Registration Dossier

Administrative data

Description of key information

Skin irritation- rabbits: slightly irritating
Eye irritation- rabbits: serious damage to the eyes (not reversed after 7 days)

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records
Reference
Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Very brief description of methods and results. Characterization of test material was not reported.
Qualifier:
according to
Guideline:
other: Draize skin irritation technique
Deviations:
not specified
GLP compliance:
no
Species:
rabbit
Strain:
other: Albino rabbits
Type of coverage:
occlusive
Vehicle:
unchanged (no vehicle)
Controls:
not specified
Amount / concentration applied:
undiluted
Duration of treatment / exposure:
24 hour(s)
Observation period:
72 hours after application of the test material
Number of animals:
6
Details on study design:
TEST SITE
- Area of exposure: The fur was clipped from about the sixth thorasic vertebrae to the sacral region and about 4 inches from the vertebral colum on each side using an electric clipper. Two areas, approximately 10 cm apart, on the back of each rabbit were selected as application sites.
- % coverage: no data
- Type of wrap if used: Two layers of light gauze cut into squares were secured to the selected areas by strips of 1-inch wide adhesive tape.
The trunk of each rabbit was then wrapped in polyethylene sheeting and taped at both ends.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): no data
- Time after start of exposure: 24 hours

SCORING SYSTEM: Draize, Woodward and Calv ery as described on page 48 of "Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics" published by the Food and Drug Officials of the United States.
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
mean
Time point:
other: 72 h
Score:
1.54

Mean (n=6) skin reaction scores for intact skin:
Erythema/Eschar Formation (24-h): 1.50
Edema Formation (24-h): 1.33

Erythema/Eschar Formation (72-h): 0.17
Edema Formation (72-h): 0

Mean (n=6) skin reaction scores for abraded skin:
Erythema/Eschar Formation (24-h): 1.33
Edema Formation (24-h): 1.50

Erythema/Eschar Formation (72-h): 0.17
Edema Formation (72-h): 0.17

The Primary Irritation Score was calculated to be 1.54, indicating the 

test material is mildly irritating. 

Interpretation of results:
GHS criteria not met
Remarks:
Migrated information
Conclusions:
Utilizing a method for evaluating the skin irritation potential of an experimental material, it was found that M &T Chemicals, Inc., tin bis(2 -ethylhexanoate) is a mild irritant to intact and abraded skin of the albino rabbit.
Executive summary:

A group of six (three males and three females) healthy albino rabbits was employed in this project to study the experimental material. The fur was clipped from about the sixth thorasic vertebrae to the saral region and about 4 inches from the vertebral column on each side using an electric clipper. Two areas, approximately 10 cm apart, on the back of each rabbit were selected as application sites. One site was abraded by making four epidermal incisions in a cross hatch pattern on this site. Then 0.5 ml of the experimental material was applied to each site and patches consisting of two layers of light gauze cut into squares were secured to the selected areas by stripps of 1 inch wide adhesive tape. The trunk of each rabbit was then wrapped in polyethylene sheeting and taped at both ends. The experimental material was left in contact with the skin for 24 hours after which the trunk bands were removed and the sites examined and evaluated. The sites were again examined seventy-two hours after application. The scoring method used was Draize, Woodard and Clavary.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not 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: Chracterization of the material not provided
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
GLP compliance:
not specified
Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: sanitized
- Weight at study initiation: 2.5-3.0 kg
- Housing: individually in cages with a grid floor
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 deg C
- Humidity (%): 52%

IN-LIFE DATES: From: 1980-04-02 To: 1980-04-09
Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL


Duration of treatment / exposure:
7 days
Observation period (in vivo):
7 days
Number of animals or in vitro replicates:
6
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): no washing

SCORING SYSTEM: FDA

TOOL USED TO ASSESS SCORE: standard illumination
Irritation parameter:
maximum mean total score (MMTS)
Basis:
mean
Time point:
other: 24 hours
Score:
12
Reversibility:
not fully reversible within: 7 days
Irritation parameter:
maximum mean total score (MMTS)
Basis:
mean
Time point:
other: 48 hours
Score:
13
Reversibility:
not fully reversible within: 7 days
Irritation parameter:
maximum mean total score (MMTS)
Basis:
mean
Time point:
other: 72 hours
Score:
13
Reversibility:
not fully reversible within: 7 days

No corneal responses were observed at 1 h, but scattered or diffuse areas of opacity (score 1) were noted in all treated eyes a t 24 h, 48 h and 72 h. At 7 days, the response was more severe in all but one of the treated eyes, and in one eye complete corneal opacity (score 4) prevented observation of the iris. Very slight iridial responses were noted in 5/6 eyes treated with stannous octoate at 1 h. The maximum score for iridial damage (2) was recorded for 5/6 treated eyes at 24 h and all observable irises a t 48 h, 72 h and 7 days. Positive responses for conjunctival redness and chemosis (2 or above) and moderate or severe discharge (score 2 or 3) were recorded in all eyes treated with stannous octoate at all readings.

Interpretation of results:
highly irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Tin bis(2 -ethylhexanoate) elicited severe ocular responses involving the cornea and iris, as well as marked conjunctival responses.
Executive summary:

Six New Zealand White rabbits (3 male,3 female) were used in the study. Test material, at 0.1 mL, placed into the right eye by gently pulling the lower eyelid away from the eyeball to form a sac into which the test material was dropped. The lids were then gently held together for 1 or 2 sec. The other eye remained untreated to serve as a control. Instillation of 0.1 ml of the test material into the eyes of rabbits resulted incorneal and iridial responses to treatmentand severe conjunctival reactions which persisted throughoutthe test. The study was assigned a K-2 rating. Tin bis(2 -ethylhexanaote) may be classified as a severe eye irritant in view of the corneal and iridial responses to treatment and severe conjunctival reactions which persisted throughout the test.

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irreversible damage)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Six albino rabbits (3 males, 3 females) were used in the study. The hair was clipped on the back of each animal and two areas approximately 10 cm apart were selected as application sites. The skin at one site was abraded by making four epidermal incisions in a cross hatch pattern, the other site was left unabraded. 0.5 mL of the test material was applied to each site on each animal and covered with gauze. The trunk was then wrapped in polyethylene sheeting and taped. The test material was left in contact with the skin for 24 hours, after which time the trunk bands were removed. The application sites were examined and scored at 24 and 72 hours post-treatment. Skin reactions (i.e., erythema and eschar formation and edema formation) were evaluated according to the method of Draize. The Primary Irritation Score was calculated to be 1.54, indicating the test material is mildly irritating. After 72 hours observation, very slight edema and erythema was evident in three test animals. The study was assigned a K-2 rating. [AME Test Report]

Six New Zealand White rabbits (3 male,3 female) were used in the study. Test material, at 0.1 mL, placed into the right eye by gently pulling the lower eyelid away from the eyeball to form a sac into which the test material was dropped. The lids were then gently held together for 1 or 2 sec. The other eye remained untreated to serve as a control. Instillation of 0.1 ml of the test material into the eyes of rabbits resulted in corneal and iridial responses to treatment and severe conjunctival reactions which persisted throughout the test. The study was assigned a K-2 rating. [Dow Corning Report]


Effects on skin irritation/corrosion: slightly irritating (not classified)

Effects on eye irritation: highly irritating

Justification for classification or non-classification

The Primary Irritation Score was calculated to be 1.54, indicating the test material is mildly irritating. Tin bis(2 -ethylhexanoate) may be classified as a severe eye irritant in view of the corneal and iridial responses to treatment and severe conjunctival reactions which persisted throughout the test.