Registration Dossier

Administrative data

Endpoint:
eye irritation, other
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1994
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1994
Report date:
1994

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
2,2'-(octylimino)bisethanol
EC Number:
239-555-0
EC Name:
2,2'-(octylimino)bisethanol
Cas Number:
15520-05-5
Molecular formula:
C12H27NO2
IUPAC Name:
2-[(2-hydroxyethyl)(octyl)amino]ethan-1-ol
Test material form:
other: liquid

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
details on strain: Chbb: NZW (SPF)
origin of test animal: Chemisch pharmazeutische Fabrik; Dr. Karl Thomae GmbH, 88400 Biberach; Germany; SPF-Zucht
age of test animals: 3 - 5 months
weight of test animal: 3.4 kg

Test system

Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
0.1 mL of the undiluted test item was applied
Duration of treatment / exposure:
once applied into conjunctival sac of left eye; 24 hours after treatment and at any time point when the cornea needs to be inspected with fluorescein-sodium solution, the eye was washed with physiological saline solution (Temperature about 37°C).
Observation period (in vivo):
evaluation of the treated eye was performed after:
1 h, 24 h, 48 h, 72 h and 7 days
Number of animals or in vitro replicates:
1

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
other: 1-3 days
Score:
1.33
Max. score:
2
Reversibility:
not fully reversible within: 7 days
Remarks on result:
other: Seven days after the application of test item the cornea showed diffuse opacity areas and additional an advanced vascularization was observed.
Irritation parameter:
iris score
Basis:
animal #1
Time point:
other: 1-3 days
Score:
1
Max. score:
1
Reversibility:
fully reversible within: 7 days
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
other: 1-3 days
Score:
3
Max. score:
3
Reversibility:
other: Until 72 hours after application the conjunctiva showed a crimson up to diffuse strong red color and an edema up to half eye-lid closure
Remarks on result:
other: Seven days after the application of test item the conjunctiva showed still a diffuse crimson color
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
other: 1-3 days
Score:
1.33
Max. score:
2
Reversibility:
fully reversible

Applicant's summary and conclusion

Interpretation of results:
highly irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Based on the findings of this OECD 405 study in New Zealand White rabbits, the test substance is determined to be highly eye irritant.
Executive summary:

In order to assess the eye irrtating potential of the test substance, 0.1 mL of the undiluted test item was applied into the conjunctival sac of the left eye of one rabbit. The untreated eye serves as control. 24 hours after treatment and at any time point when the cornea needs to be inspected with fluorescein-sodium solution, the eye was washed with physiological saline solution (Temperature about 37°C). The assessment was performed 60 minutes, 24, 48 and 72 hours after application of test item and additionally after 7 days due to some findings. At the 24 and 72 hour time point and after 7 days, additionally a drop of fluorescein-sodium solution was instilled and the eye was examined under UV-light. The eye reactions were assessed according to the numerical scoring system (acc. to Draize). The description of the degree and nature of irritation, the presence of serious lesions and non-occular effects were noted.

Until 72 hours after application the conjunctiva showed a crimson up to diffuse strong red color and an edema up to half eye-lid closure. The iris was reddened. The cornea showed diffuse to pearly-like opacity areas. Additional a clear-colorless or white to mucous effluent and bleeding of the nictitating membrane was observed. Seven days after the application of test item the conjunctiva showed still a diffuse crimson color and the cornea diffuse opacity areas. Additional an advanced vascularization was observed.

Based on the findings of this OECD 405 study in New Zealand White rabbits, the test substance is determined to be highly eye irritant.