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Diss Factsheets

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:
2000-05-01 to 2000-09-26
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

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)
Version / remarks:
adopted 17 July 1992
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
Version / remarks:
adopted 29 December 1992
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
Test material form:
solid: flakes
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
Specific details on test material used for the study:
TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing: 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

OTHER SPECIFICS:
- measurement of pH: 4.4 (1% solution in deionized water, v/v, determined with a pH-Meter)

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
- Age at study initiation: not specified
- Weight at study initiation: Animal No. 1: 2.4 kg, Animal No. 2: 2.2 kg, Animal No. 3: 2.3 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 rabbits, 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
- Amount(s) applied (volume or weight with unit): 0.5 g (the weighed amounts of the individual doses were 497, 500 and 500 mg) were moistened with 1.0 mL deionised water

VEHICLE
- Amount(s) applied (volume or weight with unit): 1.0 mL deionised water
Duration of treatment / exposure:
4 hours
Observation period:
1, 24, 48, 72 hours
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 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 of Draize (see in box “Any other information on materials & methods incl. tables”)

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
other: 1 h
Score:
0
Max. score:
0
Reversibility:
other: not applicable
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24 h
Score:
0
Max. score:
0
Reversibility:
other: not applicable
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
48 h
Score:
0
Max. score:
0
Reversibility:
other: not applicable
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
72 h
Score:
0
Max. score:
0
Reversibility:
other: not applicable
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
other: 1 h
Score:
0
Max. score:
0
Reversibility:
other: not applicable
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24 h
Score:
0
Max. score:
0
Reversibility:
other: not applicable
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
48 h
Score:
0
Max. score:
0
Reversibility:
other: not applicable
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
72 h
Score:
0
Max. score:
0
Reversibility:
other: not applicable
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
other: 1 h
Score:
0
Max. score:
0
Reversibility:
other: not applicable
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
24 h
Score:
0
Max. score:
0
Reversibility:
other: not applicable
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
48 h
Score:
0
Max. score:
0
Reversibility:
other: not applicable
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
72 h
Score:
0
Max. score:
0
Reversibility:
other: not applicable
Irritation parameter:
edema score
Basis:
animal #1
Time point:
other: 1 h
Score:
0
Max. score:
0
Reversibility:
other: not applicable
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24 h
Score:
0
Max. score:
0
Reversibility:
other: not applicable
Irritation parameter:
edema score
Basis:
animal #1
Time point:
48 h
Score:
0
Max. score:
0
Reversibility:
other: not applicable
Irritation parameter:
edema score
Basis:
animal #1
Time point:
72 h
Score:
0
Max. score:
0
Reversibility:
other: not applicable
Irritation parameter:
edema score
Basis:
animal #2
Time point:
other: 1 h
Score:
0
Max. score:
0
Reversibility:
other: not applicable
Irritation parameter:
edema score
Basis:
animal #2
Time point:
24 h
Score:
0
Max. score:
0
Reversibility:
other: not applicable
Irritation parameter:
edema score
Basis:
animal #2
Time point:
48 h
Score:
0
Max. score:
0
Reversibility:
other: not applicable
Irritation parameter:
edema score
Basis:
animal #2
Time point:
72 h
Score:
0
Max. score:
0
Reversibility:
other: not applicable
Irritation parameter:
edema score
Basis:
animal #3
Time point:
other: 1 h
Score:
0
Max. score:
0
Reversibility:
other: not applicable
Irritation parameter:
edema score
Basis:
animal #3
Time point:
48 h
Score:
0
Max. score:
0
Reversibility:
other: not applicable
Irritation parameter:
edema score
Basis:
animal #3
Time point:
72 h
Score:
0
Max. score:
0
Reversibility:
other: not applicable
Irritation parameter:
edema score
Basis:
animal #3
Time point:
24 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.
Edema: Not observed at any observation point.
For indi
Other effects:
None

Any other information on results incl. tables

                                             Table 1: Individual scoring values

   Scores for Animal No.:      
  1   2  3
 Erythema / Eschar: 1 h/24 h/48 h/72 h  0/0/0/0
  0/0/0/0 0/0/0/0
 Edema:  1 h/24 h/48 h/72 h  0/0/0/0  0/0/0/0 0/0/0/0

 

 

 

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The test substance did not cause any adverse skin reactions in this study.
Executive summary:

In a primary dermal irritation study conducted according to guideline OECD 404, 3 female New-Zealand-White rabbits were exposed with 0.5 g succinimide in 1 mL deionised water for 4 hours. Animals then were observed for 72 hours. Irritation was scored by the method of Draize.

No symptoms of systemic toxicity were observed in the animals during the test period and no mortality occurred. All exposed skin sites were normal at each examination term.

In this study, succinimide is not a dermal irritant.