Registration Dossier

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.
Cross-referenceopen allclose all
Reason / purpose:
reference to same study
Reason / purpose:
reference to other study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1995
Report Date:
1995

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
no
Qualifier:
according to
Guideline:
EPA OPP 81-2 (Acute Dermal Toxicity)
Deviations:
no
Qualifier:
according to
Guideline:
other: MAFF Acute Dermal Toxicity
Deviations:
no
Qualifier:
according to
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

Reference
Name:
Unnamed
Type:
Constituent
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 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:
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 animal with the unresolved erythema developed scales on Day 8.
Body weight:
All animals gained or maintained body weight over the course of the study
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:
not classified
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.