Barium 3-hydroxy-4-[(4-methyl-2-sulphonatophenyl)azo]-2-naphthoate

Endpoint summary

Description of key information

Repeated dose oral toxicity:

NOAEL was considered to be 1000-1500 mg/kg bw when mice and rat treated with test chemical.

Hence the test chemical is not likely to classify as a repeated dose oral toxicity as per the criteria mentioned in CLP regulation.

Repeated dose inhalation toxicity:

The test substance has very low vapor pressure, high melting point and low partial size, so the potential for the generation of inhalable forms is low, also the normal conditions of use of this substance will not result in aerosols, particles or droplets of an inhalable size, so exposure to humans via the inhalatory route will be unlikely to occur, and therefore repeated dose toxicity by inhalation route was considered to be waived.

Repeated dose dermal toxicity:

In accordance with coloumn 2 of Annex IX, this end point was considered for waiver since the acute toxicity by the dermal route has already been provided in section 7.2.3 (as part of the Annex VIII information requirements)

Key value for chemical safety assessment

Repeated dose toxicity: via oral route - systemic effects

Link to relevant study records

Reference

Endpoint:

sub-chronic toxicity: oral

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:

Experimental data of structurally similar chemicals

Justification for type of information:

Data for the target chemical is summarized based on the structurally similar chemicals

Qualifier:

according to guideline

Guideline:

other: as below

Principles of method if other than guideline:

WoE report is based on two reproductive toxicity studies on rats 1.To evaluate the toxicity of test chemical in male and female mice by chronic study.2.Chronic toxicity study was conducted to evaluate the toxic potential of test chemical in CD male and female rats by oral feed.

GLP compliance:

not specified

Limit test:

no

Species:

other: 1. Mice, 2. Rat

Strain:

other: 1.CD-1, 2. Charies river CD®

Sex:

male/female

Details on test animals or test system and environmental conditions:

1.- Age at study initiation: (P) x wks; (F1) x wks: P: 36 days- Weight at study initiation: (P) Males: 24-30 g, Female: 20-24 g- Fasting period before study: No data available- Housing: Animals were housed individually in suspended wire mesh cages and identified ear tagged.- Diet (e.g. ad libitum): Basal laboratory diet, ad libitum. Change from Rodent Laboratory Chow@#5001 toCertified Rodent Chow.- Water (e.g. ad libitum): water, ad libitum- Acclimation period: 2 weeksENVIRONMENTAL CONDITIONS- Temperature (°C): 71 °- Humidity (%): 53 %- Air changes (per hr): No data available- Photoperiod (hrs dark / hrs light): 12 hr light/12hr dark2.- Source: Charies river Breeding Laboratories. Iac. Wilningeon- Age at study initiation: (P) x wks; (F1) x wks: P: 36 days- Weight at study initiation: (P) Males: 75-155 g, Female: 75-114 g- Fasting period before study: No data available- Housing: Animals were housed individually in hanging wire mash cages.- Diet (e.g. ad libitum): Purina Laboratory diet, ad libitum. During post weaning segment Purina Laboratory diet, Rodent Laboratory Chow@#5001 and Certified Rodent Chow were used respectively.- Water (e.g. ad libitum): Tap water, ad libitum- Acclimation period: 15 daysENVIRONMENTAL CONDITIONS- Temperature (°C): 71 °- Humidity (%): 53 %- Air changes (per hr): No data available- Photoperiod (hrs dark / hrs light): 12 hr light/12hr dark

Route of administration:

oral: feed

Vehicle:

other: 1 & 2. Purina Laboratory diet

Analytical verification of doses or concentrations:

not specified

Duration of treatment / exposure:

1. 2 years, 2. 126 week

Frequency of treatment:

Daily

Remarks:

1. 0, 75, 1500 and 7500 mg/kg bw

Remarks:

0, 25, 150 and 1000 mg/kg bw

No. of animals per sex per dose:

1. Total : 6000 mg/kg body weight/day: 60 male, 60 Female0 mg/kg body weight/day: 60 male, 60 Female75 mg/kg body weight/day: 60 male, 60 Female1500 mg/kg body weight/day: 60 male, 60 Female7500 mg/kg body weight/day: 60 male, 60 Female2. Total : 1300F0 generation0 mg/kg body weight/day: 60 male, 60 Female0 mg/kg body weight/day: 60 male, 60 Female25 mg/kg body weight/day: 60 male, 60 Female150 mg/kg body weight/day: 60 male, 60 Female1000 mg/kg body weight/day: 60 male, 60 FemaleF1 generation0 mg/kg body weight/day: 70 male, 70 Female0 mg/kg body weight/day: 70 male, 70 Female25 mg/kg body weight/day: 70 male, 70 Female150 mg/kg body weight/day: 70 male, 70 Female1000 mg/kg body weight/day: 70 male, 70 Female

Control animals:

yes, concurrent vehicle

Details on study design:

Not specified.

Positive control:

Not specified.

Observations and examinations performed and frequency:

1. CAGE SIDE OBSERVATIONS: Yes- Time schedule: The mice were observed thrice daily (Monday to Friday) and twice daily (weekend and holiday) for toxicity, morbidity and mortality.DETAILED CLINICAL OBSERVATIONS: Yes- Time schedule: Detail observation recorded weekly.BODY WEIGHT: Yes- Time schedule for examinations: Individual body weight were recorded weekly during the first 14 weeks of study, biweekly (the second seven days of every 2 weeks) during the next 12 weeks and monthly (seven days during the third week of each month.FOOD CONSUMPTION AND COMPOUND INTAKE (if feeding study):- Food consumption for each animal determined and mean daily diet consumption calculated as g food/kg body weight/day: Yes , Individual food consumption were recorded weekly during the first 14 weeks of study, biweekly (the second seven days of every 2 weeks) during the next 12 weeks and monthly (seven days during the third week of each month.- Compound intake calculated as time-weighted averages from the consumption and body weight gaindata: Yes / No / No dataFOOD EFFICIENCY:- Body weight gain in kg/food consumption in kg per unit time X 100 calculated as time-weighted averages from the consumption and body weight gain data: Yes ,but available on request ,but not in this paper.WATER CONSUMPTION AND COMPOUND INTAKE (if drinking water study): Yes, but available on request, but not in this paper.OPHTHALMOSCOPIC EXAMINATION: No data availableHAEMATOLOGY: Yes- Time schedule for collection of blood: On 3, 6, 12 and 18 month.- Anaesthetic used for blood collection: Yes (identity) / No / No data- Animals fasted: No data available- How many animals: 10 /mice /sex/group- Parameters checked in table [No.?] were examined.CLINICAL CHEMISTRY: Yes / No / No data- Time schedule for collection of blood:- Animals fasted: Yes / No / No data- How many animals:- Parameters checked in table [No.?] were examined.URINALYSIS: YesNEUROBEHAVIOURAL EXAMINATION: No data available.2. CAGE SIDE OBSERVATIONS: YesDETAILED CLINICAL OBSERVATIONS: YesF0; the clinical sign and mortality was observed twice dailyPups: the clinical sign and mortality was observed once dailyF1: the clinical sign and mortality was observed twice dailyBODY WEIGHT: Yes- Time schedule for examinations:F0; the body weight was observed weekly. For females body weight was observed individually on 0,6,15 and 21 of gestationPups: The pups were weighed as a litter on 1 and 4 day of lactation. Even on 21 day they were observed for lactation.F1: the body weight was observed weekly for first 14 weeks and biweekly for next 12 weeks and once mortality thereafter.FOOD CONSUMPTION AND COMPOUND INTAKE (if feeding study):- Food consumption for each animal determined and mean daily diet consumption calculated as g food/kgbody weight/day: Yes ,F0; the food consumption was observed weekly for 1st 10 weeks.F1: the food consumption was observed weekly for 1st 14 weeks. Biweekly (the second 7 days of every2 week)the next 12 weeks and once monthly (7 days during the last week of each month)- Compound intake calculated as time-weighted averages from the consumption and body weight gaindata: YesF0; Compound consumption was calculated from the diet consumption and body weight measurement.F1: Compound consumption was calculated from the diet consumption and body weight measurement.FOOD EFFICIENCY:- Body weight gain in kg/food consumption in kg per unit time X 100 calculated as time-weightedaverages from the consumption and body weight gain data: No data availableWATER CONSUMPTION AND COMPOUND INTAKE (if drinking water study): No data availableOPHTHALMOSCOPIC EXAMINATION: Yes- Time schedule for examinations:F0; the ophthalmoscopic examination was observed for all rats till 15.F1: the ophthalmoscopic examination was observed for all male rats on 3, 6,12, 18 and 21 month while 24 month for females..HAEMATOLOGY: - Yes, Blood was obtained by puncture of orbital sinus pleura.- Time schedule for collection of blood: During the3, 6,12, 18 and 21 of month for male while on 24month for females- Anaesthetic used for blood collection: No data available- Animals fasted: Yes- How many animals: 10 rats /sex were selected .While only 9 rats were selected from 1000 mg/kg/day at21 months.- Parameters checked in table [No.?] were examined. Hemoglobin, Haematocrits, Differential leukocytecount, Erythrocyte reticulocytes countCLINICAL CHEMISTRY: Yes, Blood was obtained by puncture of orbital sinus pleura.- Time schedule for collection of blood: During the3, 6,12, 18 and 21 of month for male while on 24 month for females- Anaesthetic used for blood collection: No data available- Animals fasted: Yes- How many animals: 10 rats /sex were selected .While only 9 rats were selected from 1000 mg/kg/day at21 months.- Parameters checked in table [No.?] were examined. Glucose ,BUN,SGOT,SGPT Creatinine and Serumtotal proteinURINALYSIS: Yes- Time schedule for collection of urine: 3, 6,12, 18 and 21 of month for female- Metabolism cages used for collection of urine: Yes- Animals fasted: Yes- Parameters checked in table [No.?] were examined. pH ,specific gravity, Quantative test for protein,glucose ,bilirubin, Ketones occult blood colour and appearance.NEUROBEHAVIOURAL EXAMINATION: No data availableOTHER: AT 20 months of study, blood was collected from 2 fasted rats /sex/group and send for virologyand microbiology test. The blood was taken from rat who was showing the sign of pulmonary distress.

Sacrifice and pathology:

1. GROSS PATHOLOGY: Yes ,After 24 month, all surviving mice were sacrificed by carbon dioxide asphyxiation. Complete external examination was performed, including all orifices, each carcasses and content of abdomen, thoracic and cranial cavities were examined.HISTOPATHOLOGY: Yes, The following tissue were weighed and fixed in buffered neutral formalin. Brain ,liver kidney and spleen , abdominal aorta ,adrenal (2)bone and bone marrow, blood amear2,eye, gall bladder,ovary,testis (2)epididymides, heart ,intestine, liver ,lung, lymph node, mammary gland,mandibular,salivary gland nerve pancreas, pituitary ,seminal vesicle, skeleton muscle, skin, spinal cord ,spleen,stomach,thymus,trachea, thyroid ,urinary bladder, uterus and prostrate.Other examinationsOTHER: Stool analysis was also performed2. GROSS PATHOLOGY: Yes,F1: After 12 months of the dietary consumption 10 rats / sex /group was scarified by carbon di oxide asphyxiation. Rats were observed for macroscopic changes in brain ,kidney ,liver, spleen, testes, thyroid, heart, uterus and ovaries.HISTOPATHOLOGY: Yes, Animals were observed for microscopic changes. The following tissue were stained with Hematoxylin and eosin abdominal aorta ,adrenal (2)bone and bone marrow, blood amear2,eye, gall bladder,ovary,testis (2)epididymides, heart ,intestine, liver ,lung, lymph node, mammary gland,mandibular,salivary gland nerve pancreas, pituitary ,seminal vesicle, skeleton muscle, skin, spinal cord ,spleen,stomach,thymus,trachea,thyroid ,urinary bladder, uterus and prostrate.

Statistics:

1. Statistically analysis was performed for two tailed pair wise statistical comparisons. Body weight, clinical pathology parameters, organ weight, compared by analysis of one way variances homoginicity of variances by Barrletts test and survival indices compared using Chi- square test were used.2. Statistically analysis were performed by using fertility indices, gestation 4, 14 and 21 day survival indices were compared by using Chi- square test and /or Fishur’s extract probability. The mean number of liveborn pups per litter and the litter mean per weight at day 0,4,14 and 21 were compared by analysis ofvariance (one way classification), Barletts test for homogenicty of variances and the appropriate t-test (for equal and unequal variances).For F1 rat: all pair wise statistical comparison were two tailed with the probability level for significance at 0.01. Body weight, food consumption and absolute and relative body weight were compared by analysis of variances and appropriate t-test. Data for animals with malignant tumors, with beings and all tumorscombined were analyzed separately by sex.Homogenicity was analysed by cor’s test and cehan-Breslow generalized Krunkal-Wallis test. For thehistopathologically

Clinical signs:

effects observed, non-treatment-related

Description (incidence and severity):

1. No significant changes were observed in treated group dose level 75, 1500 and 7500 mg/kg bw/day compare to control.2. F0; No statically significant change were observed in the treated rat at dose level of 0, 25, 150, or 1000 mg/kg bw/day compare to control.Pups: No statically significant change was observed in the treated rat at dose level of 0, 25, 150, or 1000 mg/kg bw/day compare to control.F1: No statically significant change were observed in the treated rat at dose level of 0, 25, 150, or 1000 mg/kg bw/day compare to control.

Description (incidence):

1. Mortality; Slight compound related increase in mortality was observed in male mice during last 6 months of study at 7500 mg/kg bw.2. MortalityF0; When treated with 150 mg/kg bw, 3 rats were died.When treated with 1000 mg/kg bw one rat died and in control 3 rats were died.Pups: No statically significant change were observed in the treated rat at dose level of 0, 25, 150, or 1000 mg/kg bw/day compare to control.F1: No statically significant change were observed in the treated rat at dose level of 0, 25, 150, or 1000 mg/kg bw/day compare to control.

Body weight and weight changes:

effects observed, treatment-related

Description (incidence and severity):

1. No significant changes were observed in treated group 75, 1500 and 7500 mg/kg bw/day compare to control.2. F0; No effect on body weight of treated rat was observed as comparable to control.F1: When treated with 1000 mg/kg bw, significant decrease in body weight was observed in male rat ascomparable to control.When treated with 25 and 150 mg/kg bw, slightly decreased body weight was observed as comparable to control.

Food consumption and compound intake (if feeding study):

effects observed, non-treatment-related

Description (incidence and severity):

1. No significant changes were observed in treated group 75, 1500 and 7500 mg/kg bw/day compare to control.2. F0; No effect on food consumption of treated male and female rats was observed as comparable to control.F1: No effect on food consumption of treated male and female offspring’s was observed as comparable to control.

Food efficiency:

not specified

Water consumption and compound intake (if drinking water study):

not specified

Ophthalmological findings:

no effects observed

Description (incidence and severity):

2. F0; No effect on Opthalmoscopic examination of treated male and female rats was observed as comparable to control.F1: No effect on Opthalmoscopic examination of treated male and female offspring’s was observed as comparable to control.

Haematological findings:

no effects observed

Description (incidence and severity):

1. No significant changes were observed in treated group dose level 75, 1500 and 7500 mg/kg bw/day compare to control.2. F0; No effect on Hematology of treated male and female rats was observed as comparable to control.F1: No effect on Hematology of treated male and female offspring’s was observed as comparable to control.

Clinical biochemistry findings:

no effects observed

Description (incidence and severity):

2. F0; No effect on clinical chemistry of treated male and female rats was observed as comparable to control.

Urinalysis findings:

no effects observed

Description (incidence and severity):

2. F0; No effect on urine analysis of treated male and female rats was observed as comparable to control.

Behaviour (functional findings):

not specified

Immunological findings:

not specified

Organ weight findings including organ / body weight ratios:

no effects observed

Description (incidence and severity):

1. No significant changes were observed in treated group dose level 75, 1500 and 7500 mg/kg bw/day compare to control.2. F0; No effect on organ weight of treated male and female rats was observed as compared to controlF1: No effect on organ weight of treated male and female offspring was observed as compared to control.

Gross pathological findings:

no effects observed

Description (incidence and severity):

1. No significant changes were observed in treated group dose level 75, 1500 and 7500 mg/kg bw/day compare to control.2. F0; No gross pathological changes were observed in treated male and female rats as compared to control.F1: No gross pathological changes were observed in treated male and female offspring as compared to control.

Neuropathological findings:

not specified

Histopathological findings: non-neoplastic:

effects observed, treatment-related

Description (incidence and severity):

1. Statically significant renal changes were observed in the dose level of 7500 mg/kg bw/day of treated male but it was not related to the compound consumed.No changes were observed on the treated female at dose level of 75, 1500 and 7500 mg/kg bw/day as compare to control.2. F0; An acceleration of testicular changes (degeneration of the testicular tubules) was observed in treated male rat, a common effect in ageing rats. However, at the termination of the study, the increased incidence was not of statistical significance.F1: An acceleration of testicular changes (degeneration of the testicular tubules) was observed in treated male rat, a common effect in ageing rats. However, at the termination of the study, the increased incidence was not of statistical significance.

Histopathological findings: neoplastic:

not specified

Other effects:

no effects observed

Description (incidence and severity):

2. Virology:No effect on virology of treated male and female rats was observed as compared to control.Microbiology:No effect on Microbiology of treated male and female rats was observed as compared to control

Dose descriptor:

NOAEL

Effect level:

1 000 - 1 500 mg/kg bw/day (nominal)

Based on:

test mat.

Sex:

male/female

Basis for effect level:

body weight and weight gain

clinical biochemistry

clinical signs

food consumption and compound intake

gross pathology

haematology

histopathology: non-neoplastic

mortality

ophthalmological examination

organ weights and organ / body weight ratios

other: Virology and Microbiology

Remarks on result:

other: No effect observed

Critical effects observed:

not specified

System:

other: not specified

Organ:

not specified

Treatment related:

not specified

Dose response relationship:

not specified

Relevant for humans:

not specified

Conclusions:

NOAEL was considered to be 1000-1500 mg/kg bw when mice and rat treated with test chemical.

Executive summary:

Data available for the test chemicals was reviewed to determine the repeated dose oral toxicity of the test chemical and read across. The studies are as mentioned below:

In a chronic toxicity study, CD male and female mice were exposed to test chemical in the concentration 0, 0, 75, 1500 and 7500 mg/kg bw/day oral in feed. Slight compound related increase in mortality was observed in male mice during last 6 months of study at 7500 mg/kg bw. Hair and exposed skin area appeared red, a reddish brown ventral abdomen and/or anogenital region was observed reddish brown in colour at 1500 and 7500 mg/kg bw and anogenital region was observed orange in colored at 75 mg/kg bw. No effect on body weight, food consumption, Organ weight and hematological value of treated mice was observed as compare to control. Similarly, No effect on gross pathology of treated male and female mice was observed as compared to control. Revealed degenerative renal changes were observed in 7500 mg/kg bw treated male mice but it was not compound related. Therefore, NOAEL was considered to be 1500 mg/kg/day for CD male and female mice, when they were exposed to test chemical by oral feed.

In a chronic toxicity and carcinogenicity study, Charies river CD® male and female rat were exposed to test chemical in the concentration 0, 0, 25, 150 and 1000 mg/kg/day orally in feed. In the parental generation, 3 rats were died at 150 mg/kg bw, one rat died at 1000 mg/kg bw and 3 rats were died in in control. No effect on body weight and food consumption, ophthalmoscopic examination, haematology, clinical chemistry, urinalysis, virology and microbiology of treated male and female rats was observed as comparable to control. Similarly, No effect on reproductive performance such as Fertility index, gestation index and effect on parturition and lactation were observed as compared to control. No effect onorgan weight and gross pathology were observed as compared to control in F0 and F1 generation. In addition, anacceleration of testicular changes (degeneration of the testicular tubules) was observed in treated male rat, a common effect in ageing rats. However, at the termination of the study, the increased incidence was not of statistical significance. Therefore, NOAEL was considered to be 1000 mg/kg/day for F0 generation and F1 generation when Charies river CD® male and female rat were exposed to test chemical orally in feed.

Based on the data available from the test chemical and read across, barium 3-hydroxy-4-[(4-methyl-2-sulphonatophenyl)azo]-2-naphthoate does not exhibit repeated dose oral toxicity in the range of 1000-1500 mg/kg bw. Hence the test chemical is not likely to classify as a repeated dose oral toxicity as per the criteria mentioned in CLP regulation.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

NOAEL

1 000 mg/kg bw/day

Study duration:

chronic

Species:

rat

Quality of whole database:

Data is Klimisch 2

Repeated dose toxicity: inhalation - systemic effects

Link to relevant study records

Reference

Endpoint:

repeated dose toxicity: inhalation, other

Data waiving:

other justification

Justification for data waiving:

other:

Endpoint conclusion

Endpoint conclusion:

no study available

Quality of whole database:

Wavier

Repeated dose toxicity: inhalation - local effects

Link to relevant study records

Reference

Endpoint:

repeated dose toxicity: inhalation, other

Data waiving:

other justification

Justification for data waiving:

other:

Endpoint conclusion

Endpoint conclusion:

no study available

Quality of whole database:

Waiver

Repeated dose toxicity: dermal - systemic effects

Endpoint conclusion

Endpoint conclusion:

no study available

Repeated dose toxicity: dermal - local effects

Endpoint conclusion

Endpoint conclusion:

no study available

Mode of Action Analysis / Human Relevance Framework

Repeated dose oral toxicity:

Data available for the test chemicals was reviewed to determine the repeated dose oral toxicity of the test chemical and read across. The studies are as mentioned below:

In a chronic toxicity study, CD male and female mice were exposed to test chemical in the concentration 0, 0, 75, 1500 and 7500 mg/kg bw/day oral in feed. Slight compound related increase in mortality was observed in male mice during last 6 months of study at 7500 mg/kg bw. Hair and exposed skin area appeared red, a reddish brown ventral abdomen and/or anogenital region was observed reddish brown in colour at 1500 and 7500 mg/kg bw and anogenital region was observed orange in colored at 75 mg/kg bw. No effect on body weight, food consumption, Organ weight and hematological value of treated mice was observed as compare to control. Similarly, No effect on gross pathology of treated male and female mice was observed as compared to control. Revealed degenerative renal changes were observed in 7500 mg/kg bw treated male mice but it was not compound related. Therefore, NOAEL was considered to be 1500 mg/kg/day for CD male and female mice, when they were exposed to test chemical by oral feed.

In a chronic toxicity and carcinogenicity study, Charies river CD® male and female rat were exposed to test chemical in the concentration 0, 0, 25, 150 and 1000 mg/kg/day orally in feed. In the parental generation, 3 rats were died at 150 mg/kg bw, one rat died at 1000 mg/kg bw and 3 rats were died in in control. No effect on body weight and food consumption, ophthalmoscopic examination, haematology, clinical chemistry, urinalysis, virology and microbiology of treated male and female rats was observed as comparable to control. Similarly, No effect on reproductive performance such as Fertility index, gestation index and effect on parturition and lactation were observed as compared to control. No effect onorgan weight and gross pathology were observed as compared to control in F0 and F1 generation. In addition, anacceleration of testicular changes (degeneration of the testicular tubules) was observed in treated male rat, a common effect in ageing rats. However, at the termination of the study, the increased incidence was not of statistical significance. Therefore, NOAEL was considered to be 1000 mg/kg/day for F0 generation and F1 generation when Charies river CD® male and female rat were exposed to test chemical orally in feed.

Based on the data available from the test chemical and read across, barium 3-hydroxy-4-[(4-methyl-2-sulphonatophenyl)azo]-2-naphthoate does not exhibit repeated dose oral toxicity in the range of 1000-1500 mg/kg bw. Hence the test chemical is not likely to classify as a repeated dose oral toxicity as per the criteria mentioned in CLP regulation.

Repeated dose inhalation toxicity:

The test substance has very low vapor pressure, high melting point and low partial size, so the potential for the generation of inhalable forms is low, also the normal conditions of use of this substance will not result in aerosols, particles or droplets of an inhalable size, so exposure to humans via the inhalatory route will be unlikely to occur, and therefore repeated dose toxicity by inhalation route was considered to be waived.

Repeated dose dermal toxicity:

In accordance with coloumn 2 of Annex IX, this end point was considered for waiver since the acute toxicity by the dermal route has already been provided in section 7.2.3 (as part of the Annex VIII information requirements)

Justification for classification or non-classification

Based on the data available from the test chemical and read across, barium 3-hydroxy-4-[(4-methyl-2-sulphonatophenyl)azo]-2-naphthoate does not exhibit repeated dose oral, dermal and inhalation toxicity. Hence the test chemical is not likely to classify as a repeated dose oral toxicity as per the criteria mentioned in CLP regulation.