Sodium chlorodifluoroacetate

Endpoint summary

Description of key information

Acute oral toxicity: Key study. Test method according to OECD 423, GLP study. The LD50 of the test item is 5000 mg/kg g body weight by oral route in the rat.

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records

Reference

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

From 20-07-2022 to 15-08-2022

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

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

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test type:

fixed dose procedure

Limit test:

yes

Species:

rat

Strain:

Sprague-Dawley

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- 12 Females (nulliparous and non-pregnant)
- Age: 9-10 weeks old.
- Housing: Three animals were housed in standard polycarbonate cage (size: L 430 x B 280 x H 210 mm) with stainless steel mesh top grill having facilities for holding pelleted feed and drinking water in water bottle fitted with stainless steel sipper tube. Clean sterilized corn
cob was provided as bedding material.
- Diet: Altromin Maintenance Diet for rats and mice manufactured by Altromin Spezialfutter GmbH & Co. KGAd libitum.
- Water: Ad libitum. Deep bore-well water passed through reverse osmosis unit was provided in plastic water bottles with stainless steel sipper tubes.
- Acclimatization: Healthy young adult animals used for Step-I, Step-I confirmation, Step-II and Step- II confirmation were acclimatized for five, seven, nine and twelve days respectively to laboratory condition prior to treatment and were observed for clinical signs once daily. Veterinary examination of all the animals was performed on the day of receipt.

ENVIRONMENTAL CONDITIONS
- Temperature: 19,8ºC to 22,9ºC
- Humidity: 45 to 65%
- Air changes: 12 to 15 air changes/hour
- Light hours: 12 hours light and 12 hours darkness.

Route of administration:

oral: gavage

Vehicle:

other: Distilled water. The test item is soluble in distilled water as evidenced by the in-house solubility/suspendibility test.

Details on oral exposure:

DOSAGE PREPARATION: The required quantity of test item was weighed, grind well using mortar and pestle by adding little volume of vehicle and transferred into the measuring cylinder. Again a small quantity of vehicle was added to mortar, mixed well and transferred into the measuring cylinder. The rinsing procedure was repeated to ensure complete transfer of the test item formulation into a measuring cylinder. Finally, the volume was added to the required mark to get a desired concentration.

DOSAGE ADMINSTRATION: by gavage, in a single dose

Doses:

Step 1: 300 mg/kg bw
Step 2: 2000 mg/kg bw

No. of animals per sex per dose:

Step 1 (300 mg/kg bw): 3 animal
Step 1 confirmation (300 mg/kg bw): 3 animals.
Step 2 (2000 mg/kg bw): 3 animal
Step 2 confirmation (2000 mg/kg bw): 3 animals.

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: All the animals were observed for clinical signs of toxicity and mortality at 20 to 30 mins, 1 hr (±10 mins), 2 hrs (±10 mins), 3 hrs (±10 mins) and 4 hrs (±10 mins) post dosing on day 1 and once daily thereafter for clinical signs of toxicity and twice daily for mortality during the 14 days observation period.
- Necropsy of survivors performed: yes.
- Clinical signs including body weight: included changes in skin, fur, eyes and mucous membranes and also respiratory, circulatory, autonomic and central nervous systems and somatomotor activity and behaviour pattern

Key result

Sex:

female

Dose descriptor:

LD50

Effect level:

>= 5 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortality occurred during the study.

Clinical signs:

other:

Body weight:

lower than 10% body weight loss

Remarks:

No adverse changes were observed in body weight and percent change in body weight with respect to day 1.

Gross pathology:

The macroscopic examination of the animals at the end of the study did not reveal treatment related changes.

Table 1. Individual animal body weight (g) and percent change in body weight with respect to day 1. 

Study Steps & Dose (mg/kg body weight)	Animal No.	Sex	Volume Administered (mL)	Body Weight (g) on Day			Percent Change in Body Weight with Respect to Day
				1	8	15	1 to 8	1 to 15
Step-I & 300	Rh2248	F	1.7	173.01	187.22	204.85	8.21	18.40
	Rh2249	F	1.8	175.36	189.46	208.54	8.04	18.92
	Rh2250	F	1.7	170.67	184.46	208.54	7.89	17.10
			Mean	173.01	186.94	204.42	8.05	18.14
			SD	2.35	2.68	4.36	0.16	0.94
			n	3	3	3	3	3
Step-I Confrimation & 300	Rh2251	F	1.7	172.47	187.11	204.51	8.49	18.58
	Rh2252	F	1.7	171.08	186.24	201.88	8.86	18.00
	Rh2253	F	1.7	164.37	179.53	198.18	9.22	20.61
			Mean	169.31	184.29	201.52	8.86	19.06
			SD	4.33	4.15	3.18	0.37	1.37
			n	3	3	3	3	3
Step-II & 2000	Rh2254	F	1.8	178.61	194.66	208.31	8.99	16.63
	Rh2255	F	1.8	181.91	196.59	211.58	8.07	16.31
	Rh2256	F	1.8	175.55	188.05	202.11	7.12	15.13
			Mean	178.69	193.10	207.33	8.06	16.02
			SD	3.18	4.48	4.81	0.93	0.79
			n	3	3	3	3	3
Step-II Confirmation & 2000	Rh2257	F	1.7	170.55	187.82	202.45	10.13	18.70
	Rh2258	F	1.8	176.97	192.65	208.92	8.86	18.05
	Rh2259	F	1.8	180.99	197.21	210.88	8.96	16.51
			Mean	176.17	192.56	207.42	9.32	17.76
			SD	5.27	4.70	4.41	0.70	1.12
			n	3	3	3	3	3

Interpretation of results:

other: No category (CLP Regulation EC no. 1272/2008)

Conclusions:

The LD50 of the test item is 5000 mg/ kg body weight by oral route in the rat.

Executive summary:

Acute Oral Toxicity - Acute Toxic Class Method” and classified as “Category 5 or unclassified (2000 < ATE ≤ 5000 mg/kg body weight)”

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

> 2 000 - <= 5 000 mg/kg bw

Quality of whole database:

Key study with Klimisch score = 1

Acute toxicity: via inhalation route

Endpoint conclusion

Endpoint conclusion:

no study available

Acute toxicity: via dermal route

Endpoint conclusion

Endpoint conclusion:

no study available

Justification for classification or non-classification

Based on the available data, the substance is not classified for acute toxicity (oral) according to CLP Regulation (EC) no. 1272/2008.