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Toxicological information

Skin irritation / corrosion

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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

Constituent 1
Chemical structure
Reference substance name:
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
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(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
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

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 4 h
Score:
0
Max. score:
0
Irritation parameter:
erythema score
Basis:
mean
Time point:
24 h
Score:
0.5
Max. score:
1
Reversibility:
fully reversible
Irritation parameter:
erythema score
Basis:
mean
Time point:
48 h
Score:
0.7
Max. score:
2
Reversibility:
fully reversible
Irritation parameter:
erythema score
Basis:
mean
Time point:
72 h
Score:
0.7
Max. score:
2
Reversibility:
fully reversible
Irritation parameter:
erythema score
Basis:
mean
Time point:
7 d
Score:
0.7
Max. score:
2
Reversibility:
fully reversible
Irritation parameter:
erythema score
Basis:
mean
Time point:
14 d
Score:
0.5
Max. score:
1
Reversibility:
fully reversible
Irritation parameter:
erythema score
Basis:
mean
Time point:
21 d
Score:
0
Max. score:
0
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.