Acetic acid, 2-chloro-, reaction products with 2-C11-13-alkyl-4,5-dihydro-1H-imidazole-1-ethanol and sodium hydroxide

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

June 25, 1980 - August 4, 1980

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: The study meets the EC Standards (conducted equivalent to OECD 401). Deviations: lack of study design details in the report, observation period of only 5 days, no body weight measurements, no clinical examinations and no necropsy carried out.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1980

Report date:

1980

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

yes

Remarks:

lack of study design details in the report, observation period of only 5 days, no body weight measurements, no clinical examinations and no necropsy carried out

GLP compliance:

no

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Reaction products of 1H-Imidazole-1-ethanol, 4,5-dihydro-, 2-(C11-C13 odd-numbered alkyl) derivs. and sodium hydroxide and chloroacetic acid

EC Number:

938-645-3

Cas Number:

1689515-39-6

Molecular formula:

Not applicable (a generic molecular formula cannot be provided for this specific UVCB substance)

IUPAC Name:

Reaction products of 1H-Imidazole-1-ethanol, 4,5-dihydro-, 2-(C11-C13 odd-numbered alkyl) derivs. and sodium hydroxide and chloroacetic acid

Constituent 2

Reference substance name:

Water

EC Number:

231-791-2

EC Name:

Water

Cas Number:

7732-18-5

Molecular formula:

H2O

IUPAC Name:

Oxidane

Constituent 3

Test material form:

other: aqueous solution

Details on test material:

- Physical state: Aqueous solution
- Appearance: No data
- Composition of test material, percentage of components: see section confidential details on test material

Test animals

Species:

mouse

Strain:

CF-1

Sex:

not specified

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Weight at study initiation: ca. 20 gram
No further details available

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

No data available

Doses:

10, 15 and 20 mL/kg (aqueous solution)

No. of animals per sex per dose:

10 animals per dose (sex unknown)

Control animals:

other: not required

Details on study design:

- Duration of observation period following administration: 5 days

Results and discussion

Effect levels

Effect levels 1

Key result

Sex:

not specified

Dose descriptor:

LD50

Effect level:

> 15 - < 20 mL/kg bw

Based on:

test mat.

Remarks:

(aqueous solution)

Remarks on result:

other: Aqueous solution with a solid content of approximately 37%

Effect levels 2

Key result

Sex:

not specified

Dose descriptor:

LD50

Effect level:

> 16 050 - < 21 400 mg/kg bw

Based on:

test mat.

Remarks:

(aqueous solution)

Remarks on result:

other: Aqueous solution with a solid content of approximately 37%

Effect levels 3

Sex:

not specified

Dose descriptor:

LD50

Effect level:

> 5 939 - < 7 918 mg/kg bw

Based on:

other: expressed as solid content

Remarks on result:

other: Results expressed for the substance

Mortality:

- No mortalities occurred in the group administered 10 ml/kg.
- One and all ten animals died in the group of mice receiving 15 and 20 ml/kg bw, respectively

Clinical signs:

other: no data

Gross pathology:

no data

Any other information on results incl. tables

RESULTS 

Group	Dose (mL/kg b.w.)	Mortality	Group mortality (%)
1	10.0	0/10	0
2	15.0	1/10	10
3	20.0	10/10	100

 

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

In an acute oral toxicity study conducted equivalent to OECD 401, the LD50 was determined to be between 15 and 20 mL/kg (aqueous solution), which can be converted to between 16,050 and 21,400 mg/kg (for the aqueous solution). This corresponds to a LD50 between 5,939 and 7,918 mg/kg for the substance.