[No public or meaningful name is available]

Endpoint summary

Key value for chemical safety assessment

Toxic effect type:

dose-dependent

Repeated dose toxicity: via oral route - systemic effects

Link to relevant study records

Reference

Endpoint:

short-term repeated dose toxicity: oral

Remarks:

combined repeated dose and reproduction / developmental screening

Type of information:

read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Study period:

2002

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Justification for type of information:

For the read-across justification see section 13.

Reason / purpose for cross-reference:

read-across source

Qualifier:

according to guideline

Guideline:

OECD Guideline 422 (Combined Repeated Dose Toxicity Study with the Reproduction / Developmental Toxicity Screening Test)

GLP compliance:

yes

Limit test:

no

Specific details on test material used for the study:

Impurities: C14-C20 fatty acid: 10.9%, C24 fatty acid: 2.3%

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River Japan, Hino, Tokyo
- Age at study initiation: 8 weeks
- Weight at study initiation: male: 312.1 - 363.7 g; female: 205.3 - 230.8 g
- Housing: metal wire floor cages
- Diet: ad libitum CE-2, CLEA Japan
- Water: ad libitum tap water
- Acclimation period: 7 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 24 ± 1
- Humidity (%): 50 - 65
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12 / 12

Route of administration:

oral: gavage

Vehicle:

corn oil

Details on oral exposure:

PREPARATION OF DOSING SOLUTIONS:
prepared more frequently than once a week; aliquots were kept by each concentration refrigerated in airtight condition. It was confirmed that the test substance in the preparation solution was stable for 9 days in refrigeration and shading, and it was confirmed that the administered sample prepared during the test period contained a predetermined amount of the test substance uniformly.

VEHICLE
- Justification for use and choice of vehicle (if other than water): due to insolubility in water
- Amount of vehicle (if gavage): 5 mL/kg bw

Analytical verification of doses or concentrations:

yes

Duration of treatment / exposure:

- males: 42 days (from the end of mating period and the day before autopsy)
- females: from 14 days prior to mating to day 3 of lactation

Frequency of treatment:

once daily

Dose / conc.:

1 000 mg/kg bw/day (nominal)

Remarks:

1000 mg / kg is the limit dose.
The medium dose was 300 mg / kg and the low dose was 100 mg / kg. Rats in the control group were treated with corn oil as a medium for docosanoic acid under the same conditions as in the docosanoic acid administration group.

No. of animals per sex per dose:

13 in each group

Control animals:

yes, concurrent vehicle

Details on study design:

Dose selection rationale: based on preliminary result in a 14 day-repeated dose toxicity study with the limit dose of 1000 mg / kg, where no signs of toxicity were found

Observations and examinations performed and frequency:

CAGE SIDE OBSERVATIONS: Yes
- Time schedule: at least once a day during the breeding period

BODY WEIGHT: Yes
- Time schedule for examinations: males: days 1, 8, 15, 22, 29, 36, 42 and autopsy day; pregnancy females: premating days 1, 8, 15; pregnancy days: 0, 7, 14, 20; lactation days: 0, 4 (day of autopsy); non pregnancy females: day 1, 8, 15, 22, 25 (day of autopsy).

FOOD CONSUMPTION:
- Food consumption for each animal determined and mean daily diet consumption calculated as g food/kg body weight/day: Yes

FOOD 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

WATER CONSUMPTION: No data

OPHTHALMOSCOPIC EXAMINATION: No

HAEMATOLOGY: Yes (males only)
- Time schedule for collection of blood: prior to autopsy
- Anaesthetic used for blood collection: Yes (identity): pentobarbital sodium (using EDTA-2K as an anticoagulant)
- Animals fasted: 18 - 24 hours before sacrifice
- How many animals: all surviving animals
- Parameters checked: red blood cell count (RBC), white blood cell count (WBC), haemoglobin content (Hb), mean corpuscular volume (MCV), haematocrit (Ht), mean corpuscular haemoglobin content (MCH), mean corpuscular haemoglobin concentration (MCHC)

CLINICAL CHEMISTRY: Yes (males only)
- Animals fasted: 18 - 24 hours before sacrifice
- How many animals: all surviving animals
- Parameters checked: total protein, albumin, total cholesterol concentration, glucose, urea nitrogen, creatinine, alkaline phosphatase activity, GOT, GPT, γ-GTP, triglyceride concentration, inorganic phosphorus, total bilirubin, calcium, sodium, potassium, chlorine, A/G ratio

URINALYSIS: No

Sacrifice and pathology:

After deep anesthesia with sodium pentobarbital, autopsy was performed.The weights of the heart, liver, kidneys, thymus, testis and epididymis were measured.

Pathological findings and histopathology (control and 1000 mg/kg bw /day group):
male: heart, liver, spleen, kidney, adrenal, testis, epididymis, brain, thymus, bladder
female: brain, liver, spleen, thymus, kidney, adrenal, bladder, heart, ovary

Statistics:

Yates test, Mann-Whitney U test, Fisher exact test, Bartlett test, Dunnett test, Scheffe test, Kruskal-Wallis test

Clinical signs:

no effects observed

Mortality:

no mortality observed

Body weight and weight changes:

effects observed, treatment-related

Description (incidence and severity):

significant increase was observed in 100 mg/kg bw/day group (non-adverse) compared with the control group

Food consumption and compound intake (if feeding study):

effects observed, treatment-related

Description (incidence and severity):

significant decrease was observed in 100 mg/kg bw/day group during lactation (on 0 to 4 days of lactation) (non-adverse) for females.
In males, there was no significant difference in food intake between the control group and the docosanoic acid administration group at any time.

Food efficiency:

not examined

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

not examined

Ophthalmological findings:

not examined

Haematological findings:

effects observed, treatment-related

Description (incidence and severity):

significant decrease of mean corpuscular haemoglobin concentration in the 300 and 1000 mg/kg bw/day groups (non-adverse)

Clinical biochemistry findings:

effects observed, treatment-related

Description (incidence and severity):

non-adverse

Urinalysis findings:

not examined

Behaviour (functional findings):

not examined

Immunological findings:

not examined

Organ weight findings including organ / body weight ratios:

effects observed, treatment-related

Description (incidence and severity):

non-adverse

Gross pathological findings:

effects observed, treatment-related

Description (incidence and severity):

non-adverse

Neuropathological findings:

not examined

Histopathological findings: non-neoplastic:

effects observed, treatment-related

Description (incidence and severity):

non-adverse

Histopathological findings: neoplastic:

no effects observed

Details on results:

CLINICAL SIGNS AND MORTALITY
- Males: No deaths or abnormalities in general condition were observed in any of the treated groups
- Females: No deaths were observed in any treated group

BODY WEIGHT AND WEIGHT GAIN
- Males: significant increase (p<0.01) compared to control was observed in 100 mg/kg bw/day group between 8 - 15 days and between 15 - 29 days. However, since no change was observed in other groups, it was considered not related to the dosing of compound.
- Females: no significant change in body weight was noted

FOOD CONSUMPTION AND COMPOUND INTAKE (if feeding study)
- Males: no changes in food consumption related to the dosing of compound
- Females: significant decrease (p<0.01) compared to control was observed during lactation in 100 mg/kg bw/day group. However, since no other changes in food consumption were noted in 300 mg/kg bw/day and 1000 mg/kg bw/day, it was not related to the dosing with the compound.

HAEMATOLOGY
- Males: a significant decrease (p<0.01) of mean corpuscular haemoglobin concentration (MCHC) compared to control was found in the 300 and 1000 mg/kg bw/day dose group, respectively. No other differences were noted.

CLINICAL CHEMISTRY
- Males: a significant decreased ALP level (p<0.05) compared to control was found in all dosing groups. A significant decreased glucose level (p<0.05) compared to control was found in the high dose group. While a significant increase in chloride (p<0.05) was found in the 300 mg/kg bw/day group, a significant decrease in calcium content (p<0.01) and in total protein (p<0.05) was noted in this group. However, all the findings lack a dose-dependency and were regarded as incidental.

ORGAN WEIGHTS
- Males: in 100 mg/kg bw/day males, the actual weight ratio of liver weight compared to control values were increased (p <0.05) . No other significant differences were found in all groups. Thus, this finding lacks a dose-dependency and was regarded as incidental.
- Females: actual kidney weight was significantly reduced (p<0.05) in the 100 mg/kg bw/day group. No other weight changes were noted. Thus, this finding lacks a dose-dependency and was regarded as incidental.

GROSS PATHOLOGY
Males:
- Heart: myocardial degeneration was noted in one animal of the control group and the 1000 mg/kg bw/day group, respectively
- Liver: periportal fatty change of the liver was found in all animals of the control and the high dose group. Focal necrosis was noted in one animal of the high-dose group.
- Spleen: all animals of the control and the high-dose group showed brown pigment deposits of the spleen as well as extramedullary hematopeiosis
- Kidney: while fibrosis was only found in 1/13 animals of the control group, eosinophilic bodies and basophilic tubules in the cortex were noted in animals of both control and 1000 mg/kg bw/day groups
- Adrenal gland: one animal of the high-dose group showed fibrosis
- Testis: atrophy of the seminiferous tubules was observed in two animals of the 1000 mg/kg bw/day dose group, with one animal affected on both sides and one side affected in the other animal. No other abnormalities were noted.
- Epididymis: abnormal sperm granuloma was found in one animal of the control group
- Brain: no abnormal findings noted
- Thymus: no abnormal findings noted
- Bladder: no abnormal findings noted

Females:
- Brain: one animal of the high-dose group showed abnormal mineral deposition in the thalamus
- Liver: focal necrosis and fibrosis was found in one animal of the control group, while one animal of the high-dose group showed only focal necrosis
- Spleen: brown pigmentation and extramedullary hematopeiosis was found in animals of the control and the high-dose group, but no varying degrees of frequency was observed
- Thymus: atrophy and bleeding was observed in animals of both groups, control and high-dose group, respectively
- Kidney: basophilic tubules of the cortex and a dilatation of the renal pelvis was seen in the control and high-dose group
- Adrenal gland: cortical necrosis was observed in one animal of the control group
- Heart: no abnormal findings noted
- Bladder: no abnormal findings noted

Key result

Dose descriptor:

NOAEL

Effect level:

>= 1 000 mg/kg bw/day (nominal)

Based on:

test mat.

Sex:

male/female

Basis for effect level:

other: no adverse substance-related systemic effects were noted

Critical effects observed:

not specified

Conclusions:

Repeated oral administration of 100, 300 and 1000 mg / kg of docosanoic acid to male and female rats showed no deaths in any of the administration groups, and the effects of docosanoic acid administration on general condition, body weight transition and food intake. In the blood test of males after 42 doses, the mean corpuscular hemorrhage concentration was significant in the administration group of 300 mg / kg or more, the alkaline fastase activity was significant in each docosanoic acid administration group, and the glucose concentration was significant in the 1000 mg / kg administration group. However, since all the changes were mild and no concomitant changes were observed in other test items including pathological tests, these are considered to be accidental changes and have no toxicological significance. Histopathological examination showed very slight atrophy of the seminiferous tubules in 2 animals in the 1000 mg / kg administration group, both of which are spontaneous histological images due to localized changes. There was no effect of docosanoic acid on the conception rate. No effects of docosanoic acid administration were observed on maternal gestational age, fertility, parturition and lactation status, as well as birth viability, body weight, sex ratio and morphology.
Based on the above results, the no-effect level for repeated dose toxicity and reproductive and developmental toxicity of docosanoic acid is considered to be 1000 mg / kg / day under the conditions of this study.
Thus the NOEL value for Reaction mass of stearic acid and stearic anhydride is comparable.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

NOAEL

1 000 mg/kg bw/day

Study duration:

subacute

Species:

rat

Repeated dose toxicity: inhalation - systemic effects

Link to relevant study records

Reference

Endpoint:

short-term repeated dose toxicity: inhalation

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 412 (Subacute Inhalation Toxicity: 28-Day Study)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Limit test:

no

Species:

rat

Strain:

Wistar

Sex:

male/female

Route of administration:

inhalation: aerosol

Type of inhalation exposure:

whole body

Analytical verification of doses or concentrations:

yes

Details on analytical verification of doses or concentrations:

The concentrations of the test item in the exposure chamber were analyzed by collecting samples at 2,
4 and 6 hours after chamber equilibrium time during the exposure period. Samples in triplicate were taken for each time point for dose concentration analysis. The chamber concentration analysis was performed once a week (on days 1, 8, 15, 22).

Duration of treatment / exposure:

up to 28 days (4 Weeks)

Frequency of treatment:

6 hours exposure daily, 5 days a week

Dose / conc.:

0 mg/L air

Remarks:

Control group

Dose / conc.:

0.6 mg/L air (nominal)

Dose / conc.:

1.2 mg/L air

Dose / conc.:

2.4 mg/L air

Remarks:

including recovery group

No. of animals per sex per dose:

5 males, 5 females for each group

Control animals:

yes, concurrent no treatment

Clinical signs:

no effects observed

Description (incidence and severity):

No clinical signs of illness were observed in any of the male and female animals of main study treated concentration of 0.60, 1.20 and 2.40 mg/L.

Mortality:

no mortality observed

Description (incidence):

No mortality was observed in any of the male and female animals of main study treated with test item concentration of 0.60, 1.20 and 2.40 mg/L throughout the experimental period.

Body weight and weight changes:

no effects observed

Description (incidence and severity):

No adverse effect on body weight and body weight gain (%) was observed for treated groups when
compared with vehicle control group. The changes observed were within the historical background
range with respect to age and sex of the animals.

Food consumption and compound intake (if feeding study):

no effects observed

Description (incidence and severity):

No adverse effects on food consumption were observed in treated group animals when compared with control group animals.

Food efficiency:

not examined

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

not examined

Haematological findings:

effects observed, non-treatment-related

Description (incidence and severity):

Hematology parameters viz Erythrocyte count (RBC), Hemoglobin (Hb), Hematocrit (PCV), Mean
corpuscular volume (MCV), Mean corpuscular hemoglobin (MCH), Mean corpuscular hemoglobin concentration (MCHC), White blood cell count (WBC), Differential Counts (Neutrophils, basophils and Lymphocytes), Reticulocyte, platelets, APTT and Prothrombin time (PT) did not show any
toxicologically relevant findings in both the sexes of treatment group and females of recovery group.
At week 6, reticulocyte count and basophils were found to be increased in high dose (G4R) when compared with control (G1R) in males.
The significant changes observed in the hematological parameters are marginal and could not be
attributed to the test item administration as these values were within clinical and biological variation.

Clinical biochemistry findings:

effects observed, non-treatment-related

Description (incidence and severity):

Clinical biochemistry parameters viz Blood Urea Nitrogen, Creatinine, Cholesterol, Triglycerides,
Alkaline phosphatase (ALP), Bilirubin total, Sodium (Na), Chloride (CO, Calcium (Ca), Protein,
Albumin, Globulin and A/G Ratio did not show any toxicologically relevant findings in males of
treatment group. There is no toxicologically relevant findings except glucose (GLU) in males of
recovery group. There is no toxicologically relevant findings in females of recovery group
Week 4 analyses showed statistically increased glucose (GLU) levels in intermediate dose group (G3) and high dose group (G4) when compared with control group (G1) for males. Increased Aspartate aminotransferase (AST) and Alanine aminotransferase (ALT) levels in intermediate dose group (G3) whereas increased Phosphorus (PHOS) and Potassium (K) levels in high dose group (G4) when compared with control group (G1) for males. In females, decreased glucose (GLU) and Increased Phosphorus (PHOS) levels were observed in intermediate dose group (G3) and high dose group (G4) when compared with control group (01). Increased Calcium (Ca) levels in low dose group (G2) and high dose group (G4) in females) when compared with control group (G1). Increased Globulin (GLB) levels in intermediate dose group (G3) when compared with control group (G1).
Even though there is statistical significance observed, these changes may not be biologically significant since all the values were well within the normal biological range.

Endocrine findings:

not examined

Urinalysis findings:

not examined

Behaviour (functional findings):

not examined

Immunological findings:

not examined

Organ weight findings including organ / body weight ratios:

effects observed, non-treatment-related

Description (incidence and severity):

There were no treatment related changes in terminal fasting body weight and organ weights in any of
the treatment groups when compared to vehicle control.
In main group males, there was increase in absolute and relative weight of liver in group 3 when
compared to control. In recovery group male animals, increase in absolute and relative weight of
adrenal and decrease in absolute and relative weight of thymus was observed in group 4R when compared to the corresponding control group. These changes were considered incidental in the absence of similar weight changes in the main group high dose (Group 4) animals.
In females, increase in absolute weight of brain in group 3 and 4 when compared to control group was
considered incidental as there was no changes in the relative organ weights for these organs. In recovery group female animals, decrease in absolute and relative weight of spleen was observed in
group 4R when compared to the corresponding control group. These changes were considered
incidental as there were no weight changes observed at main group high dose animals when compared to control.

Gross pathological findings:

effects observed, non-treatment-related

Description (incidence and severity):

There were no treatment related gross findings in males and females.
Single incidence of unilateral small sized testes was observed in group 1 male animal (Animal No.
04). Microscopically, atrophy of seminiferous tubules in testes of moderate severity was observed and
was considered incidental. In animal No. 28 of group 3, dark red discoloration in liver, enlarged spleen and dilated heart was observed. Microscopically, congestion with moderate and minimal severity was observed in liver and spleen respectively and heart showed moderately dilated right auricle and ventricle. Congestion in liver and spleen may be attributed to right sided heart failure.

Neuropathological findings:

not examined

Histopathological findings: non-neoplastic:

effects observed, non-treatment-related

Description (incidence and severity):

There were no treatment related histopathological findings attributable to the test item in any tissues of
high dose (2.40 mg/L) group animals of both sexes.
One or two incidence of microscopic findings observed in liver, lungs, testes, epididymides and larynx were considered incidental as they were common background findings observed in the species.

Histopathological findings: neoplastic:

no effects observed

Key result

Dose descriptor:

NOAEC

Effect level:

>= 2.4 mg/L air (nominal)

Based on:

test mat.

Sex:

male/female

Basis for effect level:

other: no treatment-related effects were observed

Key result

Critical effects observed:

no

Lowest effective dose / conc.:

2.4 mg/L air (nominal)

System:

other: no treatment-related effects were observed

Conclusions:

Stearinsaureanhydrid was exposed daily to group of Wistar rats for a period of 22 days at doses of 0.6, 1.2 and 2.4 mg/L. No test item related changes in the body weights, feed consumption, haematology and organ weights were observed. Macroscopic and microscopic examination revealed no abnormality attributable to the treatment at the highest dose (2.4 mg/L). In the absence of gross and histopathological findings in the organs and due to negligible change in the profile of animals of high dose (G4) high dose is considered to have low observed effect. Hence, under the conditions of the experiment and based on the findings of the present study entitled "Acute Inhalation Toxicity Study in Rats with Stearinsaureanhydrid", the No Observed Adverse Effect Concentration (NOAEC) was found to be the highest dose level employed, i.e. 2.40 mg/L.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

NOAEC

2.4 mg/L

Study duration:

subacute

Species:

rat

Repeated dose toxicity: inhalation - local effects

Endpoint conclusion

Endpoint conclusion:

no study available

Repeated dose toxicity: dermal - systemic effects

Link to relevant study records

Reference

Endpoint:

short-term repeated dose toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 410 (Repeated Dose Dermal Toxicity: 21/28-Day Study)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Species:

rat

Strain:

Wistar

Sex:

male/female

Vehicle:

water

Duration of treatment / exposure:

28 days

Frequency of treatment:

five days per week

No. of animals per sex per dose:

0 (G1, Control), 250 (G2, Low dose), 500 (G3, Intermediate dose) and 1000 (G4, High dose), 0 (G1R, Control recovery) and 1000 (G4, High dose recovery) mg/kg body weight/day. Each group consisted of five males and five females.

Control animals:

yes, concurrent vehicle

Details on study design:

Known weight of the Stearinsaureanhydrid was moistened with minimum volume of distilled water, so as to prepare a paste. The paste thus prepared was evenly applied to the groups of male and females rats by dermal route applied to the skin on a five days per week basis for 4 weeks. Control group of animals were similarly treated but with distilled water alone.

Observations and examinations performed and frequency:

The following observations were performed: Mortality/ Viability (Twice daily), Ophthalmoscopy (before start of treatment and towards end of the treatment period), clinical signs (daily), body weights and feed consumption (once weekly), haematology, clinical biochemistry and urine analysis at the end of treatment ( after 4 weeks) and recovery (6 weeks).
At the end of the treatment and recovery period, all animals were weighed, sacrificed and necropsied. Histological examination was performed on all organs and tissues of control and high dose group animals as per the study plan and target organs of low, intermediate as well as in control recovery and high dose recovery groups. Urine samples were collected for analysis and blood was sampled for clinical pathology from all the animals.

Clinical signs:

no effects observed

Description (incidence and severity):

No clinical signs of illness were observed in any of the animals during treatment and recovery period.

Dermal irritation:

no effects observed

Mortality:

no mortality observed

Description (incidence):

Mortality was not observed in any of the animals of the different treatment groups during the study.
No clinical signs of illness were observed in any of the animals during treatment and recovery period.

Body weight and weight changes:

no effects observed

Description (incidence and severity):

Body weights and Body weights gain of male and female of all the treated animals were comparable with the respective control group animals during dosing period of 28 days and recovery period of 14 days.

Food consumption and compound intake (if feeding study):

no effects observed

Description (incidence and severity):

During the 28 consecutive days of dosing period and post -dosing recovery period of 14 days the quantity of feed consumed by animals across different dose groups was found to be comparable with that of respective control animals.

Food efficiency:

not examined

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

not examined

Ophthalmological findings:

no effects observed

Description (incidence and severity):

No abnormalities were observed in the ophthalmological examination conducted during
acclimatization and at the end of treatment in the control and high dose group.

Haematological findings:

effects observed, non-treatment-related

Description (incidence and severity):

No treatment-related effect were detected in the measured hematological parameters of treatment and recovery groups compared with respective control groups.

Clinical biochemistry findings:

effects observed, non-treatment-related

Description (incidence and severity):

No treatment-related effect were detected in the measured biochemistry parameters of treatment and recovery groups compared with respective control groups.

Endocrine findings:

not examined

Urinalysis findings:

no effects observed

Description (incidence and severity):

No treatment-related effect were observed either in the group mean values or in the incidence of semi quantitative observations made across different dose groups.
No test item related changes in the urinary parameters were observed in the treatment and recovery
groups compared with respective control groups.

Behaviour (functional findings):

not examined

Immunological findings:

not examined

Organ weight findings including organ / body weight ratios:

effects observed, non-treatment-related

Description (incidence and severity):

No test item related changes were observed in absolute, relative organ weights values of male and
female animals during treatment and recovery period.

Gross pathological findings:

no effects observed

Description (incidence and severity):

There were no treatment related macroscopic findings across different groups of both sexes.

Neuropathological findings:

not examined

Histopathological findings: non-neoplastic:

no effects observed

Description (incidence and severity):

There were no treatment related microscopic findings across different groups of both sexes.

Histopathological findings: neoplastic:

no effects observed

Description (incidence and severity):

There were no treatment related microscopic findings across different groups of both sexes.

Key result

Dose descriptor:

NOAEL

Effect level:

> 1 000 mg/kg bw/day (nominal)

Based on:

test mat.

Sex:

male/female

Basis for effect level:

other: no treatment related effects

Key result

Critical effects observed:

no

Conclusions:

In the present study, No test item related changes in body weight, body weight gain, clinical signs, ophthalmic examination findings, feed consumption and urine analysis were noted. Minor changes in hematological, clinical biochemistry and organ weights were recorded at the end of treatment and recovery periods. But, the variations observed were considered incidental and the respective tissues revealed no abnormalities in macroscopic and histopathological examination. There were no treatment related systemic effects at any dose level. In the light of above observations, the No Observed Adverse Effect Level (NOAEL) of Stearinsaureanhydrid) for Wistar rats via the dermal route could be considered as >1000 mg/kg body weight under the experimental conditions.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

NOAEL

1 000 mg/kg bw/day

Study duration:

subacute

Species:

rat

Repeated dose toxicity: dermal - local effects

Endpoint conclusion

Endpoint conclusion:

no study available