2-heptadecyl-1H-imidazole

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

30 May 2017 - 22 Jan 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

Test guideline 1

Qualifier:

according to guideline

Guideline:

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

Version / remarks:

adopted 17 Dec 2001

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.1100 (Acute Oral Toxicity)

Version / remarks:

Dec 2002

Deviations:

no

Test guideline 3

Qualifier:

according to guideline

Guideline:

EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)

Version / remarks:

adopted May 2008

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Remarks:

Landesleitstelle Bayern, Bayerisches Landesamt für Gesundheit und Lebensmittelsicherheit, Schwabach, Deutschland

Test type:

acute toxic class method

Limit test:

yes

Test material

Test material information

1

Reference substance name:

2-heptadecyl-1H-imidazole

EC Number:

245-589-7

EC Name:

2-heptadecyl-1H-imidazole

Cas Number:

23328-87-2

Molecular formula:

C20H38N2

IUPAC Name:

2-heptadecyl-1H-imidazole

Test animals

Species:

rat

Strain:

other: WISTAR Crl:WL (Han)

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River, 97633 Sulzfeld, Germany
- Females (nulliparous and non-pregnant): yes
- Age at study initiation: 8 -11 weeks
- Weight at study initiation: step 1, animals no. 1-3: 204 g – 207 g, step 2, animals no 4-6: 158 g – 163 g
- Fasting period before study: yes, the animals were fasted for 16 - 19 h before dosing.
- Housing: Full barrier in an air conditioned room, animals were kept in groups in IVC cages, type III H, polysulphone cages on Altromin saw fibre bedding
- Diet: Altromin 1324 maintenance diet, ad libitum
- Water: tap water, sulphur acidified to a pH of appriximately 2.8, ad libitum
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3
- Humidity (%): 55 ± 10
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: Step 1, animals no.1, 2, 3: 07 Nov 2017, Step 2, animals no. 4, 5, 6: 14 Nov 2017 To: 28 Nov 2017

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

corn oil

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 0.2 g/mL
- Amount of vehicle (if gavage): 10 mL
- Justification for choice of vehicle: This vehicle was chosen due to its non-toxic characteristics.
- Lot/batch no.: lMKCC0462 (Sigma-Aldrich)
- Expiry date: 31 Dec 2017

MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg bw

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

3 per step / 2 steps performed

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: The animals were weighed on day 1 (prior to the administration) and on days 8 and 15.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs: A clinical examination was made several times on the day of dosing (at least once during the first 30 minutes and with special attention given during the first 4 hours post-dose). As soon as symptoms were noticed they were recorded. Thereafter, the animals were observed for clinical signs once daily until the end of the observation period. All abnormalities were recorded. Cageside observations included changes in the skin and fur, eyes and mucous membranes. Also respiratory, circulatory, autonomic and central nervous systems and somatomotor activity and behaviour pattern were examined. Particular attention was directed to observations of tremor, convulsions, salivation, diarrhoea, lethargy, sleep and coma. All animals were subjected to gross necropsy and examined macroscopically for gross pathological changes. In the absence of gross pathological changes no tissues were preserved for a possible histopathological evaluation.

Results and discussion

Effect levels

Key result

Sex:

female

Dose descriptor:

LD50 cut-off

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortality occurred during the study period.

Clinical signs:

Acute oral toxicity characteristics including slightly reduced spontaneous activity, slight piloerection, hunched posture and half eyelid-closure were observed in one of six animals after a single dose administration.

Body weight:

None of the animals showed weight loss during the observation period.

Gross pathology:

No specific gross pathological changes were recorded for any animal.

Any other information on results incl. tables

 Table 1: Mortality Data, LD₅₀Cut-Off

Starting Dose (mg/kg bw)	Number of Animals	Number of Intercurrent Deaths	LD50 Cut-Off
2000	6	0	> 2000

bw = body weight

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:

Under the conditions of the present study, a single oral application of the test substance to rats at a dose of 2000 mg/kg bw was associated with signs of toxicity but not mortality.
The median lethal dose of test substance after a single oral administration to female rats, observed over a period of 14 days is: LD50 cut-off (rat): > 2000 mg/ kg bw.

CLP: not classified