Ceraphyl 55

Endpoint summary

Description of key information

The skin and eye irritation/corrosion potential of Ceraphyl 55 was investigated. The skin irritation studies did not show any adverse effect, while the eye irritation studies showed a mild irritation activity, but not corrosion.

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

Reliability:

1 (reliable without restriction)

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

yes

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: Millbrook Breeding Labs, Amherst, MA
- Supplied on: 02/04/04
- Date of birth: 11/09/03 and 11/16/03
- Weight at study initiation: 2.5-2.7 for females
- Housing: Suspended wire cages. Bedding was placed beneath the cages and changed at least three times per week
- Diet (e.g. ad libitum): Fresh PMI Rabbit Chow (Diet #5321) was provided daily
- Water (e.g. ad libitum): Free available
- Acclimation period: minimum 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C) and humidity: controlled
- Photoperiod (hrs dark / hrs light): 12 hr light/12 hr dark

Type of coverage:

semiocclusive

Preparation of test site:

clipped

Vehicle:

unchanged (no vehicle)

Amount / concentration applied:

0.5 ml/site

Duration of treatment / exposure:

4 hours

Number of animals:

1 male and 2 females rabbits

Details on study design:

The dorsal area of the trunk of each animal was clipped free of hair. The test site was approximately 10x10 cm.
The day after the preparation, 0.5 ml/site of the test article was applied under a 2.5x2.5 cm, 4 ply surgical gauze patches. The patch was secured with a non-irritant adhesive and the torso of the animal was wrapped with plastic in a semi-occlusive manner. A layer of extra tape covered the plastic in order to prevent displacement and possible evaporation of the test article.
The test material stayed in contact with the skin of the animals for 4 hours at which time, the wrapping was gently removed and the skin was gentle washed with distilled water.
The test sites were scored for dermal irritation at 60 minute, 24, 48 and 72 hour time points. Erythema and edema were scored according to the numerical Draize score. Any areas of ulcerations, necrosis and tissue damage was also recorded.

Irritation parameter:

erythema score

Basis:

animal: #1, #2, #3

Time point:

other: 60 minutes

Score:

1

Max. score:

4

Reversibility:

fully reversible within: 24 hours

Remarks on result:

other: No mortaly occurred

Irritation parameter:

erythema score

Basis:

animal #1

Remarks:

#2, #3

Time point:

other: 24, 48, 72 hours

Score:

0

Max. score:

4

Remarks on result:

other: No mortality occurred

Irritation parameter:

edema score

Basis:

animal: #1, #2

Time point:

other: 60 minutes

Score:

1

Max. score:

4

Reversibility:

fully reversible within: 24 hours

Remarks on result:

other: No mortality occurred

Irritation parameter:

edema score

Basis:

animal #3

Time point:

other: 60 minutes

Score:

0

Max. score:

0

Remarks on result:

other: No mortality occurred

Irritation parameter:

edema score

Basis:

animal: #1, #2, #3

Time point:

other: 24, 48, 72 hours

Score:

0

Max. score:

0

Remarks on result:

other: No mortality occurred

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The test article Ceraphyl 55 is not irritating under test conditions.

Executive summary:

The test material Ceraphyl 55 was tested on 1 male and 2 female New Zealand White rabbits. A volume of 0.5 ml of the test article was applied to a patch and placed to the dorsal area of the trunk of each animal. The test site was secured with a non-irritant adhesive and the torso of the animal was wrapped with plastic in a semi-occlusive manner. The test material stayed in contact with the skin of the animals for 4 hours. The skin treated was scored for erythema and edema at 60 minute, 24, 48 and 72 hour time points according to the numerical Draize score. Any evidence of ulcerations, necrosis and tissue damage was also recorded. The result of the test shows erythema and edema score of 1 in 2 and 3 animals respectively at 60 minute time point. The dermal irritation was fully reversible within 24 hours. At 24, 48, 72 hour time points, the erythema and edema scores were 0 in all animals. In conclusion, the test material Ceraphyl 55 is considered to be not irritant under the condition of this test.

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

Reliability:

1 (reliable without restriction)

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

GLP compliance:

yes (incl. QA statement)

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Millbrook Breeding Labs, Amherst, MA
- Date of birth: 11/02/03
- Data received: 01/21/04
- Weight at study initiation: 2.8-3.1
- Housing: The animals were housed 1/cage in suspended cages
- Diet (e.g. ad libitum): Fresh PMI Rabbit Chow (Diet #5321)was provided daily
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature and humidity: Controlled
- Humidity (%):
- Photoperiod (hrs dark / hrs light): 12 hr dark/12 hr light

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

Duration of treatment / exposure:

72 hours

Observation period (in vivo):

1, 24 48 72 hours post dose

Number of animals or in vitro replicates:

3 rabbits

Details on study design:

Prior to start the test, rabbits were checked for ocular irritation and corneal abnormalities. A 0.1 ml aliquot of the test article was placed into the conjunctival sac on one eye of each rabbit using a syringe. The lids of the eye were hold together for approximately one second to prevent test material loss. The eyes were observed using a flashlight equipped with a high intensity bulb. The observations included irritation of the cornea, iris and conjunctiva at 1, 24, 48 and 72 hours. Sodium fluorescein dye procedure was used at the 24-hour time point observation interval. Ocular reactions were scored according to the Draize numerical technique.
At the end of the study, animals were sacrificed using CO2.
Bodyweights were recorded before the test.

Irritation parameter:

overall irritation score

Basis:

animal #1

Time point:

other: 1 hour

Score:

10

Max. score:

110

Reversibility:

fully reversible within: 48 hours

Irritation parameter:

overall irritation score

Basis:

animal #1

Time point:

other: 24 hours

Score:

2

Max. score:

110

Reversibility:

fully reversible within: 48 hours

Irritation parameter:

overall irritation score

Basis:

animal #1

Time point:

other: 48, 72 hours

Score:

0

Max. score:

110

Irritation parameter:

overall irritation score

Basis:

animal #2

Time point:

other: 1 hour

Score:

10

Max. score:

110

Reversibility:

fully reversible within: 24 hours

Irritation parameter:

overall irritation score

Basis:

animal #2

Time point:

other: 24, 48, 72 hours

Score:

0

Max. score:

110

Irritation parameter:

overall irritation score

Basis:

animal #3

Time point:

other: 1 hour

Score:

10

Max. score:

110

Reversibility:

fully reversible within: 48 hours

Irritation parameter:

overall irritation score

Basis:

animal #3

Time point:

other: 24 hours

Score:

2

Max. score:

110

Reversibility:

fully reversible within: 48 hours

Irritation parameter:

overall irritation score

Basis:

animal #3

Time point:

other: 48, 72 hours

Score:

0

Max. score:

110

Irritant / corrosive response data:

No corneal opacity or iritis. Conjunctival irritation was noted in 3/3 eyes. Effects were still evident in 2/3 animals at 24 hrs but had resolved by 48 hrs.

Interpretation of results:

slightly irritating

Remarks:

Migrated information not classified Criteria used for interpretation of results: EU

Conclusions:

The test material Ceraphyl 55 is considered to be minimally irritant under the condition of this study, so the level and frequency of the effects did not meet the criteria for classification as eye irritation.

Executive summary:

The test material Ceraphyl 55 was tested in 3 New Zealand White rabbits. A 0.1 ml aliquot of the test article was placed into the conjunctival sac on one eye of each rabbit using a syringe. The eyes were observed using a flashlight equipped with a high intensity bulb. The observations included irritation of the cornea, iris and conjunctiva at 1, 24, 48 and 72 hours. Sodium fluorescein dye procedure was used at the 24-hour time point observation interval. Ocular reactions were scored according to the Draize numerical technique. The results show no evidence of corneal opacity or iritis. A conjunctival irritation was noted in 3/3 animals 1 hr after treatment. Effects were still evident in 2/3 animals at 24 hrs but were fully reversible within 48 hours. In conclusion, Ceraphyl 55 is considered to be a minimal irritant, but not corrosive, under the condition of this study.

Endpoint conclusion

Endpoint conclusion:

adverse effect observed (irritating)

Additional information

Four studies are available on skin and eye irritation/corrosion.

In a primary dermal irritation study (Consumer Product Testing, 1985) six young adult New Zealand white rabbits were exposed to 0.5 g of Ceraphyl 55 for 24 hours under occluded contact to intact skin. After 24 hours of exposure the wrapping material was removed and the skin was gently wiped. Animals were then observed and scored after 24 and 72 hours post-treatment. Edema and erythema were scored. Based on the findings of this study, the test material Ceraphyl 55 was not considered to be a skin irritant to rabbits.

A second study conducted by MB Research Laboratories (2004) performed an acute dermal irritation test following the OECD 404, under GLP conditions. The test material Ceraphyl 55 was tested on 1 male and 2 female New Zealand White rabbits. A volume of 0.5 ml of the test article was applied to a patch and placed to the dorsal area of the trunk of each animal. The test site was secured with a non-irritant adhesive and the torso of the animal was wrapped with plastic in a semi-occlusive manner. The test material stayed in contact with the skin of the animals for 4 hours. The skin treated was scored for erythema and edema at 60 minute, 24, 48 and 72 hour time points according to the numerical Draize score. Evidence of any ulcerations, necrosis and tissue damage was also recorded. The result of test showed erythema and edema scores of 1 in 2 and 3 animals respectively at the 60 minute time point. The dermal irritation was fully reversible within 24 hours. At 24, 48, 72 hour time points, the erythema and edema scores were 0 in all animals. In conclusion, the test material Ceraphyl 55 is considered to be not irritant under the condition of this test.

In addition, a primary ocular irritation test was conducted by Consumenr Product Testing (1985) .The test material Ceraphyl 55 was investigated for eye irritation potential in 9 rabbits. A dose of 0.1 ml of the test article was placed in one eye of each animal selected for the test. The lower lid of the eye was gently pulled away from the eye ball to form a cup into which the test article was dropped. The contralateral eye remained untreated and served as control. The eyes of 6 rabbits remained unwashed for 24 hours. After that, the eyes were observed, scored and gently washed. The eye of the other three rabbits, were irrigated for 4 seconds following instillation of the test article with sufficient lukewarm water at room temperature to wash out all visible test article. Observations were made at 24, 48, 72 hours after treatment with the test material. Effects were limited to the conjunctiva and were fully reversible within 72 hours after treatment. Minimal irritation was observed after 24 hrs only, after the wash procedure.

The last study available was performed by MB Research Laboratories (2004).

The test material Ceraphyl 55 was tested in 3 New Zealand White rabbits. A concentration of 0.1 ml aliquot of the test article was placed into the conjunctival sac on one eye of each rabbit using a syringe. The eyes were observed using a flashlight equipped with a high intensity bulb. The observations included irritation of the cornea, iris and conjunctiva at 1, 24, 48 and 72 hours. Sodium fluorescein dye procedure was used at the 24-hour time point observation interval. Ocular reactions were scored according to the Draize numerical technique. The results show no evidence of corneal opacity or iritis. Mild conjunctival irritation was noted in 3/3 eyes 1 hr after treatment but was fully reversible within 48 hours. In conclusion, Ceraphyl 55 is considered to a be miminally irritant, but not corrosive, under the condition of this study.

Effects on eye irritation: slightly irritating

Justification for classification or non-classification

Data for skin irritation/corrosion shows that exposure to Ceraphyl 55 will likely not cause classification of the category. Based on the data available, Ceraphyl 55 is not required to be classified under the EU CLP Regulation (EC No. 1272/2008) and subsequent amendments thereof, for skin and eye irritation/corrosion.

Results from eye irritation studies show minimal eye irritation and no corrosion, so the level and frequency of the effects did not meet the criteria for classification as an eye irritant under the EU CLP Regulation (EC No. 1272/2008).