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Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: comparable to guideline with acceptable restrictions (occlusive conditions, 72 h reading missing, 8-day observation period)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1981
Report date:
1981

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
yes
Remarks:
occlusive conditions, 72 h reading missing, limited documentation
GLP compliance:
no

Test material

Constituent 1
Reference substance name:
2-cyano-2-[2,3-dihydro-3-(tetrahydro-2,4,6-trioxo-5(2H)-pyrimidinylidene)-1H-isoindol-1-ylidene]-N-methylacetamide
EC Number:
278-388-8
EC Name:
2-cyano-2-[2,3-dihydro-3-(tetrahydro-2,4,6-trioxo-5(2H)-pyrimidinylidene)-1H-isoindol-1-ylidene]-N-methylacetamide
Cas Number:
76199-85-4
IUPAC Name:
2-cyano-N-methyl-2-[3-(2,4,6-trioxotetrahydropyrimidin-5(2H)-ylidene)-2,3-dihydro-1H-isoindol-1-ylidene]acetamide
Details on test material:
- Test substance number: 80/345
- Physical state: solid, yellow
- Analytical purity: 88 %
- Stability: At least 2 years under normal conditions
- Expiration date of the lot/batch: October 1983

Test animals

Species:
rabbit
Strain:
Vienna White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Gaukler Offenbach/Main, Germany
- Weight at study initiation: male 2.98 kg, female 3.72 kg
- Housing: one animal per cage of stainless steel with wire mesh walk floors, floor area: 40 cm x 51 cm,
- Diet (e.g. ad libitum): Ovator Solikanin 4 mm; Muskator-Werke, Duesseldorf , Germany (about 130 g per animal per day)
- Water (e.g. ad libitum): About 250 ml per animal per day: demineralized water (Monday-Friday), tap water (Saturday/Sunday)
- Acclimation period: About 8 days before the beginning of the study in the skin laboratory; same housing conditions as during the study

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 26
- Humidity (%): Conventional (about 30 - 70%)
- Photoperiod (hrs dark / hrs light): 12 h/12 h

Test system

Type of coverage:
occlusive
Preparation of test site:
other: clipping of the fur at least 15 hours before beginning of the study
Vehicle:
water
Controls:
other: Untreated skin sites of the same animal
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g of the test substance is applied
- Concentration (if solution): 50 % aqueous formulation
Duration of treatment / exposure:
4 hours
Observation period:
8 days
Number of animals:
1 male, 1 female
Details on study design:
TEST SITE
- Area of exposure: 2.5 cm x 2.5 cm, Upper third of the back or flank

REMOVAL OF TEST SUBSTANCE
- Washing (if done): At the end of the exposure period with Lutrol and Lutrol/water (1:1)

SCORING SYSTEM: According to J. H. Draize: Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics. In Dermal Toxicity pp. 46 - 59, 1959. Austin, Tex.: Association of Food and Drug Officials of the United States, Texas, State Department of Health

READINGS: 30 - 60 minutes after removal of the test patches and 24 h, 48 h and 8 d after the beginning of application

ADDITIONAL EXAMINATIONS: After sacrifice the animals are examined by gross pathology. If there are clinical signs of necroses, these are confirmed by gross-pathological examination after incision of the skin.


Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24 - 48 h
Score:
0
Max. score:
4
Reversibility:
other: no effects
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24 - 48 h
Score:
0
Max. score:
4
Reversibility:
other: no effects
Irritant / corrosive response data:
No effects were observed 8 days after the treatment.
Other effects:
No other effects.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information

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