1-Ethyl-3-methylimidazolium Diethyl Phosphate

Endpoint summary

Description of key information

The registration substance was tested for its skin irritant properties in New Zealand White rabbits. The study was performed according to OECD Guideline 404.With reference the reported scores it is concluded that the registration substance does not have to be classified as irritant to the skin according to the criteria laid down in the EU Classification Labelling and Packaging Regulation (1272/2008/EC).

An in vivo eye irritation study in rabbits was conducted with the test substance. The studies were conducted according to OECD Guideline 405.

With reference the reported scores the registration substance does not have to be classified as irritant to the eyes according to the criteria laid down in the EU Classification Labelling and Packaging Regulation (1272/2008/EC).

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Reference

Endpoint:

skin irritation: in vivo

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

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Version / remarks:

2015

Deviations:

no

Qualifier:

according to guideline

Guideline:

EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Specific details on test material used for the study:

Yellow liquid
Batch no.: Batch 1.3
20% water (Correction factor 1.25)

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Manfred Bauer Kaninchen, 74632 Neuenstein, Germany
- Age at study initiation: approx. 8.5 months
- Weight at study initiation: 3.5 - 3.9 kg
- Housing: individually in cages measuring 380 mm x 425 mm x 600 mm
- Diet (e.g. ad libitum): ssniff k-H V 2333 (ssniff Spezialdiäten GmbH, 59494 Soest, Germany), ad libitum
- Water (e.g. ad libitum): tap water ad libitum
- Acclimation period: 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 3°C
- Humidity (%): 30 - 70%
- Air changes (per hr):
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES:
From: 07.11. To: 29.11.2016

Type of coverage:

semiocclusive

Preparation of test site:

clipped

Vehicle:

unchanged (no vehicle)

Controls:

not required

other: the surrounding untreated skin served as a control

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.625 mL
- Concentration (if solution): pure

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

NEGATIVE CONTROL
- Amount(s) applied (volume or weight): no required

POSITIVE CONTROL
- Amount(s) applied (volume or weight): not required

Duration of treatment / exposure:

4 h

Observation period:

14 days
readings: 60 min, 24, 48, 72 h, 7 and 14 d after patch removal

Number of animals:

3

Details on study design:

TEST SITE
- Area of exposure: approx. 6 cm(2)
- % coverage: 100
- Type of wrap if used: gauze patch

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

OBSERVATION TIME POINTS
(indicate if minutes, hours or days)
60 min, 24, 48, 72 h, 7 and 14 days after patch removal

SCORING SYSTEM: according to Draize

Irritation parameter:

erythema score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Irritation parameter:

edema score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Irritant / corrosive response data:

Under the present test conditions, none of the three rabbits exposed for 4 hours to 0.625 mL of the test item (semi-occlusive conditions) revealed any skin reaction.

Other effects:

There were no systemic intolerance reactions.

Interpretation of results:

GHS criteria not met

Conclusions:

According to GHS and EC regulation 1272/2008 the test item is non-irritating.

Executive summary:

The test substance was tested for its skin irritant properties in 3 New Zealand White rabbits. Due to the water content of 20% 0.625 mL of the substance were applied to the clipped skin. None of the three rabbits exposed for 4 h revealed any skin reaction. There were no systemic intolerance reactions.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records

Reference

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

Nov - Dec 2016

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Version / remarks:

2012

Deviations:

no

Qualifier:

according to guideline

Guideline:

EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)

Version / remarks:

2008

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Specific details on test material used for the study:

Yellow liquid
Batch no.: Batch 1.3
20% water (Correction factor 1.25)

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Manfred Bauer Kaninchen, 74632 Neuenstein, Germany
- Age at study initiation: approx. 8.5 months
- Weight at study initiation: 3.8 - 4.8 kg
- Housing: individually in cages with dimensions of 380 mm x 425 mm x 600 mm
- Diet (e.g. ad libitum): ssniff K-H V2333 (ssniff Spezialdiäten GmbH, 59494 Soest, Germany), ad libitum
- Water (e.g. ad libitum): tap water, ad libitum
- Acclimation period: 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 3°C
- Humidity (%): 30 - 70%
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES:
From: 07.11. To: 07.12.2016

Vehicle:

unchanged (no vehicle)

Controls:

yes, concurrent no treatment

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.125 mL
- Concentration (if solution): 80 %
Due to the water content of the test item of 20% a correction factor of 1.25 was used.

VEHICLE
no vehicle utilised

Duration of treatment / exposure:

No washing of the eye after application of test substance performed

Observation period (in vivo):

The eyes were examined ophthalmoscopically with a slit lamp prior to the administra-tion and 1, 24, 48, 72 hours and 7, 14 and 21 days after the administration.

Number of animals or in vitro replicates:

3

Details on study design:

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

SCORING SYSTEM:
According to Draize scale

TOOL USED TO ASSESS SCORE:
One day before and 24 hours after administration, fluorescein was applied to the eyes before being examined to aid evaluation of the cornea for possible lesions. The fluorescein test was repeated on each day of observation.

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Irritation parameter:

iris score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

2

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

3

Irritation parameter:

chemosis score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Irritant / corrosive response data:

Conjunctival redness (grade 1) was observed in all animals 1 hour after administration.
The corneae and the irises were not affected by administration of the test item.

Other effects:

There were no systemic intolerance reactions.

Interpretation of results:

GHS criteria not met

Conclusions:

According to EC Regualtion 1272/2008 the test item is non-irritating to the eye. Classification and labelling are not necessary.

Executive summary:

The test substance was tested for its eye irritant potential in rabbit eyes according to OEC 405.

Under the present test conditions, a single instillation of 0.125 mL test item into the conjunctival sac of the right eye of 3 rabbits caused the following changes: Conjunctival redness (grade 1) was observed in all animals 1 hour after administration.

The corneae and the irises were not affected by administration of the test item.

There were no systemic intolerance reactions.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no study available

Justification for classification or non-classification

With reference the reported absence of any effects it is concluded that the registration substance does not have to be classified, neither as irritant to the skin nor as eye irritating according to the criteria laid down in the EU Classification Labelling and Packaging Regulation (1272/2008/EC).