Registration Dossier

Administrative data

Description of key information

Skin irritation/corrosion and eye irritation results determined using OECD test guidelines 404 and 405.
Skin - not irritating
Eye - 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
Study period:
1986
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: guideline study in compliance with GLP
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
GLP compliance:
yes
Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Kleintierfarm Madoerin AG, CH-4414 Fuellinsdorf
- Age at study initiation: 12-14 weeks
- Weight at study initiation: 2080 t o 2310 g
- Housing: individually
- Diet: standard rabbit pellet - Nafag No. 814, Gossau, Swi tzerland (ad libitum)
- Water: ad libitum
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/-3
- Humidity (%): 30-70
- Photoperiod (hrs dark / hrs light): 12/12
Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
other: distilled water containing 0.5% carboxymethylcellulose and 0.1% polysorbate 80
Controls:
other: untreated skin of same animal
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g


Duration of treatment / exposure:
4 hours
Observation period:
3 days
Number of animals:
3 females
Details on study design:
An area of at least 6 cm2 was shaved on both flanks of the animals approximately 24 hours before treatment. A gauze patch (20 cm2) bearing 0.5 g of the test substance was applied to the flank. A control gauze patch was applied to the contralateral flank. Both gauze patches were moistened before application with distilled water containing 0.5% carboxymethylcellulose and 0.1% polysorbate 80. The patches were loosely covered with aluminum foil held in place for by an adhesive tape. The animals were checked daily for systemic symptoms and mortality.

SCORING SYSTEM:
as described in OECD guideline 404
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 1 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 24 h
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24-72 hours
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24-72 hours
Score:
0
Max. score:
4
Irritant / corrosive response data:
The test item induced slight erythema reactions only at the 1h timepoint.

Individual skin reaction scores:

  Animal No. 1(f) 2(f) 3(f)
Erythema 1 h 1 1 1
24 h 0 0 0
48 h 0 0 0
72 h 0 0 0
mean 24-72 h 0 0 0
Edema 1 h 0 0 0
24 h 0 0 0
48 h 0 0 0
72 h 0 0 0
mean 24-72 h 0 0 0

Individual body weights (g):

Animal No.

1 (f)

2 (f) 3 (f)
at start of test 2095 2080 2310
after 3 days (end) 2170 2110 2380
Interpretation of results:
not irritating
Remarks:
Migrated information
Conclusions:
The test item is considered to be "not irritating" to rabbit skin.
Executive summary:

The primary skin irritation potential of the test substance was investigated according to OECD test guideline no. 404. The test item was applied by topical application of 0.5 g to the intact left flank of each of three young adult New Zealand White rabbits. The duration of treatment was four hours. The scoring of skin reactions was performed 1, 24, 48 and 72 hours after removal of the patches. The test item induced slight erythema reactions when applied to albino rabbit skin. The reactions were observed only one hour after removing the

bandages. Because the mean values of the recordings 24 to 72 hours after application are scored zero, the test substance can be classified as non-irritant.

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:
1986
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: guideline study according to GLP
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
GLP compliance:
yes
Remarks:
QAU statement available
Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Kleintierfarm Madoerin AG, CH-4414 Fuellinsdorf
- Age at study initiation: 12-14 weeks
- Weight at study initiation: 2050 to 2170 g
- Housing: individually
- Diet: Nafag No. 814, Gossau, Switzerland, ad libitum
- Water: ad libitum
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 3
- Humidity (%): 30-70
- Photoperiod (hrs dark / hrs light): 12/12
Vehicle:
not specified
Controls:
other: untreated eye of the same animal
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 ml
Observation period (in vivo):
7 days
Number of animals or in vitro replicates:
3 females
Details on study design:
0.1 ml of the test substance was placed into the conjunctival sac of the right eye of each animal, after gently pulling away the lower lid from the eyeball. The lids were then held together for about one second in order to prevent loss of the test material. The left eye remained untreated and served as a control. The animals were checked daily for systemic symptoms and mortality. The ocular reactions were evaluated 1, 24, 48, and 72 hours after the
instillation.

SCORING SYSTEM: OECD scoring system

TOOL USED TO ASSESS SCORE: hand-slit lamp
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 24, 48 and 72 h
Score:
0
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24, 48 and 72 h
Score:
0
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 24, 48 and 72 h
Score:
0.56
Reversibility:
fully reversible within: 7 days
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 24, 48 and 72 h
Score:
0
Irritant / corrosive response data:
The test substance caused mild, early-onset and transient reddening of the conjunctivae, chemosis and effects to the iris. All observed effects were reversible within 7 days the latest (for details see table).

Individual reactions:

cornea iris conjunctival redness chemosis
Animal #1 (F)
1 hrs 0 1 2 1
24 hrs 0 0 1 0
48 hrs 0 0 0 0
72 hrs 0 0 0 0
7 days 0 0 0 0
Animal #2 (F)
1 hrs 0 1 2 1
24 hrs 0 0 1 0
48 hrs 0 0 0 0
72 hrs 0 0 0 0
7 days 0 0 0 0
Animal #3 (F)
1 hrs 0 1 2 1
24 hrs 0 0 1 0
48 hrs 0 0 1 0
72 hrs 0 0 1 0
7 days 0 0 0 0

Body weights

Animal No. 1 2 3
at start of test 2120 2050 2170
after 3 days 2170 2110 2140
sfter 7 days 2310 2260 2310
Interpretation of results:
not irritating
Remarks:
Migrated information
Conclusions:
The test item is considered to be "not irritating" to the rabbit eye.
Executive summary:

The primary eye irritation potential of the test substance was investigated according to OECD test guideline no. 405. The test item was applied by instillation of 0.1 mL into the left eye of each of three young adult New Zealand White rabbits. Scoring of irritation effects was performed approximately 1, 24, 48 and 72 hours, as well as 7 days after test item application. The mean score was calculated across 3 scoring times (24, 48 and 72 hours after instillation) for each animal for corneal opacity, iris, redness and chemosis of the conjunctivae, separately. The instillation of the test substance into the eye resulted in mild, early-onset and transient reddening of the conjunctivae, chemosis and effects to the iris. All observed effects were reversible and were no longer evident 7 days after treatment, the end of the observation period for all animals. No abnormal findings were observed in the cornea of any animal at any of the examinations. A slight loss of weight was observed in animal No. 3 on day 3.

In conclusion, the test item did not induce significant or irreversible damage to the rabbit eye and is considered to be "not irritating" to the rabbit eye.

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

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Justification for selection of skin irritation / corrosion endpoint:
Result determined using OECD test guideline 404.

Justification for selection of eye irritation endpoint:
Result determined using OECD test guideline 405.

Justification for classification or non-classification

Based on the data available the substance does not trigger any of the requirements for classification.

The registered substance is therefore not classified.