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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
Study period:
1999
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP OECD study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1999
Report Date:
1999

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
liquid

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
Animals were received from Ace Animals, Boyertown, PA on 5/18/99
The pretest body weight range was 2.3-2.7 kg.
The animals were born the weeks of 2/28 through 3/21/99
The animals were identified by cage notation and a uniquely numbered metal eartag and housed 1/cage in suspended wire cages.
Bedding was placed beneath the cages and changed at !east three times/week
Fresh Purina Rabbit Chow (Diet #5321) was provided daily. Water was freely available. The animal room, reserved exclusively for rabbits on acute tests, was temperature controlled (68 - 72°F) with a humidity range of 57- 72%, had a 12 hour light/dark cycle, and was kept clean and vermin free.

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount applied: 0.5 mL (undiluted)

Duration of treatment / exposure:
4 hours
Observation period:
Until 7 days after removal of the patch
Number of animals:
3
Details on study design:
The test article was placed under a 2.5 x 2.5 cm, 4 ply, surgical gauze patch
The patch was secured with non-irritating tape. The torso was wrapped with plastic in a semi-occlusive manner and secured with non-irritating tape which completely covered the plastic. Residual test article was removed from the test site by gentle washing with distilled water at the end of the exposure period, prior to scoring fur dermal reactions.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
2
Max. score:
4
Reversibility:
not fully reversible within: 7 days
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0.3
Max. score:
4
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0.3
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
edema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
1.3
Max. score:
4
Reversibility:
not fully reversible within: 7 days
Irritation parameter:
edema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4

Any other information on results incl. tables

Body Weight observations:

R.abbitEartag:

F2084

F2103

F2106

Sex:

Pre test Body Weight-kg

F

2.7

F

2.3

F

-2.6

72 Hour Body Weight-kg

2.7

2.4

2.5

Tenninal Body Weight-kg

2.8

2.8

2.7

Erythema and escar scores:

R.abbitEartag:

F2084

F2103

F2106

60 minutes

2

2

1

24 hours

2

2

1

48 hours

1

2

0

72 hours

0

2

0f

7 days

0

2

0f

f: flaking skin

Edema scores:

R.abbitEartag:

F2084

F2103

F2106

60 minutes

1

1

0

24 hours

1

2

0

48 hours

0

1

0

72 hours

0

1

0

7 days

0

1

0

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The substance TBEC elicited slight skin irritation in an OECD 404 test, but doesn't need to be classified as irritating to skin, according to EU regulation, since mean scores for erythema, eschar formation, and oedema, are less than 2 (only one animal with a mean score of 2 for erythema and eschar formation).
Executive summary:

The acute dermal irritation potential of TBEC was evaluated in rabbits according to OECD 404 guideline . The substance was applied undiluted to the skin of 3 New-Zealand White albino rabbits and held in contact for 4 hours by means of a semi-occlusive dressing.

Oedemal reactions were scored at 60 minutes after removal of wrappings. Reactions were scored again at 24, 48 and 72 hours and on day 7 following patch removal.The skin was also evaluated for ulceration and necrosis or any evidence of tissue destruction at these timeperiods. Bodyweights were recorded pre-test, 72 hours and at termination.

Mean scores for erythema, eschar formation, and oedema, were less than 2 (excepting for one animal: a mean score of 2 for erythema and eschar formation was recorded).Erythema was barely perceptible to slight at 60 minutes and 24 hours following patch removal and absent to slight at 48 and 72 hours and on day 7. Edema was absent to barely perceptible at 60 minutes following patch removal, absent to slight at 24 hours and absent to barely perceptible at 48 and 72 hours and on day 7.

There were no abnormal physical signs noted during the observation period.