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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:
17 September 2013 - 22 September 2013
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: The study was performed according to OECD guidelines and GLP.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2013
Report Date:
2013

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
other: liquid
Details on test material:
Name: PREPOLYMER D
Chemical Name: Reaction mass of Bis (2-chloroethoxy)methane and 1,15-dichloro-3,5,8,11,13-pentaoxa-pentadecane
Batch/Lot Number: 030613
Purity: 100% (multi constituent substance)
Appearance: slightly brownish liquid

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
Species and strain: New Zealand White rabbits
Source: S&K-LAP Kft.
2173 Kartal, Császár út 135, Hungary
Justification of strain: The New Zealand White rabbit is one of the standard strains used for acute irritation toxicity studies.
Animal health: Only animals in acceptable health condition were used for the test. Both eyes of each animal provisionally selected for testing were examined prior to starting the study. Animals showing eye irritation, ocular defects or pre-existing corneal injury were not used.
Number of animals: 2 animals
Age of animals at treatment: ~12 weeks old (adult)
Sex: Male
Body weight range on the day of treatment: 3240 g and 3410 g
before euthanasia: 3291 g and 3477 g
Date of receipt: 30 August 2013
Acclimatization time: at least 18 days
Animal identification: The individual identification was by engraved ear tag. The cages were marked with individual identity cards with information about study code, sex, dose, cage number and individual animal number.

Animal health: Only healthy animals were used for the test. The veterinarian certified health status.
Number of animal room: 610
Light: 12 hours daily, from 6.00 a.m. to 6.00 p.m.
(and during of the analgesic/anaesthetic treatment)
Temperature
during the study: 20 ± 3°C
Relative humidity
during the study: 38 - 78 %
Housing/Enrichment: Rabbits were individually housed in AAALAC approved metal wire rabbit cages. Cages were of an open wire structure and cages were placed together to allow some social interaction with rabbit(s) in adjoining cages
Ventilation: 15-20 air exchanges/hour
The temperature and relative humidity values were measured continuously. The measured range was checked at least daily during the acclimatisation and experimental phases.

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: The untreated right eye served as control.
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 ml
Duration of treatment / exposure:
72 hours
Observation period (in vivo):
The eyes were examined at 1, 24, 48 and 72 hours after treatment. The duration of the observation period was sufficient to identify reversibility or irreversibility of changes.
Number of animals or in vitro replicates:
2
Details on study design:
The test substance was not rinsed from the eyes.

SCORING SYSTEM: The eye irritation scores were evaluated according to the scoring system by Draize (1977) and OECD 405 (02 October 2012)

TOOL USED TO ASSESS SCORE: none

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
mean
Time point:
other: 24-48-72 hours
Score:
0.33
Max. score:
4
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 24-48-72 hours
Score:
0
Max. score:
4
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24-48-72 hours
Score:
0
Max. score:
2
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 24-48-72 hours
Score:
0
Max. score:
3
Irritation parameter:
other: discharge
Basis:
mean
Time point:
other: 24-48-72 hours
Score:
0
Max. score:
3
Irritant / corrosive response data:
see attached table

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The test item, applied to rabbit eye mucosa, caused conjunctival redness and transient discharge. The effects were fully reversible within 48 hours. The substance is not classified as irritating based on these results.
Executive summary:

An acute eye irritation study of the test item was performed in New Zealand White rabbits.

The irritation effects of the test item were evaluated according to the Draize method (OECD No.: 405, 2012). Rabbits were treated with analgesic and anaesthetic as per the regulatory guideline. Two animals were used to make the classification according to the Sponsor request. The test item was placed into the conjunctival sac of the left eye of each animal. The untreated right eye served as control. A volume of 0.1 mL of the test item was administered as a single dose. The eyes were examined at 1, 24, 48 and 72 hours after the application. Initial Pain Reaction (IPR/PR) was not observed. First animal (No: 00166) clinical observation At one hour after the application: Conjunctival redness (score 2), chemosis (score 1) and discharge (score 3) were found. At 24 hours after the application: Conjunctival redness (score 1) was found. At 48 and 72 hours after the application There were no clinical signs, and no conjunctival or corneal effects observed. The effects were fully reversible therefore the animal was euthanized. Second animal (No: 00159) clinical observation At one hour after the application: Conjunctival redness (score 2), chemosis (score 1) and discharge (score 3) were found. At 24 hours after the application: Conjunctival redness (score 1) was found. At 48 and 72 hours after the application There were no clinical signs, and no conjunctival or corneal effects observed. The effects were fully reversible therefore the animal was euthanized. There were no clinical sign of systemic toxicity observed in the animals during the study and no mortality occurred. During the study, the control eye of each animal was symptom-free. The body weights of the animal were considered to be within the normal range of variability. The animal individual mean scores (considering readings at 24, 48 and 72 hours after the treatment) were as follows:

chemosis : 0.00, 0.00

discharge : 0.00, 0.00

redness : 0.33, 0.33

cornea opacity : 0.00, 0.00

iris : 0.00, 0.00

The test item, applied to rabbit eye mucosa, caused conjunctival redness and transient discharge. The effects were fully reversible within 48 hours. The substance is not classified as irritating based on these results.