Registration Dossier
Registration Dossier
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EC number: 464-320-6 | CAS number: 423772-95-6
Toxicity to reproduction
Administrative data
- 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
Cross-referenceopen allclose all
- Reason / purpose for cross-reference:
- reference to same study
Reference
- Endpoint:
- short-term repeated dose toxicity: oral
- Remarks:
- combined repeated dose and reproduction / developmental screening (OECD 422)
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- 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
- 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
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Age at study initiation: 7-8 weeks - Route of administration:
- oral: feed
- Vehicle:
- unchanged (no vehicle)
- Details on oral 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. - Analytical verification of doses or concentrations:
- no
- Duration of treatment / exposure:
- males 45 days; females ca 54 days
- Frequency of treatment:
- continuous in diet
- Dose / conc.:
- 0 ppm
- Remarks:
- Group 1 (Control group)
- Dose / conc.:
- 1 500 ppm
- Remarks:
- Group 2 (Low dose, 100 mg/kg bw/day)
- Dose / conc.:
- 7 500 ppm
- Remarks:
- Group 3 (Mid dose, 500 mg/kg bw/day)
- Dose / conc.:
- 30 000 ppm
- Remarks:
- Group 4 (High dose, 2000 mg/kg bw/day)
- No. of animals per sex per dose:
- 12 males and 12 females/group
- Control animals:
- yes, plain diet
- Details on study design:
- No data
- Observations and examinations performed and frequency:
- CAGE SIDE OBSERVATIONS: Yes
- Time schedule: Mortality checked daily
BODY WEIGHT: Yes
- Time schedule for examinations: weekly
FOOD CONSUMPTION: measured weekly (except during mating)
HAEMATOLOGY: Yes
- Time schedule for collection of blood: only at day 37
- How many animals: Males only
- Parameters examined: haematocrit, Hb, total RBC & WBC and differential WBC
CLINICAL CHEMISTRY: Yes, males only at day 37, plasma protein, alkaline phosphatase, AAT, glucose, urea, creatinine, total and free cholesterol and triglyceride - Sacrifice and pathology:
- GROSS PATHOLOGY: Yes: Full necrospy on all animals; liver, kidneys and thymus in females and liver, kidney, thymus, testes and epididymes in males weighed
HISTOPATHOLOGY: Yes: Microscopic examination carried out on all control and top dose animals plus any obvious lesions observed at necrospy. Organs examined were liver, kidneys, adrenals, brain, heart, spleen, ovaries or testes and epididymes. - Other examinations:
- The results of foetal examinations and reproductive parameters are reported in the appropriate sections
- Statistics:
- Using the SAS-stat program analysis of variance plus Dunnett's test if changes were significant.
- Clinical signs:
- no effects observed
- Mortality:
- no mortality observed
- Body weight and weight changes:
- effects observed, non-treatment-related
- Description (incidence and severity):
- There were no significant changes in body weight or body weight gain in the 3 weeks prior to mating for both sexes or in males after mating.
- 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.
- Water consumption and compound intake (if drinking water study):
- not examined
- 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, treatment-related
- Description (incidence and severity):
- Males only examined: There were significant (but non-dose related) differences in free cholesterol (increased) and triglycerides (decreased) at all dose levels. Total cholesterol levels were not significantly increased. Plasma glucose was elevated with statistical significance in the low and mid-dose groups (See Table 7.5.1/1)
- Urinalysis findings:
- not specified
- Behaviour (functional findings):
- not specified
- Immunological findings:
- not specified
- Organ weight findings including organ / body weight ratios:
- no effects observed
- Description (incidence and severity):
- There were no significant differences in absolute or relative organ weights in males or females.
- Gross pathological findings:
- effects observed, non-treatment-related
- Neuropathological findings:
- not specified
- Histopathological findings: non-neoplastic:
- effects observed, non-treatment-related
- Histopathological findings: neoplastic:
- not examined
- Other effects:
- not specified
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- 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
- 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).
- 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, 500and 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.
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).
Therefore, the test substance should not be classified according to the criteria of the Regulation (EC) No.1272/2008 (CLP) and to the GHS.
Table 7.5.1/1: Clinical biochemicals
findings (males)
Parameter |
Control |
100 |
500 |
2000 mM |
Free chol |
0.29 |
0.38** |
0.37** |
0.36* |
Total chol |
1.30 |
1.56 |
1.56 |
1.40 |
Triglycerides |
0.78 |
0.42** |
0.49* |
0.46** |
Glucose |
6.8 |
7.8* |
7.9* |
7.6 |
* p<0.05 ** P<0.01
- Reason / purpose for cross-reference:
- reference to same study
Reference
- 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.
Data source
Reference
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 1 992
- Report date:
- 1992
Materials and methods
Test guideline
- 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
Test material
- Reference substance name:
- Octadecan-1-ol
- EC Number:
- 204-017-6
- EC Name:
- Octadecan-1-ol
- Cas Number:
- 112-92-5
- Molecular formula:
- CH3(CH2)17OH
- IUPAC Name:
- octadecan-1-ol
- Test material form:
- not specified
Constituent 1
Test animals
- 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
Administration / exposure
- 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
Doses / concentrationsopen allclose all
- 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
Examinations
- 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
Results and discussion
Results: P0 (first parental generation)
General toxicity (P0)
- 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 / performance (P0)
- Reproductive function: oestrous cycle:
- not examined
- Reproductive function: sperm measures:
- not examined
- Reproductive performance:
- not specified
Effect levels (P0)
- 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.
Target system / organ toxicity (P0)
- Key result
- Critical effects observed:
- no
Results: F1 generation
General toxicity (F1)
- 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
Details on results (F1)
Effect levels (F1)
- 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
Target system / organ toxicity (F1)
- Key result
- Critical effects observed:
- no
Overall reproductive toxicity
- Key result
- Reproductive effects observed:
- no
- Lowest effective dose / conc.:
- 2 000 mg/kg bw/day (nominal)
Applicant's summary and conclusion
- 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.
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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.
