Registration Dossier

Administrative data

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

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1993
Report Date:
1993

Materials and methods

Test guideline
Qualifier:
according to
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. certificate)
Test type:
standard acute method
Limit test:
yes

Test material

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

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals 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

Administration / exposure

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

Results and discussion

Preliminary study:
In the range-finding study, no mortality or clinical signs of toxicity were observed (only one rat treated with 2000 mg/kg).
Effect levels
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:
Animals appeared normal throughout the study period.
Body weight:
All animals showed expected gain in bodyweight over the study period.
Gross pathology:
No abnormalities were noted at necropsy.
Other findings:
None

Applicant's summary and conclusion

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.