1-(1-methyl-2-propoxyethoxy)propan-2-ol

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

November 30, 1994 - March 3, 1995

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: The study was conducted according to OECD TG 402 and in accordance with the principles of GLP.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1995

Report date:

1995

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EPA OPP 81-2 (Acute Dermal Toxicity)

Deviations:

no

Test guideline 3

Qualifier:

according to guideline

Guideline:

other: MAFF Acute Dermal Toxicity

Deviations:

no

Test guideline 4

Qualifier:

according to guideline

Guideline:

other: EEC Methods Number B.2 Acute Toxicity (Dermal

Deviations:

no

Principles of method if other than guideline:

not applicable

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

1-(1-methyl-2-propoxyethoxy)propan-2-ol

EC Number:

249-949-4

EC Name:

1-(1-methyl-2-propoxyethoxy)propan-2-ol

Cas Number:

29911-27-1

Molecular formula:

C9H20O3

IUPAC Name:

1-(1-methyl-2-propoxyethoxy)propan-2-ol

Details on test material:

99.32% (by weight) dipropylene glycol n-propyl ether (DPnP), 0.30% propylene glycol n-propyl ether isomer 2 (PnP-2) and 0.16% dipropylene glycol (DPG)

Test animals

Species:

rabbit

Strain:

New Zealand White

Sex:

male/female

Details on test animals or test system and environmental conditions:

Rabbits were obtained from Hazleton Research Products, Inc. (Kalamazoo, MI) and weighed 2.37 - 2.69 kg upon arrival. They were housed in a room maintained at 40-60% relative humidity, 19 +/- 3 degrees C, and a 12 hour light/12 hour dark cycle. Room air exchanged 15 times/hour. Four ounces of Purina Certified Rabbit Chow #5322 (Purina Mills Inc., St. Louis, MO) were provided daily and tap water was provided ad libitum. Animals were acclimated for at least two weeks before use.

Administration / exposure

Type of coverage:

occlusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

The test material was applied to trunk skin that had been clipped free of fur the day the previous day. The site was then covered with a piece of gauze, non-absorbent cotton (10 x 14 cm), and an elastic rabbit jacket. Twenty four hours later, the dressings were removed and the site was wiped with water and dried with a soft, disposable towel.

Duration of exposure:

24 hours

Doses:

2000 mg/kg

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

Animals were observed for signs of toxicity frequently on the day of dosing and at least once each work day throughout the two-week observation period. The skin was evaluated for irritation after removal of the dressing. Animals were weighed prestudy, the day of treatment and on Days 2, 8, and 15.

At study termination all animals were euthanized and subjected to a gross necropsy. The eyes were examined in situ using a moistened glass microscope slide applied to the corneal surface.

Statistics:

Means and standard deviations were calculated for body weights and the data were evaluated for statistical outliers by a sequential test. Outliers were not "routinely excluded" from statistical analysis.

Results and discussion

Preliminary study:

not applicable

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

>= 2 000 mg/kg bw

Mortality:

No deaths

Clinical signs:

other: No signs indicative of systemic toxicity. Erythema was noted on all animals (one or two days after exposure; resolved by Day 9 in all except one rabbit) and edema was noted on four animals immediately after test material removal (resolved by Day 3). The

Gross pathology:

No treatment-related findings

Other findings:

None

Any other information on results incl. tables

None

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

As per LD50 dose > 2000 mg/kg bw, dipropylene glycol n-propyl ether will not be classified toxic via the dermal route.

Executive summary:

Dipropylene glycol n-propyl ether (DPnP), which has a purity of 99.32%(by weight), was evaluated for dermal toxicity. Five New Zealand White rabbits per sex received a single, 24-hour, dermal exposure of 2000 mg/kg of DPnP. Parameters evaluated included body weights, in-life observations and gross pathologic evaluation.

 

All rabbits survived the 2000 mg/kg limit test established by the guidelines, therefore, no other dose levels were tested. All rabbits gained or maintained body weight during the two week observation period.

 

No clinical signs indicative of systemic toxicity were noted. Erythema was observed on all animals, one or two days after exposure. Edema was noted on four of the animals immediately after test material removal, and was resolved by test day three on all animals. The erythema was resolved by test day nine in all but one rabbit. This rabbit had erythema for the entire two week observation period, and developed scales on test day eight. No treatment-related observations were made at necropsy.

 

Under the conditions of this study, the acute dermal LD50 of dipropylene glycol n-propyl ether was greater than 2000 mg/kg, the limit dose, for male and female New Zealand White rabbits.