[No public or meaningful name is available]

Endpoint summary

Description of key information

Oral (OECD 420): LD50 (rat, f) > 2000 mg/kg bw

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:

11 Feb - 22 Jun 2021

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 420 (Acute Oral Toxicity - Fixed Dose Method)

Version / remarks:

adopted 2001

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test type:

fixed dose procedure

Limit test:

no

Species:

rat

Strain:

other: Crl:WI(Han)

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River (UK) Ltd., Margate, UK
- Females nulliparous and non-pregnant: yes
- Age at study initiation: 8 - 10 weeks
- Weight at study initiation: 169 - 198 g , weight variation did not exceed ± 20% of the mean weight
- Fasting period before study: overnight
- Housing: in groups of up to five per cage, clean European soft wood bedding (Datesand Ltd., Manchester, UK) was provided on a weekly basis
- Diet: 5LF2 EU Rodent Diet 14%, ad libitum
- Water: mains water via water bottles, ad libitum
- Acclimation period: 7 - 15 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 - 25
- Humidity (%): 40 - 70
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12 / 12

IN-LIFE DATES: From: 23 Feb 2021 To: 24 Mar 2021

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

MAXIMUM DOSE VOLUME APPLIED: 2.32 mL/kg bw

DOSAGE PREPARATION: test substance was used undiluted, no dosage preparation was necessary

Doses:

300 and 2000 mg/kg bw

No. of animals per sex per dose:

1 female (300 mg/kg bw) and 5 females (2000 mg/kg bw)

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations: animals were observed at the beginning and the end of the working day for signs of ill health or overt toxicity.
- Necropsy of survivors performed: yes; inspection of external surfaces and orifices, all viscera and tissue within the abdominal, thoracic and cranial cavities, free-hand sectioning of the liver and kidneys and examination of representative sections of mucosal surfaces of the stomach, small and large intestines
- Clinical signs were recorded immediately post-dose, at approx. 15 and 30 min post-dose, once per hour between 1 and 4 h post-dose, twice daily on Days 2, 3 and 4 and once daily from Day 5 to last day of the observation period, rats were weighed on the day before dosing)and on Days 1, 4, 8 and 15 (before necropsy).

Preliminary study:

A preliminary test was performed to establish the dosing regimen for the main test. 1 female each was dosed at 300 and 2000 mg/kg bw. No mortality or adverse effects occurred and a dose level of 2000 mg/kb bw was selected for the main study.

Key result

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

All animals survived until scheduled necropsy.

Clinical signs:

other: No clinical signs were recorded.

Gross pathology:

No abnormalities were noted at necropsy, except for abnormal shaped pituitary, pelvic dilatation and soft kidney, which were noted in a single animal dosed at 2000 mg/kg bw.

Table 1: Mortality Data

Dose Level (mg/kg bw)	Mortality Ratio
300 2000	0/1 0/5

 

Table 2: Clinical Signs Following Treatment

Dose Level (mg/kg bw)	Clinical Sign	Animal Number
		42	43	44	45	46	47
300	No observations	ü	-	-	-	-	-
2000	No observations	-	ü	ü	ü	ü	ü

Key: ü             No clinical signs seen throughout the observation period

 

Table 3: Individual Body Weights and Weekly Increments

Dose Level (mg/kg bw)	Animal Number	Body Weight (g) at:					Increment (g)
		Day -1	Day 1	Day 4	Day 8	Day 15	Day 1 to 8	Day 8 to 15
300	42	181	169	184	194	204	25	10
2000	43	181	179	183	185	200	6	15
	44	184	172	198	202	210	30	8
	45	191	189	199	209	207	20	-2
	46	205	198	219	223	226	25	3
	47	184	176	192	194	235	18	41

A minus symbol [-] indicates a body weight loss

 

Table 4: Necropsy Findings

Dose Level: 300 mg/kg bw

Animal Number	Time and Manner of Death (Day)	Necropsy Comments
42	15T	No macroscopic changes

 

Dose Level: 2000 mg/kg bw

Animal Number	Time and Manner of Death (Day)	Necropsy Comments
43	15T	No macroscopic changes
44	15T	Pituitary: Abnormal shape # Kidney: pelvic dilatation, right, moderate # Kidney: soft, left, moderate #
45	15T	No macroscopic changes
46	15T	No macroscopic changes
47	15T	No macroscopic changes

T           Animal killed by exsanguination under deep inhalation anaesthesia at completion of observation period

#           Sample preserved in neutral buffered formalin

 

Interpretation of results:

other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No. 1272/2008.

Conclusions:

In this acute oral toxicity study in female rats a LD50 value of > 2000 mg/kg bw was determined.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

> 2 000 mg/kg bw

Quality of whole database:

The available information comprises an adequate and reliable (Klimisch score 1) study performed with the registered substance. The selected study is thus sufficient to fulfil the standard information requirements set out in Annex VII, Item 8.5, of Regulation (EC) No. 1907/2006.

Acute toxicity: via inhalation route

Endpoint conclusion

Endpoint conclusion:

no study available

Acute toxicity: via dermal route

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

Acute oral toxicity

The acute oral toxicity of fatty acids, C6-18 (branched and linear) alkyl and hydrocarbons, C10-18, n-alkanes, branched alkanes, cycloalkanes, aromatics (EC No. 942-654-8) was tested in a study performed according to OECD guideline 420 under GLP conditions (Covance, 2021a). In a preliminary study fasted female Crl:WI(Han) rats were given the test substance as a single dose by oral gavage at dose levels of 300 and 2000 mg/kg bw. Since there were no deaths in the preliminary study at a dose level of 2000 mg/kg bw, a further four fasted females were given a single oral dose of the test substance at a level of 2000 mg/kg bw. All surviving animals were killed on Day 15 and subsequently underwent a full necropsy. There were no deaths at either dose level and no clinical signs were observed. All rats achieved body weight gains over the study period. No abnormalities were noted at necropsy, except for abnormal shaped pituitary, pelvic dilatation and soft kidney, which were noted in 1/5 animal dosed at 2000 mg/kg bw. Since no mortality occured, the LD50 of the test substance was determined to be > 2000 mg/kg bw.

Justification for classification or non-classification

The available data on acute toxicity of fatty acids, C6-18 (branched and linear) alkyl and hydrocarbons, C10-18, n-alkanes, branched alkanes, cycloalkanes, aromatics (EC No. 942-654-8) do not meet the criteria for classification according to Regulation (EC) No. 1272/2008 (CLP) and are therefore conclusive but not sufficient for classification.