Reaction products of 1H-Imidazole-1-ethanol, 4,5-dihydro-, 2-(C7 odd-numbered alkyl) derivs. and sodium hydroxide and chloroacetic acid

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

weight of evidence

Study period:

1999

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

test procedure in accordance with national standard methods with acceptable restrictions

Remarks:

Study in accordance with US FHSA/CPSC design, 16 CFR 1500 for Acute Oral Toxicity testing

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1999

Report date:

1999

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: FHSA/CPSC Design, 16 CFR 1500 for Acute Oral Toxicity testing

Principles of method if other than guideline:

Oral (gavage) administration of 5000 mg/kg of test item to rats, followed by 14-day observation

GLP compliance:

yes

Test type:

other: estimated LD50

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

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

EC Number:

271-792-5

EC Name:

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

Cas Number:

68608-64-0

Test material form:

solid - liquid: aqueous solution

Details on test material:

Substance tested as different commercial products:
- Mackam 2CY-75, 15% solids (active + impurities) [batch L-48049] in Acute Oral Toxicity, Skin Irritation and Eye Irritation
- Miranol J2M Conc, 49% solids (typical) [batch 2902D77] in Acute Oral Toxicity, or [batch 4349D78] in Skin Irritation and Eye Irritation
- Miranol J2M Anhydrous Acid, 100% solids (assumed) [batch 5958D80] in Acute Oral Toxicity
- Miranol J2M Freeze Dried, 100% solids (measured) [batch R-0469-203-19] in Genetic Toxicity In Vitro

Specific details on test material used for the study:

Trade name: Mackam 2CY-75
Purity: 15% solids (active and impurities)
Chemical active ingredient: Disodium caprylo amphoacetate
CAS No.: 68608-64-0
Batch No.: L-48049

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Harlan Sprague Dawley, Indianapolis, Indiana
- Age at study initiation: 6 to 10 weeks
- Weight at study initiation: 200-245 grams
- Fasting period before study: overnight prior to dosing
- Housing: individually in stainless steel cages

ENVIRONMENTAL CONDITIONS
- Temperature, humidity and light controlled room (no details provided)

IN-LIFE DATES: No details provided

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Doses:

5 mL/kg (globally equivalent to 5000 mg/kg of commercial product, i.e. 750 mg/kg of solid content)

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations: frequently on the day of dosing
- Weighing: prior to dosing and at the end of the 14 days
- Necropsy of survivors performed: yes
- Other examinations performed: no

Results and discussion

Effect levels

Effect levels 1

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 5 mL/kg bw

Based on:

test mat.

Effect levels 2

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 750 mg/kg bw

Based on:

other: solid content

Mortality:

No mortality

Clinical signs:

other: No clinical signs

Gross pathology:

No significant findings

Applicant's summary and conclusion

Interpretation of results:

study cannot be used for classification

Conclusions:

The oral LD50 in rats was higher than 5 mL/kg, globally equivalent to 750 mg/kg expressed as solid content.

Executive summary:

Disodium caprylo amphodiacetate, as Mackam 2CY-75, 15% solids, was tested for acute oral toxicity in Sprague-Dawley rats.  The test article was administered as such by gavage as a single oral dose at 5 mL/kg dose volume to 5 rats per gender fasted overnight. Examinations for mortality and clinical signs were performed daily for 14 days. A complete gross necropsy was performed at sacrifice.

No mortality or clinical changes were observed over the observation period.

Under the conditions of the experiment, the oral LD50 was higher than 5 mL/kg, globally equivalent to 750 mg/kg expressed as solid content assuming a specific gravity of 1.