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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
Study period:
21 Aug - 24 Aug 1962
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Basic data given: study report which meets basic scientific principles.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1962
Report Date:
1962

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Principles of method if other than guideline:
BASF test: In principle, the methods described in OECD Guideline 401 were used.
5 rats per dose were treated by gavage with preparations of the test substance in 2-20 % traganth. Group-wise documentation of clinical signs was performed over the 7-day study period. Body weight was determined before the start of the study only, as it was needed for determination of dose. The clinical signs and findings were reported in summary form.
GLP compliance:
no
Test type:
standard acute method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Isobutyl acrylate
- Physical state: liquid
- Analytical purity: no data
- Impurities (identity and concentrations): 0.006% Hydrochinonmonomethylether.

Test animals

Species:
rat
Strain:
not specified
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Weight at study initiation: 122-271 g

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
other: aqueous emulsion with traganth
Doses:
200; 1600; 3200; 4000; 5000; 6400 µL/kg bw (corresponding to 178; 1424; 2848; 3560; 4450; 5696 mg/kg bw) Calculation of concentrations (mg/kg bw) based on density of the test substance (0.89 g/mL).
No. of animals per sex per dose:
5 animals/dose
Control animals:
no
Details on study design:
- Duration of observation period following administration: 7 days
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, gross pathology

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
ca. 4 895 mg/kg bw
Mortality:
No mortality was observed during the 7 day observation period in the 178 to 3560 mg/kg bw dose groups. One rat died within the first 24 hours in the 4450 mg/kg bw dose group. In the 5696 mg/kg bw dose group, all 5 rats died within the first 24 hours.
Clinical signs:
Clinical symptoms in the highest dose group were narcosis, staggering gait, apathy and abdominal position. Some animals of the other dose groups showed slight apathy after dose administration.
Gross pathology:
Kidneys were hyperemic in 4 of the sacrificed animals. No changes were observed in the deceased animals.

Any other information on results incl. tables

Dose (mg/kg bw)

No. of animals

Mortality after

1 h

24 h

48 h

7 days

5696

5

0/5

5/5

5/5

5/5

4450

5

0/5

1/5

1/5

1/5

3560

5

0/5

0/5

0/5

0/5

2848

5

0/5

0/5

0/5

0/5

1424

5

0/5

0/5

0/5

0/5

178

5

0/5

0/5

0/5

0/5

Original value reported: LD50 = 5500 µL/kg bw (corresponding to ca. 4895 mg/kg bw).

Applicant's summary and conclusion

Interpretation of results:
practically nontoxic
Remarks:
Migrated information Criteria used for interpretation of results: EU