Ceraphyl 55

Acute Toxicity: oral

Administrative data

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)

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1985

Report date:

1985

Materials and methods

Test guideline

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

Test material

Test material information

Constituent 1

Details on test material:

- Name of test material (as cited in study report): Tridecyl Neopentanoate
- Lot/batch No.:: P100-39, 7-24-85

Test animals

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.

Administration / exposure

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.

Results and discussion

Effect levels

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

Applicant's summary and conclusion

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.