Registration Dossier

Diss Factsheets

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: The study was conducted according to the O.E.C.D. test guideline 402 with GLP compliance.

Data source

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

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

Constituent 1
Chemical structure
Reference substance name:
4,4'-Isopropylidenediphenol, oligomeric reaction products with 1-chloro-2,3-epoxypropane, reaction products with 2-methylimidazole
EC Number:
500-181-0
EC Name:
4,4'-Isopropylidenediphenol, oligomeric reaction products with 1-chloro-2,3-epoxypropane, reaction products with 2-methylimidazole
Cas Number:
68002-42-6
Molecular formula:
(C15H16O2.C4H6N2.C3H5ClO)x
IUPAC Name:
4,4'-Isopropylidenediphenol, oligomeric reaction products with 1-chloro-2,3-epoxypropane, reaction products with 2-methylimidazole
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder
Details on test material:
As per IUCLID5 Sections 1.1. 1.2. 1.4. and 4.1.

Test animals

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 and were weighing approximately 200gm and 9-10 weeks of age. The animals were housed in an animal room with temperature maintained within the range 19-25°C and recorded relative humidity within the range 30-62 % The room was illuminated by fluorescent light to give an artificial cycle of 12 hours light/12 hours dark per day.

Animals were housed singly, in grid-bottomed cages suspended over cardboard lined excreta trays. A pelleted diet (SQC Rat and Mouse Maintenance Diet No. I Expanded, produced by Special Diets Services, Witham, Essex) and mains drinking water in polypropylene bottles were freely available. All animals were acclimatised for 5 days before dosing.

Administration / exposure

Type of coverage:
occlusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
On the day before dosing, an area on the back of each animal, comprising approximately 10% of the total body surface area, was clipped free of hair. On the day of dosing, designated day one, all animals were weighed. A dose of test substance, determined from the individual bodyweight, was spread evenly over a strip of 4 ply thick gauze and was moistened with water to ensure good skin contact. The gauze was then placed on to the prepared skin site so that the test substance was in contact with the skin. The gauze was then covered with a strip of aluminium foil. The trunk of each animal was encircled with a length of 5cm wide non-irritant surgical tape to secure the dressing and foil and the animals were returned to their cages.
Duration of exposure:
24 hr.
Doses:
2000 mf/Kg of body weight.
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
Following the 24 hr occlusive exposure, the dressings were removed and the treated site cleansed with warm water to remove any residual test substance. The animals were examined shortly after dosing and approximately 30 minutes, one, 2 and 4 hours after dosing. Observations including examination of the application site were conducted daily thereafter for a further 14 days. The animals placed on study were weighed on Day one and again on days 8 and 15.

At study termination all animals were weighed and then sacrificed by carbon dioxide asphyxiation at the end of the 15 day observation period. All animals were subject to 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. Abnormal tissues and organs were preserved in neutral buffered formaldehyde but were not processed further.


Statistics:
None conducted.

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
None
Clinical signs:
No adverse clinical signs.
Body weight:
No adverse impact upon body weight gain.
Gross pathology:
No adverse findings.
Other findings:
No evidence of dermal irritation.

Applicant's summary and conclusion

Interpretation of results:
practically nontoxic
Remarks:
Migrated information Criteria used for interpretation of results: expert judgment
Conclusions:
The acute dermal LD50 value for the test substance to the rat was > 2000 mg/Kg of body weight. Therefore, the test substance is not acutelly toxic by the dermal route of exposure.
Executive summary:

The acute dermal toxicty of the test substance, Bisphenol A, epichlorohydrin polymer, 2-methylimidazole condensate, was accessed by an O.E.C.D. test guideline 402 study in the rat. The acute dermal LD50 value for the test substance to the rat was > 2000 mg/Kg of body weight. Therefore, the test substance is not acutelly toxic by the dermal route of exposure.