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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:
18 August 1998 to 21 August 1998
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Study conducted to EU & OECD test guidance in compliance with GLP.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1998
Report date:
1998

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
Deviations:
no
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes

Test material

Constituent 1
Details on test material:
Name: T-9601
Certificate of analysis: NB 203 dated November 16, 1998
Purity: 94.7 %(m/m)± 0.5%
Appearance: red powder
Melting point: 155°C- 160°C
Solubility: <0,5 g/l in water
Batch number: HI-295
Date of production: May 29, 1998
Date of receiving: July 20, 1998
Date of expiry: May 2001
Storage conditions: darkness at approximately 5°C in a refrigerator

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
Species: New Zealand albino rabbit
Origin: Charles River Deutschland GmbH
Number of animals: 3
Body weight at start of the study: 2.8-3.0 kg
Animal maintenance: in fully air-conditioned rooms in separate cages arranged in a battery
Room temperature: 20±3°C
Relative humidity: 50 ± 20 %
Lighting time: 12 hours daily
Acclimatisation: 1 week under study conditions
Food: ssniff® K-H (V2333), ad libitum and hay (approx. 15 g daily)
Water: water from automatic water dispensers, ad libitum
Animal identification: numbered ear tags

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
other: sesame oil
Controls:
no
Amount / concentration applied:
Dose levels: 500 mg per patch
Each animal was treated with 0.5 g T-9601 pasted with 1.0 ml sesame oil (Oleum sesami DAB 10).
Duration of treatment / exposure:
Exposure 4 hours
Observation period:
72 hours after removal of patch
Number of animals:
3
Details on study design:
About 24 hours before the start of the study the hair in the dorsal region of the body of 3 rabbits was removed with an electric clipper over an area of about 25 cm2. Only animals with intact skin were used.

Each animal was treated with 0.5 g T-9601 pasted with 1.0 ml sesame oil (Oleum sesami DAB 10). The substance was administered over the whole surface of a 2.5 x 2.5 cm cellulose patch on a piece of surgical plaster (specially produced by Beiersdorf Aktiengesellschaft). The plaster was fixed to the prepared skin area and then covered with a semi-occlusive bandage.

The exposure period was 4 hours. After the exposure period all remnants of the test substance were carefully removed from the skin with warm tap water.

Examinations of the skin took place after 30 - 60 minutes as well as 24, 48 and 72 hours after removal of the patches.

Erythema, eschar formation and oedema were evaluated numerically according to the score of DRAIZE. All other changes of the skin were recorded.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Remarks:
all animals
Time point:
other: overall 24, 48, 72 hours
Score:
0
Max. score:
0
Reversibility:
fully reversible within: 3 days
Remarks on result:
other: skin discoloured orange
Irritation parameter:
edema score
Basis:
mean
Remarks:
all animals
Time point:
other: overall 24, 48, 72 hours
Score:
0
Max. score:
0
Reversibility:
fully reversible within: 3 days
Remarks on result:
other: skin discoloured orange
Irritant / corrosive response data:
The reversibility results detailed correspond to minor skin discolouration. No other effects were noted. Three days after removal of the patch the irritations were reversible
Other effects:
From one hour up to one day after removal of the patch the skin surface of the animals was discoloured orange.

Any other information on results incl. tables

Generalised Results by Animal – Animals Against Parameters – Multiple Times

Activity : Skin Irritation Results

Study: 98.0574 – T-9601 – Skin Irritation Test in Rabbits

Group sex

Animal Number

Day Number

Time Slot

Bodyweight

g

Treated Flank

Duration Treatment

Erythema

Edema

1f

313

1

 

2840

Left

4 hours

 

 

 

30-60 min. after decontamination

 

 

 

0

0

2

24 hours after decontamination

 

 

 

0

0

3

48 hours after decontamination

 

 

 

0

0

4

72 hours after decontamination

 

 

 

0

0

314

1

 

2800

Left

4 hours

 

 

 

30-60 min. after decontamination

 

 

 

0

0

2

24 hours after decontamination

 

 

 

0

0

3

48 hours after decontamination

 

 

 

0

0

4

72 hours after decontamination

 

 

 

0

0

315

1

 

2930

Left

4 hours

 

 

 

30-60 min. after decontamination

 

 

 

0

0

2

24 hours after decontamination

 

 

 

0

0

3

48 hours after decontamination

 

 

 

0

0

4

72 hours after decontamination

 

 

 

0

0

Nominal Dose: Group 1 – 0.5g (moistened)

 

Clinical Observations – Clinical Signs by Animal

Study: 98.0574 – T-9601 – Skin Irritation Test in Rabbits

Day numbers relative to Start Date

Group Sex

Animal Number

Clinical Sign

1

2

3

4

30-60 min a. decom.

24 hours a. decom.

48 hours a. decom.

72 hours a. decom

1f

313

No Abnormalities Detected

-

-

X

X

 

Skin Discoloured- Small Area

O

O

-

-

314

No Abnormalities Detected

-

-

X

X

 

Skin Discoloured – Small Area

O

O

-

-

315

No Abnormalities Detected

-

-

X

X

 

Skin Discoloured – Small Area

O

O

-

-

X = Present   O = orange

Nominal Dose: Group 1 – 0.5g (moistened)

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Based on the results of this study T-9601 is not irritating to skin.
Executive summary:

The present study was conducted in compliance with EEC-Guideline B.4."Acute Toxicity Skin Irritation" of the Directive 92/69/EEC: Commission Directive of July 31,1992 adapting to technical progress for the seventeenth time Council Directive 67/548/EEC on the approximation of the laws, regulations and administrative provisions relating to the classification, packaging and labeling of dangerous substances and OECD Guidelines for Testing of Chemicals, 404 „Acute Dermal Irritation / Corrosion", updated guideline, adopted: July 17,1992

From one hour up to one day after removal of the patch the skin surface of the animals was discolored orange.

Three days after removal of the patch the irritations were reversible

Based on the individual scores for erythema and oedema after 24, 48 and 72 hours, the following mean values were calculated as zero. No effects other than skin staining were noted.

The substance is not considered to be an irritant to the skin.

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