Registration Dossier

Diss Factsheets

Administrative data

Description of key information

Limit dose (2000 mg/Kg) acute oral and dermal studies were conducted in the rat.  

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:
1996
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: The study was conducted according to the O.E.C.D. test guideline 420 with GLP compliance.
Qualifier:
according to guideline
Guideline:
OECD Guideline 420 (Acute Oral Toxicity - Fixed Dose Method)
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Test type:
fixed dose procedure
Limit test:
yes
Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals or test system and environmental conditions:
The rats were acquired from Charles River (UK) Limited, Margate, Kent. They were 4-6 weeks old and weighing 104-120gm at the start of the study. The animals were maintained in an animal room held at 19-25°C and 30-70% relative humidity. The room was illuminated by fluorescent light to give an artificial cycle of 12 hours lightJl2 hours dark per day.

The animals were housed in groups of up to 5, by sex, in grid-bottomed cages suspended over cardboard lined excreta trays. A pelieted diet (SQC Rat and Mouse Maintenance Diet No. 1 Expanded, produced by Special Diets Services, Witham, Essex) and mains drinking water in polypropylene bottles were freely available. All animals placed on study were acclimatised for at least 5 days before dosing.

Route of administration:
oral: gavage
Vehicle:
corn oil
Remarks:
The test substance was formulated in corn oil at a concentration of 200mg/mL.
Details on oral exposure:
All animals were fasted overnight before dosing. On the day of dosing (designated day one), five animals of each sex were administered as a single dose, by gavage, using a rubber catheter attached to a graded syringe. After dosing, animals were returned to their cages and permitted access to food.

Doses:
2000 mg/Kg
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
Following dosing,the animals were examined within approximately 30 minutes, one, 2 and 4 hours after dosing. Examinations were conducted daily thereafter for a further 14 days. The animals were weighed on days 1, 2, 3, 4, 8 and 15. All animals were weighed and then sacrficed by carbon dioxide asphyxiation at the end of the 15 day observation period. The animals were subject to a gross necropsy, which included the opening of the thoracic and visceral cavities, opening and examination of the stomach and representative sections of the gastro-intestinal tract and examination of the major organs.


Statistics:
No required.
Preliminary study:
No mortality or adverse clinical signs were observed.
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
None
Clinical signs:
other: No adverse clinical signs.
Gross pathology:
No abnormalities were detected.
Interpretation of results:
practically nontoxic
Remarks:
Migrated information Criteria used for interpretation of results: expert judgment
Conclusions:
The test substance is judged to be nontoxic by the acute oral route of exposure.
Executive summary:

The test substance, Bisphenol A, epichlorohydrin polymer, 2-methylimidazole condensate, was accessed for acute oral toxicity to the rat in an O.E.C.D. test guideline 420 study. No mortality or adverse clinical signs were observed at a dose level of 2000 mg/Kg of body weight. Therefore, The test substance is judged to be nontoxic by the acute oral route of exposure

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Quality of whole database:
The findings from this study documented that the rat acute oral LD50 was > 2000 mg/Kg of body weight.

Acute toxicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no study available

Acute toxicity: via dermal route

Endpoint conclusion
Endpoint conclusion:
adverse effect observed
Dose descriptor:
LD50
Quality of whole database:
The rat dermal LD50 value was > 2000 mg/Kg of body weight.

Additional information

The rat acute oral and dermal LD50 values wer determined to be > 2000 mg/Kg of body weight. No moralities occured in either study and no adverse effects were observed.


Justification for selection of acute toxicity – oral endpoint
The study was conducted according to the O.E.C.D. test guideline 420 with GLP compliance.

Justification for selection of acute toxicity – inhalation endpoint
The test substance has no measurable vapor pressure and both acute oral and dermal studies are available.

Justification for selection of acute toxicity – dermal endpoint
The study was conducted according to the O.E.C.D. test guideline 402 with GLP compliance.

Justification for classification or non-classification

Based on the findings of the acute oral and dermal studies no Classification and Labeling is required for acute toxic effects.

Categories Display