Ceraphyl 55

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2004

Report date:

2004

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Test material form:

other: clear light yellow liquid

Details on test material:

- Name of test material (as cited in study report): Ceraphyl 55
- Supplied by: International Specialty Products
- Data received: 01/28/04
- Storage: Room temperature and humidity
- Description: Clear light yellow liquid
- Specific gravity: 0.89
- Sample preparation: The test article was used as received

Test animals

Species:

rabbit

Strain:

New Zealand White

Sex:

male/female

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: 2.4-2.7 kg for males and 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: 1 week

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

Administration / exposure

Type of coverage:

semiocclusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

The dorsal area of the trunk of each animal was prepared using a clipper. The test site was approximately 10% of the body surface. The test article was applied to the skin of the animal at a dose level of 2000 mg/kg. The dose was calculated based on the sample specific gravity. The test site was gentle covered with a 4 ply porous gauze dressing measuring 10x15 cm. The torso of the animal was wrapped with plastic in a semi-occlusive manner using a specific tape. The test material remained in contact with the skin for 24 hours. After 24 hour of exposure, the wrapping was removed by gentle washing with distilled water.

Duration of exposure:

24 hours

Doses:

2000 mg/kg

No. of animals per sex per dose:

5 females and 5 males

Details on study design:

Toxicity and pharmacological effect were recorder after 1, 2 and 4 hours post dose and once daily for the remaining 14 days.
Mortality was recorded twice per day, except for day 10.
The bodyweight was recorded prior to testing, weekly and at termination.
The sacrifice of the animals was conducted using CO2, followed by gross pathology examination.
The test sites were scored at 24 hour, 7 and 14 day time points according to the numerical Draize scoring code. Observation included evidence of ulceration, necrosis and tissue damage.

Statistics:

An estimation of the LD50 value was made based on the survival during the study.

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Remarks on result:

other: No mortality occurred during the study

Mortality:

No mortality occurred during the study

Clinical signs:

Instances of few feaces

Body weight:

The bodyweight changes were normal

Gross pathology:

Necropsy examination did not reveal any abnormities

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The LD50 for dermal toxicity of the test material Ceraphyl 55 is > 2000 mg/kg

Executive summary:

The test material Ceraphyl 55 was tested on five male and five New Zealand White rabbits to evaluate the acute dermal toxicity.

The test article was applied onto the dorsal area of the trunk of each animal. The test material was applied to the skin of the animal at a dose level of 2000 mg/kg. The test site was gentle covered with a 4 ply porous gauze dressing measuring 10x15 cm and the torso of the animal was wrapped with plastic in a semi-occlusive manner. Dermal responses were recorded at 24 hours, 7 and 17 days after exposure. The animals were also observed for mortality, pharmacological effects and body weight changes. After sacrifice, a gross pathology examination was performed.

No mortality occurred during the study. The body weight values were in the normal range and the necropsy did not reveal any abnormalities. Instances of a few faeces were observed during the 14 day. The result of the study shows that the acute dermal toxicity LD50 of Ceraphyl 55 is >2000 mg/kg.