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EC number: 289-995-2 | CAS number: 90063-37-9 Extractives and their physically modified derivatives such as tinctures, concretes, absolutes, essential oils, oleoresins, terpenes, terpene-free fractions, distillates, residues, etc., obtained from Lavandula angustifolia, Labiatae.
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data

Endpoint summary
Administrative data
Key value for chemical safety assessment
Effects on fertility
Description of key information
In a GLP reproductive and developmental toxicity screening study (similarly to OECD Guideline 421) in rats with read-across substance coriander oil, NOAEL for maternal toxicity and developmental toxicity = 500 mg/kg bw/day
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:
- key study
- Study period:
- 28 June to 05 August 1988
- Justification for type of information:
- See read-across justification in section 13
- Reason / purpose for cross-reference:
- read-across source
- Clinical signs:
- effects observed, non-treatment-related
- Description (incidence and severity):
- Clinical observations that occurred at dosage-dependent incidences and were considered to be effects of the test substance included excess salivation (250, 500 and 1000 mg/kg bw/day dosage groups), urine-stained abdominal fur, ataxia, and decreased motor activity (1000 mg/kg bw/day dosage group). Excess salivation occurred for the low and middle dosage group rats during the premating and gestation periods. High dosage group rats had excess salivation occur during the premating, gestation and lactation periods, as well as additional clinical observations occur during the premating and gestation periods. The number of rats with excess salivation was significantly increased (P≤0.05 to P≤0.01) in the middle and high dosage groups, as compared with the control group number. At 1000 mg/kg bw/day dosage group, the number of rats that also had urine stained abdominal fur, in addition to excess salivation, was significantly increased (P≤0.01), in comparison with the control group number during the premating period.
All other clinical observations were considered unrelated to the test substance. Red vaginal exudate, noted for one high dosage group rat on day 0 of gestation, was considered to be the result of trauma incurred during mating. A mass in the left inguinal area, that was probably a galactocele, was evident for one middle dosage group rat from day 0 of gestation through necropsy on day 4 post-parturition. Limited areas of alopecia occurred at biologically comparable incidences in the rats (one rat in each of the low, middle and high dosage groups). - Mortality:
- no mortality observed
- Description (incidence):
- No deaths occurred during the conduct of this study.
- Body weight and weight changes:
- effects observed, treatment-related
- Description (incidence and severity):
- Premating:
Administration of the 1000 mg/kg bw/day dosage of test substance to the rats inhibited body weight gain prior to cohabitation. Significant (P≤0.01) weight loss occurred for the 1000 mg/kg bw/day dosage group after the first dosage was given. Between days 1 and 2 of study, rats in the control, low, middle and high dosage groups had average body weight changes of +2.8, +3.8, +2.7 and -6.0++ g, respectively. In these same respective groups, average body weight gains between days 1 and 7 of study were +17.2, +18.7, +19 .1 and +13 .1 g. Body weights on day 7 of study averaged 246.8, 247.1, 246.0 and 244.4 g in the four respective groups.
Gestation
Although the effect was not clearly dosage-dependent, possibly reflecting differences in litter sizes, biologically remarkable increases in average body weight gains occurred for pregnant rats in each group given test substance, as compared with the control group value. These increases in average maternal body weight gains were statistically significant (P≤0 .05) for the low and high dosage group rats between days 6 and 14 of gestation and resulted in significantly (P≤0.05 to P≤0.01) increased average maternal body weights on days 14 and 16 of gestation.
In the control, low, middle and high dosage groups, respectively, maternal body weights averaged 251.5, 255.3, 252.4 and 259.5 g on day 0 of gestation, 326.7, 347.3**, 339.6 and 351.3** g on day 14 of gestation, and 347.8, 364.8*, 353.7 and 368.4* g on day 16 of gestation. On day 21 of gestation, maternal body weights averaged 419.1, 450.8, 434.6 and 442.8 g in these same respective groups. Between days 6 and 14 of gestation, maternal body changes averaged +44.3, +55.0*, +47.3 and +53.1* g in the control, low, middle and high dosage groups, respectively. Maternal body weight changes between days 0 and 21 of gestation averaged +167.9, +195.6, +182.1 and +183.3 g in these same respective groups.
Lactation
At the beginning of the lactation period, each group given test substance weighed more than the control group. During the four-day post-parturition period, the effect of the test substance that caused weight gain and increased feed consumption during gestation decreased in severity, although it remained present. Maternal body weights averaged 305.2, 328.2, 330.6 and 333.1 g, in the four respective groups on day 1 of lactation, and 310.5, 332.0, 326 .9 and 326.3 g on day 4 of lactation. Between days 1 and 4 post-parturition, dams in the control, low, middle and high dosage groups, respectively, gained +5.3, +3.8, -3.7 and -4.6 g. - Food consumption and compound intake (if feeding study):
- effects observed, treatment-related
- Description (incidence and severity):
- Premating:
Feed consumption values were unaffected by administration of test substance to the rats during the premating period. The differences that occurred were neither biologically important nor statistically significant among the four groups (P>0.05). In the four respective groups, feed consumption averaged 16.1, 16.5, 15.6 and 15.6 g/day. Feed consumption relative to body weight values averaged 67.4, 69.1, 66.0 and 65.6 g/kg/day for the rats in these same respective dosage groups.
Gestation:
Feed consumption values (g/day and g/kg/day) were significantly (P≤0.05 to P≤0.01) increased for the pregnant rats in each group given the test substance, as compared with the control group values. These increases in feed consumption during gestation were the possible cause of the increased weight gain during gestation that occurred for the rats given the test substance, as compared with the control group rats. It is noteworthy that not only were absolute feed consumption values (g/day) increased, but that the feed consumption relative to body weight values (g/kg/day) were also increased, indicating that the rats consumed even more feed than was necessary to maintain their body weights.
In the control, low, middle and high dosage groups, respectively, dams consumed 20.5, 23.1**, 22.6* and 23 .5** g/day between days 0 and 20 of gestation. In these same respective groups, feed consumption relative to weight values averaged 65.5, 70.7*, 70.6* and 71.4** g/kg/day between days 0 and 20 of gestation.
Lactation:
Feed consumption was increased for the middle and high dosage groups during the four-day lactation period, as compared with the control group values. Between days 1 and 4 post-parturition, absolute maternal feed consumption averaged 25.0, 25.0, 29.3 and 27.8 g/day in the four dosage groups, respectively. Maternal feed consumption relative to body weight values averaged 81.6, 75.3, 88.5 and 84.2 g/kg/day during the four-day post-parturition period for these same respective groups. - Food efficiency:
- not specified
- Water consumption and compound intake (if drinking water study):
- not examined
- Ophthalmological findings:
- not examined
- Haematological findings:
- not examined
- Clinical biochemistry findings:
- not examined
- Urinalysis findings:
- not examined
- Behaviour (functional findings):
- not examined
- Immunological findings:
- not examined
- Organ weight findings including organ / body weight ratios:
- not examined
- Reproductive function: oestrous cycle:
- not specified
- Reproductive function: sperm measures:
- not examined
- Reproductive performance:
- no effects observed
- Description (incidence and severity):
- Dosages of test substance as high as 1000 mg/kg bw/day did not adversely affect the reproductive performance of the female rats. In the 0(vehicle), 250, 500 and 1000 mg/kg bw/day dosage groups, respectively, 10, 8, 9 and 10 rats mated and were pregnant. These incidences of mating and pregnancy are within the range observed historically.
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- 500 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Sex:
- female
- Basis for effect level:
- body weight and weight gain
- food consumption and compound intake
- Clinical signs:
- no effects observed
- Mortality / viability:
- mortality observed, treatment-related
- Description (incidence and severity):
- Administration of the 1000 mg/kg bw/day dosage of test substance to the dams increased in utero and postnatal deaths of the offspring, as compared with the control group values.
All pregnant dams delivered one or more live pups. Implantation averages were similar for all groups (there were averages of 16.9, 17.0, 16.3 and 16.4 implantations per pregnant dam in the control, low, middle and high dosage groups, respectively). Delivered live litter sizes averaged 15.3, 16.0, 15.0 and 12.8 pups in the four respective groups, indicating that in utero deaths (resorptions) were increased for the high dosage group.
Pup mortality was significantly (P≤0.01) increased for litters of dams given the 1000 mg/kg bw/day dosage of test substance, as compared with the control group value. One dam had each of its five live born pups die before weighing on day 1 of lactation (the dam had a total of 16 implantation sites in utero). In the control, low, middle and high dosage groups, respectively, 97.4, 98.4, 97.8 and 87.5%** of the liveborn pups survived four days. By day 4 post-parturition, there were averages of 14.9, 15.8, 14.7 and 11 .2 surviving pups per litter. The increased incidences of clinical observations for the high dosage group pups were related to morbidity. - Body weight and weight changes:
- no effects observed
- Description (incidence and severity):
- Dosages of test substance as high as 1000 mg/kg bw/day did not adversely affect pup body weights.
- Sexual maturation:
- no effects observed
- Description (incidence and severity):
- Dosages of test substance as high as 1000 mg/kg bw/day did not adversely affect the durations of gestation and pup sex ratios.
- Other effects:
- no effects observed
- Description (incidence and severity):
- No anatomical malformations or variations were revealed by external examination or necropsy of the pups in this study.
- Key result
- Dose descriptor:
- NOAEL
- Generation:
- F1
- Effect level:
- 500 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Sex:
- not specified
- Basis for effect level:
- viability
- Key result
- Critical effects observed:
- no
- Key result
- Reproductive effects observed:
- no
- Conclusions:
- Under the test conditions, the NOAEL for maternal toxicity was 500 mg/kg bw/day based on altered body weight and food consumption at 1000 mg/kg bw/day. Increases in bodyweight and food consumption, not considered to represent a relevant adverse toxicological effect of the treatment, were observed at 250 mg/kg bw/day. The NOEL for developmental toxicity was 500 mg/kg bw/day based on the smaller live litter sizes (in utero deaths) at 1000 mg/kg bw/day.
- Executive summary:
In a Reproduction / Developmental Toxicity Screening Test conducted similarly to OECD Guideline 421 and in compliance with GLP, test substance was administered to groups of Crl: CD® (SD) BR rats (10 females/dose) at 0, 250, 500 and 1000 mg/kg bw/day by oral (gavage) for seven days prior to and then through cohabitation (maximum of seven days), gestation, delivery and a four-day lactation/post-parturition period. Clinical signs, body weight change, food consumption were monitored during the study. All animals were subjected to a gross necropsy examination. All litters were examined for number, viability, body weight, sex ratio and external morphology of the pups. Delivered pups were additionally examined for viability, clinical observations and body weight during a four-day post-parturition period.
No female rats died during the conduct of this study. All treated group rats showed excessive salivation; this observation was statistically significant at 500 and 1000 mg/kg bw/day when compared with the control group. At 1000 mg/kg bw/day, urine-stained abdominal fur occurred during the premating period, and one or two rats in this dosage group had ataxia and/or decreased motor activity occur infrequently during the premating and/or gestation periods. No other clinical or necropsy observations for the rats in this study were considered effects of the test substance.
Biologically remarkable decreases in body weight gain and food consumption occurred at 1000 mg/kg bw/day during the premating period, with significant weight loss evident for this group after the first dosage was given. During gestation, biologically remarkable increases in weight gain and food consumption occurred in all treated groups when compared with the control group. Statistically significant increases in body weight gain at 250 and 1000 mg/kg bw/day, and statistically significant increases in absolute (g/day) and relative (g/kg/day) food consumption in all treated groups when compared with the control group. These effects remained present but decreased in severity during the lactation period.
No adverse effect on the reproductive performance was observed at up to 1000 mg/kg bw/day. There were no dosage-dependent or statistically significant differences in duration of cohabitation, pregnancy incidences or implantation averages among the four groups. All pregnant dams delivered one or more live pups. At 1000 mg/kg bw/day, in utero deaths, evident as a biologically remarkable decrease in delivered live litter size, and a statistically significant increase in pup mortality, with associated observations of pup morbidity were observed.
At 1000 mg/kg bw/day, no adverse effect on the duration of gestation, pup sex ratios, pup body weights or the gross morphology of the pups were observed.
Under the test conditions, the NOAEL for maternal toxicity was 500 mg/kg bw/day based on altered body weight and food consumption at 1000 mg/kg bw/day. Increases in bodyweight and food consumption, not considered to represent a relevant adverse toxicological effect of the treatment, were observed at 250 mg/kg bw/day. The NOEL for developmental toxicity was 500 mg/kg bw/day based on the smaller live litter sizes (in utero deaths) at 1000 mg/kg bw/day.
Reference
None
Effect on fertility: via oral route
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- NOAEL
- 500 mg/kg bw/day
- Study duration:
- subacute
- Species:
- rat
Effect on fertility: via inhalation route
- Endpoint conclusion:
- no study available
Effect on fertility: via dermal route
- Endpoint conclusion:
- no study available
Additional information
In a Reproduction / Developmental Toxicity Screening Test conducted similarly to OECD Guideline 421 and in compliance with GLP, test substance was administered to groups of Crl: CD® (SD) BR rats (10 females/dose) at 0, 250, 500 and 1000 mg/kg bw/day by oral (gavage) for seven days prior to and then through cohabitation (maximum of seven days), gestation, delivery and a four-day lactation/post-parturition period. Clinical signs, body weight change, food consumption were monitored during the study. All animals were subjected to a gross necropsy examination. All litters were examined for number, viability, body weight, sex ratio and external morphology of the pups. Delivered pups were additionally examined for viability, clinical observations and body weight during a four-day post-parturition period.
No female rats died during the conduct of this study. All treated group rats showed excessive salivation; this observation was statistically significant at 500 and 1000 mg/kg bw/day when compared with the control group. At 1000 mg/kg bw/day, urine-stained abdominal fur occurred during the premating period, and one or two rats in this dosage group had ataxia and/or decreased motor activity occur infrequently during the premating and/or gestation periods. No other clinical or necropsy observations for the rats in this study were considered effects of the test substance.
Biologically remarkable decreases in body weight gain and food consumption occurred at 1000 mg/kg bw/day during the premating period, with significant weight loss evident for this group after the firstdosage was given. During gestation, biologically remarkable increases in weight gain and food consumption occurred in all treated groups when compared with the control group. Statistically significant increases in body weight gain at 250 and 1000 mg/kg bw/day, and statistically significant increases inabsolute (g/day) and relative (g/kg/day) food consumption in all treated groups when compared with the control group. These effects remained present but decreased in severity during the lactation period.
No adverse effect on the reproductive performance was observed at up to 1000 mg/kg bw/day. There were no dosage-dependent or statistically significant differences in duration of cohabitation, pregnancyincidences or implantation averages among the four groups. All pregnant dams delivered one or more live pups. At 1000 mg/kg bw/day, in utero deaths, evident as a biologically remarkable decrease in delivered live litter size, and a statistically significant increase in pup mortality, with associated observations of pup morbidity were observed.
At 1000 mg/kg bw/day, no adverse effect on the duration of gestation, pup sex ratios, pup body weights or the gross morphology of the pups were observed.
Under the test conditions, the NOAEL for maternal toxicity was 500 mg/kg bw/day based on altered body weight and food consumption at 1000 mg/kg bw/day. Increases in bodyweight and food consumption, not considered to represent a relevant adverse toxicological effect of the treatment, were observed at 250 mg/kg bw/day. The NOEL for developmental toxicity was 500 mg/kg bw/day based on the smaller live litter sizes (in utero deaths) at 1000 mg/kg bw/day.
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
In a Reproduction / Developmental Toxicity Screening Test conducted similarly to OECD Guideline 421, no adverse effect on the reproductive performance was observed at up to 1000 mg/kg bw/day in females. However, maternal toxicity was observed at 1000 mg/kg bw/day (ataxia and/or decreased motor activity in pre-mating and gestation periods, significant decreases in bodyweight gain and food consumtpion with significant weight loss during the pre-mating period) associated with a decrease in live litter size at this dose level. As no adverse effects on reproductive performance and the development of pups were observed up to evident maternal toxicity, the registered substance does not need to be classified for reproductive and developmental toxicity according to the Regulation (EC) No. 1272/2008.
Additional information
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