Propionaldehyde

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1992

Report date:

1992

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Deviations:

no

GLP compliance:

yes

Remarks:

Bushy Run Research Center

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Propionaldehyde

EC Number:

204-623-0

EC Name:

Propionaldehyde

Cas Number:

123-38-6

Molecular formula:

C3H6O

IUPAC Name:

propanal

Specific details on test material used for the study:

- Name of test material (as cited in study report): propionaldehyde
- Physical state: liquid
- Analytical purity: approx. 99.77%
- Impurities (identity and concentrations): n-propanol: 0.01%, 2-methyl butyraldehyde: 0.02%, valeraldehyde: 0.06%, propionic acid: 0.07%, propionaldehyde dimers: 0.03%, propionaldehyde trimers: 0.01%, all other: approx. 0.03%
- Storage condition of test material: 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: Hazleton Research Products, Inc. (Denver, PA, USA)
- Age at study initiation: 12 - 18 weeks old
- Weight at study initiation: 2.0 - 2.3 kg
- Fasting period before study: during acclimation: diet restricted during the first week
- Housing: individually
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least 5 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 16.1 - 21.7
- Humidity (%): 40-60
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Type of coverage:

occlusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

TEST SITE
- Area of exposure: dorsal trunk
- % coverage: no data
- Type of wrap if used: double layer of gauze sheeting was wrapped around the trunk and secured with adhesive tape. Polyethylene sheeting was then wrapped around the trunk over the gauze. To secure the polyethylene, plastic ties or rubber bands were added (at the ends of the trunk). The sheeting was protected from removal or tearing by wrapping the rabbit trunk with VETRAP® badaging tape. The ends of the VETRAP® were then secured.

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 6 mg/cm2 /(1.0 g/kg) for female; 49mg/cm2 (8.0 g/kg) for male
- Concentration (if solution): undiluted
- Constant volume or concentration used: yes

Duration of exposure:

24 hours

Doses:

1000, 2000, 4000 mg/kg b.w.

No. of animals per sex per dose:

5 female per dose
3 male per 2000mg/kg bw.

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: examination and weighing twice prior dosing; after dosing: once daily
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, histopathology

Results and discussion

Effect levels

Sex:

female

Dose descriptor:

LD50

Effect level:

2 460 mg/kg bw

95% CL:

1 790 - 3 390

Mortality:

1 male rabbit died from 8.0 g/kg. One of 3 male rabbits died after receiving 2.0 g/kg of test substance (an intermediate dose level that produced 1 of 5 female deaths). After receiving of 4.0 g/kg of propionaldehyde 5/5 female rabbits died.
Three female rabbits died within 45 minutes to 1.75 hours. All other deaths occurred at 1 to 2 days.

Clinical signs:

other: Dermal reactions included erythema, edema, ecchymosis, fissuring, necrosis, ulceration, desquamation, alopecia and scabs. Signs of toxicity included sluggishness, convulsion followed by spasms (in 1), prostration, labored breathing (in 1), rapid breathing

Gross pathology:

Necropsy of the rabbits that died revealed pale pink to red lungs (mottled in 1), 2 purple thymuses (mottled in 1) and 1 enlarged thymus. Gross pathologic evaluation of survivors revealed dark red lungs (in 1) and a white liquid-filled nodule in 1 kidney.

Any other information on results incl. tables

			mean weight, (g ± S.D.)
Dose (g/kg b.w.)	Dead/dosed	days to death	0 days	7 days	14 days
Males
2.0	1/3	2	2648 ± 53	2574 ± 45	2697 ± 14
Female
4.0	5/5	0,0,1,1,2	2697 ± 129	-	-
2.0	1/5	0	2720 ± 91	2724 ± 86	2814 ± 119
1.0	0/5	-	2640 ± 199	2738 ± 168	2933 ± 203

Applicant's summary and conclusion

Interpretation of results:

Category 5 based on GHS criteria

Conclusions:

The median lethal dose after dermal application was concluded to be 2460 mg/kg b.w. for female New Zealand white rabbits under the conditions of the study. A marked gender difference was not observed.