[No public or meaningful name is available]

Endpoint summary

Description of key information

Skin:
The skin irritation study is performed using rabbits, according to OECD Guideline 404 under GLP. The
substance is not irritating to rabbit skin.
Eye:
The eye irritation study is performed using rabbit eyes, according to OECD Guideline 405 under GLP.
The substance is slightly irritant to rabbit eyes. While based on GHS, it is not classified as eye irritant.

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:

From 06 Dec 2016 to 09 Dec 2016

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Covance Research Products Inc., Denver, PA, on 02 Nov 2016.
- Age at study initiation: The male animal was born on either 09 Jul2016 or 16 Jul2016 and the
female animals were born on 16 Ju12016.
- Weight at study initiation: The pre-test body weight range was 3.1 -3.3 kg .
- Housing: The animals were identified by cage notation and a uniquely numbered metal ear tag and
individually housed in suspended wire-bottom cages. Absorbent paper bedding was placed beneath
the cages and changed at least three times per week.
- Diet (e.g. ad libitum): Fresh PMI Rabbit Chow (Diet No. 5321) was provided daily.
- Water (e.g. ad libitum): Water was available ad libitum.
- Acclimation period: at least five days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): temperature controlled
- Humidity (%):
- Air changes (per hr):
- Photoperiod (hrs dark / hrs light): 12-hour light/dark cycle

Type of coverage:

occlusive

Preparation of test site:

clipped

Vehicle:

water

Controls:

yes, concurrent no treatment

Amount / concentration applied:

0.5 g per site and moistened with 0.6 ml of distilled water

Duration of treatment / exposure:

3 minutes, 1 hour, 4 hours

Observation period:

72 hours

Number of animals:

one male -two females

Details on study design:

TEST SITE
- Area of exposure: dorsal area of the trunk
- % coverage: 100%
- Type of wrap if used: The dose patch was secured with non-irritating tape and the rabbit was gently
held in place.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): the test site was gently washed with gauze saturated with distilled water f
ollowing patch removal.
- Time after start of exposure: 3 minutes, 1 hour, 4 hours

OBSERVATION TIME POINTS
(indicate if minutes, hours or days) Exposure Site 1 of the initial animal was scored for dermal irritation
immediately post-exposure and at one hour post-exposure. Sites 2 (one-hour exposure) and 3 (fourhour
exposure) were scored for dermal irritation at 1, 24, 48 and 72 hours hours after patch removal.

SCORING SYSTEM:
- Method of calculation: Erythema and edema were scored according to the numerical Draize scale.

Irritation parameter:

erythema score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

0

Irritation parameter:

edema score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

0

Other effects:

Systemic Observations: No abnormal physical signs were observed.
Body Weights: All three animals' weights remained the same by study termination.

Interpretation of results:

GHS criteria not met

Conclusions:

The substance is not irritating to rabbit skin.

Executive summary:

The skin irritation study is performed using rabbits, according to OECD Guideline 404 under GLP. The
substance is not irritating to rabbit skin.

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:

From 05 Dec 2016 to 19 Dec 2016

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Covance Research Products, Inc., Denver, PA, on 02 Nov 2016
- Age at study initiation: The male animals were born on 09 Jul2016 and/or 16 Jul2016 and the female
animal was born on 16 Ju12016.
- Weight at study initiation: The pre-test body weight range was 3.0 -3.2 kg.
- Housing: The animals were individually housed in suspended wire-bottom cages. Absorbent paper b
edding was placed beneath the cages and changed at least three times per week.
- Diet (e.g. ad libitum): Fresh PMI Rabbit Chow (Diet No. 5321) was provided daily.
- Water (e.g. ad libitum): Water was available ad libitum.
- Acclimation period: at least five days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): temperature controlled
- Humidity (%):
- Air changes (per hr):
- Photoperiod (hrs dark / hrs light): 12-hour light/dark cycle

Vehicle:

unchanged (no vehicle)

Controls:

yes, concurrent no treatment

Amount / concentration applied:

0.1 ml equivalent (59 mg)

Duration of treatment / exposure:

72 hours

Observation period (in vivo):

14 days

Number of animals or in vitro replicates:

two males -one female

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing (if done): no
- Time after start of exposure:

SCORING SYSTEM: Ocular reactions were graded according to the numerical Draize technique

TOOL USED TO ASSESS SCORE: Sodium fluorescein dye procedures were performed at the 24-
hour observation interval. The eye was examined with the aid of an ultraviolet light source.

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

0

Irritation parameter:

iris score

Basis:

mean

Time point:

24/48/72 h

Score:

0.22

Max. score:

1

Reversibility:

fully reversible within: 8 days

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

24/48/72 h

Score:

0.78

Max. score:

2

Reversibility:

fully reversible within: 14 days

Irritation parameter:

chemosis score

Basis:

mean

Time point:

24/48/72 h

Score:

0.44

Max. score:

1

Reversibility:

fully reversible within: 8 days

Other effects:

Systemic Observations: No abnormal physical signs were observed.
Body Weights: Two animals gained weight and one animal's weight remained the same by study term
ination.

Interpretation of results:

GHS criteria not met

Conclusions:

The substance is slightly irritant to rabbit eyes.

Executive summary:

The eye irritation study is performed using rabbit eyes, according to OECD Guideline 405 under GLP.
The substance is slightly irritant to rabbit eyes. While based on GHS, it is not classified as eye irritant.

Endpoint conclusion

Endpoint conclusion:

adverse effect observed (irritating)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no study available

Justification for classification or non-classification

Skin irritation / corrosion:
In vivo skin irritation, key study, OECD 404:
Mean score for erythema at 24, 48, 72 h for 3 tested animal: 0, 0, 0
Mean score for edema at 24, 48, 72 h for 3 tested animal: 0, 0, 0
According to Regulation (EC) No 1272/2008, table 3.2.2, this substance should not be classified for
this endpoint.

Eye irritation:
In vivo eye irritation, key study, OECD 405:
Mean scores for cornea opacity, iris, conjunctivae and chemosis at 24, 48, and 72h:
cornea opacity: 0, 0, 0;
iris: 0.33, 0.33, 0;
conjunctivae: 1, 1, 0.33;
chemosis: 1, 0.33, 0.

According to Regulation (EC) No 1272/2008, table 3.3.2, this substance should not be classified for
this endpoint.