Registration Dossier

Administrative data

Description of key information

Based on the results of an in vivo skin irritation test and an in vivo eye irritation test performed according to OECD and GLP guidelines, the test substance is considered to be not irritating to skin and eyes.

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:
18 March - 29 March 2008
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Study was performed according to OECD and EC guidelines and according to GLP principles.
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
Deviations:
no
Qualifier:
according to
Guideline:
EPA OPPTS 870.2500 (Acute Dermal Irritation)
Deviations:
no
GLP compliance:
yes
Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Harlan, Horst, The Netherlands
- Age at study initiation: at least 6 weeks old
- Weight at study initiation: 1643 - 1815 g
- Housing: Individually in labeled cages with perforated floors (dimensions 56x44x37.5 cm).
- Diet (e.g. ad libitum): Pelleted diet for rabbits approximately 100 grams per day. Hay was provided at least three times a week.
- Water (e.g. ad libitum): Free access to tap water.
- Acclimation period: at least 5 days before start of treatment under laboratory conditions


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20.3 - 21.4
- Humidity (%): 44 - 57
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12
Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
other: watery ethanol (50% v/v)
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount applied: 0.5 mL


VEHICLE
- Amount(s) applied (volume or weight with unit): 0.6 ml
Duration of treatment / exposure:
4 hours
Observation period:
72 hours
Number of animals:
3
Details on study design:
TEST SITE
- Area of exposure: 2x3 cm
- % coverage: 100
- Type of wrap if used: metalline patch of 2x3 cm. The patch was mounted on Micropore tape, which was wrapped around the abdomen and secured with Coban elastic bandage.


REMOVAL OF TEST SUBSTANCE
- Washing (if done): skin cleaned of residual test substance using tap water
- Time after start of exposure: 4 hours


SCORING SYSTEM: Draize
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: Mean 24, 48 and 72 hrs
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
mean
Time point:
other: Mean 24, 48 and 72 hrs
Score:
0
Max. score:
4
Irritant / corrosive response data:
No skin irritation was observed after 4 hours exposure to the test substance.
There was no evidence of a corrosive effect on the skin. Yellow staining of the treated skin by the test substance was observed throughout the study period. The yellow staining did not hamper the scoring of the skin reactions.
No symptoms of systemic toxicity were observed in the animals during the test period and no mortality occurred.
Other effects:
No remnants of the test substance were present on the skin.
Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Based on the results of an in vivo skin irritation test performed according to OECD and GLP guidelines, the test substance is considered to be not irritating to skin.
Executive summary:

An in vivo skin irritation test was performed according to OECD and GLP guidelines. No symptoms of systemic toxicity were observed in the animals during the test period and no mortality occurred. No oedema or eryhtema was seen in any of the three animals, at any time point (24, 48 and 72 hours). Based on these data, Y-513 is found to be not-irritant and not corrosive to the skin and is thus not classified according to Regulation (EC) 1272/2008.

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:
25 March - 03 April 2008
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Study was performed according to OECD and EC guidelines and according to GLP principles.
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
Deviations:
no
Qualifier:
according to
Guideline:
EPA OPPTS 870.2400 (Acute Eye Irritation)
Deviations:
no
GLP compliance:
yes
Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Harlan, Horst, The Netherlands
- Age at study initiation: at least 6 weeks old
- Weight at study initiation: 1604 - 1929 g
- Housing: Individually in labeled cages with perforated floors (dimensions 56x44x37.5 cm).
- Diet (e.g. ad libitum): Pelleted diet for rabbits; approximately 100 grams per day. Hay was provided at least three times a week.
- Water (e.g. ad libitum): Free access to tap water
- Acclimation period: at least 5 days before start of treatment under laboratory conditions.


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20.0 - 21.4
- Humidity (%): 44 - 70
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12
Vehicle:
unchanged (no vehicle)
Controls:
other: The other eye remained untreated and served as the reference control.
Amount / concentration applied:
TEST MATERIAL
- Amount applied: 31.8 mg (0.1 ml)

Duration of treatment / exposure:
Single instillation
Observation period (in vivo):
72 hours
Number of animals or in vitro replicates:
3
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing: not done

SCORING SYSTEM: Draize

TOOL USED TO ASSESS SCORE: 2% fluorescein
Irritation parameter:
cornea opacity score
Basis:
animal: 1, 2, 3
Time point:
other: Mean 24, 48 and 72 hours
Score:
0
Max. score:
4
Irritation parameter:
iris score
Basis:
animal: 1, 2, 3
Time point:
other: Mean 24, 48 and 72 hours
Score:
0
Max. score:
2
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
animal #1
Time point:
other: Mean 24, 48 and 72 hours
Score:
0.3
Max. score:
3
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
animal #2
Time point:
other: Mean 24, 48 and 72 hours
Score:
1
Max. score:
3
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
animal #3
Time point:
other: Mean 24, 48 and 72 hours
Score:
0.3
Max. score:
3
Reversibility:
fully reversible within: 48 hours
Irritant / corrosive response data:
Instillation of approximately 32 mg of the test substance (a volume of approximately 0.1 mL) into one eye of each of three rabbits resulted in irritation of the conjunctivae, which consisted of redness, chemosis and discharge. The irritation had completely resolved within 48 hours in two animals and within 72 hours in the other animal.

No iridial irritation or corneal opacity were observed, and treatment of the eyes with 2% fluorescein, 24 hours after test substance instillation revealed no corneal epithelial damage.

There was no evidence of ocular corrosion.

Remnants of the test substance were present in the eye and/or on the outside of the eyelids between Days 1 and 3.
Yellow staining of the fur on the head and paws, caused by the test substance, was noted during the observation period.

No symptoms of systemic toxicity were observed in the animals during the test period and no mortality occurred.
Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Based on the results of an in vivo eye irritancy test, performed according to OECD and GLP guidelines, Y-513 is considered to be non irritating to the eyes.
Executive summary:

An in vivo eye irritation test was performed according to OECD and GLP guidelines. Instillation of the test substance resulted in irritation of the conjunctiva, which consisted of redness, chemosis and discharge. The irritation had completely resolved within 48 hours (for two animals) or 72 hours (one animal).

Based on these data, Y-513 is found to be not irritant to the eye and is not classified according to Regulation (EC) 1272/2008.

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

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

An in vivo skin irritation test was performed according to OECD and GLP guidelines. No symptoms of systemic toxicity were observed in the animals during the test period and no mortality occurred. No oedema or eryhtema was seen in any of the three animals, at any time point (24, 48 and 72 hours). Furthermore, an in vivo eye irritation test was performed according to OECD and GLP guidelines. Instillation of the test substance resulted in irritation of the conjunctiva, which consisted of redness, chemosis and discharge. The irritation had completely resolved within 48 hours (for two animals) or 72 hours (one animal).


Justification for selection of skin irritation / corrosion endpoint:
One reliable study available.

Justification for selection of eye irritation endpoint:
One reliable study available.

Justification for classification or non-classification

Based on the available data, Y-513 is not classified for skin irritation and eye irritation according to Regulation (EC) 1272/2008.