Registration Dossier

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Administrative data

Description of key information

Skin irritation in vivo: 3 Vienna White rabbits m/f, 0.5 g (50% in water), semiocclusive over 4h, clipped, OECD 404: not irritating

Eye irritation in vivo: 3 Vienna White rabbits m/f, 0.1 ml bulk volume (about 57 mg substance), no wash out, OECD 405: not irritating

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:
other: Guideline study (OECD)
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
not specified
Species:
rabbit
Strain:
Vienna White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Gaukler
- Weight at study initiation: mean: female: 2.45 kg; male: 2.54 kg
- Housing: 1 rabbit per cage
- Diet (e.g. ad libitum): about 130 g per animal per day
- Water (e.g. ad libitum): about 250 ml tap water per animal per day
- Acclimation period: at least 8 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-24
- Humidity (%): 30-70
- Photoperiod (hrs dark / hrs light): 12/12
Type of coverage:
semiocclusive
Preparation of test site:
other: clipping
Vehicle:
water
Controls:
yes, concurrent vehicle
Amount / concentration applied:
Concentration: 50 %
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g
- Concentration (if solution): 50% aqueous formulation (w/w)


VEHICLE
- Amount(s) applied (volume or weight with unit): 0.5 g
- Concentration (if solution): 50%
Duration of treatment / exposure:
4 hours
Observation period:
72 hours
Number of animals:
3
Details on study design:
TEST SITE
- Area of exposure: 2.5cm x 2.5cm
- Type of wrap if used: test patches were secured in position with a porous dressing: four layers of absorbent gauze and porous bandage


REMOVAL OF TEST SUBSTANCE
- Washing (if done): with Lutrol and Lutrol/water (1:1)
- Time after start of exposure: 4 hours

SCORING SYSTEM: Draize
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 4 hours
Score:
0
Max. score:
4
Reversibility:
other: no effect
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 4 hours
Score:
0
Max. score:
4
Reversibility:
other: no effect
Irritation parameter:
erythema score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: no effect
Remarks on result:
other: 24 - 72hours
Irritation parameter:
edema score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: no effect
Remarks on result:
other: 24 - 72hours

Animal number

1

2

3

Body weight

2.54

2.41

2.49

Sex

male

female

female

Readings

Animal

Edema (score)

Erythema (score)

4 hours

1

0

0

2

0

0

3

0

0

24 hours

1

0

0

2

0

0

3

0

0

48 hours

1

0

0

2

0

0

3

0

0

72 hours

1

0

0

2

0

0

3

0

0

Evaluation of erythema and edema:

0 = none

1 = very slight

2 = well-defined

3 = moderate to sever

4 = severe to very severe

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
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:
other: Guideline study (OECD)
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
GLP compliance:
no
Species:
rabbit
Strain:
Vienna White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Gaukler
- Weight at study initiation: mean: female: 2.89kg; male: 3.04kg
- Housing: 1 rabbit per cage
- Diet (e.g. ad libitum): about 130g per animal per day
- Water (e.g. ad libitum): about 250ml tap water per animal per day
- Acclimation period: at least 8 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-24
- Humidity (%): 30-70
- Photoperiod (hrs dark / hrs light): 12/12
Vehicle:
not specified
Controls:
yes
Amount / concentration applied:
0.1 ml bulk volume (about 57mg of the test substance)
Duration of treatment / exposure:
single application to the conjunctival sac of the right eyelid;
the substance was not washed out
Observation period (in vivo):
72 hours
Number of animals or in vitro replicates:
3
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): not washed out
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
24 h
Score:
0
Max. score:
4
Reversibility:
other: no effects
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
48 h
Score:
0
Max. score:
4
Reversibility:
other: no effects
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
72 h
Score:
0
Max. score:
4
Reversibility:
other: no effects
Irritation parameter:
iris score
Basis:
mean
Time point:
24 h
Score:
0
Max. score:
2
Reversibility:
other: no effects
Irritation parameter:
iris score
Basis:
mean
Time point:
48 h
Score:
0
Max. score:
2
Reversibility:
other: no effects
Irritation parameter:
iris score
Basis:
mean
Time point:
72 h
Score:
0
Max. score:
2
Reversibility:
other: no effects
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
mean
Time point:
24 h
Score:
0
Max. score:
3
Reversibility:
other: no effects
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
mean
Time point:
48 h
Score:
0
Max. score:
3
Reversibility:
other: no effects
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
mean
Time point:
72 h
Score:
0
Max. score:
3
Reversibility:
other: no effects
Irritation parameter:
conjunctivae score
Remarks:
discharge
Basis:
mean
Time point:
24 h
Score:
0
Max. score:
3
Reversibility:
other: no effects
Irritation parameter:
conjunctivae score
Remarks:
discharge
Basis:
mean
Time point:
48 h
Score:
0
Max. score:
3
Reversibility:
other: no effects
Irritation parameter:
conjunctivae score
Remarks:
discharge
Basis:
mean
Time point:
72 h
Score:
0
Max. score:
3
Reversibility:
other: no effects
Irritation parameter:
chemosis score
Basis:
mean
Time point:
24 h
Score:
0
Max. score:
4
Reversibility:
other: no effects
Irritation parameter:
chemosis score
Basis:
mean
Time point:
48 h
Score:
0
Max. score:
4
Reversibility:
other: no effects
Irritation parameter:
chemosis score
Basis:
mean
Time point:
72 h
Score:
0
Max. score:
4
Reversibility:
other: no effects
Irritant / corrosive response data:
cornea score: area of cornea involved: had in all animals at all timepoints score 0
Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
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

There is an in vivo skin irritation study performed acc. OECD TG 404 available, which was assessed as sufficiently reliable. At all observation times (4, 24, 48, 72 hours) and in all animals both edema and erythema scores were consistently zero.

Further, there is an reliable in vivo eye irritation study performed acc. OECD TG 405 available, which consistently revealed that the substance is not irritating to the eye. All cornea opacity, iris, and conjunctivae (redness / discharge) scores were consistently zero at all observation times (24, 48, 72 hours) and in all animals.

The test designs allow to assess the need for classification acc. Regulation 1272/2008 as skin irritant (Table 3.2.2) or eye irritant (tables 3.3.2 resp. 3.3.1). As all available scores were zero, the do not exceed the limit scores triggering classification in these tables. Hence, classification as skin or eye irritant acc. Regulation 1272/2008 is not required.