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Toxicological information

Acute Toxicity: oral

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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:
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

Reference
Name:
Unnamed
Type:
Constituent
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 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 levelsopen allclose all
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 mL/kg bw
Based on:
test mat.
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 750 mg/kg bw
Based on:
other: solid content
Mortality:
No mortality
Clinical signs:
No clinical signs
Body weight:
No significant body weight changes
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.