[No public or meaningful name is available]

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

Aug - Oct 2018

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2018

Report date:

2018

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

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

Deviations:

no

GLP compliance:

yes

Test type:

acute toxic class method

Limit test:

yes

Test material

Test material information

Constituent 1

Test material form:

solid: flakes

Specific details on test material used for the study:

SOURCE OF TEST MATERIAL
- Source of test material:
Clariant Plastics and Coatings (Deutschland) GmbH,

Test animals

Species:

rat

Strain:

Wistar

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Invivo Biosciences, Shed No. 23, Katha No.3169, Assessment No. 154, Kodigehalli Village, Magadi Road, Bangalore-560091, Karnataka, India

- Females (if applicable) nulliparous and non-pregnant: [yes]
- Age at study initiation: 10 to 12 Weeks
- Weight at study initiation: 182.0 to 228.6 g

- Housing: Rats were housed individually in standard polysulfone cages (Size: approximately L 425 x B 266 x H 185 mm), with stainless steel top grill having facilities for pelleted food and drinking water in polycarbonate bottle. Additionally, polycarbonate rat huts were placed inside the cage as an enrichment object and were changed along with the cage once a week.
Bedding: steam sterilized corn cob was used and changed once a week along with the cage.

- Diet (e.g. ad libitum): Hypro Rat & Mice pellet feed, manufactured by Krishna Valley Agrotech LLP, MIDC Kupwad block, Sangli, Maharashtra, was provided to animals.
- Water (e.g. ad libitum): Deep bore-well water passed through activated charcoal filter and exposed to UV rays in Aquaguard on-line water filter-cum-purifier manufactured by Eureka Forbes Ltd, Mumbai 400 001, India, was provided to animals in polycarbonate bottles with stainless steel sipper tubes.
- Acclimation period: G1 (FTS) 8-Aug to 13-Aug 2018; G1 (STS) 8-Aug to 15-Aug 2018

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 to 23 °C
- Humidity (%): 65 to 67%
- Air changes (per hr): 12.3 air changes/hour
- Photoperiod (hrs dark / hrs light): 12 hours light and 12 hours dark cycle

IN-LIFE DATES: G1 (FTS) From: 14-Aug 2018 To: 28-Aug 2018
G1 (STS) From: 16-Aug 2018 To: 30-Aug 2018

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

corn oil

Details on oral exposure:

VEHICLE
- Justification for choice of vehicle: The corn oil is commonly used for toxicological studies in our laboratory and was found to be non-toxic in several animal species upon single and repeat dose administration.
- Lot/batch no. (if required): MKCD1021


MAXIMUM DOSE VOLUME APPLIED: 10 mL per kg


CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: 2000 mg/kg body weight

Doses:

2000 mg/kg body weight

No. of animals per sex per dose:

3 animals (females) / treatment step

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days post dosing

- Frequency of observations and weighing: At each step, the animals were observed five times on test day 1 (day of administration) i.e. at 30 minutes and four times at hourly intervals and once daily during days 2 to 15. Body weight on day 1, 8 and 15.

- Necropsy of survivors performed: yes

- Other examinations performed: clinical signs, body weight

Results and discussion

Effect levels

Key result

Sex:

female

Dose descriptor:

LD50 cut-off

Effect level:

> 5 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortality

Clinical signs:

other: There were no clinical signs and pre-terminal deaths.

Gross pathology:

There were no gross pathological changes at necropsy

Any other information on results incl. tables

TABLE 1.      Individual body weight, body weight changes and pre-terminal deaths

Group and Dose (mg/kg body weight)	Rat No.	Sex	Body weight (g)					No. dead/  No. tested	Pre-terminal deaths (%)
			Initial (Day 1)	8^thday	Weight change (day 8 – Initial)	15^thday	Weight change           (day 15 – Initial)
G1 (FTS) 2000	Rw901	F	228.6	235.9	7.3	242.6	14.0	0/3	0
	Rw902	F	196.8	201.3	4.5	209.5	12.7
	Rw903	F	182.0	188.4	6.4	193.9	11.9
G1 (STS) 2000	Rw904	F	190.5	196.2	5.7	204.8	14.3	0/3	0
	Rw905	F	202.9	209.7	6.8	217.1	14.2
	Rw906	F	221.8	226.9	5.1	233.0	11.2

 

F: Female        FTS: First Treatment Step            STS: Second Treatment Step                   

 

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Based on the results of the present study, the acute oral LD50 cut-off value is 5000 mg/kg body weight or "unclassified" for the test item,
Licocare RBW300 FL TP.

Executive summary:

The acute oral toxicity study with Licocare RBW 300 FL TP in Wistar rats was conducted to assess the toxicological profile of the test item. The dose formulation was prepared by using corn oil and administered as a single oral gavage to overnight fasted (16 to 18 hours) three female rats (G1-FTS) at a dose volume of 10 mL/kg body weight to attain the dose of 2000 mg/kg body weight. There were no clinical signs of toxicity and pre-terminal deaths. Based on the scheme - Annex 2d of the guideline OECD 423, three additional female rats were tested at the same dose of 2000 mg/kg body weight (G1-STS). There were no clinical signs of toxicity and pre-terminal deaths. Based on the scheme - Annex 2d of the guideline OECD 423, no further test was needed, hence, the dosing was stopped.

The rats were observed for mortality and clinical signs for 14 days post treatment. Body weights were recorded prior to dosing and again on days 8 and 15. Necropsy was performed for all the surviving rats at terminal sacrifice. All survived rats gained weight during experimental period. There were no gross pathological changes at necropsy.

Based on the results of the present study, the acute oral LD₅₀cut-off value is 5000 mg/kg body weight or ∞ (unclassified) for the test item.