Sodium N-(hydroxymethyl)glycinate

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

January 1997

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP study accoring 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 81-2 (Acute Dermal Toxicity)

Deviations:

no

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

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 weighed into aliquots and moistened at the time of dosing.

Test animals

Species:

rabbit

Strain:

New Zealand White

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS- Source: Ace Animals, Boyertown, PA- Quarantine period of at least one week- Body weight range was 2.0 - 2.2 kg for males and 2.0 - 2.3 kg for females- Housing: The animals were identified by cage notation and a uniquely numbered metal eartag and housed 1/cage in suspended wire cages. Bedding was placed beneath the cages and changed at least three times/week. - Diet (e.g. ad libitum): Fresh Purina Rabbit Chow (Diet #5321) - Water (e.g. ad libitum): tap water- The animal room, reserved exclusively for rabbits on acute tests, was temperature controlled, had a 12 hour light/dark cycle, and was kept clean and vermin free.

Administration / exposure

Type of coverage:

occlusive

Vehicle:

water

Details on dermal exposure:

The day prior to application of the test article, the dorsal area of the trunk of each animal was clipped free of hair. The prepared site was approximately 10% of the body surface and remained intact. A single dose of the test article was applied to the prepared site at a dose level of 2000 mg/kg. The dose was based on the dry weight. The test article was applied under a 4 layered surgical gauze patch measuring 1 O X 15 cm. The patch and test article were moistened with distilled water to enhance contact of the test article with the dose site. Gentle pressure was applied to the gauze to aid in the distribution of the test substance over the prepared site. The torso was wrapped with plastic which was secured with non-irritating tape. The test article remained in contact with the skin for 24 hours at which time the wrappings were removed. Residual test article was removed by gentle washing with distilled water.

Duration of exposure:

24 h

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

5

Control animals:

not required

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

All animals survived the 2000 mg/kg dermal application.

Clinical signs:

Instances of diarrhea and soiling of the anogenital area were noted during the observation period. Dermal reactions, well defined to moderate on day 1, were absent to severe on days 7 and 14.

Body weight:

Body weight changes were normal in 9/10 animals. One female lost weight during the first week of the study but gained normally by day 14.

Gross pathology:

Necropsy results were normal in 4/1 O animals. Treated skin abnormalities were noted in six animals.

Applicant's summary and conclusion

Interpretation of results:

practically nontoxic

Remarks:

Migrated informationCriteria used for interpretation of results: EU

Conclusions:

The LD50 is greater than 2000 mg/kg of body weight.