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Registration Dossier
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EC number: 610-522-6 | CAS number: 503155-49-5
- 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
Reproductive Toxicity
Based on the data available from different studies, the No Observed Adverse Effect Level (NOAEL) was considered to be 1000 mg/kg/day for reproductive toxicity, when rodents were treated with test chemical orally. Thus, comparing this value with the criteria of CLP regulation test chemical is not likely to classify as reproductive toxicant.
Link to relevant study records
- Endpoint:
- screening for reproductive / developmental toxicity
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- data from handbook or collection of data
- Remarks:
- Experimental data from various test chemicals
- Justification for type of information:
- Weight of evidence approach based on the data of the read-across chemicals.
- Reason / purpose for cross-reference:
- read-across source
- Reason / purpose for cross-reference:
- read-across source
- Qualifier:
- according to guideline
- Guideline:
- other: As mentioned below
- Principles of method if other than guideline:
- WoE report is based on 2 reproductive toxicity studies i.e. WoE-2 and WoE-3.
- GLP compliance:
- not specified
- Limit test:
- no
- Justification for study design:
- not specified
- Species:
- rat
- Strain:
- other: 2. Osborne-Mendel 3. Virgin female albino rats bred (COBS)3
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- 2. Rats were caged individually.
3. No Data Available - Route of administration:
- other: 2. oral: feed 3. oral: gavage
- Type of inhalation exposure (if applicable):
- not specified
- Vehicle:
- other: 2. Commercial Laboratory Chow diet 3. water
- Details on exposure:
- 2. PREPARATION OF DOSING SOLUTIONS:
DIET PREPARATION
The test chemical was mixed into a commercial laboratory chow diet for each feeding study.
3. PREPARATION OF DOSING SOLUTIONS: No Data Available
VEHICLE
- Justification for use and choice of vehicle (if other than water): Water was used as a vehicle.
- Concentration in vehicle: 15, 50 and 150 mg/kg bw
- Amount of vehicle (if gavage): 10 ml
- Lot/batch no. (if required): No Data Available
- Purity: No Data Available - Details on mating procedure:
- 2. Mating was not performed
3. - M/F ratio per cage: No Data Available
- Length of cohabitation: No Data Available
- Proof of pregnancy: Mating was confirmed by sperm-positive results of vaginal examinations. The day of insemination was considered day 0 of the gestation period.
- After ... days of unsuccessful pairing replacement of first male by another male with proven fertility: No Data Available
- Further matings after two unsuccessful attempts: [no / yes (explain)]: No Data Available
- After successful mating each pregnant female was caged (how): No Data Available
- Any other deviations from standard protocol: No Data Available - Analytical verification of doses or concentrations:
- not specified
- Duration of treatment / exposure:
- 2. two-years
3. Gestation Day 6 to 15. - Frequency of treatment:
- Once Daily
- Details on study schedule:
- No Data Available
- Remarks:
- 2. 0, 500, 1000 mg/kg bw/day
3. 0, 15, 50, 150 mg/kg bw/day - No. of animals per sex per dose:
- 2. control - 200(100/ sex)
500 mg/kgbw/day - 100 (50/sex)
1000 mg/kgbw/day - 100 (50/sex)
3. 16 to 22 pregnant rats per group. - Control animals:
- yes, concurrent vehicle
- Details on study design:
- 2. Two-year tests were run in which 400 rats were distributed into various treatment groups. The test chemical was mixed into a commercial laboratory chow diet for each feeding study.Rats were individually caged. Each animal received in the Pathology Laboratory was given a careful gross examination, and all lesions were recorded. Of those not received, most were discarded because of advanced postmortem autolysis. So far as can be determined, none of the discarded animals had tumors. Lesions which could not clearly be identified as neoplastic or nonneoplastic, and tumors, the type of which was uncertain or uncommon, were also sectioned and examined microscopically. Tissues sectioned include the following: liver, lung, heart, spleen, pancreas, stomach, small intestine, colon, kidney, adrenal, thyroid, testis (or ovary and uterus), leg muscles, leg bones with included marrow, and any tumor or other unusual condition.Sections of the mamary glands were also observed for tumours.
3. No Data Available - Positive control:
- 2. no data available
3. 2 positive control groups were treated with 200 mg/kg/day of sodium salicylate. - Parental animals: Observations and examinations:
- 2. no data available
3. No Data Available - Oestrous cyclicity (parental animals):
- 2. no data available
3. No Data Available - Sperm parameters (parental animals):
- 2. no data available
3. No Data Available - Litter observations:
- 2. no data available
3. Fetuses were removed and sacrificed for examination. An external examination of all fetuses was conducted to detect any gross abnormalities. Two-thirds of all fetuses of each sex from each litter were examined for skeletal development using the alizarin staining method. Internal development was evaluated in the remaining fetuses by freehand razor blade sectioning technique. - Postmortem examinations (parental animals):
- 2. Each animal received in the Pathology Laboratory was given a careful gross examination, and all lesions were recorded. Of those not received, most were discarded because of advanced postmortem autolysis. So far as can be determined, none of the discarded animals had tumors. Lesions which could not clearly be identified as neoplastic or nonneoplastic, and tumors, the type of which was uncertain or uncommon, were also sectioned and examined microscopically.
Tissues sectioned include the following: liver, lung, heart, spleen, pancreas, stomach, small intestine, colon, kidney, adrenal, thyroid, testis (or ovary and uterus), leg muscles, leg bones with included marrow, and any tumor or other unusual condition.Sections of the mamary glands were also observed for tumours.
3. All females were sacrificed on day 20 of gestation. Fetal swellings, implantation and resorption sites and any uterine abnormalities were noted and the number of viable fetuses present in the uterus was determined. - Postmortem examinations (offspring):
- 2. no data available
3. Two-thirds of all fetuses of each sex from each litter were examined for skeletal development using the alizarin staining method. Internal development was evaluated in the remaining fetuses by freehand razor blade sectioning technique. - Statistics:
- 2. no data available
3. Fetal viability data were subjected to 2 types of statistical analysis. First, in a chi-square analysis, the number of resorption sites per implantation site of each test animal was compared to the expected incidence. The expected incidence was calculated from data obtained from the 3 untreated control groups. The second analysis utilized the ranking method of Weil (1970). For this analysis the individual viability indices of each test group were ranked with individual viability indices of each control group. - Reproductive indices:
- 2. no data available
3. No Data Available - Offspring viability indices:
- 2. no data available
3. No Data Available - Clinical signs:
- no effects observed
- Description (incidence and severity):
- 2. no effects observed - The ingestion of the test chemical had no effect on survival, growth, or weights at autopsy of heart, liver, kidney, spleen, or testes in the test animals
3. no effects observed - No untoward reactions of the test chemical was observed. - Dermal irritation (if dermal study):
- not specified
- Mortality:
- no mortality observed
- Description (incidence):
- 2. no mortality observed - The ingestion of the test chemical had no effect on survival, growth, or weights at autopsy of heart, liver, kidney, spleen, or testes in the test animals
3. no mortality observed - No deaths at any dose groups were observed due to administration of the test chemical. - Body weight and weight changes:
- no effects observed
- Description (incidence and severity):
- 2. no effects observed - The ingestion of the test chemical had no effect on survival, growth, or weights at autopsy of heart, liver, kidney, spleen, or testes in the test animals
3. no effects observed - No effects on the maternal body weight was observed due to administration of the test chemical. The mean maternal weight gain from day 0 to 20 of gestation were 146, 134, 144, 137 and 145 g. - Food consumption and compound intake (if feeding study):
- not specified
- Food efficiency:
- not specified
- Water consumption and compound intake (if drinking water study):
- not specified
- Ophthalmological findings:
- not specified
- Haematological findings:
- not specified
- Clinical biochemistry findings:
- not specified
- 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:
- no effects observed
- Description (incidence and severity):
- 2. no effects observed - Findings, such as liver enlargement, abscesses, distendedurinary bladders, ovarian cysts, distended uteri, enlarged parathyroids, enlargement of seminal vesicles and other miscellaneous changes, were present in approximately equal incidence and degree in test and control rats. No effect due to ingestion of the test chemical on either tumor incidence or tumor type was noted in Osborne Mendel strain on this two-year experiment.
3. not specified - Histopathological findings: neoplastic:
- no effects observed
- Description (incidence and severity):
- 2. no effects observed - No effect due to ingestion of the test chemical on either tumor incidence or tumor type was noted in Osborne Mendel rats on this two-year experiment. Rats of the Osborne- Mendel strain had more tumors (especially mammary).Incidence of tumor formation in mammary glands were found to be in control and treatment groups. Thus, they are considered to be incidemtal and non treatment related in nature and strain specific.
3. not specified - Other effects:
- not specified
- Reproductive function: oestrous cycle:
- not specified
- Reproductive function: sperm measures:
- not specified
- Reproductive performance:
- no effects observed
- Description (incidence and severity):
- 2. not specified
3. no effects observed - The test chemical had no effect upon the incidence of resorptions or upon fetal viability. The ncidence of resorptions was increased in 1 of the 2 groups of dams treated with the positive control. - Dose descriptor:
- NOAEL
- Remarks:
- 2
- Effect level:
- 1 000 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- gross pathology
- histopathology: non-neoplastic
- histopathology: neoplastic
- Remarks on result:
- not determinable due to absence of adverse toxic effects
- Dose descriptor:
- NOAEL
- Remarks:
- 3
- Effect level:
- 150 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- female
- Basis for effect level:
- clinical signs
- mortality
- body weight and weight gain
- reproductive performance
- Critical effects observed:
- not specified
- Remarks on result:
- not measured/tested
- Clinical signs:
- not specified
- Dermal irritation (if dermal study):
- not specified
- Mortality / viability:
- no mortality observed
- Description (incidence and severity):
- No effect on fetal mortality or viability was observed, after administration of the test chemical.
- Body weight and weight changes:
- no effects observed
- Description (incidence and severity):
- Fetal body weights and sex distribution were unaffected by any treatment. Mean body weights were 3.9, 3.5, 4.3, 4.4 and 4.2 g for males and 3.7, 3.3, 4.0, 4.1 and 4.1 g for females from all 3 vehicle control, the 2 positive control and the 15, 50 and 150 mg/kg test groups, respectively.
- Food consumption and compound intake (if feeding study):
- not specified
- Food efficiency:
- not specified
- Water consumption and compound intake (if drinking water study):
- not specified
- Ophthalmological findings:
- not specified
- Haematological findings:
- not specified
- Clinical biochemistry findings:
- not specified
- Urinalysis findings:
- not specified
- Sexual maturation:
- no effects observed
- Description (incidence and severity):
- The distribution of sexes was 283 males and 266 females (51.5% males) for the 3 vehicle control groups, 177 males and 196 females (47.8% males) for the 2 positive control groups, 110 males and 113 females (49.3 % males) for the 15 mg/kg test group, 103 males and 101 females (50.5 % males) for the 15 mg/kg test group and 97 males and 81 females (54.5 % males) for the 150 mg/kg test group.
- Anogenital distance (AGD):
- not specified
- Nipple retention in male pups:
- not specified
- Organ weight findings including organ / body weight ratios:
- not specified
- Gross pathological findings:
- not specified
- Histopathological findings:
- no effects observed
- Description (incidence and severity):
- External abnormalities were somewhat more numerous among pups from animals treated with sodium salicylate. These abnormalities included runt, craniorachischisis, gastroschisis, spiraled caudia and talipes. The numbers of fetuses with external abnormalities from dams treated with the test chemical did not differ from those of controls.
- Other effects:
- not specified
- Behaviour (functional findings):
- not specified
- Developmental immunotoxicity:
- not specified
- Remarks on result:
- not measured/tested
- Remarks:
- 2
- Dose descriptor:
- NOAEL
- Remarks:
- 3
- Generation:
- F1
- Effect level:
- 150 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- viability
- sexual maturation
- mortality
- histopathology: non-neoplastic
- Critical effects observed:
- not specified
- Remarks on result:
- not measured/tested
- Reproductive effects observed:
- no
- Treatment related:
- no
- Conclusions:
- Based on the data available from different studies, the No Observed Adverse Effect Level (NOAEL) was considered to be 1000 mg/kg/day for reproductive toxicity, when rodents were treated with test chemical orally. Thus, comparing this value with the criteria of CLP regulation test chemical is not likely to classify as reproductive toxicant.
- Executive summary:
Data available from different studies were reviewed to determine the reproductive toxicity of test chemical. The studies are as mentioned below:
Combined Repeated Dose and Carcinogenicity was performed to determine the toxic nature of the test chemical in Osborne Mendel rats. Two-year tests were run in which 400 male and female Osborne Mendel rats were distributed into various treatment groups. The treatment groups were - 100 rats/dose (50/sex) and 100 rats/sex for controls. The test chemical (500 mg/kg bw/day, 1000 mg/kg bw/day) was mixed into a commercial laboratory chow diet for each feeding study. Rats were individually caged. Each animal received in the Pathology Laboratory was given a careful gross examination, and all lesions were recorded. Of those not received, most were discarded because of advanced postmortem autolysis. So far as can be determined, none of the discarded animals had tumors. Lesions which could not clearly be identified as neoplastic or non-neoplastic, and tumors, the type of which was uncertain or uncommon, were also sectioned and examined microscopically. Tissues sectioned include the following: liver, lung, heart, spleen, pancreas, stomach, small intestine, colon, kidney, adrenal, thyroid, testis (or ovary and uterus), leg muscles, leg bones with included marrow, and any tumor or other unusual condition. Sections of the mammary glands were also observed for tumors. Findings, such as liver enlargement, abscesses, distended urinary bladders, ovarian cysts, distended uteri, enlarged parathyroid, enlargement of seminal vesicles and other miscellaneous changes, were present in approximately equal incidence and degree in test and control rats. Rats of the Osborne- Mendel strain had more tumors (especially mammary).Incidence of tumor formation in mammary glands were found to be in control and treatment groups. Thus, they are considered to be incidental and non-treatment related in nature and strain specific. No effect due to ingestion of the test chemical on either tumor incidence or tumor type was noted in Osborne Mendel strain on this two-year experiment. Considering all the observations, the No Observed Adverse Effect Level was considered to be 1000 mg/kg bw/day in Osborne Mendel rats.
In supporting with the above result, another prenatal developmental toxicity study was performed using the test chemical in Virgin female albino rats (COBS). The animals were dosed with the test chemical during gestation day 6 to 15 to assess its teratogenic potential. The dose range selected for the study was 0, 15, 50 and 150 mg/kg bw as control, low dose, mid dose and high dose groups, respectively. Eight groups, ranging in size from 16 to 22 pregnant animals each, were studied: 3 control groups received vehicle alone, 2 positive control groups were treated with 200 mg/kg/day of sodium salicylate4 3 test groups received 15,50 or 150 mg/kg/day of the test chemical. The vehicle employed was 1.5 % aqueous methylcellulose, and the concentrations of test material were such that all animals received equivalent volumes of vehicle or test suspension per unit of body weight. Food and water were available ad libitum. After the administration, the effects on the pregnant females were observed. No untoward reactions of the test chemical was observed. No effects on the maternal body weight was observed due to administration of the test chemical. The mean maternal weight gain from day 0 to 20 of gestation were 146, 134, 144, 137 and 145 g. The test chemical had no effect upon the incidence of resorptions or upon fetal viability. The incidence of resorptions was increased in 1 of the 2 groups of dams treated with the positive control. No effect on fetal mortality or viability was observed, after administration of the test chemical. Fetal body weights and sex distribution were unaffected by any treatment. Mean body weights were 3.9, 3.5, 4.3, 4.4 and 4.2 g for males and 3.7, 3.3, 4.0, 4.1 and 4.1 g for females from all 3 vehicle control, the 2 positive control and the 15, 50 and 150 mg/kg test groups, respectively. The distribution of sexes was 283 males and 266 females (51.5% males) for the 3 vehicle control groups, 177 males and 196 females (47.8% males) for the 2 positive control groups, 110 males and 113 females (49.3 % males) for the 15 mg/kg test group, 103 males and 101 females (50.5 % males) for the 15 mg/kg test group and 97 males and 81 females (54.5 % males) for the 150 mg/kg test group. External abnormalities were somewhat more numerous among pups from animals treated with sodium salicylate. These abnormalities included runt, craniorachischisis, gastroschisis, spiraled caudia and talipes. The numbers of fetuses with external abnormalities from dams treated with the test chemical did not differ from those of controls. Thus, based on all the available data, and observations and results, it was concluded that the NOAEL for the test chemical was 150 mg/kg bw for maternal and fetal development.
Based on the data available from different studies, NOAEL was considered to be 1000 mg/kg/day for reproductive toxicity, when rodents were treated with test chemical orally. Thus, comparing this value and effects with the criteria of CLP regulation test chemical is not likely to classify as reproductive toxicant.
Reference
2.
Lesions observed in the 2 year feeding study
Parameter |
Control |
1% |
2% |
Number of rats started |
200 |
100 |
100 |
Number of survivors at 80 weeks |
158 |
75 |
78 |
Number received by pathology |
171 |
89 |
89 |
Number of males with tumors |
25 |
9 |
10 |
Number of females with tumors |
42 |
14 |
22 |
Total number of rats with tumors |
67 |
23 |
32 |
Tumor type in each rat |
|
|
|
Fibroadenoma, mammary |
19 |
9 |
12 |
Adenocarcinoma |
18 |
6 |
7 |
Lymphosarcoma |
18 |
7 |
5 |
Lymphoblastoma |
5 |
0 |
0 |
Fibrosacroma |
0 |
0 |
4 |
Interstitial cell tumor |
5 |
4 |
2 |
Endometrial sarcoma |
3 |
1 |
0 |
Other tumors |
10 |
1 |
5 |
Other pathology |
|
|
|
Chronic pneumonia |
34 |
18 |
16 |
Granular kidneys |
49 |
23 |
23 |
Splenic enlargement |
27 |
16 |
13 |
Splenic atrophy |
17 |
16 |
9 |
Testicular atrophy |
8 |
8 |
4 |
Adrenal enlargement |
5 |
2 |
3 |
Chronic arteritis |
2 |
2 |
0 |
Effect on fertility: via oral route
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- NOAEL
- 1 000 mg/kg bw/day
- Study duration:
- subchronic
- Species:
- rat
- Quality of whole database:
- Data is Klimicsh 2 and from handbook or collection of data.
Effect on fertility: via inhalation route
- Endpoint conclusion:
- no study available
Effect on fertility: via dermal route
- Endpoint conclusion:
- no study available
Additional information
Reproductive Toxicity
Data available from different studies were reviewed to determine the reproductive toxicity of test chemical. The studies are as mentioned below:
Combined Repeated Dose and Carcinogenicity was performed to determine the toxic nature of the test chemical in Osborne Mendel rats. Two-year tests were run in which 400 male and female Osborne Mendel rats were distributed into various treatment groups. The treatment groups were - 100 rats/dose (50/sex) and 100 rats/sex for controls. The test chemical (500 mg/kg bw/day, 1000 mg/kg bw/day) was mixed into a commercial laboratory chow diet for each feeding study. Rats were individually caged. Each animal received in the Pathology Laboratory was given a careful gross examination, and all lesions were recorded. Of those not received, most were discarded because of advanced postmortem autolysis. So far as can be determined, none of the discarded animals had tumors. Lesions which could not clearly be identified as neoplastic or non-neoplastic, and tumors, the type of which was uncertain or uncommon, were also sectioned and examined microscopically. Tissues sectioned include the following: liver, lung, heart, spleen, pancreas, stomach, small intestine, colon, kidney, adrenal, thyroid, testis (or ovary and uterus), leg muscles, leg bones with included marrow, and any tumor or other unusual condition. Sections of the mammary glands were also observed for tumors. Findings, such as liver enlargement, abscesses, distended urinary bladders, ovarian cysts, distended uteri, enlarged parathyroid, enlargement of seminal vesicles and other miscellaneous changes, were present in approximately equal incidence and degree in test and control rats. Rats of the Osborne- Mendel strain had more tumors (especially mammary).Incidence of tumor formation in mammary glands were found to be in control and treatment groups. Thus, they are considered to be incidental and non-treatment related in nature and strain specific. No effect due to ingestion of the test chemical on either tumor incidence or tumor type was noted in Osborne Mendel strain on this two-year experiment. Considering all the observations, the No Observed Adverse Effect Level was considered to be 1000 mg/kg bw/day in Osborne Mendel rats.
In supporting with the above result, another prenatal developmental toxicity study was performed using the test chemical in Virgin female albino rats (COBS). The animals were dosed with the test chemical during gestation day 6 to 15 to assess its teratogenic potential. The dose range selected for the study was 0, 15, 50 and 150 mg/kg bw as control, low dose, mid dose and high dose groups, respectively. Eight groups, ranging in size from 16 to 22 pregnant animals each, were studied: 3 control groups received vehicle alone, 2 positive control groups were treated with 200 mg/kg/day of sodium salicylate4 3 test groups received 15,50 or 150 mg/kg/day of the test chemical. The vehicle employed was 1.5 % aqueous methylcellulose, and the concentrations of test material were such that all animals received equivalent volumes of vehicle or test suspension per unit of body weight. Food and water were available ad libitum. After the administration, the effects on the pregnant females were observed. No untoward reactions of the test chemical was observed. No effects on the maternal body weight was observed due to administration of the test chemical. The mean maternal weight gain from day 0 to 20 of gestation were 146, 134, 144, 137 and 145 g. The test chemical had no effect upon the incidence of resorptions or upon fetal viability. The incidence of resorptions was increased in 1 of the 2 groups of dams treated with the positive control. No effect on fetal mortality or viability was observed, after administration of the test chemical. Fetal body weights and sex distribution were unaffected by any treatment. Mean body weights were 3.9, 3.5, 4.3, 4.4 and 4.2 g for males and 3.7, 3.3, 4.0, 4.1 and 4.1 g for females from all 3 vehicle control, the 2 positive control and the 15, 50 and 150 mg/kg test groups, respectively. The distribution of sexes was 283 males and 266 females (51.5% males) for the 3 vehicle control groups, 177 males and 196 females (47.8% males) for the 2 positive control groups, 110 males and 113 females (49.3 % males) for the 15 mg/kg test group, 103 males and 101 females (50.5 % males) for the 15 mg/kg test group and 97 males and 81 females (54.5 % males) for the 150 mg/kg test group. External abnormalities were somewhat more numerous among pups from animals treated with sodium salicylate. These abnormalities included runt, craniorachischisis, gastroschisis, spiraled caudia and talipes. The numbers of fetuses with external abnormalities from dams treated with the test chemical did not differ from those of controls. Thus, based on all the available data, and observations and results, it was concluded that the NOAEL for the test chemical was 150 mg/kg bw for maternal and fetal development.
Based on the data available from different studies, NOAEL was considered to be 1000 mg/kg/day for reproductive toxicity, when rodents were treated with test chemical orally. Thus, comparing this value and effects with the criteria of CLP regulation test chemical is not likely to classify as reproductive toxicant.
Effects on developmental toxicity
Effect on developmental toxicity: via oral route
- Endpoint conclusion:
- no study available
Effect on developmental toxicity: via inhalation route
- Endpoint conclusion:
- no study available
Effect on developmental toxicity: via dermal route
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
Comparing the NOAEL value and effects observed on rodents, with the criteria of CLP regulation the given test chemical is not likely to classify as reproductive toxicant.
Additional information
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