
- Abnormalities:
- no effects observed
- Fetal body weight changes:
- effects observed, non-treatment-related
- Description (incidence and severity):
- A total of 7 small foetuses (< 2.7 g) were detected: 2 out of 318 in the control group, 1 out of 327 in the low dose group, 1 out of 356 in the mid-dose group and 3 out of 391 in the high dose group. No treatment-related abnormalities or malformations were noted.
- Reduction in number of live offspring:
- not examined
- Changes in sex ratio:
- no effects observed
- Changes in litter size and weights:
- no effects observed
- Changes in postnatal survival:
- not examined
- External malformations:
- no effects observed
- Skeletal malformations:
- effects observed, non-treatment-related
- Description (incidence and severity):
- A total of 8 foetuses showed skeletal malformations:
– In Group 1, one foetus with cleft palate and no ossification of ischium and pubis
– In Group 2, one foetus, with pubis no ossification, one foetus with absence of digits and ischium and pubis non ossification, one foetus with presphenoid of skull no ossification and another foetus with absence of digits
– In Group 3, one foetus and two other foetuses with pubis no ossification.
Taken into account that pubis unossified was mainly observed in small foetuses (foetal weight < 2.7 g), that the litter incidence of malformations was similar to controls and that no foetuses were affected in the high dose group, they were considered incidental, as well as the other alterations (anomalies and variations) recorded. - Visceral malformations:
- effects observed, non-treatment-related
- Description (incidence and severity):
- A total of 5 foetuses showed malformations:
– In Group 1, one foetus (dam no. X1210035) with unilateral microphtalmia
– In Group 2, one foetus (dam no. X1210097) with brain bilateral ventricles enlarged extreme
– In Group 3, one foetus with unilateral pelvic dilatation extreme
– In Group 4, one foetus with malformation of heart and great vessels (dextrocardia,absence of aortic arch and subclavian artery) and another foetus with brain bilateral ventricles enlarged extreme.
These findings, as well as the other alterations (anomalies and variations) were considered incidental and not treatment-related, having a comparable distribution between groups, with a quite similar incidence in termof number of foetuses affected. - Other effects:
- no effects observed
- Dose descriptor:
- NOAEL
- Effect level:
- >= 1 000 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Remarks on result:
- not determinable due to absence of adverse toxic effects
- Abnormalities:
- no effects observed
- Developmental effects observed:
- no
- Conclusions:
- On the basis of the results obtained in this study, the high dose level (1000 mg/kg bw/day) was considered the NOAEL (No Observed Adverse Effect Level) for maternal toxicity and developmental toxicity of Guerbet alcohols, C24-26, branched and cyclic.
- Executive summary:
The effects of Guerbet alcohols, C24-26, branched and cyclic, were investigated after oral administration in female rats during pregnancy and on embryo-foetal development. Doses of 0., 100 , 300 and 1000 mg/kg bw/d were administered. All animals were administered during the gestation period, starting from Day 3 through Day 19 post coitum at the dosing volume of 5 mL/kg. Body weight, daily clinical signs and food consumption were recorded during the in vivo phase. All females were caesarean-sectioned on Day 20 post coitum and subjected to post mortem examination. Blood collection for hormone determination in association to determination of the thyroid weight from all females were performed onDay 20 post coitum. The number of corpora lutea, implantations, early and late intrauterine deaths, live and dead foetuses, uterus weight, foetal weight and sex were recorded. All foetuses were examined for external abnormalities. The anogenital distance (AGD) in all live foetuses were recorded. Approximately one half of the foetuses in each litter was examined for fixed-visceral and skeletal abnormalities. One female of Group 2 died on Day 20 post coitum, immediately after the blood collection. The cause of death could be considered related to the bleeding procedure. A total of 6 females were found not pregnant at necropsy: 3 in the control group, 2 in the low dose group and 1 in the mid-dose group. The number of females with live foetuses on Day 20 post coitum was: 22 in the control and low dose groups, 24 in the mid-dose group and 25 in the high dose group. No adverse clinical signs were observed throughout the study both in control and treated females. Body weight and body weight gain were unaffected by treatment. No relevant differences in food consumption were noted between control and treated females. No changes were recorded between control and treated groups in the levels of TSH, T3 and T4. Terminal bodyweight, uterusweight and absoluteweight gainwere unaffected by treatment. Litter data and sex ratios were unaffected by treatment. No treatment-related differences were noted in the mean values of the anogenital distance of foetuses of both sexes maternally exposed at all dose levels compared to the control group. No treatment-related changes were observed in the absolute and relative thyroid weight of treated females, when compared to control data. A single female animal from the low dose group was found dead on Day 20 of gestation. No relevant changes were observed at micro- and macroscopic observations. The pathological picture of this animal did not allow to establish the cause of death. Females that completed the treatment period did not show relevant macroscopic changes that could be considered treatment-related. No treatment-related findings were noted in the microscopic evaluation of the thyroid gland of treated females when compared to the controls. No treatment-related findings were noted at the external examination of foetuses. Malformations of part of the skeleton were recorded in control (one foetus), low (four foetuses) and mid- dose groups (three foetuses). Taken into account that pubis and ischium unossified were mainly observed in small foetuses (foetal weight < 2.7 g) and with a litter incidence similar to controls and that no foetuses were affected in the high dose group, these major alteration were considered incidental, as well as the other minor alterations (anomalies and variations) recorded. Major alterations of soft tissueswere recorded in control and treated groups. These findings, as well as the other minor alterations (anomalies and variations)were considered incidental and not treatment-related, having a comparable distribution between groups, with a quite similar incidence in termof number of foetuses affected.
On the basis of the results obtained in this study, the high dose level (1000 mg/kg bw/day) was considered the NOAEL (No Observed Adverse Effect Level) for maternal toxicity and developmental toxicity.
Reference
Effect on developmental toxicity: via oral route
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- NOAEL
- 1 000 mg/kg bw/day
- Species:
- rat
Effect on developmental toxicity: via inhalation route
- Endpoint conclusion:
- no study available
Effect on developmental toxicity: via dermal route
- Endpoint conclusion:
- no study available
Additional information
OECD 414 developmental toxicity study in rats is available for the substance Guerbet alcohols, C24-26, branched and cyclic. The substance is not cumulatively toxic to pregnant rats and does not reveal embryotoxic, fetotoxic or developmental effects up to the highest dose tested (1000 mg/kg bw/d).
Supporting data on the structurally related linear C22 alcohol docosan-1 -ol are available. In a one generation study with docosan-1-ol in rats no adverse effects in any of the parental, reproductive or foetal parameters were observed.
Furthermore a published well-documented developmental toxicity study in rabbits on the 1-docosanol is available. In the study no substance-related maternal and developmental toxicity up to the highest dose tested (to 2000 mg/kg bw/d) was observed.
Based on this data it can be conclued that Guerbet alcohols, C24-26, branched and linear does not show developmental effects in rats and rabbits.
Justification for classification or non-classification
Available data are conclusive but not sufficient for classfication of Guerbet alcohols, C24-26, branched and linear with regard to reproductive toxicity and developmental toxicity/teratogenicity.
Additional information
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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