1-Ethyl-3-methylimidazolium Diethyl Phosphate

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

Nov 2016

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2017

Report date:

2017

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Version / remarks:

1987

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.3 (Acute Toxicity (Dermal))

Version / remarks:

2008

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

1-Ethyl-3-methylimidazolium Diethyl Phosphate

Cas Number:

848641-69-0

Molecular formula:

C6H11N2 C4H10O4P

IUPAC Name:

1-Ethyl-3-methylimidazolium Diethyl Phosphate

Test material form:

liquid

Details on test material:

Batch No 187-9-113-Y
Expiry date: 2021-1-30

Specific details on test material used for the study:

Batch no.: Batch 1.3
Purity: 80% (20% water)
Correction factor: 1.25

Test animals

Species:

rat

Strain:

Sprague-Dawley

Remarks:

Crl:CD(SD)

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River Laboratories Germany GmbH, Sulzfeld, Germany
- Females (if applicable) nulliparous and non-pregnant: yes
- Age at study initiation:
males: approx. 8 weeks; females: approx. 10 weeks
- Weight at study initiation:
males: 265-307 g; females: 229-245 g
- Fasting period before study: no
- Housing: During the 14-day observation period the animals were kept singly in MAKROLON
cages (type III plus)
- Diet (e.g. ad libitum): Commercial diet, ssniff® R/M-H V1534 (ssniff Spezialdiäten GmbH, 59494 Soest, Germany; ad libitum
- Water (e.g. ad libitum): drinking water; ad libitum
- Acclimation period: 10 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22°C ± 3°C
- Humidity (%): 55% ± 15%
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES:
From: 07.11. To: 30.11.2017

Administration / exposure

Type of coverage:

occlusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

TEST SITE
- Area of exposure:
on the animal´s back between the fore and hind extremities and had an area of at least 5 cm x 6 cm (approx. 1/10 of body surface).
- % coverage:
100%
- Type of wrap if used:
The test patch was occlusive. The test item was held in contact with the skin with 8 layers of gauze. The gauze was covered with a plastic sheet and secured with adhesive plaster strips on the application site

REMOVAL OF TEST SUBSTANCE
- Washing (if done): none
- Time after start of exposure: n.a.

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2.19 mL/kg bw corresponding to 2000 mg/kg bw
- Concentration (if solution): pure substance applied
- Constant volume or concentration used: yes

VEHICLE
- Amount(s) applied (volume or weight with unit): n.a., applied as such

Duration of exposure:

24 h

Doses:

Limit dose:
- 2000 mg/kg bw

No. of animals per sex per dose:

5

Control animals:

not required

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing:
Observations were performed before and immediately, 5, 15, 30, and 60 min, as well as 3, 6, and 24 hours after administration. During the follow-up period (two weeks), changes of skin and fur, eyes and mucous membranes, respiratory and circulatory function, autonomic and central nervous system and somatomotor activity as well as behaviour pattern, were observed at least once a day until all symptoms subsided, thereafter each working day.Attention was also paid to possible tremors, convulsions, salivation, diarrhoea, lethargy, sleep, and coma. Individual body weights were recorded before administration of the test item and thereafter in weekly intervals up to the end of the study.
- Necropsy of survivors performed: yes

Statistics:

not required

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No death was recorded within the test period (one dosing day and 14 days of recovery).

Clinical signs:

No clinical signs observed

Body weight:

One of the 5 female animals appeared to be reduced in body weight gain at the end of the study.

Gross pathology:

No signs of abnormalities were noted at necropsy.

Other findings:

No skin reactions were observed at the application site.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The LD50 (dermal) of the substance is greater than 2000 mg/kg bw.

Executive summary:

The acute dermal toxicity of the test item was assessed in a study according to OECD Guideline 402 with rats. As a result of the study, the LD50 (dermal) was determined to be > 2000 mg/kg bw.

No death or clinical symptoms were recorded within the test period (one dosing day and 14 days of recovery). One of the 5 female animals appeared to be reduced in body weight gain at the end of the study.

No skin reactions were observed at the application site. No signs of abnormalities were noted at necropsy.