Sodium N-(hydroxymethyl)glycinate

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation / corrosion, other

Remarks:

Animal study from the period before entry into force of the in-vitro skin irritation requirement.

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: This study was subject to the EPA Guidelines for Good Laboratory Practice Standards 40 CFR Parts 160 & 792. The test method was performed according to the internationally accepted EPA guideline 81-5. Test substance data lacked purity.

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 81-5 (Acute Dermal Irritation)

Deviations:

no

GLP compliance:

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:

- Name of test material: Suttocide®A- Appearance: white powder- Lot/batch No.: Not specified- Purity: Not specified- Sample praparation: The test article was weighed, applied to the site on the rabbit and covered with a gauze patch moistened with distilled water.

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS- Source: Ace Animals, Boyertown, PA - Quarantine period of at least one week.- Sex: males- Weight at study initiation: 2.0 -2.2 kg.- identification: cage notation and a uniquely numbered metal eartag.- Housing: individually in wire-meshed cages with bedding. - Diet: Fresh Purina Rabbit Chow (Diet #5321).- Water: ad libitum.- Identification: ear tags and color coded cage cards- Animal room: reserved exclusively for rabbits on acute tests, temperature controlled with a 12 hour light/dark cycle, and kept clean and vermin free.

Test system

Type of coverage:

semiocclusive

Preparation of test site:

clipped

Vehicle:

water

Remarks:

5 % or 0.5 %

Controls:

not required

Amount / concentration applied:

100% -Test substance as such

Duration of treatment / exposure:

4h

Observation period:

72 h in total

Number of animals:

6

Details on study design:

TEST SITE- Clipping: 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 1 O x 15 cm and remained intact. - Application: TEST SUBSTANCE:- 0.5 g of the test article was placed under a 2.5 x 2.5 cm, moistened 4 ply, surgical gauze patch. Gentle pressure was applied to the gauze to aid in the distribution of the test substance over the prepared site. The patch was secured with non-irritating tape. The torso was wrapped with plastic in a semi-occlusive manner and secured with non-irritating tape which completely covered the plastic.SCORING:- The test sites were scored for dennal irritation at 30 to 60 minutes after removal of wrappings. Reactions were scored again at 24, 48 and 72 hours following patch removal. - Erythema and edema were scored according to the numerical Draize technique below. The skin was also evaluated for ulceration and necrosis or any evidence of tissue destruction. EVALUATION:Erythema & Eschar:- 0= No erythema - 1= Very slight erythema (barely perceptible) - 2= Well defined erythema - 3= Moderate to severe erythema - 4= Severe erythema (beet redness) to slight eschar formation (injuries in depth) Edema: - 0= No edema - 1= Very slight edema (barely perceptible) - 2= Slight edema (edges of area well-defined by definite raising) - 3= Moderate edema (raised approximately 1.0 mm) - 4= Severe edema (raised more than 1.0 mm, extending beyond the area of exposure)- In evaluating the average irritation, scores for individual intact and abraded exposure sites were recorded separately for each of the two scoring time intervals. A total for erythema and eschar formation was added to a total for edema then divided by 4 to yield the individual animal score. - The mean of the three scores was calculated and this score represents the mean primary irritation score. Analysis of Data:- Dermal irritation is the production of reversible inflammatory changes in the skin following exposure to the test article. - Dermal corrosion is the production of irreversible tissue damage to the skin fallowing exposure to the test article.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Time point:

other: 30-60 minutes

Score:

0.5

Remarks on result:

other: Individual scores: 0;0;0;1;1;1

Results 2

Irritation parameter:

erythema score

Basis:

mean

Time point:

other: 24h

Score:

0.33

Remarks on result:

other: Individual scores: 0,0,0,1,0,1

Results 3

Irritation parameter:

erythema score

Basis:

mean

Time point:

other: 48 + 72 h

Score:

0

Reversibility:

fully reversible

Remarks on result:

other: Individual scores: 0; 0; 0; 0; 0; 0.

Results 4

Irritation parameter:

edema score

Basis:

mean

Time point:

other: 30 - 60 minutes

Score:

0.17

Remarks on result:

other: Individual scores: 0;0;0;0;0;1.

Results 5

Irritation parameter:

edema score

Basis:

mean

Time point:

other: 24 + 48 + 72 h

Score:

0

Reversibility:

fully reversible

Remarks on result:

other: Individual scores: 0;0;0;0;0;0.

Applicant's summary and conclusion

Interpretation of results:

slightly irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Suttocide®A was determined to be slightly irritating to the skin of rabbits, when administered as such.