Registration Dossier
Registration Dossier
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EC number: 286-185-0 | CAS number: 85187-95-7
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- other: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- From December 11 to 19, 1978
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 979
- Report date:
- 1979
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- other: "Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics" (1959), the US Association of Food and Drug Officials (AFDO)
- GLP compliance:
- no
- Remarks:
- Study conducted before 1981
Test material
- Reference substance name:
- Basic Red 018 Acetate - Similar Substance 01
- IUPAC Name:
- Basic Red 018 Acetate - Similar Substance 01
- Test material form:
- solid
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- Himalayan
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: WIGA Versuchstierzuchtanstalt, 8741 Sulzfeld, Germany
- Weight at study initiation: 1.5 to 2 kg
- Housing: housed individually in metal cages
- Diet: standard rabbit food - NAFAG, Gossau SG ad libitum
- Water: ad libitum
- Acclimation period: for a minimum of 4 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 1 °C
- Humidity (%): 55 ± 5 %
- Photoperiod (hrs dark / hrs light): 10 hours light cycle day
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- shaved
- Vehicle:
- other: propylene glycol + saline (70 : 30 parts)
- Controls:
- not specified
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied: 0.5 g of test material
- Concentration: 50 % - Duration of treatment / exposure:
- 24 hours
- Observation period:
- 7 days
- Number of animals:
- 3 male and 3 female
- Details on study design:
- PREPARATION
Before treatment the entire back and the flank of the rabbits were shaved with an electric clipper and immediately before treatment the shaven skin on one side was slightly scarified with the help of a "SchröpfSchnäpper", Aesculap, Switzerland
TEST SITE
- Area of exposure: 2.5 x 2.5 cm
- Type of wrap if used: gauze patches. The patches were covered with an impermeable material and were fastened to the body of the rabbit with adhesive tape.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- edema score
- Basis:
- animal: 265, 267, 268, 269
- Time point:
- other: mean score following grading at 24, 48, 72 hours
- Score:
- ca. 0.33
- Max. score:
- 1
- Reversibility:
- fully reversible within: 48 hours
- Remarks on result:
- other: intact skin
- Irritation parameter:
- edema score
- Basis:
- animal:
- Time point:
- other: 266, 270
- Score:
- ca. 0
- Max. score:
- 0
- Reversibility:
- other: No dermal effects observed
- Remarks on result:
- other: intact skin
Any other information on results incl. tables
Due to intensive staining by the test compound erythema was not assessable. For the purpose of calculating the primary irritation index erythema was assumed to be equal to edema based on the correlation existing (Marzulli and Maibach, Fol. Cosm. Tox. 13, 355, 1975).
Applicant's summary and conclusion
- Interpretation of results:
- other: CLP criteria not met
- Conclusions:
- Non irritant
- Executive summary:
Method:
The skin irritation was determined in an irritation test on rabbits according to the Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics (1959), the US Association of Food and Drug Officials (AFDO), similar to OECD guideline 404. During the test 3 male and 3 female of Hymalaian rabbit were exposed to the substance on intact and abradeed skin, nevertheless in order to evaluate the irritation potential of the substance only the scores registered on intact skin were considered.
Due to intensive staining by the test compound erythema was not assessable. For the purpose of calculating the primary irritation index erythema was assumed to be equal to edema based on the correlation existing (Marzulli and Maibach, Fol. Cosm. Tox. 13, 355, 1975).
Result:
Not irritating
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