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Diss Factsheets
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EC number: 947-684-5 | 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
Endpoint summary
Administrative data
Key value for chemical safety assessment
Effects on fertility
Description of key information
The test item, Licowax R 21 S FL (formulated in Refined Ground Nut Oil) was administered by gavage to three treatment groups, each oftwelve male and twelve female Wistar rats, for up to 42 days. Males were treated for two weeks premating phase, up to two weeks mating and post-mating, females for two weeks premating phase, up to two weeks mating, three weeks gestation and 13 days lactation at dose levels of 100, 300 and 1000 mg/kg bw/d. A control group of twelve males and twelve females was dosed with the vehicle control (refined ground nut oil).
Results:
1. Mating and fertility
No treatment-related effects were detected on mating performance. All the female animals of control, low, intermediate and high dose groups showed positive evidence of mating. No significant difference was observed in the pre-coital interval of female animals between control, low, intermediate and high dose group.Oestrous cyclicity was checked for all the female animals. Regular oestrous cycle was observed in all the animals of different groups in the study.Mating index for all groups was 100%.
One dam each from control, intermediate and high dose group was observed to be not pregnant.The pregnancy index for Control -0, Low-100, Intermediate-300 and high dose -1000 mg/kg/day groups were observed 100%.
Of the litters born, litter sizes at birth and subsequently on days 1 and 4 post partum were comparable to control
There were no treatment-related effects observed in fertility of treated animals.
2. Gestation and parturition
There were no differences in gestation lengths. The gestation length for treated females was comparable to controls. All animals showed gestation lengths between 20 to 24 days.
The parturition index was 91.67 % in control; intermediate dose and high dose groupwhereas in intermediate dose it was observed 100.00 %.
3. Pre and post natal loss
The pre and post natal losses in all treated groups were comparable with findings in the control group whereas marginal decrease and increase in percentage post implantation loss was observed in the low dose group and high dose group, respectively. No dose response relationship was observed.
4. Litter size and live birth
Of the litters delivered, in all the treatment groups, litter size at birth and subsequently on Day 1 and 4 post-partum were comparable to controls. No significant difference in the live birth was noted between control and treated groups.No nipple retention was found in any of the male litter from vehicle control, low, intermediate and high dose groups.
5. Sex ratio
No significant difference in sex ratio was observed in any of the treated groups when compared with vehicle control.
6. Offspring growth and development
Offspring body weights were recordedon day 1, day 4 and 13 were recorded. No significant changes in the offspring body weight were observed in Low (G2- 100 mg/kg body), intermediate (G3- 300 mg/kg body) and high dose group (G4- 1000 mg/kg body) when compared with control (G1- 0 mg/kg body) group.
No significant differences in theAnogenital distances (AGD) between control and treated animals were observed
7. Litter weights
Offspring body weightson day 1, day 4 and 13 were recorded. No significant changes in the offspring body weight were observed.
No toxicologically relevant findings were noted in thyroxine (T4) and thyroid stimulating hormone (TSH) levels in parent animals (males, females) and pups (male and female).
Based on the results of the OECD 422 study performed with Liccowax R21 S the NOAEL (reproduction/developmental) is derived at 1000 mg/kg bw/d.
Effect on fertility: via oral route
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- NOAEL
- 1 000 mg/kg bw/day
- Study duration:
- subacute
- Species:
- rat
- Quality of whole database:
- reliable without restriction
Effect on fertility: via inhalation route
- Endpoint conclusion:
- no study available
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
There is no evidence to suggest that a classification for reproductive toxicity is appropriate.
With reference to the OECD 422 studies performed with the registration substance, it is concluded that the test item is not subject to classification and labelling according to Regulation 1272/2008/EC regarding reproductive toxicity.
Additional information
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