Acetic acid, chloro-, sodium salt, reaction products with 4,5-dihydro-2-undecyl-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:

November 9, 1976 - December 21, 1976

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1976

Report date:

1976

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 7 days, no body weight measurements, no data about the clinical examinations and necropsy

GLP compliance:

no

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Acetic acid, chloro-, sodium salt, reaction products with 4,5-dihydro-2-undecyl-1H-imidazole-1-ethanol and sodium hydroxide

EC Number:

271-794-6

EC Name:

Acetic acid, chloro-, sodium salt, reaction products with 4,5-dihydro-2-undecyl-1H-imidazole-1-ethanol and sodium hydroxide

Cas Number:

68608-66-2

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 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:

water

Constituent 3

Reference substance name:

Sodium chloride

EC Number:

231-598-3

EC Name:

Sodium chloride

Cas Number:

7647-14-5

Molecular formula:

ClNa

IUPAC Name:

Sodium chloride

Test material form:

liquid

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:

rat

Strain:

other: Charles River

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River
- Age at study initiation: no data
- Weight at study initiation: 200-300 g
- Fasting period before study: 18 hours
- Housing: Raised wire mesh cages
- Diet (e.g. ad libitum): Lab Blox ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: no data

ENVIRONMENTAL CONDITIONS
- Temperature (°C): no data
- Humidity (%): no data
- Air changes (per hr): air conditioned quarters
- Photoperiod (hrs dark / hrs light): no data

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

water

Details on oral exposure:

VEHICLE
The test material was diluted 1+1 (w/w) with water just prior to dosing.

Doses:

5.0, 5.5, 6.25 and 6.5 mL/kg bw (aqueous solution)

No. of animals per sex per dose:

5

Control animals:

other: not required

Details on study design:

- Duration of observation period following administration: 7 days
- Frequency of observations: daily observations (no weighing)
- Necropsy of survivors performed: yes

Statistics:

The method of Litchfield & Wilcoxon (1949) was used for calculating the oral LD50.

Results and discussion

Effect levels

Effect levels 1

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

5.85 mL/kg bw

Based on:

test mat.

Remarks:

(aqueous solution)

95% CL:

5.4 - 6.3

Remarks on result:

other: Aqueous solution with a solid content of approximately 50%

Effect levels 2

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

6 844.5 mg/kg bw

Based on:

test mat.

Remarks:

(aqueous solution)

Remarks on result:

other: Aqueous solution with a solid content of approximately 50%

Effect levels 3

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

3 422 mg/kg bw

Based on:

other: expressed as solid content

Remarks on result:

other: Results expressed for the substance

Mortality:

One, three, seven and seven animals died in the group of rats receiving 5.0, 5.5, 6.25 and 6.5 mL/kg bw (aqueous solution), respectively

Clinical signs:

other: no data

Gross pathology:

no data

Any other information on results incl. tables

RESULTS: 

Group	Dose (mL/kg b.w.) (aqueous solution)	Mortality	Group mortality (%)
1	5.0	1/10	10
2	5.5	3/10	30
3	6.25	7/10	70
4	6.5	7/10	70

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 5.85 mL/kg (aqueous solution), converted to be 6844 mg/kg (as the density is 1.17 g/mL). This would correspond to a LD50 of 3422 mg/kg for the substance.

Executive summary:

The test material was tested as an aqueous solution (ca. 50% solids) for acute oral toxicity in the rat. The test article was administered as a 1:1 dilution in water in a single oral dose at 5.0, 5.5, 6.25, and 6.5 mL/kg dose volumes to groups of 10 fasted rats. Examinations for mortality and clinical signs were performed daily for 7 days. One and 3 animals died in the groups administered 5.0 and 5.5 mL/kg, respectively. Seven animals died in the groups receiving 6.25 and 6.5 mL/kg of the test substance. Based on these results, the acute oral LD50 was calculated to be 5.85 mL/kg (aqueous solution), with 95% confidence limits of 5.4 - 6.3 mL/kg.

With a density documented to be approximately 1.17, the LD50 is estimated to be 6844 mg/kg for the aqueous solution. This corresponds to a LD50 of 3422 mg/kg for the substance.