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Acute Toxicity: dermal

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Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1988
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: The study methodology followed was equivalent or similar to OECD TG 402 and the report contains sufficient information to permit a meaningful evaluation of study results
Cross-referenceopen allclose all
Reason / purpose for cross-reference:
reference to same study
Reason / purpose for cross-reference:
reference to other study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1988
Report date:
1988

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
not specified
Principles of method if other than guideline:
not applicable
GLP compliance:
no
Test type:
standard acute method
Limit test:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Butyl propionate
EC Number:
209-669-5
EC Name:
Butyl propionate
Cas Number:
590-01-2
Molecular formula:
C7H14O2
IUPAC Name:
butyl propanoate
Details on test material:
- Name of test material (as cited in study report): UCAR n-butyl propionate
- Physical state: clear clolourless low viscosity liquid
- Analytical purity: 99+ %
- Impurities (identity and concentrations): < 1%
- Lot/batch No.: 51-18
- Stability under test conditions: yes
- Storage condition of test material: at room temperature

Test animals

Species:
rabbit
Strain:
New Zealand White
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: assumed to be in-house
- Age at study initiation: young adults
- Weight at study initiation: 2.0 - 3.0 kg
- Diet (e.g. ad libitum): ad libitum except during exposure
- Water (e.g. ad libitum): adlibitum except during exposure

Administration / exposure

Type of coverage:
occlusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
New Zealand White rabbits, weighing between 2.0 and 3.0 kg, were subjected to 24 hours of contact with the test material which was retained under impervious sheeting on the clipped, intact skin of the trunk. Gauze was wrapped around the trunk over the sample to prevent leakage and Vetrap Bandaging Tape was wrapped over the impervious sheeting and the animal is returned to its cage for the contact period. Doses were varied by adjusting the volume or weight of the test material. After the contact period, excess fluid is removed to avoid accidental ingestion.
Duration of exposure:
24 hours
Doses:
16 ml/kg
No. of animals per sex per dose:
5 males + 5 females
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Observations for skin reactions were made at 1 hour, 7 days and 14 days, body weights were recorded at weekly intervals
- Necropsy of survivors performed: yes
Statistics:
Descriptive statistical methods were used.

Results and discussion

Preliminary study:
not applicable
Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 16 mL/kg bw
Based on:
test mat.
Remarks on result:
other: > 14008 mg/kg (based on specific gravity of 0.8755)
Mortality:
Although no mortalities attributable to the dermal exposure were noted in either of the sexes, one male rabbit was humanely sacrificed on day 7 because of an apparent injury to one limb.
Clinical signs:
other: Local dermal effects noted were edema, necrosis, desquamation, fissuring, ulceration, scabs and alopecia. Diarrhoea was noted in one animal with recovery by 14 days.
Gross pathology:
Gross pathological changes included a pitted surface of the kidneys in one male and dark red lungs in one female
Other findings:
None

Any other information on results incl. tables

None

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Under the conditions of the study, the LD50 of UCAR n-butyl propionate to male and female New Zealand rabbits are in excess of 10000 mg/kg and hence based on the Guidance to Regulation (EC) No. 1272/2008 on Classification, Labelling and Packaging of substances and mixtures, UCAR n-butyl propionate will not be classified for acute dermal toxicity.
Executive summary:

New Zealand White rabbits, weighing between 2.0 and 3.0 kg, were subjected to 24 hours of contact with the test material (UCAR n-butyl propionate; 16 ml/kg) which was retained under impervious sheeting on the clipped, intact skin of the trunk. Gauze was wrapped around the trunk over the sample to prevent leakage and Vetrap Bandaging Tape was wrapped over the impervious sheeting and the animal is returned to its cage for the contact period. Doses were varied by adjusting the volume or weight of the test material. After the contact period, excess fluid is removed to avoid accidental ingestion. Observations for skin reactions were made at 1 hour, 7 days and 14 days, body weights were recorded at weekly intervals.

Although no mortalities attributable to the dermal exposure were noted in either of the sexes, one male rabbit was humanely sacrificed on day 7 because of an apparent injury to one limb. Local dermal effects noted were edema, necrosis, desquamation, fissuring, ulceration, scabs and alopecia. Diarrhoea was noted in one animal with recovery by 14 days. Normal body weight gain was noted in all the animals. Gross pathological changes included a pitted surface of the kidneys in one male and dark red lungs in one female. Under the conditions of the study, the LD50 of UCAR n-butyl propionate to male and female New Zealand rabbits are in excess of 16.0 ml/kg (> 14008 mg/kg, based on specific gravity of 0.8755) and hence based on the Guidance to Regulation (EC) No. 1272/2008 on Classification, Labelling and Packaging of substances and mixtures, UCAR n-butyl propionate will not be classified for acute dermal toxicity.