Zinc distearate

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Justification for type of information:

Experimental test result performed using standard test guidelines.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2014

Report date:

2014

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)

Principles of method if other than guideline:

The aim of this study was to assess the toxicity potential of test chemical after single oral administration in rats and an observation period of 14 days.

GLP compliance:

yes

Test type:

acute toxic class method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Zinc distearate

EC Number:

209-151-9

EC Name:

Zinc distearate

Cas Number:

557-05-1

Molecular formula:

C18H36O2.1/2Zn

IUPAC Name:

zinc distearate

Test material form:

solid: particulate/powder

Details on test material:

Name: Zinc distearate
Molecular Formula: C36H70O4.Zn
Molecular Weight: 632.335 g/mole
Appearance: Free flowing white powder
AI Content (purity): 99.86%

Test animals

Species:

rat

Strain:

Wistar

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source:In-House Bred at Sa-Ford, Animal Facility(CPCSEA Registration No. 1256/bc/09/CPCSEA)
- Age at study initiation:8- 10 weeks at the time of dosing
- Weight at study initiation:Minimum: 137 g Maximum: 168 g (Individual body weights were within ± 8% prior to treatment after overnight fasting)
-Health Status:Healthy young adult animals were used for the study. Females were nulliparous and non pregnant
- Housing:The animals were housed individually in polycarbonate cages.
- Diet (e.g. ad libitum):All animals were provided conventional laboratory rodent diet (Nutrivet Life Sciences, Pune) ad libitum. Batch No 400004
- Water (e.g. ad libitum):Aqua guard filtered tap water was provided ad libitum via drinking bottles
- Acclimation period:Animal nos. 1-3 were acclimatized for 6 days and 4-6 for 9 days prior to administration of the test item.
-Room Sanitation:The experimental room floor and work tops were swept and mopped with disinfectant solution every day.
-Cages and water bottle:All the cages and water bottles were changed at least twice every week
ENVIRONMENTAL CONDITIONS
Temperature : Minimum: 19.80°C Maximum: 23.20°C
Relative humidity:Minimum: 48.60 % Maximum: 63.20 %
Light-dark-rhythm:12:12
Air Changes: More than 12 changes per hour
IN-LIFE DATES: From: May 07, 2014 To: May 27 and 30, 2014

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

corn oil

Details on oral exposure:

VEHICLE
- Amount of vehicle :10 ml
- Justification for choice of vehicle:Corn oil was selected as a vehicle because test item was not soluble in distilled water.
- Lot/batch no. (if required):MKBD4650
- Purity:N/A
MAXIMUM DOSE VOLUME APPLIED:10 ml/kg body weight.

Doses:

G1/ 2000mg/kgbw

No. of animals per sex per dose:

6 Females

Control animals:

not specified

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing:daily
- Necropsy of survivors performed: yes
- Other examinations performed:
Clinical Observation:- After test item administration, individual animals were frequently observed at 30 minutes, 1, 2, 3 and 4 hours post dosing on day 0 (day of dosing). Subsequently, all surviving animals were observed once a day during the 14 day observation period.
Mortality - All animals were observed twice daily (morning and evening) for morbidity and mortality, throughout the acclimatization and study period.
Body weight - All rats were weighed on days 0 (prior to dosing), 7 and 14.
Pathology - At the end of 14 day observation period, all rats were euthanised by overdose of CO2 for external and internal observations.

Statistics:

not specified

Results and discussion

Preliminary study:

not specified

Effect levels

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Remarks on result:

other: No effect on mortality, clinical sign, body weight and gross pathology

Mortality:

No mortality was observed througout the experimentation period in treated female rats.

Clinical signs:

other: At 2000mg/kg, all the six animals were observed with normal clinical sign till day 14

Gross pathology:

No external and internal gross pathological examination were seen in all the six animals treated with 2000 mg/kg body weight during terminal sacrifice

Other findings:

not specified

Any other information on results incl. tables

Table 1: Individual Animal Body Weight (g) andBody Weight Change

Sex:Female

Animal No.	Group/ Dose (mg/kg)	Body Weight (gram)			Body Weight Change (%)
		Day 0	Day 7	Day 14	Day 0-7	Day 0-14
1	G1/ 2000	137	169	177	23.36	29.20
2		154	174	188	12.99	22.08
3		139	165	183	18.71	31.65
4		147	175	191	19.05	29.93
5		147	182	194	23.81	31.97
6		168	194	207	15.48	23.21

Table 2: Summary of Animal Body Weight (g) and Body Weight Changes (%)

Sex:Female

Group/ Dose (mg/kg)		Rats Body Weight (g)			Body Weight Changes (%)
		Day 0	Day 7	Day 14	0-7	0-14
G1/ 2000	Mean	148.67	176.50	190.00	18.90	28.01
	SD	11.29	10.33	10.28	4.26	4.30
	n	6	6	6	6	6

Keys:SD = Standard Deviation, n = Number of Animals

Table 3: Individual Animal Clinical Signs and Symptoms

 Sex:Female

Animal No.	Group/ Dose (mg/kg)	Hours (Day 0)
		1/2	1	2	3	4
1	G1/ 2000	1	1	1	1	1
2		1	1	1	1	1
3		1	1	1	1	1
4		1	1	1	1	1
5		1	1	1	1	1
6		1	1	1	1	1

Applicant's summary and conclusion

Interpretation of results:

other: Not classified

Conclusions:

The acute oral LD50 was considered to be >2000 mg/kg body weight, when Wistar female rats were treated with test chemical orally by gavage.

Executive summary:

Acute oral toxicity study of test chemical performed on Rats as per OECD No. 423. Six female Wistar rats were selected for acute oral toxcity. Rats were fasted for 16 to 18 hours, prior to dosing (water was given ad libitum). After test item administration, feed was withheld for a further 4 hours. The time interval between dosing was determined by the onset, duration and severity of toxic signs Three rats of group G1 were dosed with starting dose of 2000 mg/kg body weight and the animals showed no mortality post dosing, so another three rats of the same group were dosed with 2000 mg/kg weight and no mortality was observed. At 2000mg/kg, all the six animals were observed with normal clinical sign till day 14 . No mortality was observed througout the experimentation period. Mean body weight of animals treated with 2000mg/kg body weight was observed with gain on day 7 and 14, as compared to day 0 .No external and internal gross pathological examination were seen in all the six animals treated with 2000 mg/kg body weight during terminal sacrifice Under the conditions of this; acute oral toxicity study of test chemical in female rats is as given below: The acute oral LD50 value of test chemical was >2000 mg/kg body weight. Thus by considering the CLP criteria for acute toxicity rating for the chemicals, it infers that test chemical does not exhibit acute oral toxicity i.e it is acutely non toxic to animals