Reaction mass of 2,2'-[methylenebis(2,1-phenyleneoxymethylene)]bis(oxirane) and 2,2'-[methylenebis(4,1-phenyleneoxymethylene)]bis(oxirane) and 2-({2-[4-(oxiran-2-ylmethoxy)benzyl]phenoxy}methyl)oxirane

Eye irritation

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: In accordance with internationally valid GLP principles

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1988

Report date:

1988

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Reaction mass of 2,2'-[methylenebis(4,1-phenyleneoxymethylene)]dioxirane and [2-({2-[4-(oxiran-2-ylmethoxy)benzyl]phenoxy}methyl)oxirane and [2,2'-[methylenebis(2,1-phenyleneoxymethylene)]dioxirane

EC Number:

701-263-0

Cas Number:

9003-36-5

Molecular formula:

C6 H6. C3 H5 Cl . C H2 O)x

IUPAC Name:

Reaction mass of 2,2'-[methylenebis(4,1-phenyleneoxymethylene)]dioxirane and [2-({2-[4-(oxiran-2-ylmethoxy)benzyl]phenoxy}methyl)oxirane and [2,2'-[methylenebis(2,1-phenyleneoxymethylene)]dioxirane

Details on test material:

EPIKOTE 862

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

ANIMALS
Source: Sittingbourne Research Centre Breeding Unit
Age: 3-6 months
Acclimatization: 2 weeks
Housing: singly in stainless steel cages
Food: ad libitum, Standard Rabbit Diet, S.Q.C. and water
Temperature: 16-22 degrees C
Lighting: 12 hour light dark cycle

Test system

Vehicle:

unchanged (no vehicle)

Controls:

no

Amount / concentration applied:

0.1 mL

Duration of treatment / exposure:

The eyes were not washed after treatment

Observation period (in vivo):

7 days

Number of animals or in vitro replicates:

3 male, 3 female

Details on study design:

The eye irritancy was assessed using a method based on that described in the OECD Guidelines. 6 rabbits, between 4.2 and 5.1 kg were used. 0.1 mL of undilute test substance was placed into the lower conjunctival sac of one eye on each rabbit and the lids held together for a few seconds to prevent lose of material. The eyes were not washed. An initial pain assessment was made and graded on scale from 1 to 6. The eye irritancy was scored at 1, 4, 24, 48, 72 hours and 7 days after exposure for cornea, iris and conjunctivae using the standard scores.

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:

0

Results 2

Irritation parameter:

iris score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

0

Results 3

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

0

Results 4

Irritation parameter:

chemosis score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

0

Other effects:

No initial pain response

Any other information on results incl. tables

Animal No. and sex	Initial effect		Time after instillation
			1 h	4 h	24 h	48 h	72 h	7 d
921 M         923 M         924 M         879 F         878 F         906 F	None         None         None         None         None         None	Redness Chemosis Opacity Iris   Redness Chemosis Opacity Iris   Redness Chemosis Opacity Iris   Redness Chemosis Opacity Iris   Redness Chemosis Opacity Iris   Redness Chemosis Opacity Iris	0 0 0 0   0 0 0 0   0 0 0 0   0 0 0 0   0 0 0 0   0 0 0 0	0 0 0 0   0 0 0 0   0 0 0 0   0 0 0 0   0 0 0 0   0 0 0 0	0 0 0 0   0 0 0 0   0 0 0 0   0 0 0 0   0 0 0 0   0 0 0 0	0 0 0 0   0 0 0 0   0 0 0 0   0 0 0 0   0 0 0 0   0 0 0 0	0 0 0 0   0 0 0 0   0 0 0 0   0 0 0 0   0 0 0 0   0 0 0 0	0 0 0 0   0 0 0 +0   0 0 0 0   0 0 0 0   0 0 0 0   0 0 0 0
Mean Score   Grade	1	Redness Chemosis Opacity Iris	0 0 0 0	0 0 0 0	0 0 0 0	0 0 0 0	0 0 0 0	0 0 0 0

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information

Conclusions:

In the rabbit eye irritancy test, 0.1 mL of the test material caused no irritation. On administration of the test material there was no initial pain response.

Executive summary:

Six adult albino rabbits were used to evaluate eye irritating properties of BPFDGE when instilled in eye. The test substance (0.1 ml undiluted) was instilled in the conjunctiva sac of one eye. Irritation and injury to the cornea, iris, and conjunctiva were scored at 1, 24, 48, 72 hr and 7 days after the initial exposure. Based on the findings from this study, BPFDGE is not an eye irritant.