Registration Dossier

Administrative data

Key value for chemical safety assessment

Toxic effect type:
dose-dependent

Effects on fertility

Description of key information

Based on the available results and applying the weight of evidence approach, the NOAEL for maternal animals and fetus can be considered to be 1180 mg/kg/day. Hence, the test chemical can be considered to non-reprotoxic and classified under the category “Not Classified” as per CLP Regulation.

Link to relevant study records
Reference
Endpoint:
screening for reproductive / developmental toxicity
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
data from handbook or collection of data
Remarks:
Weight of evidence approach based on various test chemicals
Justification for type of information:
Weight of evidence approach based on various test chemicals
Reason / purpose for cross-reference:
read-across source
Reason / purpose for cross-reference:
read-across source
Qualifier:
according to guideline
Guideline:
other: Weight of evidence approach based on various test chemicals
Principles of method if other than guideline:
Weight of evidence approach based on various test chemicals
GLP compliance:
not specified
Limit test:
no
Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals or test system and environmental conditions:
2. TEST ANIMALS

- Weight at study initiation: (P) Males: x-x g; Females: x-x g; (F1) Males: x-x g; Females: x-x g
: females: 175-225 g in body weight
Route of administration:
other: 2. oral: gavage; 3. oral: feed
Type of inhalation exposure (if applicable):
not specified
Vehicle:
other: 2. corn oil; 3. feed
Details on exposure:
2. PREPARATION OF DOSING SOLUTIONS: test doses, representing the levels of the composite samples and not the active ingredients, on a per kg basis were 125, 250 or 500 mg of the test chemical suspended in corn oil

VEHICLE
- Justification for use and choice of vehicle (if other than water):
- Concentration in vehicle: The volume of vehicle or vehicle plus chemical was 10 ml/kg body weight.
- Amount of vehicle (if gavage): The volume of vehicle or vehicle plus chemical was 10 ml/kg body weight.
Details on mating procedure:
2. - M/F ratio per cage: Female Wistar rats were paired overnight with proven males, and the morning that a positive vaginal smear was observed was counted as day 1 of gestation.
- Length of cohabitation:
- Proof of pregnancy: [vaginal plug / sperm in vaginal smear] referred to as [day 0 / day 1] of pregnancy: Female Wistar rats were paired overnight with proven males, and the morning that a positive vaginal smear was observed was counted as day 1 of gestation.
3. - M/F ratio per cage: 1:1
- Other:There were two litters in the first generation and one in the second. Parents were mated 1:1 after approximately 10 weeks of exposure to the test chemical for the F1a and F2a litters.For the F1b mating, parents were paired 10 days after weaning of the F1a pups.
Analytical verification of doses or concentrations:
yes
Details on analytical verification of doses or concentrations:
3. Groups of Wistar (Chbb=Thom (SPF)) rats (24 of each sex per group) received diets containing the test chemical at 0, 1000, 4000 or 12 000 ppm. Achieved intakes were reported to be approximately 0, 96, 381 and 1180 mg/kg bw per day at 0, 1000, 4000 and 12 000 ppm, respectively.
Duration of treatment / exposure:
2. day 6 to day 15 of gestation
3. second generation
Frequency of treatment:
2, 3. daily
Remarks:
Study 2: 0, 125, 250, 500 mg/kg/day
Remarks:
Study 3: diets containing the test chemical at 0, 1000, 4000 or 12 000 ppm - nominal; actual intake - 0, 96, 381 and 1180 mg/kg bw per day
No. of animals per sex per dose:
2. Twenty mated females, randomly selected, were assigned to each experimental group
3. 24 of each sex per group
Control animals:
yes, concurrent vehicle
Parental animals: Observations and examinations:
2. CAGE SIDE OBSERVATIONS: Yes / No / No data: yes
- Time schedule:
- Cage side observations checked in table [No.?] were included.

DETAILED CLINICAL OBSERVATIONS: Yes / No / No data
- Time schedule:

BODY WEIGHT: Yes / No / No data: yes
- Time schedule for examinations:Females were weighed at frequent intervals during gestation.
3. CAGE SIDE OBSERVATIONS: Yes / No / No data: yes
- Time schedule:
- Cage side observations checked in table [No.?] were included.

DETAILED CLINICAL OBSERVATIONS: Yes / No / No data: yes
- Time schedule:

BODY WEIGHT: Yes / No / No data: yes
- Time schedule for examinations:

FOOD CONSUMPTION AND COMPOUND INTAKE (if feeding study): yes
- Food consumption for each animal determined and mean daily diet consumption calculated as g food/kg body weight/day: Yes / No / No data
- Compound intake calculated as time-weighted averages from the consumption and body weight gain data: Yes / No / No data

WATER CONSUMPTION AND COMPOUND INTAKE (if drinking water study): Yes / No / No data
- Time schedule for examinations:

OTHER:
Litter observations:
2. STANDARDISATION OF LITTERS
- Performed on day 4 postpartum: [yes/no]
- If yes, maximum of [...] pups/litter ([...]/sex/litter as nearly as possible); excess pups were killed and discarded.

PARAMETERS EXAMINED
The following parameters were examined in [F1 / F2 / F3] offspring:
[number and sex of pups, stillbirths, live births, postnatal mortality, presence of gross anomalies, weight gain, physical or behavioural abnormalities, anogenital distance (AGD), pup weight on the day of AGD, presence of nipples/areolae in male pups, other. Particular attention should be paid to the external reproductive genitals which should be examined for signs of altered development; gross evaluation of external genitalia]

GROSS EXAMINATION OF DEAD PUPS:
[no / yes, for external and internal abnormalities; possible cause of death was/was not determined for pups born or found dead]

3. STANDARDISATION OF LITTERS
- Performed on day 4 postpartum: [yes/no]
- If yes, maximum of [...] pups/litter ([...]/sex/litter as nearly as possible); excess pups were killed and discarded.

PARAMETERS EXAMINED
The following parameters were examined in [F1 / F2 / F3] offspring:

[number and sex of pups, stillbirths, live births, postnatal mortality, presence of gross anomalies, weight gain, physical or behavioural abnormalities, anogenital distance (AGD), pup weight on the day of AGD, presence of nipples/areolae in male pups, other. Particular attention should be paid to the external reproductive genitals which should be examined for signs of altered development; gross evaluation of external genitalia]
: pup survival, and physical and behavioural development (ear and eye opening, grip strength and pupillary reflex) were recorded. No evaluation of date of sexual maturation was included in the protocol.
Postmortem examinations (parental animals):
2. SACRIFICE
- Male animals: All surviving animals [describe when, e.g. as soon as possible after the last litters in each generation were produced.]
- Maternal animals: All surviving animals [describe when, e.g. after the last litter of each generation was weaned.]: On the 22nd day of gestation, each dam was killed, its uterine contents removed, its
number of corpora lutea determined, and was then necropsied.

GROSS NECROPSY
- Gross necropsy consisted of [external and internal examinations including the cervical, thoracic, and abdominal viscera.]: On the 22nd day of gestation, each
dam was killed, its uterine contents removed, its number of corpora lutea determined, and was then necropsied.

HISTOPATHOLOGY / ORGAN WEIGHTS
The tissues indicated in Table [#] were prepared for microscopic examination and weighed, respectively.
3. SACRIFICE
- Male animals: All surviving animals [describe when, e.g. as soon as possible after the last litters in each generation were produced.]
- Maternal animals: All surviving animals [describe when, e.g. after the last litter of each generation was weaned.]

GROSS NECROPSY
- Gross necropsy consisted of [external and internal examinations including the cervical, thoracic, and abdominal viscera.]: All parental animals were necropsied after weaning of their offspring and subjected to pathological examination.

HISTOPATHOLOGY / ORGAN WEIGHTS
The tissues indicated in Table [#] were prepared for microscopic examination and weighed, respectively.
Postmortem examinations (offspring):
2. SACRIFICE
- The F1 offspring not selected as parental animals and all F2 offspring were sacrificed at [#?] days of age.
- These animals were subjected to postmortem examinations (macroscopic and/or microscopic examination) as follows:

GROSS NECROPSY
- Gross necropsy consisted of [external and internal examinations including the cervical, thoracic, and abdominal viscera.]

HISTOPATHOLOGY / ORGAN WEIGTHS
The tissues indicated in Table [#] were prepared for microscopic examination and weighed, respectively.: The fetuses were weighed and examined for viabilitand external malformations. Early resorptions
or implantation sites and fetuses dying at a late stage in their development, were recorded. Two-thirds of the live fetuses from each litter were examined for skeletal development after alizarin red staining. The remainder, fixed in Bouin's fluid, were dissected to study visceral anomalies.
3. SACRIFICE
- The F1 offspring not selected as parental animals and all F2 offspring were sacrificed at [#?] days of age.
- These animals were subjected to postmortem examinations (macroscopic and/or microscopic examination) as follows:

GROSS NECROPSY
- Gross necropsy consisted of [external and internal examinations including the cervical, thoracic, and abdominal viscera.]: A gross necropsy examination was performed on all pups not selected for mating. Further examinations were performed on any pups found dead or dying or showing macroscopic changes.

HISTOPATHOLOGY / ORGAN WEIGTHS
The tissues indicated in Table [#] were prepared for microscopic examination and weighed, respectively.
Statistics:
2. To determine effects on maternal body weight, the mean and standard error were calculated for each experimental group, and values of t_ were obtained for test and control group differences in means. Fetal values were analysed with the litter as the basic unit. The proportion (p_) of litter having a particular attribute was calculated and transformed to a normally distributed variable arc sin/p_ value . The mean and standard error of these values for various.test groups were then derived . The t_ test was used for comparison of test and the respective control values.
Clinical signs:
no effects observed
Description (incidence and severity):
2. No sign of toxicity was noticed during pregnancy, in any treatment or control group
3. No adverse effects were observed
Mortality:
no mortality observed
Description (incidence):
3. No adverse effects were observed
Body weight and weight changes:
no effects observed
Description (incidence and severity):
2. Any adverse effect on maternal body weight was noticed during pregnancy, in any treatment or control group
3. No adverse effects were observed
Food consumption and compound intake (if feeding study):
no effects observed
Description (incidence and severity):
3. No adverse effects were observed
Food efficiency:
not specified
Water consumption and compound intake (if drinking water study):
not specified
Ophthalmological findings:
not specified
Haematological findings:
not specified
Clinical biochemistry findings:
not specified
Urinalysis findings:
not specified
Behaviour (functional findings):
not specified
Immunological findings:
not specified
Organ weight findings including organ / body weight ratios:
no effects observed
Histopathological findings: non-neoplastic:
no effects observed
Description (incidence and severity):
2. No adverse effect was related to any treatment were observed
3. Examination of the parental animals did not identify any adverse effects of test chemical administration
Histopathological findings: neoplastic:
not specified
Other effects:
not specified
Reproductive function: oestrous cycle:
not specified
Reproductive function: sperm measures:
not specified
Reproductive performance:
no effects observed
Description (incidence and severity):
2. Number of females pregnant in the different test groups varied within the control range and was unrelated to treatment.Resorption of fetuses at 125 mg/kg was increased, although not significantly .
3. There was no effect on mating, fertility, pregnancy outcome, litter size.
Dose descriptor:
NOAEL
Effect level:
1 180 mg/kg bw/day (nominal)
Based on:
test mat.
Sex:
male/female
Basis for effect level:
clinical signs
mortality
body weight and weight gain
food consumption and compound intake
organ weights and organ / body weight ratios
gross pathology
histopathology: non-neoplastic
reproductive performance
Critical effects observed:
no
Clinical signs:
not specified
Dermal irritation (if dermal study):
not specified
Mortality:
not specified
Body weight and weight changes:
no effects observed
Description (incidence and severity):
3. Significant reductions in maternal body weight gain were seen in males and in females during pregnancy and lactation at 12 000 ppm in the F1 matings
Food consumption and compound intake (if feeding study):
not specified
Food efficiency:
not specified
Water consumption and compound intake (if drinking water study):
not specified
Ophthalmological findings:
not specified
Haematological findings:
not specified
Clinical biochemistry findings:
not specified
Urinalysis findings:
not specified
Behaviour (functional findings):
no effects observed
Description (incidence and severity):
3. Attainment of physical developmental markers and behavioural results were similar in all groups of pups
Immunological findings:
not specified
Organ weight findings including organ / body weight ratios:
no effects observed
Description (incidence and severity):
3. There were no adverse findings in the reproductive organs
Gross pathological findings:
no effects observed
Description (incidence and severity):
3. There were no adverse findings in the reproductive organs
Neuropathological findings:
not specified
Histopathological findings: non-neoplastic:
no effects observed
Description (incidence and severity):
3. Top-dose female, but not male, parents had an increased incidence of nephritis in both generations, but a reduction in calcification in F1 parents
Histopathological findings: neoplastic:
not specified
Other effects:
not specified
Reproductive function: oestrous cycle:
not specified
Reproductive function: sperm measures:
not specified
Reproductive performance:
no effects observed
Description (incidence and severity):
3. There was no effect on mating, fertility, pregnancy outcome, litter size.
Dose descriptor:
NOAEL
Effect level:
1 180 mg/kg bw/day (nominal)
Based on:
test mat.
Sex:
male/female
Basis for effect level:
clinical signs
body weight and weight gain
organ weights and organ / body weight ratios
gross pathology
histopathology: neoplastic
reproductive performance
Critical effects observed:
no
Clinical signs:
not specified
Dermal irritation (if dermal study):
not specified
Mortality / viability:
no mortality observed
Description (incidence and severity):
3. There was no effect on Pup survival in all the generations
Body weight and weight changes:
effects observed, treatment-related
Description (incidence and severity):
3. Pup body weights were similar to control values at birth, but were significantly lower by day 21 at 12000 ppm in all generations
Food consumption and compound intake (if feeding study):
not specified
Food efficiency:
not specified
Water consumption and compound intake (if drinking water study):
not specified
Ophthalmological findings:
not specified
Haematological findings:
not specified
Clinical biochemistry findings:
not specified
Urinalysis findings:
not specified
Sexual maturation:
not specified
Organ weight findings including organ / body weight ratios:
no effects observed
Description (incidence and severity):
3. Examinations of pups and parental animals did not identify any adverse effects of the test chemical administration
Gross pathological findings:
no effects observed
Description (incidence and severity):
3. Examinations of pups and parental animals did not identify any adverse effects of the test chemical administration
Histopathological findings:
no effects observed
Description (incidence and severity):
2. The incidence of anomalous fetuses in the 250 mg/kg group was borderline significant (p--0 .05) and it was noted that this was most likely not significant in relation to the absence of significant findings in the 500mg/kg dose group
3. Examinations of pups and parental animals did not identify any adverse effects of the test chemical administration
Other effects:
not specified
Behaviour (functional findings):
no effects observed
Description (incidence and severity):
3. Attainment of physical developmental markers and behavioural results were similar in all groups of pups.
Developmental immunotoxicity:
not specified
Dose descriptor:
NOAEL
Generation:
F1
Effect level:
1 180 mg/kg bw/day (nominal)
Based on:
test mat.
Sex:
male/female
Basis for effect level:
viability
clinical signs
body weight and weight gain
organ weights and organ / body weight ratios
gross pathology
histopathology: non-neoplastic
Critical effects observed:
no
Clinical signs:
not specified
Dermal irritation (if dermal study):
not specified
Mortality / viability:
no mortality observed
Description (incidence and severity):
3. There was no effect on Pup survival in all the generations
Body weight and weight changes:
no effects observed
Description (incidence and severity):
3. Pup body weights were similar to control values at birth, but were significantly lower by day 21 at 12000 ppm in all generations
Food consumption and compound intake (if feeding study):
not specified
Food efficiency:
not specified
Water consumption and compound intake (if drinking water study):
not specified
Ophthalmological findings:
not specified
Haematological findings:
not specified
Clinical biochemistry findings:
not specified
Urinalysis findings:
not specified
Sexual maturation:
not specified
Organ weight findings including organ / body weight ratios:
no effects observed
Description (incidence and severity):
3. There were no adverse findings in the reproductive organs
Gross pathological findings:
no effects observed
Description (incidence and severity):
3. Examinations of pups and parental animals did not identify any adverse effects of the test chemical administration
Histopathological findings:
no effects observed
Description (incidence and severity):
3. Examinations of pups and parental animals did not identify any adverse effects of the test chemical administration
Other effects:
not specified
Behaviour (functional findings):
not specified
Developmental immunotoxicity:
not specified
Dose descriptor:
NOAEL
Generation:
F2
Effect level:
1 180 mg/kg bw/day (nominal)
Based on:
test mat.
Sex:
male/female
Basis for effect level:
viability
clinical signs
body weight and weight gain
organ weights and organ / body weight ratios
gross pathology
histopathology: non-neoplastic
Critical effects observed:
no
Reproductive effects observed:
no
Conclusions:
Based on the available results and applying the weight of evidence approach, the NOAEL for maternal animals and fetus can be considered to be 1180 mg/kg/day. Hence, the test chemical can be considered to non-reprotoxic and classified under the category “Not Classified” as per CLP Regulation.
Executive summary:

Various studies have been reviewed to determine the reproductive toxicity potential of the test chemical. These include in vivo experimental studies performed on rats for the test chemicals. The results are mentioned below:

Teratogenicity studies were conducted in rats treated orally from days 6-15 of gestation with single daily doses of the test chemical. Pregnant female Wistar rats (20 per group) received the following test doses of the test chemical suspended in com oil once per day by esophageal intubation: 0, 125, 250, or 500 mg/kg from day 6 to 15 of gestation. On the 22nd day of gestation, dams were killed and uterine contents were removed and analyzed . Females were weighed at frequent intervals during gestation. On the 22nd day of gestation, each dam was killed, its uterine contents removed, its number of corpora lutea determined, and was then necropsied. The fetuses were weighed and examined for viability nd external malformations. Early resorptions or implantation sites and fetuses dying at a late stage in their development, were recorded. Two-thirds of the live fetuses from each litter were examined for skeletal development after alizarin red staining. The remainder, fixed in Bouin's fluid, were dissected to study visceral anomalies. No signs of toxicity or any adverse effects were seen in the dams . Resorption of fetuses at 125 mg/kg was increased, although not significantly. The incidence of anomalous fetuses in the 250 mg/kg group was borderline significant (p--0 .05). It was noted that this was most likely not significant in relation to the absence of significant findings in the 500 mg/kg dose group. Hence, the NOAEL can be considered to be 500 mg/kg/day for maternal rats and fetus.

This result is supported by a multi-generational study performed to determine the toxicity potential of the test chemical.Groups of Wistar (Chbb=Thom (SPF)) rats (24 of each sex per group) received diets containing the test chemical at 0, 1000, 4000 or 12 000 ppm. Achieved intakes were reported to be approximately 0, 96, 381 and 1180 mg/kg bw per day at 0, 1000, 4000 and 12 000 ppm, respectively. There were two litters in the first generation and one in the second. Parents were mated 1:1 after approximately 10 weeks of exposure to the test chemical for the F1a and F2a litters. For the F1b mating, parents were paired 10 days after weaning of the F1a pups. Litters were not culled on day 4 postpartum. Clinical signs, body weights, feed consumption, mating parameters, gestation and delivery parameters, pup survival, and physical and behavioural development (ear and eye opening, grip strength and pupillary reflex) were recorded. No evaluation of date of sexual maturation was included in the protocol. A gross necropsy examination was performed on all pups not selected for mating. Further examinations were performed on any pups found dead or dying or showing macroscopic changes. All parental animals were necropsied after weaning of their offspring and subjected to pathological examination.There was no effect on mating, fertility, pregnancy outcome, litter size or pup survival. Significant reductions in maternal body weight gain were seen in males and in females during pregnancy and lactation at 12 000 ppm in the F1 matings. Pup body weights were similar to control values at birth, but were significantly lower by day 21 at 12 000 ppm in all generations. Examinations of pups and parental animals did not identify any adverse effects of the test chemical administration. Attainment of physical developmental markers and behavioural results were similar in all groups of pups. Top-dose female, but not male, parents had an increased incidence of nephritis in both generations, but a reduction in calcification in F1 parents. There were no adverse findings in the reproductive organs. The NOAEL for reproductive toxicity was 12 000 ppm (equivalent to 1180 mg/kg bw per day), the highest dose tested.

Based on the available results and applying the weight of evidence approach, the NOAEL for maternal animals and fetus can be considered to be 1180 mg/kg/day. Hence, the test chemical can be considered to non-reprotoxic and classified under the category “Not Classified” as per CLP Regulation.

Effect on fertility: via oral route
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
NOAEL
1 180 mg/kg bw/day
Study duration:
chronic
Species:
rat
Quality of whole database:
Klimisch Rating 2
Effect on fertility: via inhalation route
Endpoint conclusion:
no study available
Effect on fertility: via dermal route
Endpoint conclusion:
no study available
Additional information

Toxicity to reproduction

Various studies have been reviewed to determine the reproductive toxicity potential of the test chemical. These include in vivo experimental studies performed on rats for the test chemicals. The results are mentioned below:

Teratogenicity studies were conducted in rats treated orally from days 6-15 of gestation with single daily doses of the test chemical. Pregnant female Wistar rats (20 per group) received the following test doses of the test chemical suspended in com oil once per day by esophageal intubation: 0, 125, 250, or 500 mg/kg from day 6 to 15 of gestation. On the 22nd day of gestation, dams were killed and uterine contents were removed and analyzed . Females were weighed at frequent intervals during gestation. On the 22nd day of gestation, each dam was killed, its uterine contents removed, its number of corpora lutea determined, and was then necropsied. The fetuses were weighed and examined for viability nd external malformations. Early resorptions or implantation sites and fetuses dying at a late stage in their development, were recorded. Two-thirds of the live fetuses from each litter were examined for skeletal development after alizarin red staining. The remainder, fixed in Bouin's fluid, were dissected to study visceral anomalies. No signs of toxicity or any adverse effects were seen in the dams . Resorption of fetuses at 125 mg/kg was increased, although not significantly. The incidence of anomalous fetuses in the 250 mg/kg group was borderline significant (p--0 .05). It was noted that this was most likely not significant in relation to the absence of significant findings in the 500 mg/kg dose group. Hence, the NOAEL can be considered to be 500 mg/kg/day for maternal rats and fetus.

This result is supported by a multi-generational study performed to determine the toxicity potential of the test chemical.Groups of Wistar (Chbb=Thom (SPF)) rats (24 of each sex per group) received diets containing the test chemical at 0, 1000, 4000 or 12 000 ppm. Achieved intakes were reported to be approximately 0, 96, 381 and 1180 mg/kg bw per day at 0, 1000, 4000 and 12 000 ppm, respectively. There were two litters in the first generation and one in the second. Parents were mated 1:1 after approximately 10 weeks of exposure to the test chemical for the F1a and F2a litters. For the F1b mating, parents were paired 10 days after weaning of the F1a pups. Litters were not culled on day 4 postpartum. Clinical signs, body weights, feed consumption, mating parameters, gestation and delivery parameters, pup survival, and physical and behavioural development (ear and eye opening, grip strength and pupillary reflex) were recorded. No evaluation of date of sexual maturation was included in the protocol. A gross necropsy examination was performed on all pups not selected for mating. Further examinations were performed on any pups found dead or dying or showing macroscopic changes. All parental animals were necropsied after weaning of their offspring and subjected to pathological examination.There was no effect on mating, fertility, pregnancy outcome, litter size or pup survival. Significant reductions in maternal body weight gain were seen in males and in females during pregnancy and lactation at 12 000 ppm in the F1 matings. Pup body weights were similar to control values at birth, but were significantly lower by day 21 at 12 000 ppm in all generations. Examinations of pups and parental animals did not identify any adverse effects of the test chemical administration. Attainment of physical developmental markers and behavioural results were similar in all groups of pups. Top-dose female, but not male, parents had an increased incidence of nephritis in both generations, but a reduction in calcification in F1 parents. There were no adverse findings in the reproductive organs. The NOAEL for reproductive toxicity was 12 000 ppm (equivalent to 1180 mg/kg bw per day), the highest dose tested.

Based on the available results and applying the weight of evidence approach, the NOAEL for maternal animals and fetus can be considered to be 1180 mg/kg/day. Hence, the test chemical can be considered to non-reprotoxic and classified under the category “Not Classified” as per CLP Regulation.

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

Based on the available results and applying the weight of evidence approach, the NOAEL for maternal animals and fetus can be considered to be 1180 mg/kg/day. Hence, the test chemical can be considered to non-reprotoxic and classified under the category “Not Classified” as per CLP Regulation.

Additional information