[[(2-ethylhexyl)oxy]methyl]oxirane

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

from September 29, 1983 to October 10, 1983

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1983

Report date:

1983

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

not specified

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

[[(2-ethylhexyl)oxy]methyl]oxirane

EC Number:

219-553-6

EC Name:

[[(2-ethylhexyl)oxy]methyl]oxirane

Cas Number:

2461-15-6

Molecular formula:

C11H22O2

IUPAC Name:

2-{[(2-ethylhexyl)oxy]methyl}oxirane

Test material form:

other: liquid

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

Experimental animals:
Rationale
The albino rabbit has been selected as being a recognized species for the conduct of acute eye irritation studies.
Source: Kleintierfarm Madoerin AG, CH-4414 Fuellinsdorf
Initial age range: 12 - 14 weeks
Initial body weight range: 2000 - 2310 g
Individual identification: numbered ear tags; The cages were marked with sex, animal No., GU-Project No. and the company code of the
test article.
Husbandry: Animals were housed individually in metal cages. The animal room was air conditioned: temperature 20 ±3 ° C, relative humidity 30 - 70%; 12 hours light/day, approximately 15 air changes/h.
Diet and water: Rabbit food, NAFAG, No. 814 Tox, NAFAG AG, Gossau, SG (Switzerland), and water were provided ad libitum.
Euthanasia: At the end of the observation period, the animals were killed by the intravenous injection of hypnotic T61 (Hoechst).

Test system

Vehicle:

unchanged (no vehicle)

Controls:

other: left eye remained untreated and served as the control

Amount / concentration applied:

0.1 mL of the test article was placed into the conjunctival sac of the right eye of each animal, after gently pulling away the lower lid from the eyeball. The lids were then held together for about one second in order to prevent loss of the test material.

Duration of treatment / exposure:

1 second

Observation period (in vivo):

The ocular reactions were examined 1, 24, 48, and 72 hours after substance instillation and again during the following observation period.

Number of animals or in vitro replicates:

3 females

Details on study design:

The ocular irritation scores were evaluated according to the scoring system.
The irritating and/or corrosive potential of the test article (theoretical range: non irritant - extremely irritant) was assessed on the basis of the maximum irritant effect observed
- in one or several of the ocular tissues (conjunctiva, iris, cornea), observed over the range of observation time
- in one or more animals and taking into account the reversibility of the effect.
Symptoms: daily (a.m. and p.m. on working days, once daily on weekends and holidays).
Body weight: At begin of the acclimatisation and end of test
Mortality: Daily (a.m. and p.m. on working days, once daily on weekends and holidays).

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

not specified

Results 2

Irritation parameter:

iris score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

2

Reversibility:

not specified

Results 3

Irritation parameter:

chemosis score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

not specified

Results 4

Irritation parameter:

conjunctivae score

Basis:

animal #1

Remarks:

mean value

Time point:

24/48/72 h

Score:

0

Max. score:

3

Reversibility:

fully reversible within: 48hrs

Results 5

Irritation parameter:

conjunctivae score

Basis:

animal #2

Remarks:

mean value

Time point:

24/48/72 h

Score:

ca. 0.33

Max. score:

3

Reversibility:

fully reversible within: 48hrs

Results 6

Irritation parameter:

conjunctivae score

Basis:

animal #3

Remarks:

mean value

Time point:

24/48/72 h

Score:

ca. 0.33

Max. score:

3

Reversibility:

fully reversible within: 48 hrs

Irritant / corrosive response data:

The reaction scores of treated eyes are summarized in the table 1 and table 2 below.

Other effects:

The animals showed a normal body weight development.
No other reactions to treatment were recorded during the whole observation period.

Any other information on results incl. tables

Table 1 individual eye scores

Animal No./Sex	54/F	55/F	56/F	Evaluation
After 1 h	0	0	0	0= non irritant 1= slightly irritant 2= irritant 3-4 = severely irritant += corrosion Cornea
After 24 h	0	0	0
After 48 h	0	0	0
After 72 h	0	0	0
After 7 days	0	0	0
After 1 h	0	0	0	0= non irritant 1= irritant 2= severely irritant += corrosion Iris
After 24 h	0	0	0
After 48 h	0	0	0
After 72 h	0	0	0
After 7 days	0	0	0
After 1 h	1	2	2	0= non irritant 1= slightly irritant 2= irritant 3= severely irritant += corrosion Conjuctival(redness)
After 24 h	0	1	1
After 48 h	0	0	0
After 72 h	0	0	0
After 7 days	0	0	0
After 1 h	1	1	1	0= no swelling 1= slightly swelling 2= swelling 3-4 = severe swelling Chemosis(swelling)
After 24 h	0	0	0
After 48 h	0	0	0
After 72 h	0	0	0
After 7 days	0	0	0

Table 2 Mean value of 24 -72 hrs

	Cornea	Iris	conjuctiva	chemosis
54/F	0	0	0	0
55/F	0	0	0.33	0
56/F	0	0	0.33	0

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Remarks:

Criteria used for interpretation of results: EU CLP

Conclusions:

It can be concluded that test substance is slightly irritant and not corrosive when applied to the rabbit eye mucosa; there was a clear tendency of recovery towards the end of the observation period.

Executive summary:

Acute eye irritation study was established to assess the potential of eye irritation of test substance. 0.1 mL of the test article was placed into the conjunctival sac of the right eye of each animal, after gently pulling away the lower lid from the eyeball. The ocular reactions were examined 1, 24, 48, and 72 hours after substance instillation and again during the following observation period. The animals showed a normal body weight development. No other reactions to treatment were recorded during the whole observation period. Because the mean values of the readings 24 to 72 hours after instillation of test substance are below the threshold of significance, and there was a clear tendency of recovery towards the end of the observation period the test substance does not require classification for eye effects in accordance with CLP (Regulation EC No. 1272/2008).