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EC number: 400-320-4 | CAS number: 94933-05-8
- 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
NOAEL (rat, male and female, oral) = 800 mg/kg bw/day
Effect on fertility: via oral route
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- NOAEL
- 800 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 order to provide information on toxicity as well as any possible effects of the test item on male and female reproductive performance, a study was performed according to the OECD Guideline 421 (2016).The effects of the test item on male and female reproductive performance such as gonadal function, mating behaviour, conception, development of conceptus, parturition and early lactation of the offspring were investigated.
All doses (0, 50, 200 and 800 mg/kg/day) were administered orally, by gavage to 10 males and 10 females per dose group. The control group received softened water (by reverse osmosis). The dose volume was 10 ml/kg bodyweight. Males were treated for 2 weeks prior to pairing and during pairing with females until theday before necropsy, for a total of 28 or 29 days. Females were treated for 2 weeks prior to pairing, and thereafter during pairing, post coitum and post partum periods until Day 13 post partum (for at least 51 days). Four not pregnant females were dosed up to the day before necropsy.
The following investigations were performed: mortality check, clinical signs, body weight, food consumption, oestrous cycle, mating performance, litter data, sex ratios, macroscopic observations and organ weights.
Histopathological examination was performed on control and high dose groups, on allabnormalities detected during post mortem observation from all groups and on one found dead male.
The identification of the stages of the spermatogenic cycle was also performed in all males of the control and high dose groups. Thyroid hormone determination was performed in all parental males. Clinical signs were recorded in all pups. Thyroid weight and thyroid hormone determination of 1 pup/sex/litter (where possible) at Day 14 post partum were determined. All pups found dead in the cage were examined for external and internal abnormalities. All culled pups sacrificed at Day 4 post partum were subjected to an external examination. Sex was confirmed by internal gonads inspection. All live pups sacrifice on Day 14 post partum were examined for extenal abnormalities and sex confirmation by gonadal inspection. The presence of nipples/areolae was verified in male pups.
Mortality and fate of females
One male from the high dose group was found dead on Day 7 of the pre-mating phase of the study. No clinical signs were observed prior to death. On the basis of the macroscopic (dark fluid contents in the thoracic cavity and dark colour of lungs) and microscopic observation (essentially chronic inflammation and necrosis in the lungs with brown foreign material, test item like, and brown pigment-laden macrophages in the alveoli of the lungs), the cause of death was attributed to a misdosing.
Two females receiving 50 mg/kg/day and one female receiving 200 mg/kg/day were proved not pregnant at necropsy. In addition, one female receiving 800 mg/kg/day had unilateral total resorption in the left horn and was not pregnant in the right one. The number of females with live pups on Day 14 post partum was: 10 in the control, 8 in the low dose (50mg/kg/day), 9 in the mid-dose (200mg/kg/day) and 9 in the high dose group (800mg/kg/day).
Clinical signs
No relevant clinical signs were observed during the study. Staining observed in high dose group of both sexes and in females of mid-dose group was considered related to the colour of the test item.
Observations of the cage tray
Staining in the cage tray and red faeces generally observed in mid- and/or high dose groups were considered related to the colour of the test item which was eliminated by the animals.
Body weight and body weight gain
No relevant differences in body weight and body weight gain were noted between control and treated males and females throughout the study.
Food consumption
No effects on food consumption were observed in both sexes.
Thyroid hormone determination
Parental males
No changes in thyroid hormones were recorded in parental male animals of all treated groups.
Pups – Day 14 post partum
Changes observed in thyroid stimulating hormone of some female pups of the high dose group were considered of no toxicological relevance due to the absence of other related changes.
Oestrous cycle, reproductive parameters, pairing combination and mating performance
Oestrous cycle, pre-coital intervals, copulatory index and fertility index did not show intergroup differences.
Implantation, pre-birth loss data and gestation length of females
No significant differences were observed for these parameters between treated and control groups. All pregnant dams gave birth on Day 22 post coitum (mean value).
Litter data at birth, on Days 1 and 4 post partum (before culling) and on Day 13 post partum (after culling) and sex ratio of pups
Litter data at birth, on Days 4 and 13 post partum recorded on treated groups were comparable to those of the control group. Sex ratios at birth, on Days 4 and 14 post partum did not show differences between groups, when calculated as the percentage of males.
Clinical signs of pups
Pre-weaning clinical signs were comparable between treated and control groups.
Anogenital distance
No relevant differences were seen between the control and treated pups in anogenital distance.
Necropsy findings in decedent pups, in pups sacrificed on Days 4 and 14 post partum and nipple count
Necropsy findings in decedent pups and in pups sacrificed on Days 4 and 14 post partum did not reveal any treatment-related effect. No nipples were observed in male pups on Day 14 post partum.
Pups thyroid weight on Day 14 post partum
No differences were noted in thyroid weight between control and treated pups.
Terminal body weight and organ weights
Terminal body weight and organ weights did not show relevant differences between control and treated groups.
Macroscopic observations
No remarkable differences were noted at post mortem examination in treated animals sacrificed at the end of the study, when compared with controls.
Microscopic observations
No treatment-related changes were observed in treated animals sacrificed at the end of the study, when compared to the controls.
Effects on developmental toxicity
Description of key information
NOAEL (rat, male and female, oral) = 800 mg/kg bw/day
Effect on developmental toxicity: via oral route
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- NOAEL
- 800 mg/kg bw/day
- Study duration:
- subacute
- Species:
- rat
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
According to CLP Regulation (EC 1272/2008), 3.7 Reproductive toxicity section, reproductive toxicity includes adverse effects on sexual function and fertility in adult males and females, as well as developmental toxicity in the offspring.
The available experimental data are adequate for classification and labelling and the substance does not meet the criteria to be classified for reproductive toxicity, according to CLP Regulation (EC) No. 1272/2008.
Additional information
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.
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