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EC number: 946-365-8 | CAS number: -
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
![](https://echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
Developmental toxicity / teratogenicity
Administrative data
- Endpoint:
- developmental toxicity
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- 1991/05/07-1991/06/12
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: According to OECD Guideline 414.
- Justification for type of information:
- Hydrocarbons, C9-C10, aromatics, >1% Naphthalene are a combination of Hydrocarbons, C9 Aromatics and Hydrocarbons, C10-C12 Aromatics. Read across data is available for Hydrocarbons, C9 Aromatics and Hydrocarbons, C10-C12 Aromatics and the worst case scenario for each end point has been presented.
Cross-reference
- Reason / purpose for cross-reference:
- read-across: supporting information
Reference
- Endpoint:
- developmental toxicity
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- 1991/05/07-1991/06/12
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: According to OECD Guideline 414.
- Justification for type of information:
- Hydrocarbons, C9-C10, aromatics, >1% Naphthalene are a combination of Hydrocarbons, C9 Aromatics and Hydrocarbons, C10-C12 Aromatics. Read across data is available for Hydrocarbons, C9 Aromatics and Hydrocarbons, C10-C12 Aromatics and the worst case scenario for each end point has been presented.
- Reason / purpose for cross-reference:
- read-across source
- Species:
- rat
- Details on maternal toxic effects:
- Maternal toxic effects:yes
Details on maternal toxic effects:
CLINICAL IN-LIFE OBSERVATIONS
Low incidences of alopecia, urine staining, nasal discharge, red material around snout, dry rales, swollen area, soft stool, and mal-occluded or broken incisors were observed intermittently throughout the groups and considered incidental and unrelated to treatment. All animals survived to the scheduled cesarean sections on 21G. One animal in each of the low and high dose groups, and three animals in the mid-dose group were not pregnant.
BODY WEIGHTS
There were no significant differences in mean body weight at any interval between treated groups and controls. However, there was a noted body weight gain suppression observed in the treated groups when compared to controls, with the high dose group demonstrating a statistically significant change (GD 6-15). Overall body weight differences were not significant (GD 0-21).
FOOD CONSUMPTION
A significant decrease in mean maternal food consumption was observed in the high dose group at the GD 6-9 interval when compared with controls. Overall (GD 0-21) there were no significant changes observed in any of the treated groups when compared to the control group.
ORGAN WEIGHT
No significant changes.
MATERNAL NECROPSY OBSERVATIONS
The incidental findings observed at necropsy were not attributed to the treatment.
UTERINE IMPLANTATION DATA
There were no statistical differences between treated and control animals for any uterine implantation parameter. - Key result
- Dose descriptor:
- NOAEL
- Effect level:
- 150 mg/kg bw/day
- Basis for effect level:
- other: maternal toxicity
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- > 450 mg/kg bw/day
- Basis for effect level:
- other: developmental toxicity
- Abnormalities:
- not specified
- Details on embryotoxic / teratogenic effects:
- Embryotoxic / teratogenic effects:no effects
Details on embryotoxic / teratogenic effects:
FETAL BODY WEIGHTS
There were no statistical differences between treated and control groups.
FETAL VARIATIONS AND MALFORMATIONS
There were no statistical differences in the incidences of fetal variations or malformations were observed in treated groups when compared with controls on either a per fetus or per litter basis. Visceral variations were observed in all groups included dilated renal pelvis and distended and/or convoluted ureters. Umbilical artery and/or vein on the left side of the urinary bladder were observed in one fetus in the control group and in two fetuses from two litters in the mid-dose group. No innominate artery was observed in two fetuses from one litter in the low dose group. Skeletal variations were observed throughout the groups and consisted primarily of hypoplastic or misshapen elements of the skull, sternebrae, vertebrae, or ribs. These findings are common in gestation day 21 rat fetuses and the incidence or severities were not considered treatment-related.
The majority of malformations were observed in a single instance in the low and high dose as well as additional malformations in control animals. External malformations included cleft palate, low set ears, anury, and anal atresia. Visceral malformations were also correlative to those fetuses with external malformations. Skeletal malformations were observed throughout the dose groups and consisted primarily of single instances of malformed or fused skull bones, agenesis of the ribs, vertebral arches or centra, and duplicates or extra bones of the hind paw. All malformations were considered spurious and unrelated to treatment.
FETAL SKELETAL OSSIFICATION SITES
There was a statistically significant decrease in the mean number of ossification sites in the proximal phalanges of the hindpaw in the high dose group. However, the number falls within the normal range of 0-3 and the decrease in the high dose group was not considered biologically significant. - Key result
- Dose descriptor:
- NOAEL
- Effect level:
- > 450 mg/kg bw/day
- Sex:
- male/female
- Basis for effect level:
- other: Developmental Toxicity
- Key result
- Abnormalities:
- no effects observed
- Key result
- Developmental effects observed:
- no
- Conclusions:
- The maternal NOAEL was determined to be 150 mg/Kg and a developmental NOAEL was determined to be greater than 450 mg/Kg. MRD-90-884 was not teratogenic under the conditions of this study and would not warrant classification under either the EU GHS or the EU Requirements for dangerous substances and preparations guidelines.
- Executive summary:
This data is being read across from the source study that tested Hydrocarbons, C10-C13, aromatics, >1% naphthalene based on analogue read across.
The objective of this study was to determine the teratogenic potential of MRD-90-884 when administered to pregnant rats during gestational day (GD) 6 through GD 15. The test material was administered by oral gavage at doses of 75, 150, and 450 mg/Kg at a volume of 5 mL/Kg.
There were no treatment-related clinical in-life observations or any observable abnormalities in the dams for any dose group. All animals survived to scheduled cesarean sections on GD 21. There were no significant differences between treated and control animals for any uterine implantation parameter. Mean fetal body weights for treated groups were comparable to control groups. There were no statistically significant differences in the incidences of total or individual variations or malformations when analyzed on either a fetus or litter basis.
The maternal NOAEL was established as 150 mg/Kg and a developmental NOAEL was established as greater than 450 mg/Kg. MRD-90-884 was not teratogenic under the conditions of this study and would not warrant classification under either the EU GHS or the EU requirements for dangerous substances and preparations guidelines.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 992
- Report date:
- 1992
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 414 (Prenatal Developmental Toxicity Study)
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- EPA OPP 83-3 (Prenatal Developmental Toxicity Study)
- GLP compliance:
- yes
- Limit test:
- no
Test material
- Reference substance name:
- Hydrocarbons, C10-C13, aromatics, >1% naphthalene
- EC Number:
- 926-273-4
- Molecular formula:
- None available - not a single isomer - see remarks
- IUPAC Name:
- Hydrocarbons, C10-C13, aromatics, >1% naphthalene
Constituent 1
Test animals
- Species:
- rat
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
Sex: Male (50), Female (100)
Weight (Female): 242 - 340 g (day 0)
Age at study initiation: Approximately 10-11 weeks
Housing: Individually
Diet (e.g. ad libitum): Purina Certified Rodent 5002 Chow, ad libitum
Water (e.g. ad libitum): Automatic watering system, ad libitum
Acclimation period: 21d
ENVIRONMENTAL CONDITIONS
Temperature (°F): 68-76
Humidity (%): 40-70%
Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- corn oil
- Details on exposure:
- Mated females were dosed once daily by oral gavage from GD 6 through GD 15. Dose levels were based on the most recent body weights. Doses were administered at 0, 75, 150, and 450 mg/kg and dose volumes were 5 ml/kg for all groups.
- Analytical verification of doses or concentrations:
- yes
- Details on analytical verification of doses or concentrations:
- gas chromatography verification
- Details on mating procedure:
- Females were placed in males’ cages in a 1:1 ratio based on sequential ID numbers. Mating was confirmed the following morning by observation of a copulatory plug or by the presence of sperm in a vaginal rinse. The day mating was confirmed was the female’s day 0 of gestation (GD 0). After confirmed mating, the female was returned to her own cage and a new female was placed into the male’s cage until the required number of mated females was obtained by continuous cohabitation.
- Duration of treatment / exposure:
- Mated females were dosed once daily by oral gavage from GD 6 through GD 15. Dose levels were based on the most recent body weights. Doses were administered at 0, 75, 150, and 450 mg/kg and dose volumes were 5 ml/kg for all groups.
- Frequency of treatment:
- Mated females were dosed once daily by oral gavage from GD 6 through GD 15.
- Duration of test:
- 21 days
Doses / concentrationsopen allclose all
- Dose / conc.:
- 0 mg/kg bw/day
- Remarks:
- dose volumes were 5 mL/Kg
- Dose / conc.:
- 75 mg/kg bw/day
- Remarks:
- dose volumes were 5 mL/Kg
- Dose / conc.:
- 150 mg/kg bw/day
- Remarks:
- dose volumes were 5 mL/Kg
- Dose / conc.:
- 450 mg/kg bw/day
- Remarks:
- dose volumes were 5 mL/Kg
- No. of animals per sex per dose:
- Male (50), Female (100) total; 25 Females per dose
- Control animals:
- yes
- Details on study design:
- PARAMETERS Analyzed for Statistical Differences
- mean body weight and gravid uterine weight of pregnant animals
- mean body weight change of pregnant animals
- mean food consumption of pregnant animals
- mean number of corpora lutea per dam
- mean number of implantations per dam
- mean number of resorptions per dam
- mean number of live fetuses per litter
- mean number of live male fetuses per litter
- mean number of live female fetuses per litter
- mean number of dead fetuses per litter
- mean number of malformed fetuses per litter
- mean number of affected (resorbed, dead or malformed) offspring per litter
- mean number of fetuses with developmental variations per litter
Live fetuses as fraction of implants, dead fetuses as fraction of implants, and resorptions as fraction of implants, were calculated for each litter. Fractions were transformed by Cochran’s transformation followed by the arc sine transformation. The raw fractions and the transformed fractions were tested for statistical significance. Transformed percentages (with statistical analyses) were not presented in the report since statistical significance was not found.
Examinations
- Maternal examinations:
- All females were examined by a gross necropsy.
- Ovaries and uterine content:
- Uterine weight with ovaries attached was measured at necropsy. Uterine contents were examined and the numbers and locations of implantation sites, early and late resorptions, live, dead, and externally malformed fetuses were recorded. Corpora lutea were counted and recorded. The uteri of all apparently non-pregnant dams were stained to confirm pregnancy status.
- Fetal examinations:
- Each live fetus was weighed and examined externally for gross malformations, including cleft palate. All live fetuses were euthanized by intramuscular injection into the tongue with sodium pentobarbital prior to internal examination. The sex of each live fetus was determined by external examination and confirmed internally only on those fetuses receiving visceral examinations.
Approximately one-half of the fetuses of each litter were decapitated. These heads were preserved in Bouin’s solution for at least two weeks. Free-hand razor blade sections of the heads were examined for the presence of abnormalities. The viscera of all decapitated fetuses were also examined by fresh dissection. The remaining fetuses were eviscerated, processed for skeletal staining with Alizarin red, and examined for the presence of malformations and ossification variations. Representative malformations were photographed. - Statistics:
- STATISTICAL METHODS (see "Further details on study design" field for parameters measured)
Bartlett’s test of homogeneity of variance was used to determine if the groups had equivalent variances at the 1% level of significance.
1. If the variances were equivalent, the hypothesis that there was no difference in response between the groups was tested using a one-way ANOVA, and if it was significant, Dunnett’s test was performed to determine which treatment groups differed from the control. A linear regression to test for a dose response was also performed and tested for lack of fit to the regression.
2. If the variances were not equivalent, then a Kruskal-Wallis (non-parametric) test was performed to determine if the treatment effects were equivalent. If there was a difference, a rank sum comparison was used to determine which treatment groups differed from the control. Jonckheere’s test for ordered response was also performed.
The following were calculated and analyzed for statistical significance:
- incidences of individual and total malformations
- incidences of individual and total variations
A standard chi square analysis was performed to determine if the proportion of incidences differed between the groups tested. Each group was then compared to each control group using a 2 x 2 Fisher Exact test. Armitage’s test for linear trend in the dosage groups was performed.
Results and discussion
Results: maternal animals
Maternal developmental toxicity
- Details on maternal toxic effects:
- Maternal toxic effects:yes
Details on maternal toxic effects:
CLINICAL IN-LIFE OBSERVATIONS
Low incidences of alopecia, urine staining, nasal discharge, red material around snout, dry rales, swollen area, soft stool, and mal-occluded or broken incisors were observed intermittently throughout the groups and considered incidental and unrelated to treatment. All animals survived to the scheduled cesarean sections on 21G. One animal in each of the low and high dose groups, and three animals in the mid-dose group were not pregnant.
BODY WEIGHTS
There were no significant differences in mean body weight at any interval between treated groups and controls. However, there was a noted body weight gain suppression observed in the treated groups when compared to controls, with the high dose group demonstrating a statistically significant change (GD 6-15). Overall body weight differences were not significant (GD 0-21).
FOOD CONSUMPTION
A significant decrease in mean maternal food consumption was observed in the high dose group at the GD 6-9 interval when compared with controls. Overall (GD 0-21) there were no significant changes observed in any of the treated groups when compared to the control group.
ORGAN WEIGHT
No significant changes.
MATERNAL NECROPSY OBSERVATIONS
The incidental findings observed at necropsy were not attributed to the treatment.
UTERINE IMPLANTATION DATA
There were no statistical differences between treated and control animals for any uterine implantation parameter.
Effect levels (maternal animals)
open allclose all
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- 150 mg/kg bw/day
- Basis for effect level:
- other: maternal toxicity
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- > 450 mg/kg bw/day
- Basis for effect level:
- other: developmental toxicity
Maternal abnormalities
- Abnormalities:
- not specified
Results (fetuses)
- Details on embryotoxic / teratogenic effects:
- Embryotoxic / teratogenic effects:no effects
Details on embryotoxic / teratogenic effects:
FETAL BODY WEIGHTS
There were no statistical differences between treated and control groups.
FETAL VARIATIONS AND MALFORMATIONS
There were no statistical differences in the incidences of fetal variations or malformations were observed in treated groups when compared with controls on either a per fetus or per litter basis. Visceral variations were observed in all groups included dilated renal pelvis and distended and/or convoluted ureters. Umbilical artery and/or vein on the left side of the urinary bladder were observed in one fetus in the control group and in two fetuses from two litters in the mid-dose group. No innominate artery was observed in two fetuses from one litter in the low dose group. Skeletal variations were observed throughout the groups and consisted primarily of hypoplastic or misshapen elements of the skull, sternebrae, vertebrae, or ribs. These findings are common in gestation day 21 rat fetuses and the incidence or severities were not considered treatment-related.
The majority of malformations were observed in a single instance in the low and high dose as well as additional malformations in control animals. External malformations included cleft palate, low set ears, anury, and anal atresia. Visceral malformations were also correlative to those fetuses with external malformations. Skeletal malformations were observed throughout the dose groups and consisted primarily of single instances of malformed or fused skull bones, agenesis of the ribs, vertebral arches or centra, and duplicates or extra bones of the hind paw. All malformations were considered spurious and unrelated to treatment.
FETAL SKELETAL OSSIFICATION SITES
There was a statistically significant decrease in the mean number of ossification sites in the proximal phalanges of the hindpaw in the high dose group. However, the number falls within the normal range of 0-3 and the decrease in the high dose group was not considered biologically significant.
Effect levels (fetuses)
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- > 450 mg/kg bw/day
- Sex:
- male/female
- Basis for effect level:
- other: Developmental Toxicity
Fetal abnormalities
- Key result
- Abnormalities:
- no effects observed
Overall developmental toxicity
- Key result
- Developmental effects observed:
- no
Applicant's summary and conclusion
- Conclusions:
- The maternal NOAEL was determined to be 150 mg/Kg and a developmental NOAEL was determined to be greater than 450 mg/Kg. MRD-90-884 was not teratogenic under the conditions of this study and would not warrant classification under either the EU GHS or the EU Requirements for dangerous substances and preparations guidelines.
- Executive summary:
The objective of this study was to determine the teratogenic potential of MRD-90-884 when administered to pregnant rats during gestational day (GD) 6 through GD 15. The test material was administered by oral gavage at doses of 75, 150, and 450 mg/Kg at a volume of 5 mL/Kg.
There were no treatment-related clinical in-life observations or any observable abnormalities in the dams for any dose group. All animals survived to scheduled cesarean sections on GD 21. There were no significant differences between treated and control animals for any uterine implantation parameter. Mean fetal body weights for treated groups were comparable to control groups. There were no statistically significant differences in the incidences of total or individual variations or malformations when analyzed on either a fetus or litter basis.
The maternal NOAEL was established as 150 mg/Kg and a developmental NOAEL was established as greater than 450 mg/Kg. MRD-90-884 was not teratogenic under the conditions of this study and would not warrant classification under either the EU GHS or the EU requirements for dangerous substances and preparations guidelines.
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.
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