Reaction mass of 4,4'-Isopropylidenediphenol, oligomeric reaction products with 1-chloro-2,3-epoxypropane and Orthophosphoric acid, oligomeric reaction products with 4,4'-isopropylidenediphenol -1-chloro-2,3-epoxypropane co-oligomer

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

11/2006-12/2006

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Guideline GLP study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2007

Report date:

2007

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

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

Deviations:

no

GLP compliance:

yes

Test type:

fixed dose procedure

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

4,4'-Isopropylidenediphenol, oligomeric reaction products with 1-chloro-2,3-epoxypropane

EC Number:

500-033-5

EC Name:

4,4'-Isopropylidenediphenol, oligomeric reaction products with 1-chloro-2,3-epoxypropane

Cas Number:

25068-38-6

Molecular formula:

(C15 H16 O2 . C3 H5 Cl O)x

IUPAC Name:

4,4'-Isopropylidenediphenol, oligomeric reaction products with 1-chloro-2,3-epoxypropane

Test animals

Species:

rat

Strain:

Wistar

Sex:

female

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Doses:

2000 mg/kg

No. of animals per sex per dose:

5

Control animals:

no

Results and discussion

Effect levels

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Any other information on results incl. tables

Following administration of the test material in dose 2000 mg/kg b.w. to one female (the sighting study) no signs of toxicity were noticed during the 14-day observation period. The female survived 14-day observation period. Following administration of the test material in dose 2000 mg/kg b.w. to the next four females (the main study), no signs of toxicity were noticed during 14-day observation period. All females survived the 14-day observation period.

Following the first week of experiment the body weight gain was normal. During the second week of experiment, except for the female No 4, the body weight gain was minimal or was not observed at all.

During the macroscopic examination of the test animals no pathological changes were noticed.

Applicant's summary and conclusion

Interpretation of results:

practically nontoxic

Remarks:

Migrated information Criteria used for interpretation of results: OECD GHS

Conclusions:

Taking into account the obtained results, one may say that the median oral acute
dose (LD50) for Epidian 6 – epoxy resin with an average molecular mass , 700 is
higher than 2000 mg/kg b.w.
The test material Epidian 6 – epoxy resin with an average molecular mass , 700
can be classified as:
- category 5 /nonclassified/ – according to the Globally Harmonized System (GHS)
- category U – according to the EU Scheme for transition period for full
implementation of the Globally Harmonized System (GHS).

Executive summary:

Acute oral toxicity study of Epidian 6 – epoxy resin with an average molecular mass , 700 for rats was performed according to the agreement with Zakłady Chemiczne "ORGANIKA – SARZYNA" S.A., Nowa Sarzyna. The study was coded OS-29/06. The methodological basis was the OECD Guideline for Testing of Chemicals No 420/EU Method B.1 BIS as well as Good Laboratory Practice Principles (GLPOECD, 1997). Following single administration of the test material in dose of 2000 mg/kg b.w. to one female, no signs of toxicity were noticed during 14-day observation period. The female survived 14-day observation period. Following administration of the test material in dose of 2000 mg/kg b.w. to the next four females, no signs of toxicity were noticed during 14-day observation period. All females survived the 14-day observation period. All animals were euthanized after 14-day observation period, dissected and examined macroscopically. The test animals did not show any pathological changes. Taking into account the obtained results, one may say that the median oral acute dose (LD50) for Epidian 6 – epoxy resin with an average molecular mass , 700 is higher than 2000 mg/kg b.w. The test material Epidian 6 – epoxy resin with an average molecular mass , 700 can be classified as: - category 5 /nonclassified/ – according to the Globally Harmonized System (GHS) - category U – according to the EU Scheme for transition period for full implementation of the Globally Harmonized System (GHS).