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Description of key information

In a primary skin and eye irritation study, no skin or eye irritating effects were observed in New Zealand rabbits.

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:
study well documented, meets generally accepted scientific principles, acceptable for assessment
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
GLP compliance:
no
Species:
rabbit
Strain:
other: English Silver
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Weight at study initiation: 2 - 3 kg
- Housing: individually
- Diet: ad libitum (NAFAG, Gossau SG, rabbit food)
- Water: ad libitum, tap water
Type of coverage:
occlusive
Preparation of test site:
shaved
Vehicle:
other: polyethylene glycol
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied: 0.5 g

VEHICLE
- Concentration: 50 % suspension
Duration of treatment / exposure:
24 h, substance was not washed off
Observation period:
72 hours
Number of animals:
6
Details on study design:
TEST SITE
- Area of exposure: flanks
- Type of wrap if used: plastic film

SCORING SYSTEM:
Erythema and Eschar Formation:
No erythema 0
Very slight erythema (barely perceptible) 1
Well defined erythema 2
Moderate to severe erythema 3
Severe erythema (beet redness) to slight eschar formation (injuries in depth) 4
Total possible erythema score 4

Edema Formation:
No edema 0
Very slight edema (barely perceptible) 1
Slight edema (edges of area well defined by definite
raising 2
Moderate edema (raised approximately 1 mm) 3
Severe edema (raised more than 1 mm and extending beyond area of exposure) 4
Total possible edema score 4
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24/72h
Score:
0
Max. score:
4
Remarks on result:
other: Mean score for all six rabbits.
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24/72h
Score:
0
Max. score:
4
Remarks on result:
other: Mean score for all six animals.
Irritant / corrosive response data:
The test substance did not cause any treatment related irritation to the intact or abraded rabbit skin.
Interpretation of results:
GHS criteria not met
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:
study well documented, meets generally accepted scientific principles, acceptable for assessment
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
GLP compliance:
no
Species:
rabbit
Strain:
other: English Silver
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Housing: individually
- Diet: ad libitum (NAFAG, Gossau SG, rabbit food)
- Water: ad libitum, tap water
Vehicle:
unchanged (no vehicle)
Controls:
other: Adjacent eye served as control.
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied: 0.1 g
Duration of treatment / exposure:
30 sec
Observation period (in vivo):
7 days
Number of animals or in vitro replicates:
6
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing: 10 mL of lukewarm water
- Time after start of exposure: 30 sec.

SCORING SYSTEM:

Cornea
A. Opacity-degree of density (area most dense taken for reading)
No opacity 0
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

B. Area of cornea involved
One quarter (or less) but not zero 1
Greater than one quarter, but less than half 2
Greater than half, but less than three quarters 3
Greater than three quarters, up to whole area 4
A x B X 5 Total maximum = 80

Iris
A. Values
Normal 0
Folds above normal, congestion, swelling, circumcorneal injection (any or all of these or combination
of any thereof) iris still reacting to light (sluggish reaction is positive) 1
No reaction to light, hemorrhage, gross destruction (any or all of these) 2
A x 5

Conjunctivae
A. Redness (refers to palpebral and bulbar conjunctivae excluding cornea and iris)
Vessels normal 0
Vessels definitely injected above normal 1
More diffuse, deeper crimson red, individual vessels not easily discernible 2
Diffuse beefy red 3

B Chemosis
No swelling 0
Any swelling above normal (includes nictitating membrane) 1
Obvious swelling with partial eversion of lids 2
Swelling with lids about half closed 3
Swelling with lids about half closed to completely closed 4

C Discharge
No discharge 0
Any amount different from normal (does not include small amounts observed in inner-canthus of
normal animals) 1
Discharge with moistening of the lids and hairs just adjacent to lids 2
Discharge with moistening of the lids and hairs, and considerable area around the eye 3
(A -f B -I- C) X 2 Total maximum =20


TOOL USED TO ASSESS SCORE: hand-slit lamp
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
iris score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
2
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
3
Irritation parameter:
chemosis score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritant / corrosive response data:
No irritating effects were seen in any of the animals.
Interpretation of results:
GHS criteria not met
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Additional information

In a primary dermal irritation study, six English silver rabbits (3/sex) were dermally exposed to 0.5 g of the test substance suspended in polyethylene glycol to the flanks (BASF, 1972). Test sites were covered with an occlusive dressing for 24 hours. Animals were then observed for 72 hours. Irritation was scored by the method of Draize et al. No erythema or edema was observed in any of the animals. In this study the test substance is not a dermal irritant.

In a primary eye irritation study, 0.1 g of the undiluted test substance was instilled into the conjunctival sac of the left eye of six English silver rabbits (3/sex) (BASF, 1972). 30 seconds after treatment the eyes of three rabbits were washed with lukewarm water. Animals were then observed for 7 days. Irritation was scored based on "Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics" (1959). No eye irritating effects were seen in any of the animals neither with nor without rinsing of the eye. In this study, the test substance is not considered as an eye irritant.

Justification for classification or non-classification

Classification, Labelling, and Packaging Regulation (EC) No 1272/2008

The available experimental test data are reliable and suitable for classification purposes under Regulation 1272/2008. As a result the substance does not need to be classified and labelled under Regulation (EC) No 1272/2008, as amended for the sixth time in Regulation (EC) No 605/2014.