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EC number: 926-191-9 | CAS number: 1181221-96-4
- 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
Description of key information
OECD 422: NOAEL (systemic) = 750 mg/kg bw/day (Harlan, 2013)
Key value for chemical safety assessment
Repeated dose toxicity: via oral route - systemic effects
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
Additional information
iGloss Crosslinker (ZQ54-2211) was administered to male rats for 28 days and to female rats for 14 days prior to pairing, through the pairing and gestation periods until the F1 generation reached day 4 post partum. The study was conducted according to OECD 422 guideline and GLP (Harlan, 2013).
The following dose levels were applied:
Group 1: 0 mg/kg body weight/day (control group)
Group 2: 75 mg/kg body weight/day
Group 3: 250 mg/kg body weight/day
Group 4: 750 mg/kg body weight/day
A standard dose volume of 4 mL/kg body weight with a daily adjustment to the actual body weight was used. Control animals were dosed with the vehicle alone (olive oil).
The following results were obtained:
Parent Animals
General Tolerability
At 750 mg/kg bw/day, one female died spontaneously at the end of the gestation period. It showed a hunched posture and ruffled fur to a slight degree starting 14 days prior to the spontaneous death. This was accompanied by a weakened condition with increasing severity and visible body weight loss. Severe ulcerations/erosions of the forestomach were observed by histopathological examination. All these findings were considered to be test item-related.
No other test item-related clinical signs were noted in males or females at any dose level.
Food Consumption
No effects on food consumption of males and females were observed at any dose level.
Body Weights
In males, mean body weight gain was dose-dependently reduced during the pre-pairing period at 250 and 750 mg/kg bw/day. The reduction in mean body weight gain resulted in reduced absolute mean body weights in these dose groups until the end of the study. During the following pairing period, mean body weight gain remained reduced at 750 mg/kg bw/day.
In females, no test item-related effects on mean body weight and mean body weight gain were noted.
Clinical Laboratory Investigations
No test item-related findings were noted.
Reproduction and Breeding Data
Mean precoital time, fertility index and conception rate were not affected by the treatment with the test item.
No effects on implantation loss or postnatal loss were observed.
Organ Weights
No effects on organ weights were noted in any group.
Macroscopical Findings and Histopathological Examinations
There were no test item-related findings noted at necropsy.
The incidence and severity of the ulceration/erosion of the glandular and forestomach, squamous hyperplasia and/or inflammatory cell infiltration in the submucosa of the stomach were dose-dependently increased at 250 and 750 mg/kg bw/day.
Litter Data - F1 Pups
Findings at First Litter Check and during Lactation
The mean number of pups at first litter check was not affected by the treatment with the test item. The sex ratio was also not affected. No abnormal pup was noted at any dose level.
Pup Weights to Day 4 Post Partum
No effects on pup weight and pup weight gain were observed.
Macroscopical Findings
At necropsy of pups, there were no abnormal findings.
Conclusion
Based on these results a general NOAEL (No Observed Adverse Effect Level) was considered to be 75 mg/kg body weight/day. However, it should be noted that this NOAEL was primarily based on local irritation at the stomach, and the only additional effect was limited to a decreased body weight gain in males. No signs of systemic toxicity were evident by hematological and clinical chemistry examinations, organ weights, as well as macroscopic and microscopic examinations.
Therefore, the systemic NOAEL is set at 750 mg/kg body weight/day and 75 mg/kg body weight/day is considered as local NOAEL for irritation at the stomach.
The NOEL (No Observed Effect Level) for reproduction/developmental toxicity was considered to be 750 mg/kg body weight/day.
Range-finder:
A non-GLP non-guideline 14-day oral gavage study was performed (Harlan 2012) to assess the tolerance of the non-pregnant rat consequent to exposure of the animals to the test item iGloss Crosslinker (ZQ54-2211) for 14 days. The results of this study were used to establish suitable dose levels for a subsequent combined repeated dose toxicity study with the reproduction/developmental toxicity screening test in the rat. Two groups of 4 male and 4 female Han Wistar rats were treated by gavage with iGloss Crosslinker (ZQ54-2211) once daily over a period of 14 days at dose levels of 300 and 1000 mg/kg bw/day. A standard dose volume of 4 mL/kg body weight was used. Control animals (0 mg/kg bw/day) were dosed with the vehicle alone (Olive oil). No deaths occurred during the study and no clinical signs were observed during the study at any dose level. Body weights were slightly lower in males at 1000 mg/kg bw/day. Body weight gain was slightly lower in females of this dose group. No effects on food consumption were noted. Except for slightly lower protein and albumin levels in males and females at 1000 mg/kg bw/day, assessment of hematology and clinical biochemistry data did not reveal any test item-related effects in males and females. No effects on organ weights were noted and no test item-related macroscopical findings were noted at any dose level. Based on these observations, dose levels of 75, 250 and 750 mg/kg bw/day were considered appropriate for the subsequent Reproduction/Developmental Toxicity Screening Test in the Han Wistar Rat.
Justification for classification or non-classification
Based on the available data, the test substance is not classified with regard to repeated dose toxicity according to Directive 67/548/EEC (DSD) and Regulation (EC) No 1272/2008 (CLP), respectively.
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