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Toxicological information

Eye irritation

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Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
December 6, 1994 - March 3, 1995
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: The study was conducted according to OECD TG 405 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 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
Deviations:
no
Qualifier:
according to
Guideline:
EPA OPP 81-4 (Acute Eye Irritation)
Deviations:
no
Qualifier:
according to
Guideline:
other: MAFF Primary Eye 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:
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 / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
Rabbits were obtained from Hazleton Research Products, Inc. (Kalamazoo, MI) and weighed 2.57 - 2.79 kg at the start of the study. They were housed individually in a room maintained at 40-60% relative humidity, 19 +/- 3 degrees C, and a 12 hour light/12 hour dark cycle. Room air was 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

Vehicle:
unchanged (no vehicle)
Controls:
other: contralateral eye
Amount / concentration applied:
0.1 g
Duration of treatment / exposure:
not applicable
Observation period (in vivo):
7 days
Number of animals or in vitro replicates:
6 (3/sex)
Details on study design:
The day prior to exposure to test material, eyes were examined with 5% aqueous fluorescein and determined to be free of defects or irritation. Test material was instilled into the conjunctival sac of the right eye of each rabbit. The left eye was untreated and served as a control. Eyes were not washed after treatment. The behaviour of each rabbit was observed immediately after exposure for pain or discomfort. Both eyes were examined with a penlight 1, 24, 48 and 72 hours and 7 days after exposure for conjunctival redness and chemosis, discharge, corneal opacity and reddening of the iris. Rabbits were weighed on the day of exposure and study termination.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
over all male animals
Time point:
other: 24, 48 and 72 hours
Score:
1
Max. score:
1
Reversibility:
fully reversible within: 8 days
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
over all female animals
Time point:
other: 24, 48 and 72 hours
Score:
0
Max. score:
1
Reversibility:
fully reversible within: 8 days
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
over all animals
Time point:
other: 24, 48 and 72 hours
Score:
0.6
Max. score:
1
Reversibility:
fully reversible within: 8 days
Irritation parameter:
iris score
Basis:
mean
Remarks:
over all male animals
Time point:
other: 24, 48 and 72 hours
Score:
0
Max. score:
0
Reversibility:
other: no effects observed
Irritation parameter:
iris score
Basis:
mean
Remarks:
over all female animals
Time point:
other: 24, 48 and 72 hours
Score:
0
Max. score:
0
Reversibility:
other: no effects observed
Irritation parameter:
iris score
Basis:
mean
Remarks:
over all animals
Time point:
other: 24, 48 and 72 hours
Score:
0
Max. score:
0
Reversibility:
other: no effects observed
Irritation parameter:
conjunctivae score
Basis:
mean
Remarks:
over all male animals
Time point:
other: 24, 48 and 72 hours
Score:
1
Max. score:
1
Reversibility:
fully reversible within: 8 days
Irritation parameter:
conjunctivae score
Basis:
mean
Remarks:
over all female animals
Time point:
other: 24, 48 and 72 hours
Score:
1
Max. score:
1
Reversibility:
fully reversible within: 8 days
Irritation parameter:
conjunctivae score
Basis:
mean
Remarks:
over all animals
Time point:
other: 24,48 and 72 hours
Score:
0.8
Max. score:
1
Reversibility:
fully reversible within: 8 days
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
over all male animals
Time point:
other: 24,48 and 72 hours
Score:
0.44
Max. score:
2
Reversibility:
fully reversible within: 8 days
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
over all female animals
Time point:
other: 24,48 and 72 hours
Score:
0.55
Max. score:
2
Reversibility:
fully reversible within: 8 days
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
over all animals
Time point:
other: 24,48 and 72 hours
Score:
0.5
Max. score:
2
Reversibility:
fully reversible within: 8 days
Irritant / corrosive response data:
Slight (grade 1 in 5) to moderate (grade 2 in 1) redness of the conjunctiva, moderate to marked chemosis (grades 2, 3, and 4 in 1, 4 and 1 rabbit, respectively) and marked discharge (grade 3) were observed 1 hour after dosing. Five of the six animals had very slight to slight opacity at 1 hour. All occular effects were resolved by the end of the study.
Other effects:
There was no effect of test material on body weight.

Any other information on results incl. tables

None

Applicant's summary and conclusion

Interpretation of results:
Category II
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Based on the results, dipropylene glycoln-propyl ether can be classified as a mild eye irritant.
Executive summary:

Dipropylene glycol n-propyl ether (DPnP), which has a purity of 99.32% (by weight), was assessed for the potential to cause ocular irritation after instillation of a 0.1 ml aliquot into the conjunctival sac of the right eye of six New Zealand White rabbits.

 

Examination of the eyes revealed slight to moderate redness of the conjunctiva, moderate to marked chemosis, and marked discharge one hour after dosing, in all animals. Five of the six animals had very slight to slight opacity, at the one hour read.

 

The redness, chemosis, discharge and corneal opacity diminished or resolved in all animals during the following three days. All ocular effects were resolved by seven days post dosing, and the test was terminated. Instillation of dipropylene glycol n-propyl ether into the eye had no effect on body weight.

 

Based on the results, dipropylene glycoln-propyl ether can be classified as a mild eye irritant.