Registration Dossier

Administrative data

Description of key information

The test item is non irritating to skin and eye.

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:
2007-12-19 to 2007-12-22
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Guideline study with GLP
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
Qualifier:
according to
Guideline:
EPA OPPTS 870.2500 (Acute Dermal Irritation)
Deviations:
no
GLP compliance:
yes (incl. certificate)
Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Millbrook Breeding Labs, Amherst, MA
- Age at study initiation: 14 weeks
- Weight at study initiation: 2.8 - 3.1 kg
- Housing: The animals were housed 1/cage in suspended cages. Bedding was placed beneath the cages and changed at least three times/week.
- Diet: Fresh PMI Rabbit Chow (Diet #5321) was provided daily.
- Water: Ad libitum
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-22°C
- Humidity (%): 30-49%
- Photoperiod (hrs dark / hrs light): 12-hour light/dark cycle
Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount applied: 0.5 mL/site.
- Concentration: Undiluted
Duration of treatment / exposure:
4 h
Observation period:
3 days (The skin reactions were evaluated after 1, 24, 48, and 72 hours)
Number of animals:
3 (2 males, 1 female)
Details on study design:
TEST SITE
- Area of exposure: 2.5 x 2.5 cm
- Type of wrap: The trunk of the rabbit was wrapped with a piece of fabric (a semiocclusive dressing) and secured with adhesive tape.

REMOVAL OF TEST SUBSTANCE
- Washing (if done):The test article was kept in contact with the skin for 4 hours at which time the wrappings were removed. The test sites were wiped with paper towels saturated with tap water and blotted dry with paper towels.
- Time after start of exposure: 4 h

SCORING SYSTEM:
according to OECD Guideline 404
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
other: 24, 48, 72 h
Score:
0
Max. score:
4
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
other: 24, 48, 72 h
Score:
0
Max. score:
4
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
other: 24, 48, 72 h
Score:
0
Max. score:
4
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24, 48, 72 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
animal #1
Time point:
other: 24, 48, 72 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
animal #2
Time point:
other: 24, 48, 72 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
animal #3
Time point:
other: 24, 48, 72 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24, 48, 72 h
Score:
0
Max. score:
4
Irritant / corrosive response data:
There was no erythema or edema noted at any observation period.
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
Study period:
2007-01-02 to 2007-01-11
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Guideline study with GLP
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
Qualifier:
according to
Guideline:
EPA OPPTS 870.2400 (Acute Eye Irritation)
Deviations:
no
GLP compliance:
yes (incl. certificate)
Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Millbrook Breeding Labs, Amherst, MA
- Age at study initiation: 14 weeks
- Weight at study initiation: 2.9 - 3.2 kg
- Housing: The animals were housed 1/cage in suspended cages. Bedding was placed beneath the cages and changed at least three times/week.
- Diet: Fresh PMI Rabbit Chow (Diet #5321) was provided daily.
- Water: Ad libitum
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17-23°C
- Humidity (%): 34-65%
- Photoperiod (hrs dark / hrs light): 12-hour light/dark cycle
Vehicle:
unchanged (no vehicle)
Controls:
other: The contralateral eye served as a control.
Amount / concentration applied:
TEST MATERIAL
- Amount applied: 0.1 mL
- Concentration: undiluted

Duration of treatment / exposure:
24 h
Observation period (in vivo):
3 days (reactions were evaluated 1, 24, 48 and 72 h after the instillation)
Number of animals or in vitro replicates:
Three rabbits (2 males - 1 female)
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing:The treated and control eye of each rabbit were washed with saline following the 24 hour observation interval for approximately one minute.
- Time after start of exposure: 24 h

SCORING SYSTEM:
According to OECD 405 scoring system

TOOL USED TO ASSESS SCORE:
Observations were performed using a Mini-Maglite(c) flash light equipped with a high intensity bulb
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
other: 24, 48, 72 h
Score:
0
Max. score:
4
Reversibility:
other: no effect
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
other: 24, 48, 72 h
Score:
0
Max. score:
4
Reversibility:
other: no effect
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
other: 24, 48, 72 h
Score:
0
Max. score:
4
Reversibility:
other: no effect
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 24, 48, 72 h
Score:
0
Max. score:
4
Reversibility:
other: no effect
Irritation parameter:
iris score
Basis:
animal #1
Time point:
other: 24, 48, 72 h
Score:
0
Max. score:
2
Reversibility:
other: no effect
Irritation parameter:
iris score
Basis:
animal #2
Time point:
other: 24, 48, 72 h
Score:
0
Max. score:
2
Reversibility:
other: no effect
Irritation parameter:
iris score
Basis:
animal #3
Time point:
other: 24, 48, 72 h
Score:
0
Max. score:
2
Reversibility:
other: no effect
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24, 48, 72 h
Score:
0
Max. score:
2
Reversibility:
other: no effect
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
other: 24, 48, 72 h
Score:
0
Max. score:
3
Reversibility:
other: no effect
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
other: 24, 48, 72 h
Score:
0
Max. score:
3
Reversibility:
other: no effect
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
other: 24, 48, 72 h
Score:
0
Max. score:
4
Reversibility:
other: no effect
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 24, 48, 72 h
Score:
0
Max. score:
3
Reversibility:
other: no effect
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
other: 24, 48, 72 h
Score:
0
Max. score:
4
Reversibility:
other: no effect
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
other: 24, 48, 72 h
Score:
0
Max. score:
4
Reversibility:
other: no effect
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 24, 48, 72 h
Score:
0
Max. score:
4
Reversibility:
other: no effect
Irritant / corrosive response data:
Under the experimental conditions employed the test item induced reactions of the iris and conjunctiva when instilled into the conjunctival sac of albino rabbits eyes. The values of the readings 24 h to 72 hours after instillation are below the threshold of significance.
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

Skin irritation

The potential of the test item to cause acute dermal irritation or corrosion was assessed by a single topical application of 0.5 mL of the test substance to the intact skin of 3 white New Zealand rabbits for 4 hours under semi-occlusive dressing (GLP-guideline study; MB Research Laboratories, 2007). The average score (24 to 72 hours) for irritation was calculated to be 0.0 for erythema and 0.0 for edema. No skin findings were induced by the test item; thus the study was terminated after 72 hours. Under the test conditions chosen and considering the described findings the test item does not give indication of an irritant property to the skin.

These findings are confirmed by a supporting study with less reliability showing an irritation score of 2/10 indicating only very slight irritation not subject to classification (Smyth, 1962).

Eye irritation

The potential of the test item to cause damage to the eye was assessed in 3 white New Zealand rabbits, subjected to a single ocular application of 0.1 mL of the test substance (GLP-guideline study; MB Research Laboratories, 2007). The average score (24 to 72 hours) for irritation was calculated to be 0.0 for corneal opacity, iris and chemosis and conjunctivae redness. The study was terminated after 72 hours. Under the test conditions chosen and considering the described findings, the test item does not give indication of an irritant property to the eye.

These findings are confirmed by a supporting study with less reliability showing an irritation score of 1/10 indicating only very slight irritation not subject to classification (Smyth, 1962).


Justification for selection of skin irritation / corrosion endpoint:
The Key study was selected (GLP and Guideline study).

Justification for selection of eye irritation endpoint:
The Key study was selected (GLP and Guideline study).

Justification for classification or non-classification

Classification is not warranted according to the criteria of EU Directive 67/548/EEC and EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No 1272/2008.