Calcium dipropionate

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

supporting study

Study period:

1957

Reliability:

3 (not reliable)

Rationale for reliability incl. deficiencies:

other: Non-GLP study similar to OECD guideline 402. However petechial hemorrhage of the lungs and hemorrhage of the intestine do raise questions on reliability of the study.

Cross-reference

Cross-reference 1

Reason / purpose for cross-reference:

reference to same study

Cross-reference 2

Reason / purpose for cross-reference:

reference to other study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1957

Report date:

1957

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Principles of method if other than guideline:

None

GLP compliance:

no

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Propionic acid

EC Number:

201-176-3

EC Name:

Propionic acid

Cas Number:

79-09-4

Molecular formula:

C3H6O2

IUPAC Name:

propionic acid

Details on test material:

- Name of test material (as cited in study report): Propionic acid
- Lot/batch No.: 2732

Test animals

Species:

rabbit

Strain:

New Zealand White

Sex:

male

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Rabbits were procured locally.
- Age at study initiation: 3 to 5 months of age
- Weight at study initiation: 2.5 kg (average)
- Diet (e.g. ad libitum): Rockland rabbit ration

Administration / exposure

Type of coverage:

other: vinylite sheeting

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

TEST SITE
- Area of exposure: Clipped skin of the trunk
- Type of wrap if used: Vinylite sheeting was used to retain the dose

REMOVAL OF TEST SUBSTANCE
- Time after start of exposure: 24 hour

TEST MATERIAL
- Undiluted test material was used

Duration of exposure:

24 hours

Doses:

0.625 and 0.3125 ml/kg

No. of animals per sex per dose:

4 male rabbits/dose

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days

Statistics:

Thompson's method of calculating the LD50 was used.

Results and discussion

Preliminary study:

No data

Effect levels

Effect levels 1

Sex:

male

Dose descriptor:

LD50

Effect level:

0.5 mL/kg bw

Based on:

test mat.

95% CL:

0.38 - 0.67

Effect levels 2

Sex:

male

Dose descriptor:

LD50

Effect level:

495 mg/kg bw

Based on:

test mat.

Mortality:

0.625 ml/kg- 3/4
0.3125 ml/kg-0/4

Clinical signs:

other: The covered applications caused necrosis of the skin.

Gross pathology:

Petechial hemorrhage of the lungs, mottled livers, surface pitted and congested kidneys and hemorrhage of the intestine were observed.

Other findings:

None

Any other information on results incl. tables

None

Applicant's summary and conclusion

Conclusions:

By skin penetration, the LD50 of Propionic acid in rabbits for 24 hour contact period is 0.50 (0.38 to 0.67) ml/kg. However, rabbits are not the preferred species for acute dermal toxicity studies. Classification and labeling for acute dermal toxicity should be based on rat studies.

Executive summary:

Male albino New Zealand strain rabbits, 3 to 5 months of age and averaging 2.5 kg in weight were immobilized during the 24 -hour skin contact period. Thereafter, the VINYLITE sheeting used to retain the dose in contact with the clipped skin of the trunk was removed and the animals were caged for the remainder of the 14 -day observation period. The rabbits were procured locally and maintained on Rockland rabbit ration. Thompson's method of calculating the LD50 was used.

These covered applications caused necrosis of the skin, petechial hemorrhage of the lungs, mottled livers, surface pitted and congested kidneys and hemorrhage of the intestine. In one rabbit that died the urine contained blood pigments. The LD50 for rabbits by skin penetration was 0.50 (0.38 to 0.67) ml/kg of the undiluted propionic acid.