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Description of key information

In all tested animals with unwashed eyes, a positive response of corneal opacity ≥ 1 and iritis ≥ 1, and both conjunctival redness and conjunctival oedema (chemosis) ≥ 2. The same was found in two out of three animals with eyes washed out after exposure. In all cases, the effects were observed to be reversible within ≤ 14 days.

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records
Reference
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.
Qualifier:
according to
Guideline:
EPA OPP 81-5 (Acute Dermal Irritation)
Deviations:
no
GLP compliance:
yes
Species:
rabbit
Strain:
New Zealand White
Details on test animals 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.
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.
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
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
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.
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.
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.
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.
Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Eye irritation

Link to relevant study records
Reference
Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: GLP study performed according to an internationally accepted guideline. Exact purity of the test substance not specified.
Qualifier:
according to
Guideline:
EPA OPP 81-4 (Acute Eye Irritation)
Deviations:
no
GLP compliance:
yes
Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS- Source: Ace Animals, Boyertown, PA on 1/07/97 - Weight at study initiation: 2.0 - 2.3 kilograms (young adults)- System of Identification: Cage number and ear tag.- Housing: individually in cages sized in accordance with bedding.- Diet: Fresh Purina Rabbit Chow (Diet #5321), ad libitum.- Water: fresh tap water, ad libitum. ENVIRONMENTAL CONDITIONS- Light cycle - 12 hours light, 12 hours dark.
Vehicle:
unchanged (no vehicle)
Remarks:
50%-solution
Controls:
not required
Amount / concentration applied:
0.1 ml equivalent (90 mg)/treated eye
Duration of treatment / exposure:
The test substance was placed in one eye of each animal by gently pulling the lower lid away from the eyeball (conjunctival cul-de-sac) to form a cup. The upper and lower lids were then gently held together for one second to prevent loss of material. The contralateral eye remained untreated and served as a control. The eyes of six rabbits remained unwashed. The eyes of the other three were washed with 20 ml of distilled water 30 seconds postdose.
Observation period (in vivo):
at 1, 24, 48 and 72 hours and on Days 7 and 14 after treatment
Number of animals or in vitro replicates:
9
Details on study design:
Scoring and grading of irritation was according to the method of Draize J.H. (1965), Appraisal of the Safety of chemicals in Food, Drugs and Cosmetics - Dermal Toxicity, page 49-52. Association of Food and Drug Officials of the U.S., Topeka, Kansas.
Irritation parameter:
overall irritation score
Remarks:
No wash out
Basis:
animal #1
Time point:
other: 1 to 14 days
Score:
>= 0 - <= 41
Max. score:
110
Reversibility:
fully reversible within: 14 days
Remarks on result:
other: Max individual irritation score: 3 (Conjunctivae)
Irritation parameter:
overall irritation score
Remarks:
No wash out
Basis:
animal #2
Time point:
other: 1 to 14 days
Score:
>= 0 - <= 39
Max. score:
110
Reversibility:
fully reversible within: 14 days
Remarks on result:
other: Max individual irritation score: 3 (Conjunctivae)
Irritation parameter:
overall irritation score
Remarks:
No wash out
Basis:
animal #3
Time point:
other: 1 to 14 days
Score:
>= 0 - <= 49
Max. score:
110
Reversibility:
fully reversible within: 14 days
Remarks on result:
other: Max individual irritation score: 3 (Cornea and conjunctivae)
Irritation parameter:
overall irritation score
Remarks:
No wash out
Basis:
animal #4
Time point:
other: 1 to 14 days
Score:
>= 0 - <= 24
Max. score:
110
Reversibility:
fully reversible within: 14 days
Remarks on result:
other: Max individual irritation score: 3 (Conjunctivae)
Irritation parameter:
overall irritation score
Remarks:
No wash out
Basis:
animal #5
Time point:
other: 1 to 14 days
Score:
>= 0 - <= 39
Max. score:
110
Reversibility:
fully reversible within: 14 days
Remarks on result:
other: Max individual irritation score: 3 (Conjunctivae)
Irritation parameter:
overall irritation score
Remarks:
No wash out
Basis:
animal #6
Time point:
other: 1 to 14 days
Score:
>= 0 - <= 27
Max. score:
110
Reversibility:
fully reversible within: 14 days
Remarks on result:
other: Max individual irritation score: 2 (Cornea and conjunctivae)
Irritation parameter:
overall irritation score
Remarks:
Washed out
Basis:
animal #1
Time point:
other: 1 to 14 days
Score:
>= 0 - <= 6
Max. score:
110
Reversibility:
fully reversible within: 2 days
Remarks on result:
other: Max individual irritation score: 2 ((Conjunctivae: discharge)
Irritation parameter:
overall irritation score
Remarks:
Washed out
Basis:
animal #2
Time point:
other: 1 to 14 days
Score:
>= 0 - <= 27
Max. score:
110
Reversibility:
fully reversible within: 14 days
Remarks on result:
other: Max individual irritation score: 3 (Conjunctivae: redness)
Irritation parameter:
overall irritation score
Remarks:
Washed out
Basis:
animal #3
Time point:
other: 1 to 14 days
Score:
>= 0 - <= 29
Max. score:
110
Reversibility:
fully reversible within: 14 days
Remarks on result:
other: Max individual irritation score: 3 (Conjunctivae: chemosis)
Interpretation of results:
slightly irritating
Remarks:
Migrated informationCriteria used for interpretation of results: EU
Conclusions:
When administered as a 50% aqueous solution: the degree of ocular irritation was minimal to slight and involved only the conjunctivae. The irritation was also reversible by day 10 after instillation.
Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Skin irritation:

Most studies reported show only a slight irritation of the skin of test animals exposed to the substance.

Eye irritation:

When administered as a 50% aqueous solution in the key study, the degree of ocular irritation was slight to moderate and involved the cornea, iris and conjunctivae. In all tested animals with unwashed eyes, a positive response of corneal opacity ≥ 1 and iritis ≥ 1, and both conjunctival redness and conjunctival oedema (chemosis) ≥ 2. The same was found in two out of three animals with eyes washed out after exposure. In all cases, the effects were observed to be reversible within ≤ 14 days. Other supporting studies confirmed the slight to moderate eye irritancy of the substance, which was reversible within the observation periods.


Justification for selection of skin irritation / corrosion endpoint:
GLP study according to an internationally accepted guideline with substance applied as such moistened with destilled water.

Justification for selection of eye irritation endpoint:
GLP study according to an internationally accepted guideline.

Effects on skin irritation/corrosion: slightly irritating

Effects on eye irritation: moderately irritating

Justification for classification or non-classification

The results of the studies on skin and eye irritation confirm a low to mild potency of irritation due to exposure to the substance. The data of the key study supports classification of sodium n-(hydroxymethyl) glycinate as irritating to eyes category 2. The key studies on skin irritation show that the potency of sodium n-(hydroxymethyl) glycinate to induce irritation is not conclusive to support classification.