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EC number: 210-502-3 | CAS number: 617-04-9
- 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
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- 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 the Combined Repeated Dose Oral Toxicity Study with the Reproduction / Developmental Toxicity Screening Test in Wistar Rats the substance was tested at 0, 100, 300 and 1000 mg/kg bw/day. No treatment-related adverse effects were observed. Thus, the NOAEL for general toxicity as well as the NOAEL for reproduction/developmental toxicity is determined to be 1000 mg/kg bw/day.
Link to relevant study records
- Endpoint:
- screening for reproductive / developmental toxicity
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 21 September 2021 to 08 December 2021
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Reason / purpose for cross-reference:
- reference to same study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 422 (Combined Repeated Dose Toxicity Study with the Reproduction / Developmental Toxicity Screening Test)
- Version / remarks:
- 29 July 2016
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Limit test:
- no
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Females nulliparous and non-pregnant: yes
- Age at study initiation: males approx. 15 weeks, females approx. 13-14 weeks
- Weight at study initiation: males: 358 - 405 g (mean: 382.88 g, ± 20% = 306.30 – 459.45 g)
females: 208 - 262 g (mean: 234.00 g, ± 20% = 187.20 – 280.80 g)
- Housing: Animals were housed in groups of 5 animals / sex / cage in type IV polysulphone cages or in double decker IVC cages during the premating period for both males and females and during post-mating period for males depending on the mating status. During mating period males and females were housed together in ratio 1:1 (male to female). After the confirmation of mating, females were kept individually during gestation/lactation period in type III H, polysulphone cages and males were returned to their original cage. In each cage Altromin saw fibre was used as bedding.
- Diet: Altromin 1324 maintenance diet for rats and mice, ad libitum
- Water: tap water, sulphur acidified to a pH of approximately 2.8 (drinking water, municipal residue control, microbiological controls at regular intervals, ad libitum
- Acclimation period: 6 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3
- Humidity (%): 55 ± 10
- Air changes (per hr): 10 times
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: 07 September 2021 To: 29 November 2021 - Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on exposure:
- PREPARATION OF DOSING SOLUTIONS:
The test item was dissolved in aqua ad injectionem.
The application volume for all groups was 5 mL/kg bw/day. - Details on mating procedure:
- - M/F ratio per cage: 1:1
- Proof of pregnancy: vaginal plug and/or sperm in vaginal smear referred to as day 0 of pregnancy - Analytical verification of doses or concentrations:
- yes
- Details on analytical verification of doses or concentrations:
- As the test item was shown to be homogenous according to a previous study (after at least 30 min without stirring), samples were not collected during the study for the investigation of homogeneity and samples were only taken for substance concentration verification in study week 1 (pre-mating period), week 3 (first week of mating), week 5 (gestation) and in the last week of the study (gestation / lactation) from all groups (16 samples).
Each sample taken during the study was retained in duplicate (sample A, sample B, each of at least 3 mL). The A-samples were analysed at Eurofins Munich (Eurofins Munich Study Phase No. STUGC21AA0522-6) and until then stored under appropriate conditions based on available stability data. The B-samples were retained at below 15 °C at BSL Munich (test facility) and discarded after completion of the final study report.
Nominal concentrations were within acceptance criterion of ±15%. - Duration of treatment / exposure:
- The animals were treated with the test item formulation or vehicle on 7 days per week for a maximum period of 63 days in females, i.e. during 14 days of pre-mating and maximum 14 days of mating in both males and females, during the gestation period and up to PND 12 in females. Males were dosed after the mating period until the minimum total dosing period of 28 days was completed.
- Frequency of treatment:
- daily
- Dose / conc.:
- 0 mg/kg bw/day (nominal)
- Dose / conc.:
- 100 mg/kg bw/day (nominal)
- Dose / conc.:
- 300 mg/kg bw/day (nominal)
- Dose / conc.:
- 1 000 mg/kg bw/day (nominal)
- No. of animals per sex per dose:
- 10 animals per sex per dose and 10 animals per sex for the control were used.
- Control animals:
- yes, concurrent vehicle
- Details on study design:
- - Dose selection rationale: Doses were chosen based on the results of a previous dose-range-finding study (reference 7.5.1-2).
- Parental animals: Observations and examinations:
- CAGE SIDE OBSERVATIONS: Yes
- Time schedule: daily
DETAILED CLINICAL OBSERVATIONS: Yes
- Time schedule: at least once a day, preferably at the same time each day. The health condition of the animals was recorded. Twice daily all animals were observed for morbidity and mortality except on weekends and public holidays when observations were made once daily.
BODY WEIGHT: Yes
- Time schedule for examinations: The animals were weighed once before the assignment to the experimental groups, on the first day of dosing and weekly thereafter as well as at the end of the study. During pregnancy, females were weighed on gestation days (GD) 0, 7, 14 and 20 and within 24 hours of parturition (day 0 post-partum), on PND 4, PND 9 and PND 13 along with pups. Inadvertently, female no. 46 was not weighed on gestation day 0. All animals were weighed directly before termination. Any animals prematurely sacrificed were weighed prior to the sacrifice.
FOOD CONSUMPTION AND COMPOUND INTAKE:
Food consumption was measured on the corresponding days of the body weight measurements after the beginning of the dose administration. Food consumption was not measured during the mating period in males and females and the post-mating period in males.
HAEMATOLOGY: Yes
- Time schedule for collection of blood: At the end of the treatment prior to or as part of the sacrifice. Blood from the abdominal aorta of the animals was collected in EDTA-coated tubes.
- Anaesthetic used for blood collection: No
- Animals fasted: No
- How many animals: 5 males and females per group
- Parameters checked in table No.1 were examined.
CLINICAL CHEMISTRY: Yes
- Time schedule for collection of blood: At the end of the treatment prior to or as part of the sacrifice. Blood from the abdominal aorta of the animals was collected in serum separator tubes.
- Animals fasted: No
- How many animals: 5 males and females per group
- Parameters checked in table No.2 were examined.
PLASMA/SERUM HORMONES: Yes
- Time of blood sample collection: at study termination
- Animals fasted: No
- How many animals: Blood samples from the adult males were assessed for serum levels for thyroid hormones (T4).
URINALYSIS: Yes
- Time schedule for collection of urine: Prior to or as part of the sacrifice of the animals.
- Metabolism cages used for collection of urine: No
- Animals fasted: No
- Parameters checked in table No. 3
NEUROBEHAVIOURAL EXAMINATION: Yes
Multiple detailed behavioural observations were made in the week before the first treatment and during the last week of the treatment in 5 randomly selected males and during the last week of the lactation period in 5 randomly selected females (only lactating females were evaluated) of each group outside the home cage using a functional observational battery. Sensory reactivity to different modalities were investigated comprising grip strength and motor activity assessments and other behavioural observations as well as rearing supported and not supported, urination, defecation, startle/ auditory response, equilibrium reflex, positional passivity, visual placing, fore and hind limb grip strength, tail pinch response, toe pinch reflex, extensor thrust/limb tone, hind limb reflex, righting reflex on the ground, air righting reflex, pupil response, body temperature and ophthalmoscopy (anterior chamber of the eye and fundus of eye). - Oestrous cyclicity (parental animals):
- Vaginal smears were examined daily from the beginning of the treatment period until evidence of mating.
- Sperm parameters (parental animals):
- The testes from group 1 and 4 males were checked during the histopathological examinations for completeness of cell populations, completeness of stages and degenerative changes.
- Litter observations:
- PARAMETERS EXAMINED
The duration of gestation was recorded and was calculated from day 0 of the pregnancy. Each litter was examined as soon as possible after the delivery of the dam to establish the number and sex of pups, stillbirths, live births, runts and the presence of gross abnormalities.
Live pups were counted and sexed and litters weighed within 24 hours of littering (PND 0) and on PND 4 and PND 13. Live pups were identified by tattooing. In addition to the observations of the parent animals, any abnormal behaviour of the offspring were recorded.
The anogenital distance (AGD) of each pup was measured on PND 0. Pup body weight measured on PND 0 was converted to cube root and used for the calculation of relative AGD (Relative AGD = AGD/Cube root of pup weight). The number of nipples/areolae in male pups was counted on PND 12. - Postmortem examinations (parental animals):
- SACRIFICE
- Male animals: All surviving animals
- Maternal animals: All surviving animals
GROSS NECROPSY
- Gross necropsy consisted of external and internal examinations including the cervical, thoracic, and abdominal viscera.
HISTOPATHOLOGY / ORGAN WEIGHTS
The tissues indicated in Table 4 were weighed, Tissues and organs in Table 5 were prepared for microscopic examination. - Statistics:
- A statistical assessment of the results of body weight, food consumption and litter data was performed for each gender by comparing values of dosed with control animals using a one-way ANOVA and a post-hoc Dunnett Test. Results of absolute and relative organ weights, parameters of haematology, blood coagulation and clinical biochemistry was statistically analysed by comparing values of dosed with control animals using either a parametric one-way ANOVA and a post-hoc Dunnett Test or a non-parametric Kruskal-Wallis Test and a post-hoc Dunn’s Test, based on the results of homogeneity and normality tests. These statistics were performed with GraphPad Prism V.6.01 software or Ascentos 1.3.4 software (p<0.05 was considered as statistically significant).
- Reproductive indices:
- copulation index, fertility index, delivery index
- Offspring viability indices:
- The number of male and female pups, sex ratio, still births, runts, litter weight data, anogenital distance, nipple retention and external abnormalities were evaluated.
- Clinical signs:
- effects observed, non-treatment-related
- Description (incidence and severity):
- No clinical signs of toxicological relevance were observed in the control group and in all treatment groups. During the mating period one male of the MD group had abnormal breathing on day 9. During the lactation phase, one female in the control group had severe piloerection on day 0, two females of the LD group had slight piloerection between days 0 and 2 and two females of the HD group had moderate piloerection on day 0 and slight piloerection between days 8 and 11, respectively. One female of the MD group had a hairless area on the neck between days 3 and 12. These signs were only observed in single animals and on a few days during the study and are therefore considered to be incidental and not adverse. One female of the MD group had a scratch/cut with signs of necrosis on the tail due to which the animal was taken out of the study. Regarding detailed clinical observation, no differences to control were noted during the treatment period.
- Mortality:
- mortality observed, non-treatment-related
- Description (incidence):
- Two mortalities occurred during the study. One male in the LD (low dose) group was found dead on study day 21, which was the 7th day of the mating phase. One female of the MD (mid dose) group was found in moribund condition on study day 9 of the premating phase. In both above-mentioned animals the cause of death was not evident from the histopathologically evaluated tissues and remained unclear. However, because (i) there were no test item-related findings in any of the organs examined in either of the above animals, (ii) no dose dependency was observed and (iii) no clinical signs of systemic toxicity were observed in the animals of this study, the cause of morbidity in both animals was considered incidental.
- Body weight and weight changes:
- no effects observed
- Food consumption and compound intake (if feeding study):
- no effects observed
- Description (incidence and severity):
- The test item had no effect on food consumption in this study. Mean daily food intake of males and females in the dose groups was comparable to the control group in this study except for in week one of the gestation phase females of the MD group consumed statistically significantly less food when compared to control animals (~15% below control). No considerable differences between the groups were observed.
- Haematological findings:
- no effects observed
- Clinical biochemistry findings:
- effects observed, treatment-related
- Description (incidence and severity):
- At the end of the treatment period, the test item showed no relevant effects on clinical biochemical parameters.
A statistically significant increase in glucose (GLUC) was noted only in females in the HD group when compared to the control group (~38% above control). Overall, a slight dose dependent increase in glucose is observed in all dose groups. For the liver parameter AP, a statistically significant increase was noted in females of the MD group when compared to the control group (~107% above control). As the other liver parameters ALAT and ASAT were unaffected and no histopathological changes in the liver were observed in females of the MD group, the mentioned increase is not considered to be related to the treatment with test item. Furthermore, no effects on liver parameters were found for males of all dose groups and no dose dependence was seen in females. - Urinalysis findings:
- effects observed, non-treatment-related
- Description (incidence and severity):
- The test item had no toxicologically relevant effect on urinary parameters analysed in selected animals at the end of the treatment period of this study. Findings in single male animals such as high level of glucose when compared to the control group and higher number of leucocytes in a control male are considered to be incidental and without relation to the treatment with test item. No specific changes in urinary parameters were noted in all female dose groups when compared to the control group.
- Behaviour (functional findings):
- no effects observed
- Immunological findings:
- no effects observed
- Organ weight findings including organ / body weight ratios:
- effects observed, non-treatment-related
- Histopathological findings: non-neoplastic:
- effects observed, non-treatment-related
- Description (incidence and severity):
- Under the conditions of this study there were no microscopic changes that could be related to the test item administration. In the lung of some dosed animals, control animals and one decedent animal, minimal mixed cell infiltrates (i.e. minimal interstitial inflammation) was observed. The minor inflammatory changes observed in the lung of the decedent animal and few surviving animals were considered to be caused by an inflammatory process most likely not related to the test item administration and deemed as incidental.
In kidneys from one control animal, one low dose group animal and two high dose group animals dilatation of the renal pelvis and compression of the adjacent renal parenchyma were noted. The pelvic dilatation observed in few animals was caused by an increased hydrostatic pressure in the lower urinary tract and was considered to be most likely incidental.
In addition, the treatment with the test item did not induce any histomorphological effects in the reproductive organs of one animal which was pregnant but did not litter, and in a decedent animal that was euthanized before mating on test day 9.
All other recorded microscopic findings were deemed to be incidental or were within the range of background alterations that may be recorded in Wistar rats. - Histopathological findings: neoplastic:
- no effects observed
- Reproductive function: oestrous cycle:
- no effects observed
- Reproductive function: sperm measures:
- no effects observed
- Description (incidence and severity):
- There were no morphological findings in the reproductive organs of males which could be attributed to the test item and stage aware evaluation of the testes did not show any indication for abnormal spermatogenesis.
- Reproductive performance:
- no effects observed
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- 1 000 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male/female
- Remarks on result:
- not determinable due to absence of adverse toxic effects
- Key result
- Critical effects observed:
- no
- Clinical signs:
- no effects observed
- Mortality / viability:
- mortality observed, non-treatment-related
- Description (incidence and severity):
- The litter parameters including the total number of pups, still births and runts born on PND 0, and the number of live pups were not statistically significantly different in test item groups compared to the control group. Observed total mortality in the MD group of 2.10% was achieved by the death of 1/11 pups of a dam and 1/13 pups of another dam and total mortality in the HD group of 0.83% between PNDs 0-4 was achieved by the death of 1/12 pups of one dam, but no mortality of pups occurred in the MD and HD groups between PNDs 4-13. As the mortality was observed for single pups of single dams from the MD and HD groups and only during the first observation days without statistical significance, no effect of the treatment with test item is considered.
- Body weight and weight changes:
- no effects observed
- Description (incidence and severity):
- No toxicological relevant differences in mean total litter weight, male or female litter weight on PND 0, 4 and 13 were observed in any of the treatment groups. The litter weights were within the normal range of variation in this strain.
- Food consumption and compound intake (if feeding study):
- not examined
- Food efficiency:
- not examined
- Water consumption and compound intake (if drinking water study):
- not examined
- Ophthalmological findings:
- not examined
- Haematological findings:
- not examined
- Clinical biochemistry findings:
- no effects observed
- Description (incidence and severity):
- Treatment with the test item had no effect on serum T4 levels of pups sacrificed on day 13.
- Urinalysis findings:
- not examined
- Sexual maturation:
- not examined
- Anogenital distance (AGD):
- no effects observed
- Nipple retention in male pups:
- no effects observed
- Organ weight findings including organ / body weight ratios:
- not examined
- Gross pathological findings:
- effects observed, non-treatment-related
- Description (incidence and severity):
- No gross external abnormalities of toxicological relevance were observed for pups of any of the groups on PNDs 0-12 or the day of sacrifice/death. Few isolated external findings in the control group included hairless area on the back of some pups, wound on the snout, PND 0 and PND 6 and in the MD group a dark snout on PND 0. These external findings were considered to be spontaneous and not related to test item treatment.
- Histopathological findings:
- not examined
- Behaviour (functional findings):
- not examined
- Developmental immunotoxicity:
- not examined
- Key result
- Dose descriptor:
- NOAEL
- Generation:
- F1
- Effect level:
- 1 000 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male/female
- Remarks on result:
- not determinable due to absence of adverse toxic effects
- Key result
- Critical effects observed:
- no
- Key result
- Reproductive effects observed:
- no
- Conclusions:
- No treatment-related adverse effects were observed in the combined repeated dose oral toxicity and reproduction/ developmental toxicity screening test with the test substance in male and female Wistar rats with dose levels of 100, 300, and 1000 mg/kg bw/da. Thus, the NOAEL for general toxicity as well as the NOAEL for reproduction/developmental toxicity is determined to be 1000 mg/kg bw/day.
- Executive summary:
The substance was tested in the Combined Repeated Dose Oral Toxicity Study with the Reproduction / Developmental Toxicity Screening Test in Wistar Rats. According to the results of a previous dose range finding study the following doses were tested: 0, 100, 300 and 1000 mg/kg bw/day. 10 animals per sex per day were treated (orally by gavage). The animals were treated with the test item formulation or vehicle on 7 days per week for a maximum period of 63 days in females, i.e. during 14 days of pre-mating and maximum 14 days of mating in both males and females, during the gestation period and up to PND 12 in females. Males were dosed after the mating period until the minimum total dosing period of 28 days were completed. No clinical signs of toxicological relevance were observed in the control group and in all treatment groups. Detailed clinical observation showed no toxicologically relevant differences in all male and female groups when compared to the control group. No test item-related effects were observed during the functional observation for males and females. The test item had no effect on body weight, body weight change and food consumption in males and females in all dose groups when comparing to control animals. No test item-related effects on the reproduction and developmental parameters analysed in this study were observed, i.e. oestrous cycle, copulation, fertility and delivery indices, number of corpora lutea, implantation sites and live pups, pre- and post-implantation loss, number of male and female pups, sex ratio, still births, runts, litter weight data, anogenital distance, nipple retention and external abnormalities. Treatment with the test item had no effect on serum T4 levels in parental males and offspring. The test item had no toxicologically relevant effect on haematological, coagulation and clinical biochemistry parameters of selected male and female animals analysed at the end of the treatment period of this study. The test item had no toxicologically relevant effects on urinary parameters analysed in selected animals at the end of the treatment period of this study. There were gross lesions observed in male and female treatment groups, which were considered to be not related to the test item. No test item related effects on absolute and relative organ weights were observed in males and females in any of the treatment groups when compared to the control groups. No test item-related microscopic changes were observed in any of the examined tissues and organs either in the decedents or in surviving animals. Based on these results, the NOAEL for general toxicity as well as the NOAEL for reproduction/developmental toxicity is determined to be 1000 mg/kg bw/day.
Reference
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:
- GLP and OECD Guideline study
Effect on fertility: via inhalation route
- Endpoint conclusion:
- no study available
Effect on fertility: via dermal route
- Endpoint conclusion:
- no study available
Additional information
OECD 422 study (reference 7.8.1-1):
The substance was tested in the Combined Repeated Dose Oral Toxicity Study with the Reproduction / Developmental Toxicity Screening Test in Wistar Rats. According to the results of a previous dose range finding study the following doses were tested: 0, 100, 300 and 1000 mg/kg bw/day. 10 animals per sex per day were treated (orally by gavage). The animals were treated with the test item formulation or vehicle on 7 days per week for a maximum period of 63 days in females, i.e. during 14 days of pre-mating and maximum 14 days of mating in both males and females, during the gestation period and up to PND 12 in females. Males were dosed after the mating period until the minimum total dosing period of 28 days were completed. No clinical signs of toxicological relevance were observed in the control group and in all treatment groups. Detailed clinical observation showed no toxicologically relevant differences in all male and female groups when compared to the control group. No test item-related effects were observed during the functional observation for males and females. The test item had no effect on body weight, body weight change and food consumption in males and females in all dose groups when comparing to control animals. No test item-related effects on the reproduction and developmental parameters analysed in this study were observed, i.e. oestrous cycle, copulation, fertility and delivery indices, number of corpora lutea, implantation sites and live pups, pre- and post-implantation loss, number of male and female pups, sex ratio, still births, runts, litter weight data, anogenital distance, nipple retention and external abnormalities. Treatment with the test item had no effect on serum T4 levels in parental males and offspring. The test item had no toxicologically relevant effect on haematological, coagulation and clinical biochemistry parameters of selected male and female animals analysed at the end of the treatment period of this study. The test item had no toxicologically relevant effects on urinary parameters analysed in selected animals at the end of the treatment period of this study. There were gross lesions observed in male and female treatment groups, which were considered to be not related to the test item. No test item related effects on absolute and relative organ weights were observed in males and females in any of the treatment groups when compared to the control groups. No test item-related microscopic changes were observed in any of the examined tissues and organs either in the decedents or in surviving animals. Based on these results, the NOAEL for general toxicity as well as the NOAEL for reproduction/developmental toxicity is determined to be 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
Classification, Labeling, and Packaging Regulation (EC) No 1272/2008
The available experimental test data are not sufficient for classification purposes according to Regulation (EC) No 1272/2008 (CLP), as amended for the eighteenth time in Regulation (EU) 2022/692.
Additional information
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