Ceraphyl 55

Endpoint summary

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records

Reference

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

29-07-1985/16-08-1985

Reliability:

1 (reliable without restriction)

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 420 (Acute Oral Toxicity - Fixed Dose Method)

Principles of method if other than guideline:

The method described by Hagan et al.1976 served as a guide.

GLP compliance:

yes (incl. QA statement)

Test type:

fixed dose procedure

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: animals were provided by a licensed dealer
- Age at study initiation: approximately 6 to 9 weeks old
- Weight at study initiation: between 120 and 220 g/bw
- Fasting period before study: 18 hours
- Housing: animals were housed in galvanized cages with indirect bedding
- Diet (e.g. ad libitum): growth and maintenance ration from a commercial producer
- Water (e.g. ad libitum): ad libitum
- Acclimation period: minimum 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): controlled
- Humidity (%) and air changes (per hr): not provided
- Photoperiod (hrs dark / hrs light): 12 hour light/dark cycle

Upon receipt, animals were carefully checked for respiratory difficulty, ocular and nasal lacrimation, dehydration, diarrhoea and general thriftiness.

Route of administration:

other: The dose was administrated using a stainless steel intragastric feeding needle

No. of animals per sex per dose:

5 male, 5 female

Details on study design:

Twenty-four hours prior the test, the animals were screened for general thriftiness and a group of 5 males and 5 females of sufficient weight was selected and labelled for the experiment.
After 18 hours of fasting, each rat was weighted and marked with an ear clip. Individual doses were calculated on the bases of the bodyweight. The dose was administrated using a stainless steel intragastric feeding needle. After that, rats were returned to their cages, which were identified with the job number, test article, dose level, sex, animal number and date of dosing.
Animals were observed for signs of pharmacologic activity and toxicity at 1,3,6 and 24 hours post dosage. Observations were made at least once daily for 14 consecutive days.
Animals were sacrificed at the end of the 14 day observation period and gross necropsy was performed.

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Remarks on result:

other: 0% Mortality

Mortality:

No mortality occurred during this study

Clinical signs:

No changes were observed during this study

Body weight:

Animals gain weight normally during this study.

Gross pathology:

No gross changes were observed

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The Acute oral LD50 of Ceraphyl 55 is for rats >5000 mg/kg.

Executive summary:

Acute oral toxicity was determined in GLP compliant study OECD 420 using 5 female and 5 male Wistar Albino rats (age 6 to 9 weeks and weight between 120 and 220). The test substance was administered neat as a single dose using a stainless steel intragastric feeding needle (5000 mg/kg bwt) following an overnight fast, and the animals observed for 14 days post-treatment. There were no deaths or any clinical signs noted following treatment and the animals gained weight normally. No gross abnormalities were detected at autopsy on study day 14. The results showed that the acute oral LD50 of Ceraphyl 55 is greater than 5000 mg/kg bwt.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

5 000 mg/kg bw

Acute toxicity: via dermal route

Link to relevant study records

Reference

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

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

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

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.

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

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.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

2 000 mg/kg bw

Additional information

Three acute toxicity studies are available on the test material Ceraphyl 55.

The first is an acute oral toxicity study conducted by Consumer Pruduct Testing (1985). The study was performed using a protocol similar to guideline study OECD 420, under GLP conditions. The test material was administrated to five females and five males Wistar Albino rats (age 6 to 9 weeks and weight between 120 and 220). A single dose was given using a stainless steel intragastric feeding needle (5000 mg/kg bwt) following an overnight fast. The animals were observed for 14 days post-treatment. There were no deaths or any clinical signs noted following treatment and the animals gained weight normally. No gross abnormalities detected at autopsy on study day 14. The results showed that the acute oral LD50 of Ceraphyl 55 is greater than 5000 mg/kg bwt.

A second oral toxicity study was conducted by MB Research Laboratories (2004). The study was design to investigate the acute toxicity potential of Ceraphyl 55 according to EPA OPPTS 870.1100 (Acute Oral Toxicity) guideline and under GLP conditions. Five female Wistar albino rats were dosed orally with the test material at 2000 mg/kg dose level. Animals were observed 1/2, 1, 2, and 4 hours postdose and thereafter once daily for 14 day for toxicity and pharmacological effects. They were observed twice daily for mortality and body weights were recorded prior pre-test, weekly and at termination phase. No mortality was observed during this study, no abnormal physical signs were noted during the observation period. Necropsy results were normal. In conclusion, the LD50 for acute oral toxicity of Ceraphyl 55 is greater than 2000 mg/kg.

 

A third study was conducted by MB Research Laboratories (2004) in order to investigate the acute dermal toxicity of Ceraphyl 55 in rabbits.

The test article was applied onto the dorsal area of the trunk of five male and five New Zealand White rabbits at 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. There were instances of a few faeces were observed during the 14 day observation period. The result of the study shows that the acute dermal toxicity LD50 of Ceraphyl 55 is >2000 mg/kg.

Justification for classification or non-classification

Based on the available data, Ceraphyl 55 does not meet the criteria for classification for acute toxicity under EU Regulation 1272/2008.