Registration Dossier

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Guideline study under GLP

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2005
Report Date:
2005

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Qualifier:
according to
Guideline:
EPA OPPTS 870.2400 (Acute Eye Irritation)
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Type:
Constituent
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder
Details on test material:
Test Substance Identification: Cetylpyridinium Chloride
Lot #00217966
Purity: 100.1% by assay.
Test Substance Description: White powder
Date Received: January 12, 2005
PSL Reference No: 050112-ID
Study Initiation Date: January 24, 2005
Dates of Test: March 9-14, 2005
Notebook No: 05-11: Pages 206-208, 209-209A, 210-216

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
Housing: The animals were singly house in suspended stainless steel caging
Animal Room Temperature Range: 20-22 Degrees C
Photoperiod: 12-hour light/dark cycle
Food: Pelleted Purina Rabbit Chow #5326
Acclimation Period: 7 days
Water: Filtered tap water was supplied ad-libitum by an automatic water dispensing system

Test system

Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
One-tenth of a milliliter (0.04 grams) of the test substance was instilled into the conjunctival sac of the right eye of each rabbit.
Duration of treatment / exposure:
Full duration of the study
Observation period (in vivo):
1, 24, 48, and 72 hours and at 4 days post-instillation throughout 14 days
Number of animals or in vitro replicates:
3 Males
Details on study design:
Test substance was instilled into the conjunctival sac of the right eye of each rabbit by pulling the lower lid away from the eyeball. The upper and lower lids were then gently held together for about one second before releasing to minimize loss of the test substance. No rinsing of the eye occurred. Ocular irritation was evaluated using a high-intensity white light (Mag Lite) in accordance with Draize et al.

Results and discussion

In vivo

Results
Irritation parameter:
maximum mean total score (MMTS)
Basis:
mean
Time point:
other: 4 days
Score:
> 86 - < 88
Max. score:
88
Reversibility:
not reversible
Remarks on result:
other: Study terminated and animals euthanized at 4 days
Irritant / corrosive response data:
All three animals exhibited corneal opacity, iritis and conjunctivitis. The overall severity increased through 48 hours, and remained extreme at 4 days post treatment. The Maximum Mean Total Score of Cetylpyridinium Chloride is 86.7. The animals were euthanized at day 4 for humane reasons.
Other effects:
One animal exhibited reduced fecal volume on Test Day 5. The other two animals appeared active and healthy during the entire observation period.

Applicant's summary and conclusion

Interpretation of results:
Category 1 (irreversible effects on the eye)
Remarks:
Migrated information Draize score > 80 (of 110) from days 2-4 Criteria used for interpretation of results: EU
Conclusions:
CPC, when instilled into the eyes of three rabbits, caused severe eye damage (corneal opacity, iritis and conjuctiveity).