Registration Dossier

Administrative data

Description of key information

In an acute oral toxicity test the test substance performed according to OECD guideline 423 (BASF SE, 2015) a LD50 value of > 300 < 2000 mg/kg bw was determined. In an acute inhalation toxicity test with the test substance (aerosol) performed similarily to OECD guideline 403 (Haskell Laboratories, 1981) a LC50 of 1.8 mg/L was determined.

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records
Reference
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
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
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
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
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)
Endpoint conclusion
Endpoint conclusion:
adverse effect observed
Dose descriptor:
LD50
Quality of whole database:
GLP guideline study

Acute toxicity: via inhalation route

Link to relevant study records
Reference
Endpoint:
acute toxicity: inhalation
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1981-9-30 - 1981-10-22
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Guideline compliant study.
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 403 (Acute Inhalation Toxicity)
Deviations:
no
GLP compliance:
no
Test type:
standard acute method
Limit test:
no
Species:
rat
Strain:
Crj: CD(SD)
Sex:
male
Details on test animals and environmental conditions:
TEST ANIMALS
- Age at study initiation: 7-8 weeks old
- Weight at study initiation: 230-270 g
- Fasting period before study:
- Housing: housed in pairs in stainless steal wire mesh cages
- Diet: Purino Rodent Chow #5002, ad libitum
- Water: ad libitum
- Acclimation period: 1 week
Route of administration:
inhalation: aerosol
Type of inhalation exposure:
whole body
Vehicle:
air
Details on inhalation exposure:
GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure apparatus:
- Exposure chamber volume:
- Method of holding animals in test chamber:
- Source and rate of air:
- Method of conditioning air:
- System of generating particulates/aerosols:

TEST ATMOSPHERE
- Brief description of analytical method used:
- Samples taken from breathing zone: yes
Analytical verification of test atmosphere concentrations:
yes
Duration of exposure:
4 h
Concentrations:
0.4, 0.7, 1.1, 1.4, 1.8 mg/L
No. of animals per sex per dose:
10 male animals per dose
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
Sex:
male
Dose descriptor:
LC50
Effect level:
1.8 mg/L air
Based on:
test mat.
Exp. duration:
4 h
Mortality:
At concentrations groups 0.4 - 1.8 no mortality occurred. At the highest dose group, 1.8 mg/L, 7 out of 10 animals died.
Clinical signs:
During exposure: All rats exhibited a clear nasal and oral discharge. Rats exposed exposed to 0.7 mg/L or greater exhibited hyperplasia of the extremities. Rats exposed to 1.1. mg/L or greater exhibited labored breathing, sporadic tremors, and convulsions.
Post exposure: Rats exposed to 0.7 mg/L exhibited a clear nasal and oral discharge. At higher concentrations, rats exhibited red nasal discharge, labored breathing, lung noise, wet perineus and cloudy eyes lasting 4 – 14 days post exposure. Severity and persistence of symptoms were proportional to exposure concentration.
Body weight:
Rats exposed to 0.4 mg/L exhibited slight weight loss but showed no adverse clinical signs. Rats exposed to higher concentrations exhibited slight to severe weight loss lasting 1 to 4 days post exposure, followed by the resumption of a normal rate of weight gain.
Gross pathology:
No data

An approximate lethal concentration of 1.8 mg/L was determined for the test substance.

Endpoint conclusion
Endpoint conclusion:
adverse effect observed
Dose descriptor:
LC50
1 800 mg/m³
Quality of whole database:
Scientifically reliable study.

Acute toxicity: via dermal route

Link to relevant study records
Reference
Endpoint:
acute toxicity: dermal
Data waiving:
other justification
Justification for data waiving:
other:
Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Acute toxicity oral

In an acute oral toxicity study performed according to the Acute Toxic Class method, doses of 2000 and 300 mg/kg bw of the test item Diethylaminoethyl Methacrylate (preparations in corn oil (20% of the test substance) were administered by gavage to three test groups of three fasted Wistar rats each (2000 mg/kg bw in 3 females, 300 mg/kg bw in 6 females). At 2000 mg/kg bw 2 of 3 animals died, at 300 mg/kg bw all animals survived. The acute oral LD50 was calculated to be LD50, oral, rat > 300 < 2000 mg/kg bw (BASF SE, 2015).

Supporting study

A single dose oral toxicity test with a read-across (RA) substance was performed according to OECD guideline 401. The RA test substance in corn oil was administered (gavage) in concentrations of 500, 100 and 2000 mg/kg bw to 5 males and 5 females rats per dose group. No mortality occurred in any of the treated groups. At necropsy, raised patches in the forestomach were observed in males of the 2000 mg/kg group. In the histopathological examination papiflomatous hyperplasia in the forestomnach was apparent. A LD50 value of > 2000 mg/kg bw was determined.

Acute toxicity inhalation

Groups of 10 male rats were exposed (whole body) to aerosol of the test substance for 4 hours in concentrations of 0.4, 0.7, 1.1, 1.4, 1.8 mg/L.

At concentrations groups 0.4 - 1.8 no mortality occurred. At the highest dose group, 1.8 mg/L, 7 out of 10 animals died.

During exposure: All rats exhibited a clear nasal and oral discharge. Rats exposed exposed to 0.7 mg/L or greater exhibited hyperplasia of the extremities. Rats exposed to 1.1. mg/L or greater exhibited labored breathing, sporadic tremors, and convulsions.

Post exposure: Rats exposed to 0.4 mg/L exhibited slight weight loss but showed no adverse clinical signs. Rats exposed to higher concentrations exhibited slight to severe weight loss lasting 1 to 4 days post exposure, followed by the resumption of a normal rate of weight gain. Rats exposed to 0.7 mg/L exhibited a clear nasal and oral discharge. At higher concentrations, rats exhibited red nasal discharge, labored breathing, lung noise, and cloudy eyes lasting 4 – 14 days post exposure. Severity and persistence of symptoms were proportional to exposure concentration.

Under the study conditions, an approximate lethal concentration of 1.8 mg/L was determined for the test substance.


Justification for selection of acute toxicity – oral endpoint
GLP guideline study

Justification for selection of acute toxicity – inhalation endpoint
The only available reliable study, performed similarly to an OECD guideline study.

Justification for classification or non-classification

Dangerous Substance Directive (67/548/EEC)

The available studies were considered reliable and suitable for classification purposes under 67/548/EEC. As a result the substance is considered to be classified as Xn; R20/22 under Directive 67/548/EEC, as amended for the 31st time in Directive 2009/2/EG.

 

Classification, Labelling, and Packaging Regulation (EC) No 1272/2008

The available experimental test data are reliable and suitable for classification purposes under Regulation 1272/2008. As a result the substance is considered to be classified as acute Tox. 4; H302: Harmful if swallowed. and Acute Tox. 4; H332: Harmful if inhaled under Regulation (EC) No. 1272/2008, as amended for the sixth time in Regulation EC 605/2014.