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Toxicological information

Acute Toxicity: oral

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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2015
Report Date:
2015

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
GLP compliance:
yes (incl. certificate)
Test type:
acute toxic class method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Diethylaminoethyl Methacrylate
- Physical state: liquid, yellowish, clear
- Analytical purity: approx. 99%
- Lot/batch No.: 8800584

Test animals

Species:
rat
Strain:
Wistar
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source:Charle River Wiga GmbH, Germany
- Age at study initiation: about 8-12 weeks
- Weight at study initiation:animals of comparable weigt (160-250 g) (+/-20%)
- Housing: single housing
- Diet (e.g. ad libitum): VRF1(P); SDS Special Diets Services, 67122 Altrip, Germany
- Water (e.g. ad libitum): Tap water ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 3°C
- Humidity (%): 30 -70
- Photoperiod (hrs dark / hrs light): 12/12 h

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
corn oil
Details on oral exposure:
2000 mg/kg: concentration 40g/100ml (5 ml/kg administration volume) 20% solution in corn oil
Doses:
300, 2000 mg/kg bw
No. of animals per sex per dose:
3
Control animals:
no

Results and discussion

Effect levels
Sex:
female
Dose descriptor:
LD50
Effect level:
> 300 - < 2 000 mL/kg bw
Mortality:
2000 mg/kg: 3/2
300 mg/kg: 3/0
Clinical signs:
In one of the two animals which died in the single 2000 mg/kg bw test group impaired general state was noted at hour 0 which increased to poor general state at hour 1, while the other animal showed poor general state from hour 0 until hour 1. Piloerection was noted in both animals from hour 0 until hour 1. In addition, dyspnoea was seen in these animals at hour 1. Furthermore, cowering position was noted in one of these animals from hour 0 until hour 1, while in the other animal abdominal position was noted at the same reading points. In the single animal that survived in this test group impaired general state and piloerection were noted from hour 0 until hour 5 after administration.
In the first 300 mg/kg bw test group all animals showed impaired general state and piloerection from hour 1 until hour 5 or study day 1, while in the second 300 mg/kg bw test group all animals showed these findings from hour 0 or 1 until hour 5 after administration. Additionally chromodacryorrhea was noted in one animal of the second test group at hour 5 only.
Body weight:
The body weight of the surviving animals increased within the normal range throughout the study period with two exceptions in the first 300 mg/kg bw test group. The body weight of two animals increased within the normal range during the first week, but slightly decreased or stagnated during the second week. This effect is observed at times in the rat strain used, because in the required age range the female animals have already reached the phase of slow growth.
Gross pathology:
In the two animals that died in the 2000 mg/kg bw test group the following macroscopic pathological findings were observed: swollen small intestine, spotted discolored liver, red discoloration of the glandular stomach, congestion of the kidneys and red discoloration of the whole intestine including the appendix.
There were no macroscopic pathological findings in the animals sacrificed at the end of the observation period (2000 mg/kg bw: 1 female; 300 mg/kg: 6 females)

Applicant's summary and conclusion