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Toxicological information

Acute Toxicity: dermal

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Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Acceptable, well documented study report which meets basic scientific principles.

Data source

Referenceopen allclose all

Reference Type:
study report
Title:
Unnamed
Year:
1968
Report Date:
1968
Reference Type:
study report
Title:
Unnamed
Year:
1967
Reference Type:
study report
Title:
Unnamed
Year:
1991

Materials and methods

Principles of method if other than guideline:
Four albino rabbits per dose group, 3-5 months of age, were applied with the undiluted test substance under VINYLITE covering to the clipped intact skin of the trunk. In order to prevent the inhalation of vapour from the chemical, the rabbits were placed in a hood with their heads protruding into the room. The animals were immobilized during the 24 hour contact period. Thereafter, excess fluid was removed to prevent ingestion. LD50 was calculated by the moving average method based on a 14-day observation period.
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
-Supplier: Union Carbide
- Physical state: liquid
- Analytical purity: no data
- Lot/batch No.: 02497

Test animals

Species:
rabbit
Strain:
New Zealand White
Sex:
male
Details on test animals and environmental conditions:
TEST ANIMALS
- Age at study initiation: 3-5 months

Administration / exposure

Type of coverage:
occlusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST SITE
- Type of wrap if used: Vinylite (impervious sheeting)


REMOVAL OF TEST SUBSTANCE
- Washing (if done): excess fluid was removed to prevent ingestion, no further data.
- Time after start of exposure: 24 h


Duration of exposure:
24 h
Doses:
0.5, 1, 2 mL/kg bw (corresponding to 445, 890, 1780 mg/kg bw) Calculation to mg/kg bw based on density of the test substance (0.89 g/mL).
No. of animals per sex per dose:
4
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, gross pathology

Results and discussion

Effect levels
Sex:
male
Dose descriptor:
LD50
Effect level:
ca. 793 mg/kg bw
95% CL:
437 - 1 441
Mortality:
0/4, 3/4 and 3/4 animals died in the dose groups of 445, 890, 1780 mg/kg bw, respectively.
Clinical signs:
No clinical signs were observed.
Gross pathology:
Congestion of the lungs and the abdominal viscera. Mottled liver. Organs of two victims were autolysed.
Other findings:
Skin irritation: ecchymosis, edema and marked erythema noted at necropsy

Any other information on results incl. tables

Mortalities:
445 mg/kg bw: 0/4
890 mg/kg bw: 3/4 (2, 4 days to death)
1780 mg/kg bw: 3/4 (1,2,3 days to death)

Original values reported: LD50 = 0.891 (0.491 -1.62) mL/kg bw which corresponds to ca. 793 (437 - 1441) mg/kg bw.

The test substance produced moderate acute toxicity by covered dermal application for 24 h in rats.

Applicant's summary and conclusion

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