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Description of key information

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:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
GLP compliance:
yes
Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Age at study initiation: adult
- Weight at study initiation: 3.0 kg (average)
- Housing: single cage
- Diet (e.g. ad libitum): Altromin, Lage, ad libitum
- Water (e.g. ad libitum): ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18°C +/- 2°C
- Humidity (%): 50-60%
- Photoperiod (hrs dark / hrs light): 12 hours

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
water
Controls:
not required
Amount / concentration applied:
500 mg of the compound were applied and covered with gauze patches in a size of about 2.5 cm x 2.5 cm.
This was wettened with 10 mL warmed water.
Duration of treatment / exposure:
4 h
Observation period:
The treated areas of the animals were examined 1 hour after patch removal. Thereafter, the readings have been repeated every 24 hours. The final control of localization has been carried out after 7 days.
Number of animals:
3
Details on study design:
TEST SITE
- Area of exposure: 2.5 x 2.5 cm
- Type of wrap if used: gauze patches were fixed with the help of adhesive plaster


REMOVAL OF TEST SUBSTANCE
- Washing (if done): residual test substance was touched away with a wet towel
- Time after start of exposure: 1 h


SCORING SYSTEM:
1. Erythema and formation of scabs:
- No erythema: 0
- slight erythema (scarcely visible): 1
- Moderate to significant erythema: 3
- Severe erythema (red purple) with formation of slight scabs (deep lesions): 4

2. Formation of oedema:
- No oedema: 0
- Very slight oedema (scarcely visible): 1
- Slight oedema (well defined outlines, swelling apparent): 2
- Moderate oedema (thickness about 1 mm): 3
- Severe oedema (thickness more than 1 mm and area larger than of the square): 4
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: no erythema observed
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: no erythema observed
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: no erythema observed
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: no edema observed
Irritation parameter:
edema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: no edema observed
Irritation parameter:
edema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: no edema observed
Irritant / corrosive response data:
No deviations from the normal findings have been observed during the whole experiment on any animal on the shave skin localizations.
Other effects:
No test-substance related findings were observed during the weighting of the animals after 7 days.
Interpretation of results:
other: not irritating according to Regulation (EC) 1272/2008
Conclusions:
As no skin reaction was induced over a period of 7 days, the test item is considered as not skin irritating. Based on these results and according to the EC criteria for classification and labelling, Regulation (EC) No. 1272/2008, the test item does not have to be classified and has no obligatory labelling requirement for skin irritation.
Executive summary:

As no skin reaction was induced over a period of 7 days in a GLP study acc. to OECD guideline no. 404, test item is considered as not skin irritating.

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:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
GLP compliance:
yes
Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Age at study initiation: adult
- Weight at study initiation: 3.2 kg (average)
- Housing: single cage
- Diet (e.g. ad libitum): Altromin, Lage, ad libitum
- Water (e.g. ad libitum): ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18°C +/- 2°C
- Humidity (%): 50-60%
- Photoperiod (hrs dark / hrs light): 12 hours
Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
100 mg
Duration of treatment / exposure:
72h
Observation period (in vivo):
Readings of eye alterations were made after 1, 2, 4, 8, 24, 48, 72 hours.
Number of animals or in vitro replicates:
3
Details on study design:
Before and after the test, the eyes of all animals were examined under UV. After weighing (16 hours starved) 0.1 g of the substance was applicated into the conjunctival pouch of the left eye. The right one stayed untreated and served as control.
The eye lesions were scored according to the system of Draize.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): the test substance was not removed


SCORING SYSTEM:
1. Cornea
a) Degree of opacity (A):
- No opacity (nor loss of brilliancy or lustre): 0
- Presence of an irritated area of diffused or disseminated appearance, details of the iris clearly visible: 1
- Presence of a translucid, irritated area easily identifiable, details of the iris slightly obscured: 2
- Presence of an opalescent, irritated area, details of the iris visible, outline of the pupil can scarcely be observed: 3
- Presence of opacity making the iris invisible: 4

b) Area of opacity (B):
- 1/4 (or less), but not zero: 1
- Between 1/4 and 1/2: 2
- Between 1/2 and 3/4: 3
- From 3/4 to the whole area: 4

The total mark is determined by multiplying the two scores by 5: A X B x 5 (maximum = 80)

2. Iris (C)
- Normal: 0
- Clearly more plicate than normal, congestion, swelling circumcorneal injection (one or several of these characteristics), iris still reacting to light (a slow reaction is a positive reaction): 1
- No reaction to light, heamorrhage, significant "destruction" (one, several or all of these characteristics): 2

The total mark is determined by multyplying the score by 5: C x 5 (maximum = 10)

3. Conjunctiva, Chemosis and Lacrimation
a) Conjuctiva (D):
- Reddening of the palpebral conjunctiva: vessels normal: 0
- Vessels clearly more injected than normal: 1
- Bright red colour, more diffuse, vessels difficult to distinguish: 2
- Diffuse blood red colour: 4

b) Chemosis (E):
- No swelling: 0
- Slight swelling, including the nictating membrane: 1
- Pronounced swelling, with inversion of the eyelid: 2
- Swelling with eyelids half closed: 3
- Swelling with eyelid closed more than half-way or completely closed: 4

c) Lacrimation (F):
- Absence: 0
- Slight lacrimation (do not take into account slight secretions normally in the inside corner): 1
- Lacrimation with moistening of the eyelids and hairs around the eyelids: 2
- Lacrimation with moistening of the eyelids and heirs on wide areas around the eye: 3

The total mark is determined by adding the three scores and multiplication of the sum by 2: (D + E + F) x 2 (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
Reversibility:
other: cornea opacity was not evident during the study
Irritation parameter:
iris score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: iridal changes were not evident
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
3
Reversibility:
fully reversible within: 24 h
Irritation parameter:
chemosis score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: chemosis was not evident during the study
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: cornea opacity was not evident during the study
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: cornea opacity was not evident during the study
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: cornea opacity was not evident during the study
Irritation parameter:
iris score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
2
Reversibility:
other: iridal changes were not evident during the study
Irritation parameter:
iris score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
2
Reversibility:
other: iridal changes were not evident during the study
Irritation parameter:
iris score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
2
Reversibility:
other: iridal changes were not evident during the study
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: chemosis was not evident during the study
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: chemosis was not evident during the study
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: chemosis was not evident during the study
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
3
Reversibility:
fully reversible within: 24 h
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
3
Reversibility:
fully reversible within: 24 h
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
3
Reversibility:
fully reversible within: 24 h
Irritant / corrosive response data:
Some conjunctiva redness (up to scores of 2) and some lacrimation were observed in all rabbit until 8h after application
Other effects:
Body weights and body weight gains were normal in all animals.
Interpretation of results:
other: not irritating according to Regulation (EC) 1272/2008.
Conclusions:
Based on the results and according to the EC criteria for classification and labelling according to GHS/CLP (Regulation (EC) No. 1272/2008), the test item does not have to be classified and has no obligatory labelling requirement as irritating to eyes.
Executive summary:

As no eye reaction were observed in a GLP study acc. to OECD guideline no. 405 at 24, 48 and 72 h,

the test item is considered as not eye irritating.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Justification for classification or non-classification

Since no classification criteria according to GHS/CLP (Regulation (EC) No. 1272/2008) are fulfilled, the substance is not classified for skin and/or eye irritation/corrosion.