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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:
28 March 2000 to 27 September 2000
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Guideline study according to GLP

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2000
Report date:
2000

Materials and methods

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

Test material

Constituent 1
Chemical structure
Reference substance name:
Succinimide
EC Number:
204-635-6
EC Name:
Succinimide
Cas Number:
123-56-8
Molecular formula:
C4H5NO2
IUPAC Name:
pyrrolidine-2,5-dione
Details on test material:
- Name of test material (as cited in study report): "SUCCINIMIDE"
- Chemical name: 2,5-Diketopyrrolidine
- Trade name: Succinimid
- Molecular formula: C4H5NO2
- Supplier: Sponsor
- CAS No.: 123-56-8
- Melting point: 123-125 °C
- Boiling point: 287 °C (decomposition)
- Batch No.: SMDS 022
- Conditions of storage: Room temperature, in the dark
- Stability at storage conditions: Stable
- Date of expiry: December 2000

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Charles River Wiga, D-97633
- Weight at study initiation: Animal No. 1: 2.4 kg, Animal No. 2: 2.2 kg, Animal No. 3: 2.3 kg
- Weith at study termination: Animal No. 1: 2.5 kg, Animal No. 2: 2.3 kg, Animal No. 3: 2.4 kg
- Housing: Optimal hygienic conditions, individual caging in metal wire cages, Ehret GmbH, D-79312 Emmendingen, type KK 016R, 79 cm x 59 cm x 38 cm, with a wooden rest shelf, 15 x 59 cm.
- Diet: Altromin 2023 diet for rabbtis, ad libitum and hay-briquettes (supplied by SSNIFF, D-59494 Soest) were offered additionally as a dietary supplement.
- Water: tap water from an automatical watering system, ad libitum.
- Acclimation period: 5 days.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): average of 22 °C
- Humidity (%): average of 61 %.
- Air changes (per hr): 12 per hour.
- Photoperiod (hrs dark / hrs light): 12 hrs dark, 12 hrs light.

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
water
Remarks:
0.5 g of the test substance were moistened with 1.0 mL deionised water
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
Samples with approximately 0.5 g of the test substance (the weighed amounts of the individual doses were 497, 500 and 500 mg), were moistened with 1.0 mL deionised water and were placed on cellulose patches) in a size of about 2.5 cm x 2.5 cm and were applied to the test sites.
Duration of treatment / exposure:
4 hours
Observation period:
The skins of the animals were examined for local alterations after the clipping procedure, one day before the application and immediately before the application. The treated areas and the surrounding untreated skin (control area) of the animals were examined for erythema/eschar and oedema as well as for other local alterations approximately 1, 24, 48 and 72 hours after patch removal.
Number of animals:
3 females
Details on study design:
TEST SITE
- Area of exposure: 2.5 cm x 2.5 cm at dorsal area of the trunk (dorsal thoracal region).
- Type of wrap if used: Samples of the test substance were spread on cellulose patches and were applied to the test sites. They were held in place by fixing them marginally with non irritating tapes. The application sites were covered semi-occlusively by a dressing. Access by the animal to the application sites was prevented by a plastic collar.

REMOVAL OF TEST SUBSTANCE
- Time after start of exposure: duration of exposure was 4 hours. At the end of the exposure period the dressing, the tapes with the patches and the collar were removed, residual test substance was removed with wet Kleenex-tissues.

SCORING SYSTEM:
The treated ares and the surrounding untreated skin (control area) were examined for erythema/eschar and oedema as well as for other local signs 1, 24, 48 and 72 hours after patch removal.
The skin was examined using a light source KL 1500 electronic.
Dermal irritation was described and recorded according to the scoring scheme for acute dermal irritation/corrosion tests. (see below).



Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Remarks:
all 3 animals
Time point:
other: 1, 24, 48, 72 h
Score:
0
Max. score:
0
Reversibility:
other: not applicable
Irritation parameter:
edema score
Basis:
mean
Remarks:
all 3 animals
Time point:
other: 1, 24, 48, 72 h
Score:
0
Max. score:
0
Reversibility:
other: not applicable
Irritant / corrosive response data:
All areas treated with the test substance and all control areas were normal before the application.
Erythema/eschar: Not observed at any observation point.
Oedema: Not observed at any observation point.
Other effects:
None

Any other information on results incl. tables

 

 

Mean Scores for Animal No.:

 

1

2

3

Erythema / Eschar:

0.0

0.0

0.0

Oedema:

0.0

0.0

0.0

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The test substance did not cause any adverse skin reactions in this study.
Executive summary:

Aim of the study

The aim of this study was to investigate possible irritation or corrosion by the test substance following a single application to the intact skin of rabbits.

Methods

Methods and investigations were performed in accordance with the OECD Guideline 404 and the Directive 92/69/EC, method B.4.

Administration of the test substance

0.5 g "Succinimide", moistened with deionised water was applied via a patch to a site of 2.5 cm x 2.5 cm of the intact skin of each of 3 New Zealand White rabbits and covered by a semi-occlusive dressing. The duration of the exposure was 4 hours.

Investigations

·      Body weights: at the start and at the termination of the test.

·      General signs of toxicity: once daily.

·      Skin examinations: 1, 24, 48 and 72 h after patch removal (p.a.).

Results

General signs of toxicity: No symptoms of systemic toxicity were observed in the animals during the test period and no mortality occurred.

Skin examinations: All exposed skin sites were normal at each examination term.

Conclusion

The following mean scores were calculated for each animal from the examinations 24 h, 48 h and 72 h p.a.:

 

 

Mean Scores for Animal No.:

 

1

2

3

Erythema / Eschar

0.0

0.0

0.0

Oedema

0.0

0.0

0.0

 

The test substance did not cause any adverse skin reactions in this study.