Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2006

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 420 (Acute Oral Toxicity - Fixed Dose Method)
Deviations:
no
GLP compliance:
no
Test type:
fixed dose procedure
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
liquid: viscous

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).