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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:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Basic data given. Only animals who died during the observation period were necropsied. Lack of data on test substance (no analytical purity).

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1980
Report date:
1980

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
yes
Remarks:
only dead animals were necropsied; no histopathology
GLP compliance:
no
Test type:
standard acute method
Limit test:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
2-methoxyethyl acrylate
EC Number:
221-499-3
EC Name:
2-methoxyethyl acrylate
Cas Number:
3121-61-7
Molecular formula:
C6H10O3
IUPAC Name:
2-methoxyethyl acrylate
Details on test material:
- Name of test material (as cited in study report): Sipomer MCA
- Physical state: clear liquid
- Analytical purity: no data
- Lot No.: E169H8
- Density: 1.01 g/cm³

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Taconic Farms
- Weight at study initiation: 200-300 g
- Fasting period before study: 18 h
- Housing: during the test period the animals were housed individually in stainless steel wire bottomed cages.
- Diet: Fisher Rat Chow; ad libitum
- Water: ad libitum
- Acclimation period: at least 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20.0-22.2
- Humidity (%): 45-55
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Details on oral exposure:
DOSAGE PREPARATION: 1.0 mL test material was diluted to 10.0 mL with water.

MAXIMUM DOSE VOLUME APPLIED: 0.6 mL/kg bw

Doses:
0.25 mL/kg bw corresponding to 252.5 mg/kg bw
0.35 mL/kg bw corresponding to 353.5 mg/kg bw
0.50 mL/kg bw corresponding to 505.0 mg/kg bw
0.55 mL/kg bw corresponding to 555.5 mg/kg bw
0.60 mL/kg bw corresponding to 606.0 mg/kg bw

Based on the density of Sipomer MCA: 1.01 g/cm³
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: daily
- Frequency of weighing: after fasting; surviving animals were weighed at the end of the 14-day observation period.
- Necropsy of survivors performed: no
- Other examinations performed: clinical signs
Statistics:
The defined oral LD50 was calculated by the Litchfield-Wilcoxin method of Probit Analysis (J. Pharmacology and Experimental Therapeutics 96: 99-115, 1949).

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
404 mg/kg bw
Based on:
test mat.
95% CL:
343.4 - 464.6
Mortality:
252.5 mg/kg bw: no animals died
353.5 mg/kg bw: 2 males and 2 females died
505.0 mg/kg bw: 2 males and 3 females died
555.5 mg/kg bw: 4 males and 4 females died
606.0 mg/kg bw: 5 males and 5 females died
Clinical signs:
other: No clinical signs were noted.
Gross pathology:
Necropsy revealed pulmonary haemorrhages (only dead animals were necropsied). Incidences:
353.5 mg/kg bw: 1 female
505.0 mg/kg bw: 1 male
555.5 mg/kg bw: 4 males, 2 females
606.0 mg/kg bw: 2 males, 1 females

Any other information on results incl. tables

Table 1. Acute oral toxicity.

 

Dose
[mg/kg bw]

Toxicological results*

Duration of clinical signs

Time of death

Mortality (%)

Males

252.5

0/0/0

---

---

0

353.5

2/0/5

---

Day 2

40

505.0

2/0/5

---

Day 3 - Day 4

40

555.5

4/0/5

---

Day 2

80

606.0

5/0/5

---

Day 2

100

Females

252.5

0/0/0

---

---

0

353.5

2/0/5

---

Day 3

40

505.0

3/0/5

---

Day 2 - Day 3

60

555.5

4/0/5

---

Day 2 - Day 3

80

606.0

5/0/5

---

Day 2- Day 4

100

LD50 = 404 mg/kg bw

                                                                                           

* first number = number of dead animals                                   

second number = number of animals with clinical signs           

third number = number of animals used

Applicant's summary and conclusion

Interpretation of results:
Category 4 based on GHS criteria
Conclusions:
CLP: Acute Oral 4, H302