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Administrative data

Description of key information

The oral and dermal LD50 values were greater than the highest doses tested.

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records

Referenceopen allclose all

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
not stated
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: The study was not conducted according to guideline/s and GLP but the report contains sufficient data for interpretation of study results
Reason / purpose:
reference to same study
Reason / purpose:
reference to other study
Qualifier:
no guideline followed
Principles of method if other than guideline:
Rabbits were orally gavaged with test material and observed for 10 days. Survivors were sacrificed and necropsied with selected tissues saved for histopathologic examination.
GLP compliance:
no
Test type:
standard acute method
Limit test:
no
Species:
rabbit
Strain:
other: albino
Sex:
male
Details on test animals and environmental conditions:
male albino rabbits (2.0-3.2 kg).
Route of administration:
oral: gavage
Vehicle:
acetone
Details on oral exposure:
Single intragastric administrations were given to male albino rabbits (2.0-3.2 kg). Due to high viscosity, EPON 828 was delivered as a 95% solution with 5% acetone.
Doses:
No additional information provided.
No. of animals per sex per dose:
No additional information provided.
Control animals:
not specified
Details on study design:
Single intragastric administrations were given to male albino rabbits (2.0-3.2 kg). Due to high viscosity, EPON 828 was delivered as a 95% solution with 5% acetone. The animals were observed for the following 10 days, and survivors were necropsied. Sections of tissues were preserved in formalin for histologic examination. LD50 values were calculated according to the method of Litchfield and Wilcoxon (1948) or the method of Weil (1952).

Litchfield, J. T., Jr., and Wilcoxon, F.; A Simplified Method of Evaluating Dose-Effect Experiments, J Pharmacol. & Exper. Therap. 96:99-113, 1949.

Weil, C. S.: Tables for Convenient Calculation of Median Effective Dose and Instructions for Their Use, Biometrics, 8:249-263, 1952.
Statistics:
LD50 values were calculated according to the method of Litchfield and Wilcoxon (1948) or the method of Weil (1952).

Litchfield, J. T., Jr., and Wilcoxon, F.; A Simplified Method of Evaluating Dose-Effect Experiments, J Pharmacol. & Exper. Therap. 96:99-113, 1949.

Weil, C. S.: Tables for Convenient Calculation of Median Effective Dose and Instructions for Their Use, Biometrics, 8:249-263, 1952.
Preliminary study:
No preliminary study conducted.
Sex:
male
Dose descriptor:
LD50
Effect level:
19 800 mg/kg bw
Remarks on result:
other: Given 95% EPON 828 in 5% acetone.
Mortality:
no data
Clinical signs:
no data
Body weight:
no data
Gross pathology:
Gross pathology was nonspecific, and the chief effect was that of local irritation.
Other findings:
The LD50 was reported to be 19,800 mg/kg. There are no specific observations or findings noted for EPON 828.

The LD50 was reported to be 19,800 mg/kg. There are no specific observations or findings noted for EPON 828.

Interpretation of results:
Category 5 based on GHS criteria
Remarks:
Migrated information
Conclusions:
The LD50 in male rabbits given 95% EPON 828 in 5% acetone was reported to be 19,800 mg/kg .
Executive summary:

The LD50 in male rabbits given 95% EPON 828 in 5% acetone was reported to be 19,800 mg/kg .

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
not specified
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: The study was not conducted according to guideline/s and GLP but the report contains sufficient data for interpretation of study results
Reason / purpose:
reference to same study
Reason / purpose:
reference to other study
Qualifier:
no guideline followed
Principles of method if other than guideline:
Rats were orally gavaged and followed for 14 days. After 14 days, survivors were sacrificed and selected tissues examined grossly.
GLP compliance:
no
Test type:
standard acute method
Limit test:
no
Species:
rat
Strain:
Long-Evans
Sex:
male
Details on test animals and environmental conditions:
Following a 14-day acclimation period, male rats weighing 150 -300 g were fasted overnight and gavaged with test material.
Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Details on oral exposure:
Six rats were dosed at 10 and 15 g/kg and 3 rats were dosed at 1 and 5 g/kg. Rats were observed for 14 days at which time they were sacrificed and the following tissues were examined grossly: eyes, heart, lungs, spleen, liver, kidneys, bladder, gonads, stomach, small intestine, large intestine, and skin.
Doses:
1, 5, 10, 15 g/kg
No. of animals per sex per dose:
6 male rats at 10 or 15 g/kg
3 male rats at 1 or 5 g/kg
Control animals:
not specified
Details on study design:
Following a 14-day acclimation period, rats were fasted overnight and gavaged with test material. Six rats were dosed at 10 and 15 g/kg and 3 rats were dosed at 1 and 5 g/kg. Rats were observed for 14 days at which time they were sacrificed and the following tissues were examined grossly: eyes, heart, lungs, spleen, liver, kidneys, bladder, gonads, stomach, small intestine, large intestine, and skin.
Statistics:
No additional information provided.
Preliminary study:
No preliminary study conducted
Sex:
male
Dose descriptor:
LD50
Effect level:
> 15 000 mg/kg bw
Remarks on result:
other: No mortality observed at 15000 mg/kg.
Mortality:
There was no mortality up to doses of 15 g/kg.
Clinical signs:
No additional information provided.
Body weight:
No additional information provided.
Gross pathology:
No abnormalities were seen at necropsy.
Other findings:
No additional information provided.

The acute oral LD50 in rats is >15,000 mg/kg.

Interpretation of results:
Category 5 based on GHS criteria
Remarks:
Migrated information
Conclusions:
The rat LD50 is >15000 mg/kg bw.
Executive summary:

Groups of male rats were orally dosed with up to 15,000 mg/kg with no mortality observed. The rat LD50 is >15000 mg/kg bw.

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
Qualifier:
according to
Guideline:
OECD Guideline 420 (Acute Oral Toxicity - Fixed Dose Method)
Deviations:
no
GLP compliance:
yes
Test type:
fixed dose procedure
Limit test:
yes
Species:
rat
Strain:
Wistar
Sex:
female
Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Doses:
2000 mg/kg
No. of animals per sex per dose:
5
Control animals:
no
Sex:
female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw

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.

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).

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
15 000 mg/kg bw

Acute toxicity: via dermal route

Link to relevant study records

Referenceopen allclose all

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
not specified
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: The study was not conducted according to guideline/s and GLP but the report contains sufficient data for interpretation of study results
Reason / purpose:
reference to same study
Reason / purpose:
reference to other study
Qualifier:
no guideline followed
Principles of method if other than guideline:
Acute study followed the method of Draize.

Draize, J.H., G. Woodard, and H.O. Calveri.: Methods for Study of Irritation and Toxicity of Substances Applied Topically to the Skin and Mucous Membranes. J. Pharmacol. Exp. Therap. 82:377-390
GLP compliance:
no
Test type:
standard acute method
Limit test:
no
Species:
rabbit
Strain:
New Zealand White
Sex:
male
Details on test animals and environmental conditions:
Male albino New Zealand rabbits, 3 to 5 months of age and averaging 2.5 kg. in weight were immobilized during the 24-hour skin contact period. Thereafter, the VINYLITE sheeting used to retain the dose in contact with the clipped skin of the trunk was removed and the animals were caged for the remainder of the 14-day observation period. The rabbits were procured locally and maintained on Rockland rabbit ration.
Type of coverage:
occlusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
The fur was removed from the entire trunk by clipping, and the dose was retained beneath an impervious sheeting.
Duration of exposure:
24 hour
Doses:
up to 20ml/kg
No. of animals per sex per dose:
4 male rabbits/dose
Control animals:
not specified
Details on study design:
Penetration of rabbit skin is estimated by a technique resembling a one-day cuff method of Draize, using groups of 4 male albino rabbits weighing 2.5 kg. The fur was removed from the entire trunk by clipping, and the dose was retained beneath an impervious sheeting. Doses greater than 20 ml/kg could not be retained in contact with the skin. The animals were immobilized for the 24-hour period, after which the film is removed and the rabbits were caged for the subsequent 14-day observation period. The LD50 was then calculated using the method of Thompson.
Statistics:
The LD50 was then calculated using the method of Thompson.

Thompson, W. R.: Use of Moving Averages and Interpolation to Estimate Median Effective Dose. Bacterial Rev. 11:115 (June 1947).
Preliminary study:
No preliminary study conducted.
Sex:
male
Dose descriptor:
LD50
Effect level:
> 20 mL/kg bw
Remarks on result:
other: Dose was calculated to be 23,032 mg/kg from the reported dose of 20 mL/kg and density of 1.1516 g/mL.
Mortality:
No additional information provided.
Clinical signs:
No additional information provided.
Body weight:
No additional information provided.
Gross pathology:
No additional information provided.
Other findings:
Results were reported only as the LD50 > 20 mL/kg.

Dose was calculated to be 23,032 mg/kg from the reported dose of 20 mL/kg and density of 1.1516 g/mL.

A group of 4 rabbits survived the dose applied undiluted. The dose was the maximum amount of fluid that could be retained in contact with the skin beneath the sheeting. There was no indication of skin condition following the exposure.

No additional information provided.

Interpretation of results:
Category 4 based on GHS criteria
Remarks:
Migrated information
Conclusions:
The dermal LD50 in rabbits is >20 ml/kg bw (23,000 mg/kg).
Executive summary:

Groups of 4 rabbits were dermally administered volumes of test material as high as 20 ml/kg bw. The dermal LD50 was >20 ml/kg (equivalent to approximately 23,000 mg/kg).

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
20 December 2006 to 3 January 2007
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Guideline study conducted under GLP
Qualifier:
according to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.3 (Acute Toxicity (Dermal))
Deviations:
no
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes
Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals and environmental conditions:
Five 9-week-old male rats with the average body weight of 297 g and five 9-week-old females with the average body weight of 180 g were used in the experiment.
During quarantine and experiment the animals were kept in air-conditioned rooms with the following parameters:
-temperature: 19 - 22 °C;
-relative air humidity: 45 - 70%;
-artificial, fluorescent lighting: 12 hours light / 12 hours darkness.
The animals were kept in cages with plastic bottom and wired lid, with dimensions: (length x width x height) 58 x 37 x 21 cm. Following administration of the test material on animals skin, each one was kept individually per cage. After removal of the test material from animals skin, during the following days of experiment the rats were kept five per cage, each sex separately.
Wooden UV-sterilized shavings were used as a litter. Each cage was equipped with label containing information on name of test material, study code, used dose, start date and planned ending date of the experiment, animal sex and animal numbers.
Type of coverage:
occlusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
The undiluted test material was applied to the dorsal skin of 10 rats (5 males and 5 females) in dose of 2000 mg/kg b.w. The area of skin treated with the test material was about 6 cm2. The test material was applied to gauze patches and then laid on the prepared skin. The gauze patches were covered with PCV foil and elastic bandage was used to make circular protecting band. After 24 hours the band and gauze patches were taken off and the residual test material was removed using water.
Duration of exposure:
24 hours
Doses:
2000 mg/kg
No. of animals per sex per dose:
5
Control animals:
not required
Details on study design:
Clinical observations comprised of evaluation of general condition of animals as well as detailed clinical observations. Evaluation of general condition of animals, i.e. observation of all animals in regards to mortality and morbidity was conducted twice a day during 14-day observation period. Following administration of the test material, detailed clinical observations were performed in hour intervals during the day of administration
(day 0). Since the first till the 14th day of observation period detailed clinical observations were performed once a day.
Body weight of animals was determined individually for each animal directly before administration of the test material (day 0) and then on seventh and fourteenth day - before the finishing of the experiment.
All animals were euthanized after 14-days observation period by peritoneal administration of sodium pentobarbital and then dissected. After opening of thorax and abdomen macroscopic examination of internal organs was performed.
Statistics:
None performed.
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Mortality:
All rats survived the 14-day observation period.
Clinical signs:
During 14-day observation period no changes on animals skin or in animals behavior were observed.
Body weight:
All animals showed normal body weight gain.
Gross pathology:
During the macroscopic studies no pathological changes in both males and females were noticed.
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 dermal acute dose (LD50) for Epidian 6 – epoxy resin with an average molecular mass<= 700 is higher than 2000 mg/kg b.w.
Executive summary:

Acute dermal toxicity study of Epidian 6 – epoxy resin with an average molecular mass < 700 to 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 were OECD Guideline for Testing of Chemicals No 402/EU Method B.3 as well as Principles of Good Laboratory Principles (GLP - OECD, 1997).

The test material was given to 10 rats (5 males and 5 females) to shaved skin of the back in single dose of 2000 mg/kg b.w. for 24 hours. Following administration of the test material no pathological changes in test animals were stated. All rats survived the

observation period.

All animals which were euthanized after 14-day observation period were dissected and studied macroscopically. During macroscopic examination no pathological changes in both males and females were observed.

Taking into account the obtained results one may say that median dermal acute dose (LD50) for Epidian 6 – epoxy resin with an average molecular mass < 700 is higher than 2000 mg/kg b.w.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
23 000 mg/kg bw

Additional information

The oral and dermal LD50 values are greater than 15,000 and 23,000 mg/kg, respectively, for studies conducted prior to 1982. More recent studies were conducted at much lower doses with no treatment-related effects reported. The inhalation LC0 value was 0.000008 ppm with no treatment-related deaths reported when testing under a saturated vapor concentration.

Justification for classification or non-classification

As per Guidance to Regulation (EC) No. 1272/2008 on classification, labelling and packaging (CLP) of substances and mixtures, BADGE will not be classified for acute oral, dermal, or inhalation toxicity.