1-propoxypropan-2-ol

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1986

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: non-GLP study equivalent to OECD guideline 402

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1986

Report date:

1986

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

GLP compliance:

not specified

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

1-propoxypropan-2-ol

EC Number:

216-372-4

EC Name:

1-propoxypropan-2-ol

Cas Number:

1569-01-3

Molecular formula:

C6H14O2

IUPAC Name:

1-propoxypropan-2-ol

Details on test material:

Name of test material (as cited in study report): PROPASOL Solvent P
- Physical state: clear, non-viscous liquid
- Lot/batch No.: #3251; S-066890

Test animals

Species:

rabbit

Strain:

New Zealand White

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Weight at study initiation: 2.0 - 3.0 kg
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum

Administration / exposure

Type of coverage:

occlusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

TEST SITE
- Area of exposure: clipped intact skin of the trunk
- Type of wrap if used: Test material was retained under impervious sheeting. Vetrap Bandaging Tape was wrapped over the impervious sheeting.

REMOVAL OF TEST SUBSTANCE
After the contact period (24 hours) excess fluid was removed to diminish ingestion.

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2.0, 4.0, 8.0 ml/kg
- Concentration (if solution): pure (liquid) substance
- Constant volume or concentration used: doses are varied by adjusting the volume of the test material

Duration of exposure:

24 hours

Doses:

2.0, 4.0, 8.0 ml/kg
The relative density of Propasol Solvent P is 0.88 g/ml.

No. of animals per sex per dose:

5

Control animals:

not specified

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: animals weights were recorded at 0 days (before dose), 7 days and 14 days (just prior to sacrifice)
- Necropsy of survivors performed: at death or sacrifice each animal was subjected to gross pathologic evaluation

Statistics:

LD50's and the estimated LD50 slopes are calculated by the moving average method and are based on a 14-day observation period.

Results and discussion

Effect levels

Effect levels 1

Sex:

male

Dose descriptor:

LD50

Effect level:

4.29 mL/kg bw

95% CL:

2.9 - 6.34

Effect levels 2

Sex:

female

Dose descriptor:

LD50

Effect level:

4.92 mL/kg bw

95% CL:

3.58 - 6.78

Effect levels 3

Sex:

male

Dose descriptor:

LD50

Effect level:

3 775 mg/kg bw

95% CL:

2 552 - 5 579

Effect levels 4

Sex:

female

Dose descriptor:

LD50

Effect level:

4 330 mg/kg bw

95% CL:

3 150 - 5 966

Mortality:

8.0 ml/kg (males): 5/5
4.0 ml/kg (males): 2/5
2.0 ml/kg (males): 0/5

8.0 ml/kg (females): 5/5
4.0 ml/kg (females): 1/5
2.0 ml/kg (females): 0/5

Clinical signs:

other: 8.0 ml/kg (males): erythema, edema, necrosis at death; ecchymosis on 2 at death; comatose appearance within 15 min; dilated pupils in 2 at death; death of 4 at 2.5-3.5 hours 4.0 ml/kg (males): erythema, edema at 1 day; ecchymosis on 2 at 1 to 7 days; necr

Gross pathology:

8.0 ml/kg (males): tracheas red
4.0 ml/kg (males): in victims: lungs mottled, dark red; tracheas red; in survivors: nothing remarkable
2.0 ml/kg (males): nothing remarkable

8.0 ml/kg (females): lungs dark red; trachea of 1 red
4.0 ml/kg (females): in victim: lungs and trachea red; in survivors: nothing remarkable
2.0 ml/kg (females): lungs of 2 mottled light and dark pink

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

PROPASOL Solvent P was moderately toxic following single dermal application. According to EU criteria no classification for acute dermal toxicity is required based on the LD50 > 2000 mg/l.

Executive summary:

Three groups of 5 male and 5 female New Zealand White rabbits, weighing between 2.0 and 3.0 kg, were subjected to 24 hours of contact with 8.0, 4.0 or 2.0 ml/kg of PROPASOL Solvent P which was retained under impervious sheeting on the clipped, intact skin of the trunk. As necessary for larger doses, gauze was wrapped around the trunk over the sample to prevent leakage. Vetrap Bandaging Tape was wrapped over the impervious sheeting and the animal was returend to its cage for the contact period. Doses were varied by adjusting the volume of the test material. After the contact period, excess fluid is removed to diminish ingestion. Observations for skin reaction were made at one hour, 7 days and 14 days after the contact period.

The LD50 for male rabbits was 4.29 ml/kg. The LD50 for females was 4.92 ml/kg. Local dermal effects included erythema, edema, ecchymosis, necrosis, desquamation, fissuring, ulceration, scabs and alopecia. A rapid comatose appearance, followed by dilated pupils, unsteady gait, sluggishness and prostration were among the signs of toxicity observed. Time to death ranged from one hour to 2 days. Survivors recovered at one to 2 days. Gross pathologic findings included red lungs and red tracheas.