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EC number: 500-130-2 | CAS number: 55818-57-0
- Life Cycle description
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- Endpoint summary
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- Endpoint summary
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- Environmental data
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- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
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- Additional toxicological data

Endpoint summary
Administrative data
Description of key information
Two studies are available to evaluate the acute toxicity of DGEBA diacrylate.
By oral and dermal routes, no mortality or severe clinical signs were observed in rats treated with 2000 mg/kg of DGEBA diacrylate.
No study by inhalation is available.
Key value for chemical safety assessment
Acute toxicity: via oral route
Link to relevant study records
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From June 16 to July 08, 1992
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Deviations:
- yes
- Remarks:
- no data about purity and no certificate of analysis of the test substance
- Principles of method if other than guideline:
- Not applicable
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- standard acute method
- Limit test:
- yes
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River (UK) Ltd., Manston, UK
- Age at study initiation: 5-8 weeks
- Weight at study initiation: Males: 142-174 g, females: 134-155 g
- Fasting period before study: Overnight
- Housing: Housed in groups of five by sex in solid-floor polypropylene cages with sawdust bedding
- Diet (e.g. ad libitum): Food (Rat and Mouse Expanded Diet No. 1, Special Diet Services Limited, Witham, UK), ad libitum
- Water (e.g. ad libitum): Mains drinking water, ad libitum
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-23 °C
- Humidity (%): 47-75%
- Air changes (per hour): 15/hour
- Photoperiod (hours dark / hours light): 12 hours dark / 12 hours light - Route of administration:
- oral: gavage
- Vehicle:
- arachis oil
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 200 mg/mL
- Amount of vehicle (if gavage): 10 mL/kg
DOSAGE PREPARATION (if unusual): Test material was freshly prepared as a suspension in arachis oil B.P. The preparation was heated to approximately 70 °C in water to ensure adequate mixing and allowed to cool before dosing.
CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: Dose was selected based on a range-finding study conducted on 1 rat/sex/dose at 2000 mg/kg bw and animals were observed for 5 days. - Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 5
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Deaths and overt signs of toxicity were recorded at 0.5, 1, 2 and 4 hours after dosing and subsequently once daily for 14 days; individual bodyweights were recorded on Day 0 (prior to dosing), 7 and 14
- Necropsy of survivors performed: Yes; surviving animals were killed by cervical dislocation and examined grossly - Statistics:
- No
- Preliminary study:
- In the range-finding study, no mortality or clinical signs of toxicity were observed (only one rat treated with 2000 mg/kg).
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD0
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- not determinable due to absence of adverse toxic effects
- Mortality:
- No deaths were observed .
- Clinical signs:
- other: Animals appeared normal throughout the study period.
- Gross pathology:
- No abnormalities were noted at necropsy.
- Other findings:
- None
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The oral LD50 for DGEBA diacrylate is higher than 2000 mg/kg bw in rats therefore it is not classified for oral acute toxicity.
- Executive summary:
In an acute oral toxicity (limit test) study performed in accordance with GLP and OECD guideline 401, groups (5/sex) of Sprague-Dawley rats were given a single oral dose of DGEBA diacrylate in arachis oil at 2000 mg/kg bw. Animals were then observed for mortality, clinical signs and bodyweights for 14 days and were all macroscopically necropsied after sacrifice. A preliminary range-finding test was also conducted on 1 rat/sex/dose at 2000 mg/kg bw and animals were observed for 5 days. In this previous test, no mortality or clinical signs of toxicity were observed.
In the main study, no deaths were observed and animals appeared normal throughout the study period. All animals showed expected gain in bodyweight over the study period. No abnormalities were noted at necropsy. The combined oral LD50 was considered to be greater than 2000 mg/kg bw.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- discriminating dose
- Value:
- 2 000 mg/kg bw
- Quality of whole database:
- The oral acute study is considered as reliable; the test was performed with the OECD guidelines (401).
Acute toxicity: via inhalation route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Acute toxicity: via dermal route
Link to relevant study records
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 04 June 2014 -- 04 July 2014
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.3 (Acute Toxicity (Dermal))
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- standard acute method
- Limit test:
- yes
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: breeder: Janvier, Le Genest-Saint-Isle, France.
- Age at study initiation: approximately 8 weeks old on the day of treatment
- Mean body weight at study initiation: within ± 20% of the mean body weight of all the study animals of the same sex (245 g for females and 412 g for males).
- Fasting period before study: No
- Housing: polycarbonate cages with stainless steel lids
- Diet: SSNIFF R/M-H pelleted diet (free access)
- Water: tap water filtered with a 0.22 µm filter (free access)
- Acclimation period: at least 5 days before the beginning of the study
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 2°C
- Humidity (%): 50 ± 20%
- Air changes (per hr): approximately 12 cycles/hour of filtered, non-recycled air
- Photoperiod (hrs dark / hrs light): 12 h/12 h
IN-LIFE DATES: 17 June 2014 to 04 July 2014 - Type of coverage:
- semiocclusive
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- TEST SITE
- Area of exposure: 10% of body surface, dorsal site
- Type of wrap if used: hydrophilic gauze pad + adhesive hypoallergenic aerated semi-occlusive dressing + restraining bandage
REMOVAL OF TEST SUBSTANCE
- Removal of dressing: 24h post-exposure
- Washing: at 24h post-exposure, with a moistened cotton pad with acetone and then water for injection
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2000 mg/kg
- Constant volume: no
- For solids, paste formed: yes - Duration of exposure:
- 24 hr
- Doses:
- 2000 mg/kg
- No. of animals per sex per dose:
- ten rats (five males + five nulliparous and non pregnant females)
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Clinical observations: frequently during the hours following treatment; then, at least once a day.
- Body weight: just before treatment, on day 1; then on days 8 and 15.
- Necropsy of survivors performed: yes (macroscopic). - Statistics:
- no
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD0
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- not determinable due to absence of adverse toxic effects
- Mortality:
- No mortality was observed in any animals.
- Clinical signs:
- other: No clinical signs indicative of systemic toxicity were observed in any animals. No cutaneous reactions were observed in any males. A very slight to well defined erythema at the application site was noted in all females from Day 2, 3 or 4 until Day 14 at t
- Gross pathology:
- There were no test item-related gross findings.
The irregular color noted in the lungs from 3/5 males treated at 2000 mg/kg/day was considered to be most probably unrelated with test item administration since this was not seen in females, and since this finding is occasionally seen in untreated rats of these strain, age, and supplier. - Other findings:
- no
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the experimental conditions of this study, the dermal LD50 of the test item was higher than 2000 mg/kg in rats.
- Executive summary:
The objective of this study was to evaluate the potential toxicity of the test item following a single dermal application to rats.
This study was based on the international guidelines (OECD No. 402 and Council Regulation No. 440/2008 of 30 May 2008, Part B.3) and was performed in compliance with the principles of Good Laboratory Practice.
Methods
The test item was applied in its original form to the skin of five female then five male Sprague-Dawley rats at the dose-level of 2000 mg/kg. The application site was covered by a semi-occlusive dressing for 24 hours.
Each animal was observed at least once a day for mortality and clinical signs for 15 days. From Day 2, any local reactions at the treatment site were also noted. Body weight was recorded on Day 1 and then on Days 8 and 15.
On completion of the observation period, the animals were sacrificed and then submitted for a macroscopic post-mortem examination. Macroscopic lesions were preserved in buffered formalin then destroyed at the finalization of the study report as no microscopic examination was performed.
Results
No unscheduled deaths occurred during the study.
No clinical signs indicative of systemic toxicity were observed in any animals.
No cutaneous reactions were observed in any males.
A very slight to well-defined erythema at the application site was noted in all females from Day 2, 3 or 4 until Day 14 at the latest along with dryness of the skin in 4/5 females from Day 4 until Day 14 at the latest. Scabs were noted in 3/5 females from Day 3 to Day 11 and wound in 1/5 females from Day 4 to Day 7.
When compared to historical control data, lower body weight gain was noted in 3/5 females between Day 1 and Day 8; and in 1/5 other females between Day 8 and Day 15. Over the period from Day 1 to Day 15, 4/5 females had a lower body weight gain when compared to historical control data.
A lower body weight gain was also noted in 3/5 males between Day 8 and Day 15 and over the study period when compared to historical control data. However, the body weight of test-item treated males on Day 1 was significantly higher than the body weight of males in historical control data. This could explain that the body weight gain of test item-treated males was lowered in some animals.
The body weights of the other animals were unaffected by the test item treatment.
There were no test item-related gross findings.
Conclusion
Under the experimental conditions of this study, the dermal LD50 of the test item was higher than 2000 mg/kg in rats.
Therefore, the test item should not be classified as toxic by dermal route according to the criteria of CLP Regulation.
Reference
Table 1.
Sex |
Female |
Male |
||
Group |
Historical control data |
1 |
Historical control data |
2 |
Dose-level (mg/kg) |
0 |
2000 |
0 |
2000 |
Body weight (mean (± SD)) |
|
|
|
|
. Day 1 |
217 (± 10.3) |
215 (± 7.6) |
333 (± 10.3) |
412 (± 15.8) |
. Day 8 |
242 (± 10.6) |
229 (± 7.1) |
372 (± 9.5) |
450 (± 16.5) |
. Day 15 |
269 (± 13.0) |
245 (± 6.2) |
422 (± 12.6) |
485 (± 25.5) |
Body weight change (mean (± SD)) |
|
|
|
|
. Days 1-8 |
+25 (± 10.0) |
14 (± 2.2) |
+39 (± 11.5) |
37 (± 4.8) |
. Days 8-15 |
+27 (± 11.1) |
17 (± 8.9) |
+50 (± 12.0) |
35 (± 10.5) |
. Days 1-15 |
+52 (± 12.9) |
31 (± 8.5) |
+89 (± 12.8) |
72 (± 12.3) |
SD: standard deviations.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- discriminating dose
- Value:
- 2 000 mg/kg bw
- Quality of whole database:
- The dermal acute study is considered as reliable; the test was performed with the OECD guidelines (402).
Additional information
Oral acute toxicity study (Walker 1993):
In an acute oral toxicity (limit test) study performed in accordance with GLP and OECD guideline 401, groups (5/sex) of Sprague-Dawley rats were given a single oral dose of DGEBA diacrylate in arachis oil at 2000 mg/kg bw. Animals were then observed for mortality, clinical signs and bodyweights for 14 days and were all macroscopically necropsied after sacrifice. A preliminary range-finding test was also conducted on 1 rat/sex/dose at 2000 mg/kg bw and animals were observed for 5 days. In this previous test, no mortality or clinical signs of toxicity were observed.
In the main study, no deaths were observed and animals appeared normal throughout the study period. All animals showed expected gain in bodyweight over the study period. No abnormalities were noted at necropsy. The combined oral LD50 was considered to be greater than 2000 mg/kg bw.
Dermal acute toxicity study (Modeste 2014):
The objective of this study was to evaluate the potential toxicity of the test item following a single dermal application to rats (OECD 402). The test item was applied in its original form to the skin of five female then five male Sprague-Dawley rats at the dose-level of 2000 mg/kg. The application site was covered by a semi-occlusive dressing for 24 hours. No unscheduled deaths occurred during the study.
No clinical signs indicative of systemic toxicity were observed in any animals. No cutaneous reactions were observed in any males. A very slight to well-defined erythema at the application site was noted in all females from Day 2, 3 or 4 until Day 14 at the latest along with dryness of the skin in 4/5 females from Day 4 until Day 14 at the latest. Scabs were noted in 3/5 females from Day 3 to Day 11 and wound in 1/5 females from Day 4 to Day 7.
When compared to historical control data, lower body weight gain was noted in 3/5 females between Day 1 and Day 8; and in 1/5 other females between Day 8 and Day 15. Over the period from Day 1 to Day 15, 4/5 females had a lower body weight gain when compared to historical control data.
A lower body weight gain was also noted in 3/5 males between Day 8 and Day 15 and over the study period when compared to historical control data. However, the body weight of test-item treated males on Day 1 was significantly higher than the body weight of males in historical control data. This could explain that the body weight gain of test item-treated males was lowered in some animals. The body weights of the other animals were unaffected by the test item treatment. There were no test item-related gross findings.
Under the experimental conditions of this study, the dermal LD50 of the test item was higher than 2000 mg/kg in rats.
Justification for classification or non-classification
Based on the available data, DGEBA diacrylate is not classified for acute toxicity according to the CLP Regulation (EC) N° (1272-2008).
Justification : oral and dermal LD50 were higher than 2000 mg/kg bw in rats.
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