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

Skin irritation / corrosion

Administrative data

Endpoint:

skin 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 404 (Acute Dermal 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

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system 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

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

unchanged (no vehicle)

Controls:

no

Amount / concentration applied:

0.5 mL

Duration of treatment / exposure:

4 hours

Observation period:

21 days

Number of animals:

3 male, 3 female

Details on study design:

A semi-occlusive patch test (OECD, 1981) was used to assess the primary skin irritancy induced by undilute test material. 6 rabbits, between 3.9 and 4.6 kg were used. Dorsal hair between the shoulders and hindquarters was closely shorn with fine electric clippers. A 6 cm2 lint patch with 0.5 mL of undilute test substance was placed on the clipped site. The patch was covered in gauze and adhered with elastic adhesive bandage. After 4 hours the wrapping and patch were removed and washed with water. The site was scored for erythema and oedema on a graded scale of 0 to 4. Observations were made 30 minutes, 4, 24, 48, 72 hours, 7, 14 and 21 days after patch removal.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Time point:

other: 4 h

Score:

0

Max. score:

0

Results 2

Irritation parameter:

erythema score

Basis:

mean

Time point:

24 h

Score:

0.5

Max. score:

1

Reversibility:

fully reversible

Results 3

Irritation parameter:

erythema score

Basis:

mean

Time point:

48 h

Score:

0.7

Max. score:

2

Reversibility:

fully reversible

Results 4

Irritation parameter:

erythema score

Basis:

mean

Time point:

72 h

Score:

0.7

Max. score:

2

Reversibility:

fully reversible

Results 5

Irritation parameter:

erythema score

Basis:

mean

Time point:

7 d

Score:

0.7

Max. score:

2

Reversibility:

fully reversible

Results 6

Irritation parameter:

erythema score

Basis:

mean

Time point:

14 d

Score:

0.5

Max. score:

1

Reversibility:

fully reversible

Results 7

Irritation parameter:

erythema score

Basis:

mean

Time point:

21 d

Score:

0

Max. score:

0

Results 8

Irritation parameter:

edema score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

0

Any other information on results incl. tables

Animal Number and Sex	Response	4 h	24 h	48 h	72 h	7 d	14 d	21 d
885 M     892 M     887 M     853 F     852 F     854 F	Erythema Oedema   Erythema Oedema   Erythema Oedema   Erythema Oedema   Erythema Oedema   Erythema Oedema	0 0   0 0   0 0   0 0   0 0   0 0	0 0   1 0   1 0   0 0   0 0   1 0	0 0   1 0   2 0   0 0   0 0   1 0	0 0   1 0   2 0   0 0   0 0   1 0	0 0   1 0   2 0   0 0   0 0   1 0	0 0   1 0   1 0   0 0   0 0   1 0	0 0   0 0   0 0   0 0   0 0   0 0
Mean Erythema score		0	0.5	0.7	0.7	0.7	0.5	0
Mean Oedem score		0	0	0	0	0	0	0

Applicant's summary and conclusion

Interpretation of results:

slightly irritating

Remarks:

Migrated information

Conclusions:

The dermal irritancy of EPIKOTE 862 is determined to be slightly to not irritating based on the GLP study performed using OECD guidelines.

Executive summary:

The erythema and oedema resulting from the application of undilute EPIKOTE 862 to rabbit skin were scored at 4, 24, 48, 72 hours and 7, 14 and 21 days post dosing. The test material caused no skin reactions 4 hours after application. Slight to moderate erythema was observed in three rabbits from 24 hours up to 14 days after application. Flaky skin was noted at 7 days and 14 days. By 21 days effects in all animals had cleared.