1H-Imidazolium, 3-ethyl-1-methyl-, C11-13-branched alkylbenzenesulfonates

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Remarks:

This study was available at the time of registration and is submitted as part of an obligation to submit all relevant information on the substance. The study was not commisioned for REACH registration purposes.

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Study was conducted by a GLP accredited laboratory using a test method eqiuivalent to OECD Testing Guideline 402.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2013

Report date:

2013

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Deviations:

not specified

GLP compliance:

yes

Test type:

standard acute method

Test material

Test material information

Constituent 1

Reference substance name:

1H-Imidazolium, 3-ethyl-1-methyl-, C9-14-branched alkylbenzenesulfonates

IUPAC Name:

1H-Imidazolium, 3-ethyl-1-methyl-, C9-14-branched alkylbenzenesulfonates

Constituent 2

Reference substance name:

EMI-DBS

IUPAC Name:

EMI-DBS

Constituent 3

Reference substance name:

1065642-34-3

Cas Number:

1065642-34-3

IUPAC Name:

1065642-34-3

Test material form:

semi-solid (amorphous): gel

Remarks:

migrated information: paste

Details on test material:

Name of test material (as cited in study report): 1H-imidazolium, 3-ethyl-1-methyl-, C9-14-branched alkylbenzenesulfonates

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Acdemy of Militray Medical Sciences
- Weight at study initiation: 200 g
- Fasting period before study: 3 days
- Housing: SPF
- Acclimation period: 3 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20~25
- Humidity (%): 40%~70%

Administration / exposure

Type of coverage:

occlusive

Vehicle:

water

Details on dermal exposure:

TEST SITE
- % coverage: 40%
- Type of wrap if used: gauze

REMOVAL OF TEST SUBSTANCE
- Washing (if done): warm water
- Time after start of exposure: 24h

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2500mg/kg bw
- Constant volume or concentration used: no
- For solids, paste formed: no

Duration of exposure:

24 h

Doses:

2500 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: 0 d; 7 d; 14 d
Necropsy of survivors performed: no
Other examinations performed: clinical signs, body weight,organ weights, histopathology

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 500 mg/kg bw

Remarks on result:

other: No 95% CL information was provided

Mortality:

No deaths were observed.

Clinical signs:

other: No clinical sign were observed.

Any other information on results incl. tables

Summary of results

Animal	Dose Level	Animal	Weight (g, Average±SD)			Death	Mortality	LD50
Sex	(mg/kg bw)	Number	0 day	7 days	14 days	Number	%	(g/kg bw)
Male	2500	5	211.4 ± 5.7	253.2 ± 9.7	288.8 ± 9.8	0	0	>2500
Female	2500	5	213.2 ± 3.2	226.2 ± 4.4	237.2 ± 3.3	0	0	>2500

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

There were no deaths and no clinical signs were observed during the observation period. The LD50 found in the study was >2500 mg/kg bw, as such EMI-DBS is not classified as an acute dermal toxin in accordance with EU CLP criteria.

Executive summary:

The acute dermal toxicity of the test substance was determined using a method equivalent to the OECD Guideline for Testing of Chemicals 402. A dose of 2500 mg/kg bw was applied occlusively by gauze to the skin of male and female Wistar rats. The rats were exposed to the test substance for 24 hours. There were no deaths and no clinical signs were observed during the observation period. The LD₅₀ found in the study was >2500 mg/kg bw, as such EMI-DBS is not classified as an acute dermal toxin in accordance with EU CLP criteria.