[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:

11 Feb - 22 Jun 2021

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2021

Report date:

2021

Materials and methods

Test guideline

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

Test material

Test material information

Constituent 1

Reference substance name:

Fatty acids, C6-18 (branched and linear) alkyl and hydrocarbons, C10-18, n-alkanes, branched alkanes, cycloalkanes, aromatics

Molecular formula:

not applicable due to UVCB substance

IUPAC Name:

Fatty acids, C6-18 (branched and linear) alkyl and hydrocarbons, C10-18, n-alkanes, branched alkanes, cycloalkanes, aromatics

Test material form:

liquid

Test animals

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

Administration / exposure

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).

Results and discussion

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.

Effect levels

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.

Any other information on results incl. tables

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

 

Applicant's summary and conclusion

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.