Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
February 7 to February 21, 1996
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: guideline test with GLP

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1996
Report Date:
1996

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
no
GLP compliance:
yes
Test type:
standard acute method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder
Details on test material:
Identity:BM1-Resin
Chemical identity:Epoxide resin based on Bisphenol A and epichlorohydrin blocked with paraphenylphenol
Intended use:Resin in toner for use in copier/printers
Appearance: White (slightly yellow) powder
Storage conditions:Room temperature
Batch number: 20001097/B160295/111
Expiry:Not advised
Purity:>98%
Date received:15 January 1996

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
ANIMAL MANAGEMENT
Equal numbers of healthy male and female CD rats of Sprague-Dawley origin (Hsd:Sprague- Dawley(CD)) were obtained from Harlan U.K. Ltd., Bicester, Oxon,England.
They were in the weight range of 96 to 116 g and approximately four to seven weeks of age prior to dosing (Day 1). All the rats were acclimatised to the experimental environment for a period of six days prior to the start of the study.
The rats were allocated without conscious bias to cages within the treatment groups. They were housed in groups of up to five rats of the same sex in metal cages with wire mesh floors in Building R14 Room 6.
A standard laboratory rodent diet (SDS LAD 1) and drinking water were provided ad libitum. Access to food only was prevented overnight prior to and approximately 4 hours after dosing.
Each batch of diet used for the study was analysed for certain nutrients,possible contaminants and micro-organisms.
Results of routine physical and chemical examination of drinking water at source, as conducted, usually weekly by the supplier, are made available to Huntingdon Life Sciences Ltd. as quarterly summaries.
Animal room temperature was set to achieve a temperature of 22 土 3°C. Relative humidity was not controlled but was anticipated to be in the range 30 - 70% RH. Permanent daily recordings of these parameters were made and these are archived with other Department raw data. Any slight deviation in temperature and humidity that may have occurred was not considered to have affected the integrity or validity of the study. Air exchange was maintained at 10 to 15 air changes per hour and lighting controlled by means of a time switch to provide 12 hours of artificial light (0700 - 1900 hours) in each 24-hour period.
Each animal was identified by cage number and ear punching. Each cage was identified by a coloured label displaying the dose level, study schedule number, animal mark and the initials of the Study Director and Home Office licensee.

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
CMC (carboxymethyl cellulose)
Details on oral exposure:
A group of ten fasted rats (five males and five females) was given a single dose by oral gavage of the test substance, formulated in 1 % w/v aqueous methylcellulose and administered at a dose level of 2.0 g/kg bodyweight.
Doses:
2000 mg/kg body weight
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
All animals were killed and examined macroscopically on Day 15, the end of the observation period.
Mortality
Cages of rats were checked at least twice daily for any mortalities.
Clinical signs
Animals were observed soon after dosing and at frequent intervals for the remainder of Day 1 (a period of four hours). On subsequent days animals were observed once in the morning and again at the end of the experimental day (with the exception of Day 15 - morning only). This latter observation was at approximately 16.30 hours on week days or 11.30 hours on Saturdays and Sundays. The nature and severity of the clinical signs and time were recorded at each observation.
All animals were observed for 14 days after dosing.
Bodyweight
The bodyweight of each rat was recorded on Days 1 (prior to dosing), 8 and 15. Individual weekly bodyweight changes and group mean bodyweights were calculated.
TERMINAL STUDIES Termination
All animals were killed on Day 15 by cervical dislocation.
Macroscopic jpathology
All animals were subjected to a macroscopic examination which consisted of opening the abdominal and thoracic cavities. The macroscolpic appearance of all tissues was recorded.
Statistics:
no data

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 treatment related effects were observed during the test.
Mortality:
There were no deaths.
Clinical signs:
Clinical signs of reaction to treatment were confined to piloerection,seen in all rats. Recovery was complete in all instances by Day 5.
Body weight:
A slightly low bodyweight gain was recorded for one male on Day 15. All other rats achieved satisfactory bodyweight gains throughout the study
Gross pathology:
No abnormalities were recorded at the macroscopic examination on Day 15.
Other findings:
No data

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The LD50 of acute oral toxicity of test article to rats was found to be greater than 2000 mg/kg body weight under the conditions of this study.
Executive summary:

This study was performed to assess the acute oral toxicity of test article to the rat. The method followed was that described in OECD Guideline for Testing of Chemicals No. 401.

A group of ten fasted rats (five males and five females) was given a single dose by oral gavage of the test substance, formulated in 1%w/v aqueous methylcellulose and administered at a dose level of 2.0 g/kg bodyweight. All animals were killed and examined macroscopically on Day15,the end of the observation period.There were no deaths. Clinical signs of reaction to treatment were confined to piloerection,seen in all rats. Recovery was complete in all instances by Day 5.A slightly low bodyweight gain was recorded for one male on Day 15. All other rats achieved satisfactory bodyweight gains throughout the study. No abnormalities were recorded at the macroscopic examination on Day 15.

The acute lethal oral dose to rats of test article was found to be greater than 2.0 g/kg bodyweight.