6-glycidyloxynapht-1-yl oxymethyloxirane

Skin sensitisation

Administrative data

Endpoint:

skin sensitisation: in vivo (non-LLNA)

Type of information:

experimental study

Adequacy of study:

key study

Study period:

30.05.1986 to 07.07.1986

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Guideline study performed under GLP.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1986

Report date:

1986

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

EPA OTS 798.4100 (Skin Sensitisation)

GLP compliance:

yes (incl. QA statement)

Type of study:

Buehler test

Test material

Test material information

Constituent 1

Reference substance name:

-

EC Number:

429-960-2

EC Name:

-

Cas Number:

27610-48-6

Molecular formula:

C16H16O4

IUPAC Name:

2-[({6-[(oxiran-2-yl)methoxy]naphthalen-1-yl}oxy)methyl]oxirane

In vivo test system

Test animals

Species:

guinea pig

Strain:

Dunkin-Hartley

Sex:

female

Details on test animals and environmental conditions:

- Twenty female albino guinea-pigs of the Hartley/Dunkin strain were obtained from D. Hall, Newchurch, Staffordshire, England.
-The guinea-pigs were all acclimated to the laboratory environment.
- Each animal was identified by ear tattoo.
- The guinea-pigs were housed in suspended cages with wire mesh floors and they had free access to tap water and a Vitamin C-enriched Guinea-pig Diet F.D.1 (Special Diets Services Limited). Hay was given once weekly.
- Animal room temperature was approximately 21°C and relative humidity 30-70%.
- Air exchange was maintained at approximately 15 air changes per hour and lighting was controlled by means of a time switch to give 12 hours of artificial light in each 24 hour period.

Study design: in vivo (non-LLNA)

Induction

Induction 1

Route:

epicutaneous, occlusive

Vehicle:

other: Acetone in Alembicol D.

Induction 2

Concentration / amount:

The following concentrations of Epiclon EXA-4032 were selected:
-Induction: 1% v/v in 5% v/v acetone in Alembicol D.
-Challenge: 0.05% v/v in 5% v/v acetone in Alembicol D.

Challenge

Challenge 1

Route:

epicutaneous, occlusive

Vehicle:

other: Acetone in Alembicol D.

Challenge 2

Concentration / amount:

The following concentrations of Epiclon EXA-4032 were selected:
-Induction: 1% v/v in 5% v/v acetone in Alembicol D.
-Challenge: 0.05% v/v in 5% v/v acetone in Alembicol D.

No. of animals per dose:

10 test animals and 10 control animals

Details on study design:

Induction exposure:
-Prior to each induction application, the skin on the left shoulder region of the guinea-pig was clipped free of hair using electric clippers.
- A 2*2 cm patch of surgical gauze (3 layers thick) was satured with approximately 0.5 ml of Epiclon EXA-4032, 1% v/v in 5% v/v acetone in Alembicol D. The patch was placed on the skin and covered by a lenght of impermeable plastic adhaesive tape (5 cm with "blenderm". This in turn was firmly secured by elastic adhesive bandage (Elastoplast 5 cm width) wound round the torso of the animal and fixed with "Sleek" impervious plastic adhasive tape. Contact with the skin was maintained for approximately 6 hours for each induction exposure.
The dressing were then removed and the resulting dermal reactions assessed approximately 24 hours later for erythema and oedema.
Nine induction applications were made in this manner three times a week during a three week period. Due to the development of severe dermal reactions, the induction site was re-located on the fifth and then the eigh inductions.
Control animal:
-During the induction period the control animals were treated similary to the test animals with the exception that the test compound was omitted from the induction applications.
Challenge:
-The test and control animals were challenged topically two weeks after the ninth induction application using Epiclon EXA-4032, 0.05% v/v in 5% v/v acetone in Alembicol D.
- Hair was removed by clipping from a 5*5 area on the right flank of each guinea-pig. A 2*2 cm gauze patch (3 layers thick) was saturated with approximately 0.5 ml of the test sample in a similar fashion to that used for the induction applications. The patch was sealed to the flank for approximately 6 hours undr a 5 cm strip of "Blenderm" covered by "Elastoplast" wound round he trunk and secured with "Sleek".

Scores:
Erythema and eschar formation.
-No erythema: 0
-Slight erythema (barely perceptible): 1
-Well-defined erythema: 2
-Moderate erythema: 3
-Severe erythema (beet redness) to slight eschar formation (injuries in depth)

Oedema formation.
-No oedema: 0
-Slight oedema (barely perceptible): 1
-Well-defined oedema (edges of area well-defined by definite raising): 2
-Moderate oedema (raised approximately 1 millimetre): 3
-Severe oedema (raised more than 1 millimetre and extending beyond area of exposure): 4

Challenge controls:

The control animals were challenged topically two weeks after the ninth induction application using Epiclon EXA-4032, 0.05% v/v in 5% v/v acetone in Alembicol D.
- Hair was removed by clipping from a 5*5 area on the right flank of each guinea-pig. A 2*2 cm gauze patch (3 layers thick) was saturated with approximately 0.5 ml of the test sample in a similar fashion to that used for the induction applications. The patch was sealed to the flank for approximately 6 hours undr a 5 cm strip of "Blenderm" covered by "Elastoplast" wound round he trunk and secured with "Sleek".

Positive control substance(s):

not specified

Results and discussion

In vivo (non-LLNA)

Results

Results 1

Reading:

1st reading

Hours after challenge:

24

Group:

test chemical

Dose level:

0.05%

No. with + reactions:

10

Total no. in group:

10

Remarks on result:

other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 0.05%. No with. + reactions: 10.0. Total no. in groups: 10.0.

Results 2

Reading:

2nd reading

Hours after challenge:

48

Group:

test chemical

Dose level:

0.05%

No. with + reactions:

10

Total no. in group:

10

Remarks on result:

other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 0.05%. No with. + reactions: 10.0. Total no. in groups: 10.0.

Results 3

Reading:

1st reading

Hours after challenge:

24

Group:

negative control

Dose level:

0.05%

No. with + reactions:

5

Total no. in group:

10

Remarks on result:

other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 0.05%. No with. + reactions: 5.0. Total no. in groups: 10.0.

Results 4

Reading:

2nd reading

Hours after challenge:

48

Group:

negative control

Dose level:

0.05%

No. with + reactions:

4

Total no. in group:

10

Remarks on result:

other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 0.05%. No with. + reactions: 4.0. Total no. in groups: 10.0.

Applicant's summary and conclusion

Interpretation of results:

Category 1 (skin sensitising) based on GHS criteria

Remarks:

Migrated information

Conclusions:

In this screening test, performed in ten albino guinea-pigs, Epiclon EXA-4032 produced evidence of delayed contact hypersensitivity in all ten animals.

Executive summary:

This study was designed to assess skin sensitisation potential.This study was performed according Guidelines as described in the Federal Register, Vol. 50, N° 188, Part II of 27 September 1985, Section 798.4100_Dermal Sensitisation.

For the experiment, twenty female albio guinea-pigs were used (10 for the test animals and 10 for control animals).

The procedure may be considered in two parts: Inuction and Challenge.

The following concentrations of Epiclon EXA-4032 were selected:

-Induction: 1% v/v in 5% v/v acetone in Alembicol D.

-Challenge: 0.05% v/v in 5% v/v acetone in Alembicol D.

-All animals were observed daily for signs of ill health or toxic signs.

In this screening test, performed in 10 albino guinea-pigs, Epiclon EXA-4032 produced evidence of delayed contact hypersensitivity in all ten animals.