Registration Dossier

Administrative data

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:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: GLP Guideline study. According to ECHA guidance, a study with a read-across substance can have no reliability of higher than 2. The study itself is valid without restriction.
Reference:
Composition 0
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes
Test material information:
Composition 1
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
- Sex: male
- Weight at study initiation: 2070-2110 g (within ± 20% of mean value)
- Housing: individually in metal cages
- Diet: ad libitum; standard rabbit pellet - Nafag No. 814, Gossau, Switzerland
- Water: ad libitum (The quality of the drinking water was according to the specifications of the "Schweizerisches Lebensmittelbuch" (Edition 1972))
- Acclimation period: 5 days
- Rationale for choice: The albino rabbit is the recommended species for skin irritation/corrosion studies

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 3
- Humidity (%): 30-70
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12/12
Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
other: contra-lateral flank covered with gauze patch
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied: 0.5 ml
Duration of treatment / exposure:
4 hours
Observation period:
The skin reactions were evaluated 1, 24, 48, and 72 hours and 7 days after removing the gauze patches.
Number of animals:
3
Details on study design:
TEST SITE
- Area of exposure: An area of approx. 6 cm2 was shaved on both flanks of the animals approximately 24 hours before treatment.
- % coverage: A gauze patch (20 cm2)
- Type of wrap if used: The patches were loosely covered with an aluminium foil (36 cm2 and held in place by an adhesive tape (Isoplast, Isoplast AG, CH-5200 Brugg)

SCORING SYSTEM: according to the OECD scoring system

Irritation parameter:
erythema score
Basis:
animal #1
Time point:
other: 24, 48 and 72 hours
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 7 days
Remarks on result:
other: Score after 1 hour was = 0
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
other: 24, 48 and 72 hours
Score:
0
Max. score:
4
Reversibility:
other: no skin irritation was observed
Remarks on result:
other: Score after 1 hour was = 0
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
other: 24, 48 and 72 hours
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 7 days
Remarks on result:
other: Score after 1 hour was = 0
Irritation parameter:
edema score
Basis:
animal #1
Time point:
other: 24, 48 and 72 hours
Score:
0
Max. score:
4
Reversibility:
other: no edema was observed
Remarks on result:
other: Score after 1 hour was = 0
Irritation parameter:
edema score
Basis:
animal #2
Time point:
other: 24, 48 and 72 hours
Score:
0
Max. score:
4
Reversibility:
other: no edema was observed
Remarks on result:
other: Score after 1 hour was = 0
Irritation parameter:
edema score
Basis:
animal #3
Time point:
other: 24, 48 and 72 hours
Score:
0
Max. score:
4
Reversibility:
other: no edema was observed
Remarks on result:
other: Score after 1 hour was = 0
Irritant / corrosive response data:
Slight scaling at the application area was observed in all animals on day 7. On the control flanks, no skin irritation effects were observed in any animal.
Other effects:
A slight loss of weight was observed in one animal on day 3 (2090 g versus 2110 g at start of test)
Interpretation of results:
not irritating
Remarks:
Migrated information
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:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: GLP Guideline study. According to ECHA guidance, a study with a read-across substance can have no reliability of higher than 2. The study itself is valid without restriction.
Reference:
Composition 0
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Version / remarks:
(adopted May 12, 1981)
Deviations:
no
GLP compliance:
yes
Test material information:
Composition 1
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
- Sex: male
- Weight at study initiation: 2060-2170 g (within ± 20% of mean value)
- Housing: individually in metal cages
- Diet: ad libitum; standard rabbit pellet - Nafag No. 814, Gossau, Switzerland
- Water: ad libitum (quality of the drinking water met the specifications of the "Schweizerisches Lebensmittelbuch" (Edition 1972))
- Acclimation period: 5 days
- Rationale for choice: The albino rabbit is the recommended species for acute eye irritation/corrosion studies

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 3
- Humidity (%): 30-70
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12/12
Vehicle:
unchanged (no vehicle)
Controls:
other: The left eye remained untreated and served as a control
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied: 0.1 ml

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 to prevent loss of the test material.
Duration of treatment / exposure:
eyes were not washed after instillation
Observation period (in vivo):
The ocular reactions were evaluated 1, 24, 48, 72 hours and 7 days after instillation
Number of animals or in vitro replicates:
3
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing: no

SCORING SYSTEM: according to the OECD scoring system

TOOL USED TO ASSESS SCORE: hand-slit lamp
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
other: 24, 48 and 72 hours
Score:
0
Max. score:
4
Reversibility:
other: no effects
Remarks on result:
other: Score after 1 hour = 0
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
other: 24, 48 and 72 hours
Score:
0
Max. score:
4
Reversibility:
other: no effects
Remarks on result:
other: Score after 1 hour = 0
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
other: 24, 48 and 72 hours
Score:
0
Max. score:
4
Reversibility:
other: no effect
Remarks on result:
other: Score after 1 hour = 0
Irritation parameter:
iris score
Basis:
animal #1
Time point:
other: 24, 48 and 72 hours
Score:
0
Max. score:
2
Reversibility:
other: no effects
Remarks on result:
other: Score after 1 hour = 1
Irritation parameter:
iris score
Basis:
animal #2
Time point:
other: 24, 48 and 72 hours
Score:
0
Max. score:
2
Reversibility:
other: no effects
Remarks on result:
other: Score after 1 hour = 0
Irritation parameter:
iris score
Basis:
animal #3
Time point:
other: 24, 48 and 72 hours
Score:
0
Max. score:
2
Reversibility:
other: no effects
Remarks on result:
other: Score after 1 hour = 0
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
other: 24, 48 and 72 hours
Score:
0.67
Max. score:
3
Reversibility:
fully reversible within: 72 hours
Remarks on result:
other: Score after 1 hour = 1
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
other: 24, 48 and 72 hours
Score:
0.67
Max. score:
3
Reversibility:
fully reversible within: 72 hours
Remarks on result:
other: Score after 1 hour = 1
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
other: 24, 48 and 72 hours
Score:
0.67
Max. score:
3
Reversibility:
fully reversible within: 72 hours
Remarks on result:
other: Score after 1 hour = 1
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
other: 24, 48 and 72 hours
Score:
0
Max. score:
4
Reversibility:
fully reversible within: 24 hours
Remarks on result:
other: Score after 1 hour = 1
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
other: 24, 48 and 72 hours
Score:
0
Max. score:
4
Reversibility:
other: no effects
Remarks on result:
other: Score after 1 hour = 0
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
other: 24, 48 and 72 hours
Score:
0
Max. score:
4
Reversibility:
fully reversible within: 24 hours
Remarks on result:
other: Score after 1 hour = 1
Other effects:
A slight loss of weight was observed in one animal on day 3 (2110 g versus 2130 g at start of test)
Interpretation of results:
not irritating
Remarks:
Migrated information
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Additional information

Justification for selection of skin irritation / corrosion endpoint:
The substance is considered to be non-irritating to skin based on the minimal erythematous response observed in an acute rabbit irritation study with its close analogue (OECD 404).

Justification for selection of eye irritation endpoint:
The substance is considered to be non-irritating to eyes based on the minimal response observed in an acute rabbit irritation study with its close analogue (OECD405).

Justification for classification or non-classification

Not classified for acute skin or eye irritancy, according to the criteria of CLP regulation EC No.1272/2008.