Butylhydroxyoxostannane

Endpoint summary

Description of key information

Skin Irritation

Under the conditions of the study the test material is not irritating to the skin.

Eye Irritation

Under the conditions of the study the test material was not irritating to the eyes.

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

Study period:

Not specified

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

study well documented, meets generally accepted scientific principles, acceptable for assessment

Qualifier:

no guideline followed

Principles of method if other than guideline:

Rabbits were treated with the test material under an occlusive dressing for 24 hours. Sites were scored according to Draize at 24 and 72 hours post treatment for oedema and erythema.

GLP compliance:

no

Remarks:

study pre-dates GLP

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Age at study initiation: young

Type of coverage:

occlusive

Preparation of test site:

other: intact and abraded

Vehicle:

unchanged (no vehicle)

Controls:

no

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied: 500 mg

Duration of treatment / exposure:

24 hours

Observation period:

72 hours

Number of animals:

3

Details on study design:

TEST SITE
- Area of exposure: two test sites located lateral to the midline of the back, 10 cm apart, premoistened. The skin on one of the test sites was abraded and one was left intact.
- Type of wrap if used: Gauze patches secured with masking tape covered the site and the trunk of each animal was then wrapped with impervious plastic sheeting.
- Prior to the application of the test material, the hair was clipped from the back and flanks of each rabbit.

REMOVAL OF TEST SUBSTANCE
- At the end of 24 hours, the plastic wrappings, patches, and all residual test material were removed.

OBSERVATION TIME POINTS
- The intact and abraded test sites were examined and scored separately for erythema and oedema on a graded scale of 0 to 4. After 72 hours, the sites were again examined and scored.
- In evaluating the average irritation present, the mean scores for erythema and oedema of the intact test sites after 24 and 72 hours were added. Similarly, the mean scores for erythema and oedema of the abraded test sites after 24 and 72 hours were added. These two values were totalled and divided by four to obtain the mean primary irritation score.

SCORING SYSTEM:
- Mean Primary Irritation Score:
0 = Non-irritating
0.1 - 0.5 = Minimally Irritating
0.6 - 1.5 = Slightly Irritating
1.6 - 3.0 = Mildly Irritating
3.1 - 5.0 = Moderately Irritating
5.1 - 6.5 = Severely Irritating
6.6 - 8.0 = Extremely Irritating

- Erythema:
Barely perceptible (Edges of area not defined) = 1
Pale red in colour and area definable = 2
Definite red in colour and area well defined = 3
Beet or crimson red in colour = 4

- Oedema:
Barely perceptible (Edges of area not defined) = 1
Area definable but not raised more than 1 mm = 2
Area well defined and raised approximately 1 mm = 3
Area raised more than 1 mm = 4

- Injury in Depth:
Escharosis, Necrosis = 8
Maximum Primary Irritation Score = 8

Irritation parameter:

edema score

Basis:

mean

Time point:

24 h

Score:

0

Max. score:

0

Reversibility:

other: not applicable

Remarks on result:

other: abraded and intact skin

Irritation parameter:

edema score

Basis:

mean

Time point:

72 h

Score:

0

Max. score:

0

Reversibility:

other: not applicable

Remarks on result:

other: abraded and intact skin

Irritation parameter:

erythema score

Basis:

mean

Time point:

24 h

Score:

1

Max. score:

2

Reversibility:

fully reversible within: 72 hours

Remarks on result:

other: abraded skin

Irritation parameter:

erythema score

Basis:

mean

Time point:

24 h

Score:

0.3

Max. score:

1

Reversibility:

fully reversible within: 72 hours

Remarks on result:

other: intact skin

Irritation parameter:

erythema score

Basis:

mean

Time point:

72 h

Score:

0

Max. score:

0

Reversibility:

other: not applicable

Remarks on result:

other: abraded and intact skin

Irritation parameter:

other: Primary irritation score

Basis:

mean

Time point:

72 h

Score:

0.3

Irritation parameter:

erythema score

Basis:

mean

Time point:

48 h

Reversibility:

other: 48 hour score not recorded

Remarks on result:

other: 48 hour score not recorded

Irritation parameter:

edema score

Basis:

mean

Time point:

48 h

Reversibility:

other: 48 hour score not recorded

Remarks on result:

other: 48 hour score not recorded

Table 1: Summary of Results

Animal Number	Irritation Scores for Abraded Skin Sites at:				Irritation Scores for Intact Skin Sites at:
	24 hours		72 hours		24 hours		72 hours
	Erythema	Oedema	Erythema	Oedema	Erythema	Oedema	Erythema	Oedema
1	1	0	0	0	1	0	0	0
2	0	0	0	0	0	0	0	0
3	2	0	0	0	0	0	0	0
Mean	1.0	0.0	0.0	0.0	0.3	0.0	0.0	0.0
Subtotal	1.0				0.3

Interpretation of results:

other: Not classified in accordance with EU Criteria.

Conclusions:

Under the conditions of this study the test material is not irritating to the skin.

Executive summary:

The skin irritation potential of the test material was investigated using New Zealand white rabbits.

Rabbits were treated with the test material under an occlusive dressing for 24 hours on both abraded and intact sites. Sites were scored according to Draize at 24 and 72 hours post treatment for oedema and erythema.

Under the conditions of this study the test material is not irritating to the skin.

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

Study period:

Not specified

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

study well documented, meets generally accepted scientific principles, acceptable for assessment

Qualifier:

no guideline followed

Principles of method if other than guideline:

Young albino rabbits of the New Zealand strain were used to evaluate the eye irritating properties of the test material. The test method was patterned after that of Draize, et al.

GLP compliance:

no

Remarks:

study pre-dates GLP

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Age at study initiation: young

Vehicle:

unchanged (no vehicle)

Controls:

yes, concurrent no treatment

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied: 0.1 mL (40 mg) test material was instilled into the conjunctival sac of the right eye of each rabbit. The left eye of the animal served as a control.

Observation period (in vivo):

1, 24, 48 and 72 hours and 7 days.

Number of animals or in vitro replicates:

3 rabbits

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing: no washing

SCORING SYSTEM:
- At each scoring interval, the cornea, iris and palpebral conjunctiva were examined and graded for irritation and injury according to a standard scoring system.
- The maximum possible score was 110 points, which indicated maximal irritation and damage to all 3 ocular tissues. Zero score indicated no irritation.
- In this scoring system, special emphasis was placed upon irritation or damage to the cornea, while less emphasis was placed upon damage to the iris and conjunctiva.
- The criteria used for assignment of the classification was the frequency, the extent and the persistence of irritation or damage which occurred to the 3 ocular tissues. The classification was obtained by selecting the maximum mean irritation score at 1, 24, 48 or 72 hours after instillation. If the rate of dissipation of injury did not meet the requirements defined for the classification appropriate for a particular numerical score, the classification was raised by 1 or more levels.

CORNEA
- Opacity (D) Degree of density (area which is most dense is taken for reading):
Scattered or diffuse area, details of iris clearly visible = 1
Easily discernible, translucent areas, details of iris slightly obscured = 2
Opalescent areas, no details of iris visible, size of pupil barely discernible = 3
Opaque, iris invisible = 4
- Area of cornea involved (A):
One quarter (or less) but not 0 = 1
Greater than one quarter but less than one half = 2
Greater than one half but less than three quarters = 3
Greater than three quarters to whole area = 4
Score equals D x A x 5
Total maximum = 30

IRIS
- Values:
Folds above normal, congestion, swelling, circumcorneal injection (any or all of these or a combination of any thereof), iris still reacting to light (sluggish reaction is positive) = 1
No reaction to light, haemorrhage, gross destruction (any or all of these) =2
Score equals value x 5
Total maximum = 10

CONJUNCTIVAE
- Redness (R) (refers to palpebral conjunctiva only):
Vessels definitely injected above normal = 1
More diffuse, deeper crimson red; individual vessels not easily discernible = 2
Diffuse, beefy red = 3
- Chemosis (S):
Any swelling above normal (includes nictitating membrane) = 1
Obvious swelling with partial eversion of the lids = 2
Swelling with lids about half-closed = 3
Swelling with lids about half-closed to completely closed = 4
- Discharge (D):
Any amount different from normal (does not include small amount observed in inner canthus of normal animals) = 1
Discharge with moistening of the lids and hairs just adjacent to the lids = 2
Discharge with moistening of the lids and hairs and considerable area around the eye = 3
Score (R + S + D) x 2
Total maximum = 20

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

0

Remarks on result:

no indication of irritation

Irritation parameter:

iris score

Basis:

mean

Time point:

24/48/72 h

Score:

1.1

Max. score:

5

Reversibility:

fully reversible within: 48 hours

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

24/48/72 h

Score:

0.7

Max. score:

4

Reversibility:

fully reversible within: 72 hours

Remarks on result:

other: redness, chemosis and discharge combined to give conjunctivae score

Table 1: Summary of Results

Tissue	Rabbit Number	1 Hour	24 Hours	48 Hours	72 Hours	7 Days
Cornea (D-A)	1	0	0	0	0	0
Iris		0	5	0	0	0
Conjunctivae (R-S-D)		4 (2-0-0)	4 (2-0-0)	2 (1-0-0)	0	0
Total		4	9	2	0	0
Cornea (D-A)	2	5(1-1)	0	0	0	0
Iris		0	5	0	0	0
Conjunctivae (R-S-D)		4 (2-0-0)	4 (2-0-0)	0	0	0
Total		9	9	0	0	0
Cornea (D-A)	3	0	0	0	0	0
Iris		0	0	0	0	0
Conjunctivae (R-S-D)		4 (1-1-0)	2 (1-0-0)	0	0	0
Total		4	2	0	0	0
Cornea	Average	1.7	0.0	0.0	0.0	0.0
Iris		0.0	3.3	0.0	0.0	0.0
Conjunctivae		4.0	3.3	0.7	0.0	0.0
Total		5.7	6.6	0.7	0.0	0.0

Interpretation of results:

other: Not classified in accordance with EU Criteria

Conclusions:

Under the conditions of this study the test material was not irritating to the eyes.

Executive summary:

The eye irritation potential of the test material was investigated using New Zealand white rabbits.

The test material was instilled into the conjunctival sac of the right eye of each rabbit. The left eye of each animal served as a control. At each scoring interval, the cornea, iris and palpebral conjunctiva were examined and graded for irritation and injury according to a standard scoring system.

Under the conditions of this study the test material was not irritating to the eyes.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

Skin Irritation

The skin irritation potential of the test material was investigated using New Zealand white rabbits. The study was awarded a reliability score of 2 in accordance with the criteria set forth by Klimisch et al. (1997).

Rabbits were treated with the test material under an occlusive dressing for 24 hours on both abraded and intact sites. Sites were scored according to Draize at 24 and 72 hours post treatment for oedema and erythema.

Under the conditions of this study the test material is not irritating to the skin.

Eye Irritation

The eye irritation potential of the test material was investigated using New Zealand white rabbits. The study was awarded a reliability score of 2 in accordance with the criteria set forth by Klimisch et al. (1997).

The test material was instilled into the conjunctival sac of the right eye of each rabbit. The left eye of each animal served as a control. At each scoring interval, the cornea, iris and palpebral conjunctiva were examined and graded for irritation and injury according to a standard scoring system.

Under the conditions of this study the test material was not irritating to the eyes.

Justification for classification or non-classification

In accordance with the criteria for classification as defined in Annex I, Regulation (EC) No 1272/2008, the substance does not require classification with respect to skin and eye corrosion or irritation.