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EC number: 464-320-6 | CAS number: 423772-95-6
- 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
- Toxic effect type:
- dose-dependent
Effects on fertility
Description of key information
No data available on the registered substance.
By analogy with octadecan-1-ol (see RAAF document), Combined repeated dose and reproduction / developmental screening (Comparable to OECD 422, GLP, Key, rel.2): NOAEL(fertility and developmental) = 2207 mg/kg bw/day in rats. No adverse effect reported at the highest dose level tested in this study.
By analogy with APG C10/16 (see RAAF document), reproduction / developmental study (OECD 421, GLP, Key, rel.1): NOAEL(fertility and developmental) = 850 mg/kg bw/day in rats. No adverse effect reported at the highest dose level tested in this study.
Link to relevant study records
- Endpoint:
- screening for reproductive / developmental toxicity
- Remarks:
- combined repeated dose and reproduction / developmental screening (OECD 422)
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- 18 August 1992
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Remarks:
- Comparable to OECD 422
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to same study
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 422 (Combined Repeated Dose Toxicity Study with the Reproduction / Developmental Toxicity Screening Test)
- Deviations:
- no
- Principles of method if other than guideline:
- Conducted according to Draft OECD 422 combined repeated dose and reproductive/developmental toxicity screening test.
- GLP compliance:
- yes (incl. QA statement)
- Limit test:
- no
- Species:
- rat
- Strain:
- Wistar
- Details on species / strain selection:
- No data.
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Moellegard Breeding Centre
- Age at study initiation: 7-8 weeks
- Weight at study initiation: not specified
- Fasting period before study: not specified
- Housing: 2 rats per cage for acclimatization period the individually
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 8 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22± 2
- Humidity (%):55 ±10%
- Air changes (per hr): not specified
- Photoperiod (hrs dark / hrs light): fluorescente light was on from 8 pm to 8 am
IN-LIFE DATES: not specified - Route of administration:
- oral: feed
- Vehicle:
- unchanged (no vehicle)
- Details on exposure:
- DIET PREPARATION:
- Diet preparation involved first mixing the octadecanol with the barley component, the proportion of which varied for each dose level. The other components of the diet were then added.
- Rate of prepartion of diet (frequency) : not specified
- Mixing appropriate amounts with (Type of food) : IT chow 101 diet
- Storage temperature of food : not specified. - Details on mating procedure:
- - M/F ratio per cage: 1:1
- Length of cohabitation: up to 22 days
- Proof of pregnancy: vaginal plug refered to as day 0 or, if the plug was recorded during the morning, day 1 of pregnancy.
- After 14 days of unsuccessful pairing replacement of first male by another male with proven fertility.
- Further matings after two unsuccessful attempts: no
- After successful mating each pregnant female was caged : individually in steel wire cages type 3 until day 20 in pregnancy where the pregnant females were placed in macrolon cages type 3.
- Any other deviations from standard protocol: none - Analytical verification of doses or concentrations:
- no
- Duration of treatment / exposure:
- Exposure period: males 45 days , females up to 54 days
Premating exposure period (males) : 14 days
Premating exposure period (females): 14 days
Duration of test : males 45 days, females up to 54 days - Frequency of treatment:
- Continuous in diet
- Details on study schedule:
- - Age at mating of the mated animals in the study: 10 (males) and 9 (females ) weeks
- Dose / conc.:
- 0 ppm
- Remarks:
- Control group
- Dose / conc.:
- 1 500 ppm
- Remarks:
- Group 2 (Mid dose, 100 mg/kg bw/day nominal in diet)
- Dose / conc.:
- 7 500 ppm
- Remarks:
- Group 3 (Low dose, 500 mg/kg bw/day nominal in diet)
- Dose / conc.:
- 30 000 ppm
- Remarks:
- Group 4 (High dose, 2000 mg/kg bw/day nominal in diet)
- No. of animals per sex per dose:
- 12 males and 12 females per group
- Control animals:
- yes, plain diet
- Details on study design:
- - Dose selection rationale: Doses chosen from the results of a preliminary test
- Rationale for animal assignment : Randomized into 4 groups with the same mean body weight
- The following design was used : 1-Octadecanol was mixed in the diet and given in the following concentrations .Group I: 0 ppm, group II : 1500 ppm , group III 7500 ppm , and group IV : 30000 ppm. - Positive control:
- none
- Parental animals: Observations and examinations:
CAGE SIDE OBSERVATIONS:No
DETAILED CLINICAL OBSERVATIONS: No
- Time schedule: not specified
BODY WEIGHT: Yes / No / No data
- Time schedule for examinations: During the experiment the males were weighed once/week.
the female were weighed during the premating period and during pregnancy once/week.
Pup litter weight was determined on day 1 an 4 after birth.
FOOD CONSUMPTION AND COMPOUND INTAKE (if feeding study):
- Food consumption for each animal determined and mean daily diet consumption calculated as g food/kg body weight/day: Yes
- Compound intake calculated as time-weighted averages from the consumption and body weight gain data: Yes
OTHER: Haemotology and clinicla biochemistry was conducted in the males.- Oestrous cyclicity (parental animals):
- Exposure was for 14 days premating covering at least 2 oestrous cycles. Ovaries were weighed and examined histopathologically at section (5 days after birth)
- Sperm parameters (parental animals):
- Macroscopic examinations were performed on each male animal
Exposure 14 days premaing , no specific sperm analyses was carried out, the testes and epididymus were weighed and examined histopathologically. - Litter observations:
- STANDARDISATION OF LITTERS
- Performed on day 4 postpartum:no
PARAMETERS EXAMINED
The following parameters were examined in [F1 / F2 / F3] offspring:
number and sex of pups, postnatal mortality, presence of gross anomalies, weight gain,
Examination of the externel malformations incliding the heead (especially eyes and cleft palate) and thoracic cave for the study of sex and malformations of internal organs.
GROSS EXAMINATION OF DEAD PUPS: no - Postmortem examinations (parental animals):
- SACRIFICE
- Male animals: All surviving animals sacrified after 45 days of dosing
- Maternal animals: All surviving animals sacrified on postnatal day 5
GROSS NECROPSY
- Gross necropsy consisted of full macroscopic examination.
HISTOPATHOLOGY / ORGAN WEIGHTS:
The liver , kidney , thymus, testes and epididymides were weighed;
The liver, kidneys, adrenals ,brain, heart , spleen , ovaries thymus , testes , epididimymides and any organs showing abnormality in macroscopic examination were fixed and the tissues from all controls and top dose treated rats (except the thymus) plus abnormalities were examined. - Postmortem examinations (offspring):
- SACRIFICE
- The F1 offspring not selected as parental animals and all F2 offspring were sacrificed at 5 days of age.
- These animals were subjected to postmortem examinations (macroscopic and/or microscopic examination) as follows:
GROSS NECROPSY
- Gross necropsy consisted of malformations including the head (especially eyes and cleft palate.) Animals were then opened to the abdomen and thoracic cavity for a study of the malformations of the internal organs.
HISTOPATHOLOGY / ORGAN WEIGTHS
No histopathology or organ weights measured - Statistics:
- Statistical ananlysisi was made on all data using the SAS-stat program.The raw data were transferred to the SAA-program and an analysis of varience was performed.All statistically significant findings were further evaluated by means of Dunnett's t-test to assess possiblbe intergroup diferences. For pregnancy rate a Chi-squared test was carried out to confirm lack of significance.
- Reproductive indices:
- Pregnancy rate , lenght of gestation ,implantations, corpora lutea and resorption were recorded.
- Offspring viability indices:
- None
- Clinical signs:
- not examined
- Mortality:
- no mortality observed
- 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):
- Food consumption was significantly increased in top dose males (p<0.001) and in mid dose females (p<0.05) at week 3. There were no other differences in food consumption.
- Food efficiency:
- no effects observed
- Description (incidence and severity):
- There were no differences in food conversion efficiency.
- Ophthalmological findings:
- not specified
- Haematological findings:
- no effects observed
- Description (incidence and severity):
- No statistically significant differences between treated and control groups (males only examined).
- Clinical biochemistry findings:
- effects observed, non-treatment-related
- Description (incidence and severity):
- A statistically significant (p< 0.05) increase in plasma glucose was observed in groups 2 and 3 , whereas an equally large, but not significant increase was observed in group 4.A statistically significant (p< 0.01) reduction in plasma triglyceride was observed in group 2 and 4.A statistically signiificant (p<0.05) increase in plasma free cholesterol was observed in group 2, 3 and 4 . None of these changes were dose-related
- Urinalysis findings:
- not specified
- Behaviour (functional findings):
- not specified
- Immunological findings:
- not specified
- Organ weight findings including organ / body weight ratios:
- no effects observed
- Histopathological findings: non-neoplastic:
- effects observed, non-treatment-related
- Histopathological findings: neoplastic:
- not specified
- Other effects:
- no effects observed
- Reproductive function: oestrous cycle:
- not examined
- Reproductive function: sperm measures:
- not examined
- Reproductive performance:
- not specified
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- ca. 2 000 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: No adverse effects observed.
- Key result
- Critical effects observed:
- no
- Clinical signs:
- not examined
- Dermal irritation (if dermal study):
- no effects observed
- Mortality / viability:
- no mortality observed
- Body weight and weight changes:
- no effects observed
- Food consumption and compound intake (if feeding study):
- no effects observed
- Food efficiency:
- no effects observed
- Clinical biochemistry findings:
- no effects observed
- Sexual maturation:
- no effects observed
- Gross pathological findings:
- no effects observed
- Histopathological findings:
- no effects observed
- Key result
- Dose descriptor:
- NOAEL
- Generation:
- F1
- Effect level:
- ca. 2 000 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- sexual maturation
- mortality
- body weight and weight gain
- clinical biochemistry
- organ weights and organ / body weight ratios
- gross pathology
- other: Litter size , litter sex ratio, survival index
- Key result
- Critical effects observed:
- no
- Key result
- Reproductive effects observed:
- no
- Lowest effective dose / conc.:
- 2 000 mg/kg bw/day (nominal)
- Conclusions:
- Based on the results of this study it is concluded that the NOAEL of test item for systemic toxicity was 30000 ppm (equivalent to 2000 mg/kg bw/day). The NOAEL of test item for reproductive/developmental effects was concluded to be 30000 ppm (equivalent to 2000 mg/kg bw/day).
- Executive summary:
In a Combined Repeated Dose Toxicity Study with the Reproduction / Developmental Toxicity Screening Test conducted similarly to OECD Guideline 422 and in compliance with GLP, octadecan-1-ol was administered to groups of Wistar rats at dietary concentrations of 1500, 7500 and 30000 ppm (100, 500 and 2000 mg/kg bw/day)
No mortality or cilnical signs were observed.The only systemic effects seen in this study were significant changes in plasma free cholesterol, triglycerides and glucose. These changes occurred at all dose levels but were not dose related. Although the reduction in plasma triglyceride levels may be indicative of mild effects in the liver, the differences in the composition of the test diets may have confounded these results.
Octadecan-1 administered to male and female rats via the diet at concentrations up to 30.000 ppm during pre-mating , mating and gestation.Pregnancy rates, uterine parameter, time to pregnancy and gestation length indicated that fertility was not affected by exposure to octadecan-1-ol. There were no microscopic changes observed in the reproductive organs.
Based on the results of this study it is concluded that the NOAEL of test item for systemic toxicity was 30000 ppm (equivalent to 2000 mg/kg bw/day). The NOAEL of test item for reproductive/developmental effects was concluded to be 30000 ppm (equivalent to 2000 mg/kg bw/day).
Therefore, the test substance should not be classified according to the criteria of the Regulation (EC) No.1272/2008 (CLP) and to the GHS.
- Endpoint:
- screening for reproductive / developmental toxicity
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- weight of evidence
- Justification for type of information:
- See RAAF document.
- Reason / purpose for cross-reference:
- read-across source
- Clinical signs:
- no effects observed
- Mortality:
- no mortality observed
- 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):
- Food consumption was significantly increased in top dose males (p<0.001) and in mid dose females (p<0.05) at week 3. There were no other differences in food consumption.
- Food efficiency:
- no effects observed
- Description (incidence and severity):
- There were no differences in food conversion efficiency.
- Ophthalmological findings:
- not specified
- Haematological findings:
- no effects observed
- Description (incidence and severity):
- No statistically significant differences between treated and control groups (males only examined).
- Clinical biochemistry findings:
- effects observed, non-treatment-related
- Description (incidence and severity):
- A statistically significant (p< 0.05) increase in plasma glucose was observed in groups 2 and 3 , whereas an equally large, but not significant increase was observed in group 4.A statistically significant (p< 0.01) reduction in plasma triglyceride was observed in group 2 and 4.A statistically signiificant (p<0.05) increase in plasma free cholesterol was observed in group 2, 3 and 4 . None of these changes were dose-related
- Urinalysis findings:
- not specified
- Behaviour (functional findings):
- not specified
- Immunological findings:
- not specified
- Organ weight findings including organ / body weight ratios:
- no effects observed
- Other effects:
- no effects observed
- Reproductive function: oestrous cycle:
- not examined
- Reproductive function: sperm measures:
- not examined
- Reproductive performance:
- not specified
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- ca. 2 000 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: No adverse effects were observed.
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- 2 207 mg/kg bw/day
- Based on:
- other: apx 20P
- Sex:
- male/female
- Basis for effect level:
- other: No adverse effects were observed.
- Key result
- Critical effects observed:
- no
- Clinical signs:
- not examined
- Dermal irritation (if dermal study):
- no effects observed
- Mortality / viability:
- no mortality observed
- Body weight and weight changes:
- no effects observed
- Food consumption and compound intake (if feeding study):
- no effects observed
- Clinical biochemistry findings:
- no effects observed
- Sexual maturation:
- no effects observed
- Gross pathological findings:
- no effects observed
- Histopathological findings:
- no effects observed
- Key result
- Dose descriptor:
- NOAEL
- Generation:
- F1
- Effect level:
- ca. 2 000 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- sexual maturation
- mortality
- body weight and weight gain
- clinical biochemistry
- organ weights and organ / body weight ratios
- gross pathology
- other: Litter size , litter sex ratio, survival index
- Key result
- Dose descriptor:
- NOAEL
- Generation:
- F1
- Effect level:
- 2 207 mg/kg bw/day (nominal)
- Based on:
- other: apx 20P
- Sex:
- male/female
- Basis for effect level:
- other: Litter size , litter sex ratio, survival index
- Key result
- Reproductive effects observed:
- no
- Conclusions:
- Based on the results of this study it is concluded that the NOAEL of test item for systemic toxicity was 30000 ppm (equivalent to 2000 mg/kg bw/day), which corresponds to 3184 mg/kg bw/day of the target registered substance. The NOAEL of test item for reproductive/developmental effects was concluded to be 30000 ppm (equivalent to 2000 mg/kg bw/day), which corresponds to 2207 mg/kg bw/day for the target registered substance.
- Executive summary:
In a Combined Repeated Dose Toxicity Study with the Reproduction / Developmental Toxicity Screening Test conducted similarly to OECD Guideline 422 and in compliance with GLP, octadecan-1-ol was administered to groups of Wistar rats at dietary concentrations of 1500, 7500 and 30000 ppm (100, 500 and 2000 mg/kg bw/day)
No mortality or cilnical signs were observed.The only systemic effects seen in this study were significant changes in plasma free cholesterol, triglycerides and glucose. These changes occurred at all dose levels but were not dose related. Although the reduction in plasma triglyceride levels may be indicative of mild effects in the liver, the differences in the composition of the test diets may have confounded these results.
Octadecan-1-ol administered to male and female rats via the diet at concentrations up to 30000 ppm during pre-mating, mating and gestation. Pregnancy rates, uterine parameter, time to pregnancy and gestation length indicated that fertility was not affected by exposure to octadecan-1-ol. There were no microscopic changes observed in the reproductive organs.
Based on the results of this study it is concluded that the NOAEL of test item for systemic toxicity was 30000 ppm (equivalent to 2000 mg/kg bw/day), which corresponds to 3184 mg/kg bw/day of the target registered substance. The NOAEL of test item for reproductive/developmental effects was concluded to be 30000 ppm (equivalent to 2000 mg/kg bw/day), which corresponds to 2207 mg/kg bw/day for the target registered substance.
Therefore, the registered substance should not be classified according to the criteria of the Regulation (EC) No.1272/2008 (CLP) and to the GHS.
- Endpoint:
- screening for reproductive / developmental toxicity
- Remarks:
- OECD 421
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- 2007
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
- Remarks:
- No data on vehicle for gavage, limited details on test substance and examinations.
- Reason / purpose for cross-reference:
- reference to same study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 421 (Reproduction / Developmental Toxicity Screening Test)
- Deviations:
- yes
- Remarks:
- No data on vehicle for gavage, limited details on test substance and examinations.
- Principles of method if other than guideline:
- Not applicable.
- GLP compliance:
- not specified
- Limit test:
- no
- Species:
- rat
- Strain:
- Sprague-Dawley
- Details on species / strain selection:
- No data.
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- According to Guideline.TEST ANIMALS
- Source: no data
- Females (if applicable) nulliparous and non-pregnant: yes
- Age at study initiation: (P) 12 wks
- Weight at study initiation: no data
- Fasting period before study: no data
- Housing: in groups of 5 per sex per cage.
- Diet (e.g. ad libitum): laboratory rodent diet (Altromin MT pelleted diet, A. Rieper, Bolzano, Italy), ad libitum.
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 7 days.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21+/- 2
- Humidity (%): 55 +/- 10
- Air changes (per hr): 15-20
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: To: no data. - Route of administration:
- oral: gavage
- Vehicle:
- not specified
- Details on exposure:
- No data
- Details on mating procedure:
- - M/F ratio per cage: 1
- Length of cohabitation: 3 days (mean pre-coital period)
- Proof of pregnancy: vaginal plug - Analytical verification of doses or concentrations:
- not specified
- Duration of treatment / exposure:
- 2 weeks before pairing and continuously thereafter, up to the day before sacrifice (study day 53, day 4 post partum).
- Frequency of treatment:
- Daily, 7 days/week.
- Dose / conc.:
- 0 mg/kg bw/day (nominal)
- Remarks:
- Control (Group 1)
- Dose / conc.:
- 100 mg/kg bw/day (nominal)
- Remarks:
- Low dose (Group 2)
- Dose / conc.:
- 300 mg/kg bw/day (nominal)
- Remarks:
- Mid dose (Group 3)
- Dose / conc.:
- 1 000 mg/kg bw/day (nominal)
- Remarks:
- High dose (Group 4)
- No. of animals per sex per dose:
- 10
- Control animals:
- yes
- Positive control:
- Not required.
- Parental animals: Observations and examinations:
- CAGE SIDE OBSERVATIONS: Yes
- Time schedule: Clinical signs were recorded daily throughout the study.
DETAILED CLINICAL OBSERVATIONS: Yes
- Time schedule: all animals were examined on arrival. Examinations of dams and litters took place on Day 4 post partum.
BODY WEIGHT: Yes
- Time schedule for examinations: body weigt gain was recorded during the study.
FOOD CONSUMPTION AND COMPOUND INTAKE (if feeding study):
- Food consumption for each animal determined and mean daily diet consumption calculated as g food/kg body weight/day: Yes - Oestrous cyclicity (parental animals):
- Vaginal smears are taken daily for 14 days prior to pairing and each morning during the pairing period to detect marked anomalies of the estrous cycle.
- Sperm parameters (parental animals):
- Parameters examined in P male parental generations:
testis weight, epididymis weight - Litter observations:
- STANDARDISATION OF LITTERS
- Performed on day 4 postpartum: no
PARAMETERS EXAMINED
The following parameters were examined in F1 offspring:
number and sex of pups, stillbirths, live births, postnatal mortality, presence of gross anomalies, weight gain, physical or behavioural abnormalities, other: implantation per litter.
GROSS EXAMINATION OF DEAD PUPS:
yes, for external and internal abnormalities; possible cause of death was not determined for pups born or found dead.
ASSESSMENT OF DEVELOPMENTAL NEUROTOXICITY: no
ASSESSMENT OF DEVELOPMENTAL IMMUNOTOXICITY: no - Postmortem examinations (parental animals):
- SACRIFICE
- Male animals: All surviving animals on Day 53 (On Day 4 post partum).
- Maternal animals: All surviving animals on Day 53 (on Day 4 post partum). - Postmortem examinations (offspring):
- SACRIFICE
- The F1 offspring not selected as parental animals and all F2 offspring were sacrificed at 4 days of age.
- These animals were subjected to postmortem examinations (macroscopic examination)
- Statistics:
- Mean values and standard deviations of the following parameters were calculated:
- litter weights at birth and sacrifice
- absolute and relative organ weights of testes, epididymis, seminal vesicles and prostate
- pre-coital intervals
- total litter size, sex ratio (%)
- implantation/litter
- gestation period
- pre-birth loss/litter (number and %) - Reproductive indices:
- - Female: copulation or fertility index.
- Males: fertility index. - Clinical signs:
- no effects observed
- Description (incidence and severity):
- No clinical signs were observed during the whole study period.
- Mortality:
- no mortality observed
- Body weight and weight changes:
- no effects observed
- Description (incidence and severity):
- No effects on body weights were noted during the study.
- Food consumption and compound intake (if feeding study):
- no effects observed
- Description (incidence and severity):
- No effects on food consumption were observed during the experimental period.
- Food efficiency:
- no effects observed
- Ophthalmological findings:
- not examined
- Haematological findings:
- not examined
- Clinical biochemistry findings:
- not examined
- Urinalysis findings:
- not specified
- Behaviour (functional findings):
- not specified
- Immunological findings:
- not examined
- Organ weight findings including organ / body weight ratios:
- no effects observed
- Histopathological findings: non-neoplastic:
- no effects observed
- Histopathological findings: neoplastic:
- no effects observed
- Other effects:
- not examined
- Reproductive function: oestrous cycle:
- no effects observed
- Description (incidence and severity):
- No effects on estrous cycle were reported.
- Reproductive function: sperm measures:
- no effects observed
- Description (incidence and severity):
- No treatment-related effects on absolute and relative weights of testis and epididymis were observed at any dose level.
- Reproductive performance:
- no effects observed
- Description (incidence and severity):
- In males and females, no substance-related effects on fertility index were observed. A slight, but not significant decrease in copulatory index was observed in females receiving the high dose (1000 mg/kg bw/d). One male in the mid dose dose group and two females in the high dose group did no mate until day 10 and were mated with another male afterwards. One female in the high dose group did not mate after a period of 20 days.
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- 1 000 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- clinical signs
- mortality
- body weight and weight gain
- food consumption and compound intake
- food efficiency
- organ weights and organ / body weight ratios
- gross pathology
- other: No treatment-related effects.
- Remarks on result:
- other: Systemic toxicity
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- 1 000 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- reproductive function (oestrous cycle)
- reproductive function (sperm measures)
- reproductive performance
- other: no adverse effects on male and female reproductive organs and performance.
- Remarks on result:
- other: Reproductive toxicity
- Key result
- Critical effects observed:
- no
- Clinical signs:
- no effects observed
- Description (incidence and severity):
- No treatment-related clinical signs were observed in pre-weaning pups.
- Mortality / viability:
- no mortality observed
- Description (incidence and severity):
- No effects on mean litter weights and sex ratios were observed between the F1 generations of treated and control animals. Some slight, but not significant variations in pre-birth loss were seen in the high dose group compared to controls.
- Body weight and weight changes:
- no effects observed
- Description (incidence and severity):
- No differences in the mean litter weight on Day 0 (birth) and Day 4 (sacrifice) were noted in treated and controls group.
- Food consumption and compound intake (if feeding study):
- not specified
- Food efficiency:
- not specified
- Ophthalmological findings:
- not examined
- Haematological findings:
- not examined
- Clinical biochemistry findings:
- not examined
- Urinalysis findings:
- not examined
- Sexual maturation:
- not examined
- Anogenital distance (AGD):
- not examined
- Nipple retention in male pups:
- not examined
- Organ weight findings including organ / body weight ratios:
- not specified
- Gross pathological findings:
- no effects observed
- Description (incidence and severity):
- Necropsy did not reveal any substance related effects in decedent or F1 pups.
- Histopathological findings:
- not specified
- Other effects:
- not specified
- Key result
- Dose descriptor:
- NOAEL
- Generation:
- F1
- Effect level:
- 1 000 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- viability
- clinical signs
- body weight and weight gain
- gross pathology
- other: No treatment-related effects were observed at all tested doses.
- Key result
- Critical effects observed:
- no
- Reproductive effects observed:
- no
- Lowest effective dose / conc.:
- 1 000 mg/kg bw/day (nominal)
- Conclusions:
- Under the conditions of a state-of-the-art reproduction/developmental toxicity screening testing according to the OECD guideline 421, no adverse effects were observed regarding male and female reproductive organs even at the very high dose of 1000 mg/kg bw/day.
- Executive summary:
In a Reproduction / Developmental Toxicity Screening Test conducted according to OECD Guideline 421, the test substance (APG C12 -C14 fatty alcohol from renewable sources, n= 1.43) was applied to 40 males and 40 females Sprague-Dawley rats prior to mating, throughout the gestation and lactation period until post partum day 3. Treatment by gavage with 0, 100, 300 and 1000 mg/kg bw/day began 7 days after allocation for both males and females. Treatment commenced when males and females were approximately 12 weeks of age, 2 weeks before pairing and continuously thereafter, up to the day before sacrifice (study day 53, day 4 post partum). Matings were monogamous.
During the study, parameters of general toxicity like clinical signs, food consumption and body weight gain were recorded in the parental generation and in the pups. Effects related to reproduction and hormone balance such as oestrous cycle, mating performance, pregnancy rates and the number of embryo resorptions were registered. Pup losses were recorded and the filial generation was examined for behavioural abnormalities and external growth abnormalities.
Under the conditions of a state-of-the-art reproduction/developmental toxicity screening testing according to the OECD guideline 421, no adverse effects were observed regarding male and female systemic toxicity and reproductive organs even at the very high dose of 1000 mg/kg bw/day. There is no indication for any impairment of reproduction, either with regard to the development of the progeny or to the effects on fertility both of the structural and functional level. Therefore, a hazard of reproductive toxicity for APG is not expected.
Based on the results of this study it is concluded that he NOAEL of test item for reproductive/developmental effects was concluded to be 1000 mg/kg bw/day.
Therefore, the test substance should not be classified according to the criteria of the Regulation (EC) No.1272/2008 (CLP) and to the GHS.
- Endpoint:
- screening for reproductive / developmental toxicity
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- weight of evidence
- Justification for type of information:
- See RAAF document.
- Reason / purpose for cross-reference:
- read-across source
- Clinical signs:
- no effects observed
- Description (incidence and severity):
- No clinical signs were observed during the whole study period.
- Mortality:
- no mortality observed
- Body weight and weight changes:
- no effects observed
- Description (incidence and severity):
- No effects on body weights were noted during the study.
- Food consumption and compound intake (if feeding study):
- no effects observed
- Description (incidence and severity):
- No effects on food consumption were observed during the experimental period.
- Food efficiency:
- no effects observed
- Ophthalmological findings:
- not examined
- Haematological findings:
- not examined
- Clinical biochemistry findings:
- not examined
- Urinalysis findings:
- not specified
- Behaviour (functional findings):
- not specified
- Immunological findings:
- not examined
- Organ weight findings including organ / body weight ratios:
- no effects observed
- Histopathological findings: non-neoplastic:
- no effects observed
- Histopathological findings: neoplastic:
- no effects observed
- Other effects:
- not examined
- Reproductive function: oestrous cycle:
- no effects observed
- Description (incidence and severity):
- No effects on estrous cycle were reported.
- Reproductive function: sperm measures:
- no effects observed
- Description (incidence and severity):
- No treatment-related effects on absolute and relative weights of testis and epididymis were observed at any dose level.
- Reproductive performance:
- no effects observed
- Description (incidence and severity):
- In males and females, no substance-related effects on fertility index were observed. A slight, but not significant decrease in copulatory index was observed in females receiving the high dose (1000 mg/kg bw/d). One male in the mid dose dose group and two females in the high dose group did no mate until day 10 and were mated with another male afterwards. One female in the high dose group did not mate after a period of 20 days.
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- 1 000 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- clinical signs
- mortality
- body weight and weight gain
- food consumption and compound intake
- food efficiency
- organ weights and organ / body weight ratios
- gross pathology
- other: No treatment-related effects.
- Remarks on result:
- other: Systemic toxicity
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- 1 000 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- reproductive function (oestrous cycle)
- reproductive function (sperm measures)
- reproductive performance
- other: no adverse effects on male and female reproductive organs and performance.
- Remarks on result:
- other: Reproductive toxicity
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- 850 mg/kg bw/day
- Based on:
- other: apx 20P
- Sex:
- male/female
- Remarks on result:
- other: No treatment-related effects.
- Remarks:
- Reproductive toxicity
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- 850 mg/kg bw/day
- Based on:
- other: apx 20P
- Sex:
- male/female
- Remarks on result:
- other: Systemic toxicity
- Key result
- Critical effects observed:
- no
- Clinical signs:
- no effects observed
- Description (incidence and severity):
- No treatment-related clinical signs were observed in pre-weaning pups.
- Mortality / viability:
- no mortality observed
- Description (incidence and severity):
- No effects on mean litter weights and sex ratios were observed between the F1 generations of treated and control animals. Some slight, but not significant variations in pre-birth loss were seen in the high dose group compared to controls.
- Body weight and weight changes:
- no effects observed
- Description (incidence and severity):
- No differences in the mean litter weight on Day 0 (birth) and Day 4 (sacrifice) were noted in treated and controls group.
- Food consumption and compound intake (if feeding study):
- not specified
- Food efficiency:
- not specified
- Ophthalmological findings:
- not examined
- Haematological findings:
- not examined
- Clinical biochemistry findings:
- not examined
- Urinalysis findings:
- not examined
- Sexual maturation:
- not examined
- Anogenital distance (AGD):
- not examined
- Nipple retention in male pups:
- not examined
- Organ weight findings including organ / body weight ratios:
- not specified
- Gross pathological findings:
- no effects observed
- Description (incidence and severity):
- Necropsy did not reveal any substance related effects in decedent or F1 pups.
- Histopathological findings:
- not specified
- Other effects:
- not specified
- Key result
- Dose descriptor:
- NOAEL
- Generation:
- F1
- Effect level:
- 1 000 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- viability
- clinical signs
- body weight and weight gain
- gross pathology
- other: No treatment-related effects were observed at all tested doses.
- Key result
- Dose descriptor:
- NOAEL
- Generation:
- F1
- Effect level:
- 850 mg/kg bw/day
- Based on:
- other: apx 20P
- Sex:
- male/female
- Basis for effect level:
- other: No treatment-related effects.
- Key result
- Critical effects observed:
- no
- Key result
- Reproductive effects observed:
- no
- Conclusions:
- Under the conditions of a state-of-the-art reproduction/developmental toxicity screening testing according to the OECD guideline 421, no adverse effects were observed regarding male and female reproductive organs even at the very high dose of 1000 mg/kg bw/day, which corresponds to 850 mg/kg bw/day for the target registered substance.
- Executive summary:
In a Reproduction / Developmental Toxicity Screening Test conducted according to OECD Guideline 421 and in compliance with GLP, the test substance (APG C12 -C14 fatty alcohol from renewable sources, n= 1.43) was applied to 40 males and 40 females Sprague-Dawley rats prior to mating, throughout the gestation and lactation period until post partum day 3. Treatment by gavage with 0, 100, 300 and 1000 mg/kg bw/day began 7 days after allocation for both males and females. Treatment commenced when males and females were approximately 12 weeks of age, 2 weeks before pairing and continuously thereafter, up to the day before sacrifice (study day 53, day 4 post partum). Matings were monogamous.
During the study, parameters of general toxicity like clinical signs, food consumption and body weight gain were recorded in the parental generation and in the pups. Effects related to reproduction and hormone balance such as oestrous cycle, mating performance, pregnancy rates and the number of embryo resorptions were registered. Pup losses were recorded and the filial generation was examined for behavioural abnormalities and external growth abnormalities.
Under the conditions of a state-of-the-art reproduction/developmental toxicity screening testing according to the OECD guideline 421, no adverse effects were observed regarding male and female systemic toxicity and reproductive organs even at the very high dose of 1000 mg/kg bw/day. There is no indication for any impairment of reproduction, either with regard to the development of the progeny or to the effects on fertility both of the structural and functional level. Therefore, a hazard of reproductive toxicity for APG is not expected.
Based on the results of this study it is concluded that he NOAEL of test item for reproductive/developmental effects was concluded to be 1000 mg/kg bw/day, which corresponds to 850 mg/kg bw/day for the target registered substance.
Therefore, the test substance should not be classified according to the criteria of the Regulation (EC) No.1272/2008 (CLP) and to the GHS.
Referenceopen allclose all
Effect on fertility: via oral route
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- NOAEL
- 850 mg/kg bw/day
- Study duration:
- subacute
- Species:
- rat
- Quality of whole database:
- The key study is GLP-compliant (OECD 421, Klimisch score = 1).
Effect on fertility: via inhalation route
- Endpoint conclusion:
- no study available
Effect on fertility: via dermal route
- Endpoint conclusion:
- no study available
Additional information
No data available on the registered susbtance.
- By analogy with octadecan-1-ol, a key study was identified (Hansen, 1992b). In this study (Similar to OECD 422, GLP), octadecan-1-ol was administered to groups of Wistar rats at dietary concentrations of 1500, 7500 and 30000 ppm (100, 500 and 2000 mg/kg bw/day)
No mortality or cilnical signs were observed.The only systemic effects seen in this study were significant changes in plasma free cholesterol, triglycerides and glucose. These changes occurred at all dose levels but were not dose related. Although the reduction in plasma triglyceride levels may be indicative of mild effects in the liver, the differences in the composition of the test diets may have confounded these results.
Octadecan-1 administered to male and female rats via the diet at concentrations up to 30.000 ppm during pre-mating , mating and gestation.Pregnancy rates, uterine parameter, time to pregnancy and gestation length indicated that fertility was not affected by exposure to octadecan-1-ol. There were no microscopic changes observed in the reproductive organs.
Based on the results of this study it is concluded that the NOAEL of test item for systemic toxicity was 30000 ppm (equivalent to 2000 mg/kg bw/day), which corresponds to 3184 mg/kg bw/day of the target registered substance. The NOAEL of test item for reproductive/developmental effects was concluded to be 30000 ppm (equivalent to 2000 mg/kg bw/day), which corresponds to 2207 mg/kg bw/day of the target registered substance.
- In a Reproduction / Developmental Toxicity Screening Test conducted according to OECD Guideline 421 and in compliance with GLP, the test substance (APG C12 -C14 fatty alcohol from renewable sources, n= 1.43) was applied to 40 males and 40 females Sprague-Dawley rats prior to mating, throughout the gestation and lactation period until post partum day 3. Treatment by gavage with 0, 100, 300 and 1000 mg/kg bw/day began 7 days after allocation for both males and females. Treatment commenced when males and females were approximately 12 weeks of age, 2 weeks before pairing and continuously thereafter, up to the day before sacrifice (study day 53, day 4 post partum). Matings were monogamous.
During the study, parameters of general toxicity like clinical signs, food consumption and body weight gain were recorded in the parental generation and in the pups. Effects related to reproduction and hormone balance such as oestrous cycle, mating performance, pregnancy rates and the number of embryo resorptions were registered. Pup losses were recorded and the filial generation was examined for behavioural abnormalities and external growth abnormalities.
Under the conditions of a state-of-the-art reproduction/developmental toxicity screening testing according to the OECD guideline 421, no adverse effects were observed regarding male and female systemic toxicity and reproductive organs even at the very high dose of 1000 mg/kg bw/day.There is no indication for any impairment of reproduction, either with regard to the development of the progeny or to the effects on fertility both of the structural and functional level. Therefore, a hazard of reproductive toxicity for APG is not expected.
Based on the results of this study it is concluded that he NOAEL of test item for reproductive/developmental effects was concluded to be 1000 mg/kg bw/day, which corresponds to 850 mg/kg bw/day for the target registered substance.
These results are supported by two studies available on other analogues ( repeated dose toxicity study (2y rat), no test substance related-effects were observed in male or female reproductive organs.
Effects on developmental toxicity
Description of key information
No data available on the registered substance. By analogy with 2 -Octyldodecan-1 -ol (OECD 414, Rel.1), the NOAEL for maternal systemic toxicity and developmental toxicity was up to 1000 mg /kg bw/day, which corresponds to 1442 mg/kg bw/day of the registered substance.
Link to relevant study records
- Endpoint:
- developmental toxicity
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- August to November 1992
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 414 (Prenatal Developmental Toxicity Study)
- Deviations:
- no
- Principles of method if other than guideline:
- Not applicable.
- GLP compliance:
- yes
- Limit test:
- no
- Species:
- rat
- Strain:
- CD-1
- Details on test animals or test system and environmental conditions:
- According to guidelineTEST ANIMALS
- Source: Charles River, Sulzfeld, Germany
- Age at study initiation: 8-10 weeks
- Weight at study initiation: mean weight 196 g
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-23
- Humidity (%): 38-58
- Air changes (per hr): 10-15
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: To: September 30 to November 4, 1992 - Route of administration:
- oral: gavage
- Vehicle:
- arachis oil
- Details on exposure:
- Test substance was administered orally by gavage once daily in the morning from day 6 up tp day 15 post coitum inclusive. All groups received a dose volume of 5ml/kg body weight, adjusted to the body weight of day 6 post coitum. Control animals were similarly dosed with the vehicle alone.
- Analytical verification of doses or concentrations:
- not specified
- Details on mating procedure:
- According to guideline.
- Duration of treatment / exposure:
- day 6 to day 15 of gestation.
- Frequency of treatment:
- daily
- Duration of test:
- until day 20 of gestation.
- Dose / conc.:
- 0 mg/kg bw/day
- Remarks:
- Group 1 (Control group)
- Dose / conc.:
- 100 mg/kg bw/day
- Remarks:
- Group 2 (Low dose, actual ingested)
- Dose / conc.:
- 300 mg/kg bw/day
- Remarks:
- Group 3 (Mid dose, actual ingested)
- Dose / conc.:
- 1 000 mg/kg bw/day
- Remarks:
- Group 4 (High dose, actual ingested)
- No. of animals per sex per dose:
- 24
- Control animals:
- yes
- Details on study design:
- none
- Maternal examinations:
- CAGE SIDE OBSERVATIONS: Yes
DETAILED CLINICAL OBSERVATIONS: Yes
BODY WEIGHT: Yes
POST-MORTEM EXAMINATIONS: Yes - Ovaries and uterine content:
- The ovaries and uterine content was examined after termination: Yes :
- Gravid uterus weight: Yes
- Number of corpora lutea: Yes
- Number of implantations: Yes
- Number of early resorptions: Yes
- Number of late resorptions: Yes - Fetal examinations:
- - External examinations: Yes: all per litter
- Soft tissue examinations: Yes: half per litter
- Skeletal examinations: Yes: half per litter
- Head examinations: Yes: half per litter - Statistics:
- yes
- Historical control data:
- no
- Clinical signs:
- no effects observed
- Mortality:
- no mortality observed
- Body weight and weight changes:
- no effects observed
- Number of abortions:
- no effects observed
- 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:
- no effects observed
- Changes in number of pregnant:
- no effects observed
- Other effects:
- no effects observed
- Details on maternal toxic effects:
- Maternal toxic effects:no effects
- Dose descriptor:
- NOEL
- Effect level:
- > 1 000 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Basis for effect level:
- other: maternal toxicity
- Remarks on result:
- other: No maternal toxicity was observed at all tested doses.
- Key result
- Abnormalities:
- not specified
- Fetal body weight changes:
- no effects observed
- Reduction in number of live offspring:
- no effects observed
- Changes in sex ratio:
- no effects observed
- Changes in litter size and weights:
- no effects observed
- Changes in postnatal survival:
- no effects observed
- External malformations:
- no effects observed
- Skeletal malformations:
- effects observed, non-treatment-related
- Description (incidence and severity):
- Group 1: no variations
Group 2: ribs rudimentary unilateral/bilateral, significant decrease at level 1%, thoracic vertebrae, dumbbell shape, significant increase at level 5%
Group 3: no variations
Group 4: thoratic vertebrae, dumbell shape, significant increase at level 1%
The statistical significant differences were considered to be incidental. The findings in the ribs rudimentare are due to the increase of the control group. The other variation effects to the thoratic vertebrae, dumbell shape are also incidental and not dose-related. The incidental character of these variations is emphasized by the fact that the values were within the normal range of variations for this strain. - Visceral malformations:
- no effects observed
- Other effects:
- no effects observed
- Details on embryotoxic / teratogenic effects:
- Embryotoxic / teratogenic effects:no effects
- Key result
- Dose descriptor:
- NOEL
- Effect level:
- > 1 000 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Sex:
- female
- Basis for effect level:
- other: embryotoxicity
- Remarks on result:
- other: No effects were observed at all tested doses.
- Key result
- Dose descriptor:
- NOEL
- Effect level:
- > 1 000 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Sex:
- female
- Basis for effect level:
- other: fetotoxicity
- Remarks on result:
- other: No effects were observed at all tested doses.
- Key result
- Abnormalities:
- not specified
- Key result
- Developmental effects observed:
- not specified
- Conclusions:
- Under the test conditions, the NOAEL for maternal systemic toxicity and developmental toxicity was up to 1000 mg /kg bw/day, as no effects were observed at all tested doses.
- Executive summary:
In a developmental toxicity study conducted according to the OECD guideline No. 414 and in compliance with GLP, 2 -octyl-1 -dodecanol diluted in arachis oil was administered to 24 females rats/dose by gavage at dose levels of 0, 100, 300 or 1000 mg/kg bw/day from days 6 through 15 of gestation.
All animals were observed twice daily for appearance and behavior. The uteri and ovaries were examined, and the number of fetuses, early and late resorptions, total implantations and corpora lutea were recorded. Gravid uterine weights were recorded, and net body weights and net body weight changes were calculated. The fetuses were weighted, sexed and examined for external, visceral and skeletal malformations and developmental variation.
All animals survived to the scheduled necropsy. No maternal effects were observed in all tested doses.
There were no test article-related internal findings at the scheduled necropsy. For the effect on fetuses, no significant changes were observed in the number of live fetuses, embryo/fetal mortality, sex ratio, body weight of live fetuses, or in the external, visceral, or skeletal examination of fetuses, at all tested animals. No test article-related fetal malformations or developmental variations were noted at any dose level in this study. No other signs of developmental toxicity were noted.
Based on the results of this study, the dose level up to 1000 mg/kg bw/day was considered to be the NOAEL(systemic effects) for maternal toxicity and the NOAEL for developmental toxicity.
Under the test conditions, the test substanceis not classified according to Regulation (EC) No.1272/2008 (CLP) criteria.
This study is acceptable and satisfies the requirement for developmental toxicity endpoint.
Reference
Effect on developmental toxicity: via oral route
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- NOAEL
- 1 000 mg/kg bw/day
- Study duration:
- subacute
- 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
No study available on the test substance, by analogy with 2 -Octyldodeca-1 -ol (see RAAF document), a key study was identified (BASF, 1992). In this study (OECD 414, GLP), 2 -octyl-1 -dodecanol diluted in arachis oil was administered to 24 femalesrats/dose by gavage at dose levels of 0, 100, 300 or 1000 mg/kg bw/day from days 6 through 15 of gestation.
All animals were observed twice daily for appearance and behavior. The uteri and ovaries were examined, and the number of fetuses, early and late resorptions, total implantations and corpora lutea were recorded. Gravid uterine weights were recorded, and net body weights and net body weight changes were calculated. The fetuses were weighted, sexed and examined for external, visceral and skeletal malformations and developmental variation.
All animals survived to the scheduled necropsy. No maternal effects were observed in all tested doses.
There were no test article-related internal findings at the scheduled necropsy. Forthe effect on fetuses, no significant changes were observed in the number of live fetuses, embryo/fetal mortality, sex ratio, body weight of live fetuses, or in the external, visceral, or skeletal examination of fetuses, at all tested animals. No test article-related fetal malformations or developmental variations were noted at any dose level in this study.No other signs of developmental toxicity were noted.
Based on the results of this study, the dose level up to 1000 mg/kg bw/day was considered to be the NOAEL(systemic effects) for maternal toxicity and the NOAEL for developmental toxicity, which corresponds to 1000 mg/kg bw/day of the registered substance.
Justification for classification or non-classification
Harmonized classification:
The substance has no harmonized classification according to the Regulation (EC) No 1272/2008.
Self-classification:
Based on the available data, no adverse effects were identified, therefore no additional classification is proposed according to the Regulation (EC) No 1272/2008 and to the GHS.
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.
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.