[No public or meaningful name is available]

Endpoint summary

Description of key information

SKin irritation:

The study is performed according to OECD Guideline 404 using rabbits. It is concluded the test item is not irritating to rabbit skin.

Eye irritation:

The study is performed according to OECD Guideline 405. It is concluded that the test item is not irritating to rabbit 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:

From 06 Dec 2016 to 09 Dec 2016

Reliability:

1 (reliable without restriction)

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
- Age at study initiation: The male animal was born on 11 Jun 2016 and the female animals were born on 04 Jun 2016.
- Weight at study initiation: The pre-test body weight range was 3.2 -3.5 kg.
- Housing: The animals were identified by cage notation and a uniquely numbered metal ear tag and individually housed in suspended wire-bottom cages.
- 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):
- 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:

no

Amount / concentration applied:

0.5 g per site and moistened with 0.4 ml of distilled water to form a pasty consistency.

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: The test article was applied over a 2 x 3 cm gauze patch.
- % coverage:
- Type of wrap if used: Gentle pressure was applied to aid in the distribution of the test article over the prepared site. 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 following 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 (four-hour 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. The skin was also evaluated for ulceration and necrosis or any evidence of tissue destruction.

Irritation parameter:

erythema score

Basis:

mean

Time point:

24/48/72 h

Score:

0.33

Max. score:

1

Reversibility:

fully reversible within: 48 hours

Irritation parameter:

edema score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

0

Reversibility:

fully reversible

Other effects:

Systemic Observations: No abnormal physical signs were observed.
Body Weights: One animal gained weight and two animals' weights remained the same by study termination.

Interpretation of results:

GHS criteria not met

Conclusions:

The test item is not irritating to rabbit skin.

Executive summary:

The study is performed according to OECD Guideline 404 using rabbits. It is concluded the test item 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 16 Dec 2016

Reliability:

1 (reliable without restriction)

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
- Age at study initiation: The male animals were born on 27 Aug 2016 and the female animal was born on 20 Aug 2016.
- Weight at study initiation: The pre-test body weight range was 2.4 - 2.7 kg.
- Housing: The animals were 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):
- 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:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 ml equivalent (60 mg)

Duration of treatment / exposure:

72 hours

Observation period (in vivo):

72 hours

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

Reversibility:

fully reversible

Irritation parameter:

iris score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

0

Reversibility:

fully reversible

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

24/48/72 h

Score:

0.67

Max. score:

1

Reversibility:

fully reversible within: 72 hours

Irritation parameter:

chemosis score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

0

Reversibility:

fully reversible

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 termination.

Interpretation of results:

GHS criteria not met

Conclusions:

The test item is not irritating to rabbit eyes.

Executive summary:

The study is performed according to OECD Guideline 405. It is concluded that the test item is not irritating to rabbit eyes.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no study available

Justification for classification or non-classification

Skin irritation / corrosion:

In vivo skin irritation, OECD 404:

Mean score for erythema at 24, 48, 72 h for 3 tested animals: 0, 0, 0

Mean score for edema at 24, 48, 72 h for 3 tested animals: 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, OECD 405:

Mean scores for cornea opacity, iris, conjunctivae and chemosis at 24, 48, and 72h:

cornea opacity: 0, 0, 0;

iris: 0, 0, 0;

conjunctivae: 0.67, 0.67, 0.67;

chemosis: 0, 0, 0.

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