oligomeric reaction product of 2-hydroxybenzaldehyde with 1-chloro-2,3-epoxypropane and phenol

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

06 October 2015 - 10 October 2015

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2016

Report date:

2016

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

yes

Remarks:

This deviation is considered to have no impact on the outcome of the study and interpretation of the results.

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

2-({2-[bis({2-[(oxiran-2-yl)methoxy]phenyl})methyl]phenoxy}methyl)oxirane; 2-({2-[bis({4-[(oxiran-2-yl)methoxy]phenyl})methyl]phenoxy}methyl)oxirane; 2-{[2-({2-[(oxiran-2-yl)methoxy]phenyl}({4-[(oxiran-2-yl)methoxy]phenyl})methyl)phenoxy]methyl}oxirane

EC Number:

942-639-6

IUPAC Name:

2-({2-[bis({2-[(oxiran-2-yl)methoxy]phenyl})methyl]phenoxy}methyl)oxirane; 2-({2-[bis({4-[(oxiran-2-yl)methoxy]phenyl})methyl]phenoxy}methyl)oxirane; 2-{[2-({2-[(oxiran-2-yl)methoxy]phenyl}({4-[(oxiran-2-yl)methoxy]phenyl})methyl)phenoxy]methyl}oxirane

Test material form:

solid

Details on test material:

Name: EPICLON EXA-7250
Batch/Lot number: B006
Appearance: Brown solid (in smaller amount colour is yellow)
Purity: >99%
Manufacture date: 02 October 2014
Expiry date: 02 March 2017
Storage condition: Room temperature 15-25°C, below 70 RH%
Safety precautions: Routine safety precautions (lab coat, gloves, safety glasses, face
mask) for unknown materials were applied to assure personnel
health and safety.

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source:S&K-LAP Kft. 2173 Kartal, Császár út 135, Hungary
- Age at study initiation:13 weeks old (young adult)
- Weight at study initiation:3584 g – 3841 g
- Housing: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
- Diet (e.g. ad libitum):Animals received UNI diet for rabbits produced by Cargill Takarmány Zrt., H-5300 Karcag, Madarasi út 0399, Hungary, ad libitum
- Water (e.g. ad libitum):The animals received municipal tap water, as for human consumption, ad libitum, from an automatic system.
- Acclimation period:at least 22 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C):19.4 –22.6 °C
- Humidity (%):36 – 80 %
- Air changes (per hr):15-20 air exchanges/hour
- Photoperiod (hrs dark / hrs light):12 hours daily, from 6.00 a.m. to 6.00 p.m.

IN-LIFE DATES: From:06 October 2015 To:10 October 2015

Test system

Vehicle:

unchanged (no vehicle)

Controls:

not required

Amount / concentration applied:

An amount of the 0.1 g of test item EPICLON EXA-7250 was administered to the animals.

Duration of treatment / exposure:

As the solid test item remained in the eye sac at the one hour observation time point, the treated eye of test animals was rinsed with physiological saline solution in all animals.

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.

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing (if done): The treated eye of test animals was rinsed with physiological saline solution in all animals.
- Time after start of exposure: 1 hour

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

Results and discussion

In vivo

Results

Irritation parameter:

overall irritation score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Reversibility:

fully reversible within: 24 hours

Remarks on result:

no indication of irritation

Other effects:

MORTALITY
There was no mortality observed during the study.
BODY WEIGHTS
The body weight of the animals was considered to be within the normal range of variability.
CLINICAL OBSERVATION
General daily examination
There were no clinical signs observed that could be related to treatment.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The test item EPICLON EXA-7250, applied to rabbit eye mucosa, caused conjunctival effects at one hour after application which were fully reversible within 24 hours.
According to Regulation (EC) No 1272/2008, EPICLON EXA-7250 does not require classification as an eye irritant.
According to the UN Globally Harmonised System of Classification and Labelling of Chemicals, EPICLON EXA-7250 does not require classification as an eye irritant.

Executive summary:

An acute eye irritation study of the test item EPICLON EXA-7250 was performed in three 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. Three animals were used to make the classification.

 

The test item was placed into the conjunctival sac of the left eye of each animal. The untreated right eye served as control. A single amount of 0.1 g of the test item was administered as a single dose.  

The eyes were examined at 1, 24, 48 and 72 hours after application.  

No Initial Pain Reaction (IPR) or any Pain Reaction (PR) was observed during the experimental period.  

Animal 1 (No: 837) clinical observation  

At one hour after the application, conjunctival redness (score 1) and discharge (score 1) were noted in the rabbit. Test item remained in the eye sac.

At 24 hours after the application, no clinical signs, and no conjunctival or corneal effects were observed.  

At 48 hours after the application, no clinical signs, and no conjunctival or corneal effects were observed.  

At 72 hours after the application, no clinical signs, and no conjunctival or corneal effects were observed.  

Animal 2 (No: 835) clinical observation  

At one hour after the application, conjunctival redness (score 1) and discharge (score 1) were noted in the rabbit. Test item remained in the eye sac.

At 24 hours after the application, no clinical signs, and no conjunctival or corneal effects were observed.  

At 48 hours after the application, no clinical signs, and no conjunctival or corneal effects were observed.  

At 72 hours after the application, no clinical signs, and no conjunctival or corneal effects were observed.  

Animal 3 (No: 832) clinical observation  

At one hour after the application, conjunctival redness (score 1) and discharge (score 1) were noted in the rabbit. Test item remained in the eye sac.

At 24 hours after the application, no clinical signs, and no conjunctival or corneal effects were observed.  

At 48 hours after the application, no clinical signs, and no conjunctival or corneal effects were observed.  

At 72 hours after the application, no clinical signs, and no conjunctival or corneal effects were observed.

The general state and behaviour of animals were normal throughout the study period.  No mortality occurred during the study. The body weights of all rabbits were considered to be within the normal range of variability.  

The animals’ individual mean scores for all aniamls (considering readings at 24, 48 and 72 hours after the treatment) were as follows:

Chemosis 0.00

Discharge 0.00

Redness 0.00

Cornea 0.00

Iris 0.00

The test item EPICLON EXA-7250, applied to rabbit eye mucosa, caused conjunctival effects at one hour after application which were fully reversible within 24 hours.  According to Regulation (EC) No 1272/2008, EPICLON EXA-7250 does not require classification as an eye irritant.  According to the UN Globally Harmonised System of Classification and Labelling of Chemicals, EPICLON EXA-7250 does not require classification as an eye irritant.