[No public or meaningful name is available]

Endpoint summary

Description of key information

Skin:

The skin irritation study is performed according to OECD Guideline 404 under GLP. Following a single dermal application for 4 hours, no erythema or edema was present at any time point in any animal, the test item is not irritating to rabbit skin. 

Eye:

The eye irritation study is performed according to OECD Guideline 405 under GLP. The test item is considered to be "not irritating" to the rabbit eye.

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 December 12, 2007 to December 26, 2007

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)

Specific details on test material used for the study:

Test material name in the study: PF-03394197-11
Lot Number: LCY33580119667

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Covance Research Products, Denver, Pennsylvania
- Age at study initiation: Approximately 4 months
- Weight at study initiation: Male: 2.78 and 2.95 kg
- Housing: Individual Stainless Steel Suspended Cages with deotized paper.
- Diet (e.g. ad libitum): Lab Diet® Certified Rabbit Diet # 5322, PMI Nutrition International, Inc. Animals were fasted on the day of arrival, and then food was increased in 25-g increments over
5 to 7 days until feeding was 125 g per day.
- Water (e.g. ad libitum): Automatic watering system, Ad libitum.
- Acclimation period: 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 61 to 72°F
- Humidity (%): 30 to 70%
- Air changes (per hr):
- Photoperiod (hrs dark / hrs light): Fluorescent lighting was provided for approximately 12 hours per day.

Type of coverage:

semiocclusive

Preparation of test site:

clipped

Vehicle:

unchanged (no vehicle)

Controls:

no

Amount / concentration applied:

0.5 g

Duration of treatment / exposure:

4 hours

Observation period:

72 hours

Number of animals:

3 males

Details on study design:

TEST SITE
- Area of exposure: dorsal trunk of each animal
- % coverage:
- Type of wrap if used: The application site was wrapped with gauze bandaging and non-irritating, semi-occlusive tape.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): the wrappings were removed and the residual test substance was removed. Any residual test substance was removed using tepid tap water and a WypAll®.
- Time after start of exposure: 4 hours

OBSERVATION TIME POINTS
(indicate if minutes, hours or days) The test site was scored for erythema/eschar and edema within 30 to 60 minutes and at 24, 48, and 72 hours following patch removal (postdose).

SCORING SYSTEM:
- Method of calculation: Draize scale for scoring skin irritation.

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

Irritant / corrosive response data:

No erythema or edema was present at any time point in any animal.

Interpretation of results:

GHS criteria not met

Conclusions:

Following a single dermal application for 4 hours, no erythema or edema was present at any time point in any animal, the test item is not irritating to rabbit skin. 

Executive summary:

The skin irritation study is performed according to OECD Guideline 404 under GLP. Following a single dermal application for 4 hours, no erythema or edema was present at any time point in any animal, 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 11-May-2009 to 26-May-2009

Reliability:

1 (reliable without restriction)

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Version / remarks:

April 24, 2002

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Specific details on test material used for the study:

Test material name in the study: PF-03394197-00
Batch Number: JFB80003
Purity: 97.17%

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Harlan France, Z1 Le Malcourlet, 03800 Gannat / France
- Age at study initiation: 17 weeks (male), 15 weeks (females)
- Weight at study initiation: 2697 g (male), 2582 - 3124 g (females)
- Housing: Individually in stainless steel cages equipped with feed hoppers and drinking water bowls.
- Diet (e.g. ad libitum): Pelleted standard Provimi Kliba 3418 rabbit maintenance diet ad libitum
- Water (e.g. ad libitum): Community tap water from Fullinsdorf ad libitum.
- Acclimation period:

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17 - 23 °C
- Humidity (%): 30 - 70%
- Air changes (per hr): 10 - 15 air changes per hour
- Photoperiod (hrs dark / hrs light): light cycle of 12 hours light and 12 hours dark

Vehicle:

unchanged (no vehicle)

Controls:

yes, concurrent no treatment

Amount / concentration applied:

0.1 g (per animal)

Duration of treatment / exposure:

24 hours

Observation period (in vivo):

7 days

Number of animals or in vitro replicates:

1 male and 2 females

Details on study design:

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

SCORING SYSTEM: Draize

TOOL USED TO ASSESS SCORE: fluorescein

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

Max. score:

0

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

24/48/72 h

Score:

0.55

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

Irritant / corrosive response data:

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 cherna sis of the conjunctivae, separately. The
individual mean scores for corneal opacity and iris were 0.00 for all three animals. The
individual mean scores for the conjunctival reddening were 0.67, 0.33 and 0.67, respectively.
The individual mean scores for the conjunctival swelling was 0.00 for each of the three animals.
No abnormal findings were observed in the cornea or iris of any animal at any of the
measurement intervals. Slight reddening of both the conjunctivae and the sclerae were observed
in all three animals at the 1 hour observation after instillation. The reddening of the conjunctivae
persisted up to the 24-hour (one female) or the 48-hour (one male, one female) observation after
application.
The reddening of the sclerae persisted up to the 72-hour observation after treatment in one male
and one female. Slight ocular discharge was present at the 1 hour observations after
administration in two females.
No abnormal findings were observed in the treated eye of any animal 7 days after treatment, the
end of the observation period for all animals.

Other effects:

No mortality occurred.
No clinical signs were observed during the course of the study.
The body weights of all rabbits were considered to be within the normal range of variability.

Interpretation of results:

GHS criteria not met

Conclusions:

The test item is considered to be "not irritating" to the rabbit eye.

Executive summary:

The eye irritation study is performed according to OECD Guideline 405 under GLP. The test item 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

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 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, 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, 0, 0;

conjunctivae: 0.67, 0.33, 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.