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EC number: 600-734-7 | CAS number: 106276-78-2
- 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
Developmental toxicity / teratogenicity
Administrative data
- Endpoint:
- developmental toxicity
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- August 2011 - June 2012
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 012
- Report date:
- 2012
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: OECD 422
- GLP compliance:
- yes (incl. QA statement)
- Limit test:
- no
Test material
- Reference substance name:
- 3,4,5,6-tetrachloro-N-[2-(4,5,6,7-tetrachloro-2,3-dihydro-1,3-dioxo-1H-inden-2-yl)-8-quinolyl]phthalimide
- EC Number:
- 250-063-5
- EC Name:
- 3,4,5,6-tetrachloro-N-[2-(4,5,6,7-tetrachloro-2,3-dihydro-1,3-dioxo-1H-inden-2-yl)-8-quinolyl]phthalimide
- Cas Number:
- 30125-47-4
- Molecular formula:
- C26H6Cl8N2O4
- IUPAC Name:
- 4,5,6,7-tetrachloro-2-[2-(4,5,6,7-tetrachloro-1,3-dioxo-2,3-dihydro-1H-inden-2-yl)quinolin-8-yl]-1H-isoindole-1,3(2H)-dione
- Test material form:
- solid: nanoform
- Details on test material:
- solid yellow
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Laboratories, Research Models and ServiceGmbH, Sulzfeld, Germany
- Age at study initiation: 10-11 weeks
- Weight at study initiation:
- Fasting period before study: no
- Housing: individually, following exceptions: During overnight matings, male and female mating partners were housed together. Pregnant animals and their litters were housed together until PND 4 (end of lactation).
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 7d
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-24
- Humidity (%): 30-70
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: August 9th, 2011 To:October 6th, 2011
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on exposure:
- PREPARATION OF DOSING SOLUTIONS:
DIET PREPARATION
- Rate of preparation of diet (frequency): weekly
- Mixing appropriate amounts with (Type of food): water
- Storage temperature of food: RT
- applied as a suspension - Analytical verification of doses or concentrations:
- yes
- Details on analytical verification of doses or concentrations:
- - according GLP
- stability of the test substance in drinking water for a period of 7 days at room temperature was proven before the start of the study
- method stability of test item in drinking water: UV/VIS spectroscopy - Details on mating procedure:
- - Impregnation procedure: cohoused
- If cohoused:
- M/F ratio per cage: 1:1
- Length of cohabitation: overnight for maximum 2 weeks
- Proof of pregnancy: sperm in vaginal smear referred to as day 0 of pregnancy - Duration of treatment / exposure:
- The duration of treatment covered a 2-week premating and a mating period in both sexes, approximately 1 week post-mating in males,
and the entire gestation period as well as 4 days of lactation and 2 weeks thereafter in females. - Frequency of treatment:
- daily
Doses / concentrationsopen allclose all
- Dose / conc.:
- 100 mg/kg bw/day (actual dose received)
- Dose / conc.:
- 300 mg/kg bw/day (actual dose received)
- Dose / conc.:
- 1 000 mg/kg bw/day (actual dose received)
- No. of animals per sex per dose:
- 10
- Control animals:
- yes, concurrent vehicle
- Details on study design:
- - Dose selection rationale: range finder test 300 and 1000 mg/kg bw, no effects up to 1000 mg/kg bw
- Rationale for animal assignment (if not random): Randomization
Examinations
- Maternal examinations:
- CAGE SIDE OBSERVATIONS: Yes
- Time schedule: twice daily
DETAILED CLINICAL OBSERVATIONS: Yes
- Time schedule: daily
BODY WEIGHT: Yes
- Time schedule for examinations: before the start of the administration period in order to randomize the animals. During the administration period body weight was determined on study day 0 (start of the administration period) and thereafter once a week at the same time of the day (in the morning).
FOOD CONSUMPTION
- weekly
- Food consumption was not determined during the mating period (male and female F0 animals).
- Food consumption of the F0 females with evidence of sperm was determined on GD 0, 7, 14 and 20.
- Food consumption of F0 females, which gave birth to a litter, was determined for PND 4
OPHTHALMOSCOPIC EXAMINATION: Yes
- Time schedule for examinations: in the course of FOB
- Dose groups that were examined: all
HAEMATOLOGY: Yes
- Time schedule for collection of blood: end of administration period
- Anaesthetic used for blood collection: Yes, anaesthetized using isoflurane (Isoba®, Essex GmbH, Munich, Germany)
- Animals fasted: Yes
- How many animals: 5/sex/dose
CLINICAL CHEMISTRY: Yes
- Time schedule for collection of blood: end of administration period
- Animals fasted: Yes
- How many animals: 5/sex/dose
URINALYSIS: Yes
- Time schedule for collection of urine: males: after mating, females: 1 day before end of administration period
- Metabolism cages used for collection of urine: Yes
- Animals fasted: Yes
NEUROBEHAVIOURAL EXAMINATION: Yes
- Time schedule for examinations: male: postnatal day 0, female: 10d after gestation
- Dose groups that were examined: all
- Battery of functions tested: sensory activity / grip strength / motor activity - Ovaries and uterine content:
- The ovaries and uterine content was examined after termination: Yes / No / No data
Examinations included:
- Gravid uterus weight: Yes
- Number of corpora lutea: No
- Number of implantations: Yes
- Number of early resorptions: No
- Number of late resorptions: No - Fetal examinations:
- - External examinations: Yes, all pubs
- Soft tissue examinations: necropsy observations macroscopically
- Skeletal examinations: No
- Head examinations: No
- Sex ratio
- Pup body weight data
- Pup clinical observations - Statistics:
- Blood parameters:
For parameters with bidirectional changes:
Non-parametric one-way analysis using KRUSKAL-WALLIS test. If the resulting p-value was equal or less than 0.05, a pairwise comparison of each dose
group with the control group was performed using WILCOXON-test (twosided) for the hypothesis of equal medians
For parameters with unidirectional changes:
Pairwise comparison of each dose group with the control group using the WILCOXON-test (one-sided) for the hypothesis of equal medians
Urinalysis parameters: WILCOXON-test (one-sided)
Food consumption: DUNNETT-test (twosided)
fertility indices: FISHER'S EXACT test
Proportions of affected pups per litter with necropsy observations: WILCOXON-test
Weight parameters: KRUSKAL-WALLIS test - Indices:
- Pup number and status at delivery
Pup viability/mortality
Sex ratio
Pup body weight data
Results and discussion
Results: maternal animals
General toxicity (maternal animals)
- Clinical signs:
- effects observed, treatment-related
- Description (incidence and severity):
- - All female animals of test group 3 (1000 mg/kg bw/d) showed yellowish discolored feces at the end of the study.
- In one female animal of test group 1 (100 mg/kg bw/d) abdominal distension was observed on study days 49 and 50. - Mortality:
- mortality observed, non-treatment-related
- Description (incidence):
- - One female of the low dose group (100 mg/kg bw/d) was sacrificed moribund on study day 50 (the animal was not pregnant). It revealed dilation of uterus and cervix with a cloudy fluid content. This was histopathologically diagnosed as a diffuse inflammation with dilation and was regarded to be the cause for the infertility of this mating pair and also the reason for sacrificing this animal. It was a single case and not regarded to be treatment-related but spontaneous in origin.
- Body weight and weight changes:
- no effects observed
- Food consumption and compound intake (if feeding study):
- effects observed, non-treatment-related
- Description (incidence and severity):
- - During the first premating week as well as in the first gestation week the food consumption in female animals of test group 3 (1000 mg/kg bw/d) was significantly increased. These findings were assessed as spontaneous in nature and not test substance-related.
- Food efficiency:
- not examined
- Water consumption and compound intake (if drinking water study):
- not examined
- Ophthalmological findings:
- no effects observed
- Haematological findings:
- no effects observed
- Clinical biochemistry findings:
- no effects observed
- Urinalysis findings:
- no effects observed
- Behaviour (functional findings):
- effects observed, non-treatment-related
- Description (incidence and severity):
- - Functional observational battery: Deviations from "zero values" were obtained in several rats. However, as most findings were equally distributed between test substance-treated groups and controls, were without a dose-response
relationship or occurred in single rats only, these observations were considered to have been incidental.
- Motor activity measurement: Deviations to the control were only noted in test group 1 (100 mg/kg bw/d), i.e. increased value in interval 6 in female animals. As no significant deviations were noted with regard to the overall motor activity and no dose-response relationship was observed, the findings were assessed as being incidental. - Immunological findings:
- not examined
- Organ weight findings including organ / body weight ratios:
- effects observed, non-treatment-related
- Description (incidence and severity):
- - The weight increase in absolute and relative spleen weight in females of test group 2 (300 mg/kg bw/d) was regarded to be incidental due to a missing dose-response relationship and missing histopathologic findings in test group 3 (1000 mg/kg bw/d).
- Gross pathological findings:
- effects observed, treatment-related
- Description (incidence and severity):
- - 7 females of test group 3 (1000 mg/kg bw/d) revealed a yellow discoloration of the glandular stomach contents. 3 females of test group 3 (1000 mg/kg bw/d) showed the same discoloration of the contents of the jejunum.
- One female animal of test group 1 (100 mg/kg bw/d) revealed a yellow discoloration of the lung (regarded to be test substance that was aspired subsequently to the gavage procedure or due to a gavage error into the trachea) and the mediastinal lymph nodes (regarded to be the physiologic clearing route of the lung).
These discolorations were caused by the test substance but were not regarded to be a treatmentrelated adverse finding. - Neuropathological findings:
- no effects observed
- Histopathological findings: non-neoplastic:
- effects observed, treatment-related
- Description (incidence and severity):
- - 2 females of test group 3 (1000 mg/kg bw/d) revealed histopathological yellow crystalline particles within the alveoli, often close to or within macrophages, rarely inside multinucleated giant cells. The same finding was also observed for the female animal of test group 1 that revealed the macropscopic finding “discoloration” in the lung. These yellow particles were regarded to be test substance that was aspired subsequently to the gavage procedure. Therefore, these discolorations in lung and mediastinal lymph node were caused by the test substance but were not regarded to be a treatment-related adverse finding.
- Histopathological findings: neoplastic:
- no effects observed
- Other effects:
- no effects observed
Maternal developmental toxicity
- Number of abortions:
- not examined
- Pre- and post-implantation loss:
- effects observed, non-treatment-related
- Description (incidence and severity):
- The mean postimplantation loss was highest in test group 2 (300 mg/kg bw/d), i.e. 28.6% compared to the control group (13.8%). As no dose-response relationship was observed, the finding was assessed as not being related to treatment.
- Total litter losses by resorption:
- not examined
- Early or late resorptions:
- not examined
- Dead fetuses:
- not examined
- Changes in pregnancy duration:
- no effects observed
- Changes in number of pregnant:
- effects observed, non-treatment-related
- Description (incidence and severity):
- 1 female of the control group, 2 females of test group 1 (100 mg/kg bw/d), 3 females of test group 2 (300 mg/kg bw/d) and 1 female of test group 3 (1000 mg/kg bw/d) were either sperm-negative or did not become pregnant. These findings were assessed to be incidental and not related to treatment as no dose-response relationship was observed.
- Other effects:
- no effects observed
- Details on maternal toxic effects:
- Maternal toxic effects:no effects
Effect levels (maternal animals)
open allclose all
- Dose descriptor:
- NOAEL
- Effect level:
- 1 000 mg/kg bw/day
- Basis for effect level:
- other: maternal toxicity
- Dose descriptor:
- NOAEL
- Effect level:
- 1 000 mg/kg bw/day
- Basis for effect level:
- other: developmental toxicity
Maternal abnormalities
- Abnormalities:
- no effects observed
Results (fetuses)
- Fetal body weight changes:
- effects observed, non-treatment-related
- Description (incidence and severity):
- (instead of fetal body weight changes, the body weight of the pups was assessed)
Mean pup body weights were significantly lower on PND1 in test groups 2 (300 mg/kg bw/d) and 3 (1000 mg/kg bw/d).
One female runt was seen in test group 2 (300 mg/kg bw/d) and 2 male and 3 female runts in test group 3 (1000 mg/kg bw/d).
These values were within the range of the biological variation inherent in the strain of rats used for this study. - Reduction in number of live offspring:
- effects observed, non-treatment-related
- Description (incidence and severity):
- one stillborn pup in test group 1 (100 mg/kg bw/d)
- Changes in sex ratio:
- no effects observed
- Changes in litter size and weights:
- no effects observed
- Changes in postnatal survival:
- effects observed, non-treatment-related
- Description (incidence and severity):
- The viability index as indicator for pup mortality between PND 0 and 4 was 99% for test groups 1 and 3 (100 and 1000 mg/kg bw/d; 1 pup of 1 female in group 1 and 3 was found dead).
These findings were assessed to be incidental and not related to treatment. - External malformations:
- no effects observed
- Skeletal malformations:
- no effects observed
- Visceral malformations:
- effects observed, non-treatment-related
- Description (incidence and severity):
- A situs inversus of the heart was observed in one pup of test group 3 (1000 mg/kg bw/d). The finding was assessed as being spontaneous in nature and without biological relevance.
- Other effects:
- no effects observed
- Details on embryotoxic / teratogenic effects:
- Embryotoxic / teratogenic effects:no effects
Effect levels (fetuses)
- Dose descriptor:
- NOAEL
- Effect level:
- 1 000 mg/kg bw/day (actual dose received)
- Sex:
- male/female
- Basis for effect level:
- other: no adverse effects observed up to and including the limit dose
Fetal abnormalities
- Abnormalities:
- not examined
Overall developmental toxicity
- Developmental effects observed:
- no
Any other information on results incl. tables
Table 1: Summary of female reproduction and delivery data
|
ORAL ADMINISTRATION(GAVAGE) - F0 FEMALES (Fl LITTER) SUMMARY OF FEMALE REPRODUCTION AND DELIVERY DATA |
|
|
|||
|
|
TEST GROUP 0 0 MG/KG BW/D |
TEST GROUP 1 100 MG/KG BW/D |
TEST GROUP 2 300 MG/KG BW/D |
TEST GROUP 3 1000 MG/KG BW/D |
|
Females on Study |
N |
10 |
10 |
10 |
10 |
|
Females Mated |
N |
10Fi |
10 |
8 |
10 |
|
Female Mating Index |
% |
100 |
100 |
80 |
100 |
|
Mating days until day 0 pc |
MEAN |
3.8D |
1.9 |
2.3 |
4.2 |
|
|
S.D. |
3.39 |
1.66 |
1.49 |
3.33 |
|
|
N |
10 |
10 |
8 |
10 |
|
days 1 to4 |
N |
9 |
9 |
8 |
9 |
|
|
% |
90 |
90 |
100 |
90 |
|
days 5 to8 |
N |
0 |
1 |
0 |
0 |
|
|
% |
0.0 |
10 |
0.0 |
0.0 |
|
days 9 to 14 |
N |
1 |
0 |
0 |
1 |
|
|
% |
10 |
0.0 |
0.0 |
10 |
|
days 15 to 21 |
N |
0 |
0 |
0 |
0 |
|
|
% |
0.0 |
0.0 |
0.0 |
0.0 |
|
Females Pregnant |
N |
9Fi |
8 |
7 |
9 |
|
Female Fertility Index |
% |
90 |
80 |
88 |
90 |
|
Duration of Gestation (Days) |
MEAN |
22.1D |
22.0 |
21.8 |
21.9 |
|
|
S.D. |
0.35 |
0.00 |
0.45 |
0.33 |
|
Implantation sites |
TOTAL |
101 |
90 |
71 |
123 |
|
|
MEAN |
11.2 D |
11.3 |
10.1 |
13.7 |
|
|
S.D. |
3.49 |
2.60 |
6.15 |
2.06 |
|
|
N |
9 |
8 |
7 |
9 |
|
Postimplantation Loss |
TOTAL |
5 |
1 |
3 |
2 |
|
|
MEAN |
0.6 D |
0.1 |
0.4 |
0.2 |
|
|
S.D. |
0.88 |
0.35 |
0.79 |
0.44 |
|
|
N |
9 |
8 |
7 |
9 |
|
% Postimplantation Loss |
MEAN |
13.8 D |
1.6 |
28.6 |
1.4 |
|
|
S.D. |
32.82 |
4.42 |
48.80 |
2.83 |
|
|
TEST GROUP 0 0 MG/KGBW/D |
TEST GROUP 1 100 MG/KG BW/D |
TEST GROUP 2 300 MG/KG BW/D |
TEST GROUP 3 1000 MG/KG BW/D |
|
Females with Liveborn |
N |
8Fi |
8 |
5 |
9 |
Gestation Index |
% |
89 |
100 |
71 |
100 |
with Stillborn Pups |
N |
0Fi |
1 |
0 |
0 |
|
% |
0.0 |
13 |
0.0 |
0.0 |
with all Stillborn |
N |
0Fi |
0 |
0 |
0 |
|
% |
0.0 |
0.0 |
0.0 |
0.0 |
Pups Delivered |
MEAN |
12.0 D |
11.1 |
13.6 |
13.4 |
|
S.D. |
0.93 |
2.80 |
2.07 |
1.81 |
|
TOTAL |
96 |
89 |
68 |
121 |
Liveborn |
N |
96Fi |
88 |
68 |
121 |
Live Birth Index |
% |
100 |
99 |
100 |
100 |
Stillborn |
N |
0Fi |
1 |
0 |
0 |
|
% |
0.0 |
1.1 |
0.0 |
0.0 |
Table 2: Summary of litter data
|
TEST GROUP0 0 MG/KGBW/D |
TEST GROUP 1 100 MG/KG BW/D |
TEST GROUP 2 300 MG/KG BW/D |
TEST GROUP 3 1000 MG/KG BW/D |
|
(Total Number of) Litters |
N |
8 |
8 |
5 |
9 |
Litters with LivebornPups |
N |
8Fi |
8 |
5 |
9 |
|
% |
100 |
100 |
100 |
100 |
Litters with StillbornPups |
N |
0Fi |
1 |
0 |
0 |
|
% |
0.0 |
13 |
0.0 |
0.0 |
Litters with all Stillborn Pups |
N |
0Fi |
0 |
0 |
0 |
|
% |
0.0 |
0.0 |
0.0 |
0.0 |
Pups Delivered |
TOTAL |
96 |
89 |
68 |
121 |
|
MEAN |
12.0 D |
11.1 |
13.6 |
13.4 |
|
S.D. |
0.93 |
2.80 |
2.07 |
1.81 |
Pups Liveborn |
N |
96Fi |
88 |
68 |
121 |
|
% |
100 |
99 |
100 |
100 |
Pups Stillborn |
N |
0Fi |
1 |
0 |
0 |
|
% |
0.0 |
1.1 |
0.0 |
0.0 |
Pups Died |
N |
0Fi |
1 |
0 |
1 |
|
% |
0.0 |
1.1 |
0.0 |
0.8 |
Pups Sacrificed Moribund |
N |
0Fi |
0 |
0 |
0 |
|
% |
0.0 |
0.0 |
0.0 |
0.0 |
Pups Cannibalized |
N |
0Fi |
0 |
0 |
0 |
|
% |
0.0 |
0.0 |
0.0 |
0.0 |
Pups Accidental Death |
N |
0 |
0 |
0 |
0 |
|
% |
0.0 |
0.0 |
0.0 |
0.0 |
Pups Sacrificed, Maternal Death |
N |
0 |
0 |
0 |
0 |
|
% |
0.0 |
0.0 |
0.0 |
0.0 |
|
TEST GROUP0 0 MG/KGBW/D |
TEST GROUP 1 100 MG/KG BW/D |
TEST GROUP 2 300 MG/KG BW/D |
TEST GROUP 3 1000 MG/KG BW/D |
|
Pups dead day 0 |
N |
0 |
0 |
0 |
0 |
|
% |
0.0 |
0.0 |
0.0 |
0.0 |
days 1 to 4 |
N |
0 |
1 |
0 |
1 |
|
% |
0.0 |
1.1 |
0.0 |
0.8 |
Pups Surviving days O to 4 |
N |
96Fi |
87 |
68 |
120 |
Viability Index |
% |
100 |
99 |
100 |
99 |
Table 3: Summary of necropsy observations
|
TEST GROUP0 0 MG/KGBW/D |
TEST GROUP 1 100 MG/KG BW/D |
TEST GROUP 2 300 MG/KG BW/D |
TEST GROUP 3 1000 MG/KG BW/D |
|
Litters Evaluated |
N |
8 |
8 |
5 |
9 |
Pups Evaluated |
N |
95 |
89 |
68 |
120 |
Live |
N |
95 |
88 |
68 |
120 |
Stillborn |
N |
0 |
1 |
0 |
0 |
HEART, SITUS INVERSUS |
|
|
|
|
|
Pup Incidence |
N |
0 |
0 |
0 |
1 |
|
% |
0.0 |
0.0 |
0.0 |
0.8 |
Litter Incidence |
N |
0Fi |
0 |
0 |
1 |
|
% |
0.0 |
0.0 |
0.0 |
11 |
Affected Pups/Litter |
MEAN% |
0.0Wi |
0.0 |
0.0 |
0.7 |
|
S.D. |
0.00 |
0.00 |
0.00 |
1.96 |
TOTAL PUP NECROPSY OBSERVATIONS |
|
|
|
|
|
Pup Incidence |
N |
0 |
0 |
0 |
1 |
|
% |
0.0 |
0.0 |
0.0 |
0.8 |
Litter Incidence |
N |
0Fi |
0 |
0 |
1 |
|
% |
0.0 |
0.0 |
0.0 |
11 |
Affected Pups/Litter |
MEAN% |
0.0Wi |
0.0 |
0.0 |
0.7 |
|
S.D. |
0.00 |
0.00 |
0.00 |
1.96 |
Statistics: D=Dunnett-test (two-sided); Fi =Fisher's exact test (one-sided); Wi=Wilcoxon-test (one-sided)
* : p<=0.05 ** : p<=0.01
Applicant's summary and conclusion
- Conclusions:
- Under the conditions of this Combined Repeated Dose Toxicity Study with the Reproduction/Developmental Toxicity Screening Test the oral administration by gavage to male and female Wistar rats did not reveal signs of toxicity. The NOAEL for reproductive performance, fertility and developmental toxicity was set to 1000 mg/kg bw/d in male and female Wistar rats.
- Executive summary:
A study according to OECD Guideline 422 was performed.
Under the conditions of this Combined Repeated Dose Toxicity Study with the Reproduction/Developmental Toxicity Screening Test the oral administration by gavage to male and female Wistar rats did not reveal signs of toxicity. The NOAEL for reproductive performance, fertility and developmental toxicity was set to 1000 mg/kg bw/d in male and female Wistar rats.
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