Registration Dossier

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
September 13, 1994 - March 3, 1995
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: The study was conducted according to OECD TG 404 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 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
Deviations:
no
Qualifier:
according to
Guideline:
EPA OPP 81-5 (Acute Dermal Irritation)
Qualifier:
according to
Guideline:
other: MAFF Primary Dermal irritation
Deviations:
no
Principles of method if other than guideline:
not applicable
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Physical state: liquid
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
Details on test animals and environmental conditions:
Rabbits were obtained from Hazleton Research Products, Inc. (Kalamazoo, MI) and weighed 2.01 - 2.38 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.

Test system

Type of coverage:
occlusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
0.5 ml
Duration of treatment / exposure:
4 hours
Observation period:
24, 48 and 72 hours
Number of animals:
6 (3/sex)
Details on study design:
The test material (0.5 ml) was applied to a Hill Top Chamber (25 mm), which was affixed with an elastic rabbit jacket to back skin (10 cm x 10 cm) that had been clipped free of fur the day the previous day. The jacket and chamber were removed four hours later, and the site was wiped with a damp, disposable towel. The application sites were graded for erythema and edema within 30 min, and 24, 48 and 72 hours after removal of the test material on Days 7 - 15. Animals were weighed on the day of treatment and at study termination.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Remarks:
mean (male)
Time point:
other: 24, 48 and 72 hours
Score:
0
Max. score:
0
Reversibility:
other: no erythema
Irritation parameter:
erythema score
Basis:
animal #2
Remarks:
mean (male)
Time point:
other: 24, 48 and 72 hours
Score:
0
Max. score:
0
Reversibility:
other: no erythema
Irritation parameter:
erythema score
Basis:
animal #3
Remarks:
mean (male)
Time point:
other: 24, 48 and 72 hours
Score:
0.67
Max. score:
1
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
erythema score
Basis:
animal #4
Remarks:
mean (female)
Time point:
other: 24, 48 and 72 hours
Score:
4
Max. score:
4
Reversibility:
not fully reversible within: 14 days
Remarks on result:
other: This female rabbit had severe erythema and gradually diminishing edema for the remainder of the study. The effects were not considered to be related to administartion of the test material since there was an error during application of the test material.
Irritation parameter:
erythema score
Basis:
animal #5
Remarks:
mean (female)
Time point:
other: 24, 48 and 72 hours
Score:
0.67
Max. score:
1
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
erythema score
Basis:
animal #6
Remarks:
mean
Time point:
other: 24, 48 and 72 hours
Score:
1
Max. score:
1
Reversibility:
fully reversible within: day 7
Irritation parameter:
edema score
Basis:
animal #1
Remarks:
mean (male)
Time point:
other: 24, 48 and 72 hours
Score:
0
Max. score:
0
Reversibility:
other: no edema
Irritation parameter:
edema score
Basis:
animal #2
Remarks:
mean (male)
Time point:
other: 24, 48 and 72 hours
Score:
0
Max. score:
0
Reversibility:
other: no edema
Irritation parameter:
edema score
Basis:
animal #3
Remarks:
mean (male)
Time point:
other: 24, 48 and 72 hours
Score:
0
Max. score:
0
Reversibility:
other: no edema
Irritation parameter:
edema score
Basis:
animal #4
Remarks:
mean (female)
Time point:
other: 24, 48 and 72 hours
Score:
2.67
Max. score:
3
Reversibility:
not fully reversible within: 14 days
Remarks on result:
other: This female rabbit had severe erythema and gradually diminishing edema for the remainder of the study. The effects were not considered to be related to administartion of the test material since there was an error during application of the test material.
Irritation parameter:
edema score
Basis:
animal #5
Remarks:
mean (female)
Time point:
other: 24, 48 and 72 hours
Score:
0
Max. score:
0
Reversibility:
other: no edema
Irritation parameter:
edema score
Basis:
animal #6
Remarks:
mean (female)
Time point:
other: 24, 48 and 72 hours
Score:
0
Max. score:
0
Reversibility:
other: no edema
Irritant / corrosive response data:
One female rabbit had severe erythema and gradually diminishing edema for the remainder of the study. The effects were not considered to be related to administration of the test material since there was an error in applying the material.

For the remaining 5 rabbits, very slight erythema (Grade 1) was observed in two females within 30 minutes and two females and one male at 24 and 48 hours. This resolved by Day 7. No edema was observed in these rabbits.

Very slight erythema (Grade 1) was
Other effects:
There was no effect on body weight.

Any other information on results incl. tables

The female rabbit that had severe erythema and gradually diminishing edema for the remainder of the study should be excluded from the study. The effects were not considered to be related to administartion of the test material since there was an error during application of the test material.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Based on the results, dipropylene glycoln-propyl ether will not be classified as irritating.
Executive summary:

Dipropylene glycol n-propyl ether (DpnP, purity 99.32% by weight) was evaluated for primary dermal irritaion. Aliquots of 0.5 ml of DPnP were applied for four hours to the intact skin on the back of six New Zealand White rabbits. Very slight erythema was observed on two of the six rabbits within 30 minutes of test material removal. Three of the six rabbits at 24 and 48 hours had very slight erythema. Very slight erythema was present on one of the six rabbits 72 hours after test material removal which was resolved by test day 7.

One of the rabbits patch was inadvertently caught under the tape and was held very tightly in place for the four hour exposure. As a result of this error in application technique, the rabbit had severe erythema and gradually diminishing edema for the remainder of the study, neither of which were interpreted to be compond related. The test was terminated 14 days after test material removal. Dermal application of 0.5 ml dipropylene glycol n-propyl ether had no effect on body weight.

Based on the results of the study, dipropylene glycol n-propyl ether will not be classified as irritating.