Sodium N-(hydroxymethyl)glycinate

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP study according to internationally accepted guidelines.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1997

Report date:

1997

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

EPA OPP 81-1 (Acute Oral Toxicity)

Deviations:

no

GLP compliance:

yes

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Sodium N-(hydroxymethyl)glycinate

EC Number:

274-357-8

EC Name:

Sodium N-(hydroxymethyl)glycinate

Cas Number:

70161-44-3

Molecular formula:

C3H7NO3.Na

IUPAC Name:

sodium N-(hydroxymethyl)glycinate

Test material form:

solid: particulate/powder

Remarks:

migrated information: powder

Details on test material:

Source: International Specialty Products Date Received: 01/13/97 Label Identity: Suttocide® A (Powder) Appearance: White powder Storage : The test article was stored at room temperature and humidity. Sample Preparation: The test article was used as a 50% mixture in distilled water.

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS- Source: Ace Animals, Boyertown, PA; born the weeks of 10/27 through 12/01/96- Age at study initiation: approx. 6 to 10 weeks- Weight at study initiation: 217 -299 grams for males and 202 - 288 grams for females- Fasting period before study: 16-20 hours prior to dosing- Housing: 5/sex/cage- Diet (e.g. ad libitum): Fresh Purina Rat Chow (Diet #5012) - Water (e.g. ad libitum): tap waterThe animal room, reserved exclusively for rats on acute tests, was temperature controlled, had a 12 hour light/dark cycle, and was kept clean and vermin free. ENVIRONMENTAL CONDITIONS- Temperature (°C):- Humidity (%):- Air changes (per hr):- Photoperiod (hrs dark / hrs light):IN-LIFE DATES: From: To:

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

water

Details on oral exposure:

The test article was mixed with distilled water to make dosing by gavage possible. The dose was based on the sample weight as calculated from the specific gravity. A single dose was administered orally by syringe and dosing needle at a dose level of 1500 mg/kg. Since compound related mortality occurred, additional dose levels were tested.

Doses:

500, 750, 1000, 1500 mg/kg body weight

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

In Vivo - Animals were observed 1, 2 and 4 hours postdose and once daily for 14 days for toxicity and pharmacological effects. The animals were observed twice daily for mortality. Body weights were recorded immediately pretest, weekly, at death and at termination in the survivors. Post Mortem - All animals were examined for gross pathology. Abnormal tissues were preserved in 10% buffered formalin for possible future microscopic examination.

Statistics:

The LD50 and 95% Confidence Limits were calculated by the method of Litchfield J.T. Jr., & F. Wilcoxon JPET 96:99.

Results and discussion

Effect levels

Effect levels 1

Sex:

male

Dose descriptor:

LD50

Effect level:

1 400 mg/kg bw

Based on:

test mat.

Remarks:

Expressed as Suttocide A (Powder)

95% CL:

>= 782 - <= 2 504

Effect levels 2

Sex:

female

Dose descriptor:

LD50

Effect level:

940 mg/kg bw

Based on:

test mat.

Remarks:

Expressed as Suttocide A (Powder)

95% CL:

>= 785 - <= 1 125

Mortality:

Dose mg/kgTreated M/FDead M/F5005/51/07505/50/010005/51/315005/55/5

Clinical signs:

Predeath physical signs included lethargy, diarrhea, piloerection, dyspnea, flaccid muscle tone, ataxia, prostration, ptosis, coma, negative righting reflex and wetness of the anogenital area. Physical signs noted in the animals which survived included lethargy, piloerection, diarrhea, soiling of the anogenital area, emaciation, ataxia, dyspnea, wetness of the anogenital area, brown staining of the nose/mouth area, black discoloration of the distal portion of the tail and loss of the distal portion of the tail.

Body weight:

Body weight changes of survivors dosed at 500 mg/kg were normal. Instances of weight loss were noted in some survivors of the other dose groups.

Gross pathology:

Necropsy results of th/! animals which died during the study revealed abnormalities of the lungs, liver, thymus and gastrointestinal tract, as well as wetness and red or brown staining of the nose/mouth area and soiling or wetness of the anogenital area. Necropsy results of the animals which survived the study were generally normal. The loss of the distal portion of the tail was noted in two survivors dosed at 1000 mg/kg.

Applicant's summary and conclusion

Interpretation of results:

Toxicity Category IV

Remarks:

Migrated informationCriteria used for interpretation of results: EU

Conclusions:

The LD50 for single oral exposure is between 300 and 2000 mg/kg bw for both male and female rats. This means that Suttocide® A should be classified as Acute oral tox. cat. 4.