Registration Dossier
Registration Dossier
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EC number: 229-398-6 | CAS number: 6507-79-5
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- other: read across from similar substacne
- Adequacy of study:
- key study
- Study period:
- May 7, 1973
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Study conducted according to internationally accepted testing procedures.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 973
- Report date:
- 1973
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: "Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics" (1959) of the US Association of Food and Drug Officials (AFDO).
- Deviations:
- not specified
- GLP compliance:
- no
Test material
- Reference substance name:
- similar substance 01
- IUPAC Name:
- similar substance 01
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- not specified
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS- Source: Russian breed- Age at study initiation: no data- Weight at study initiation: 2.2 to 3.2 kg- Housing: They were housed singly in metal cages (overall dimensions 47x32x34 cm).- Diet: A standard diet of Nafag ad libitum.- Water: drinking water were given ad libitum.- Acclimation period: 8 daysENVIRONMENTAL CONDITIONS- Temperature (°C): 18 ± 1 °C- Humidity (%): 55 ± 5 %- Photoperiod (hrs dark / hrs light): 14 hours light/day
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- other: shaved and abraded
- Vehicle:
- water
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL- Amount(s) applied (volume or weight with unit): 0.5 g .
- Duration of treatment / exposure:
- The gauze patches were removed 24 hours after application.
- Observation period:
- 24 h, 48 h, 72 h and 4th day, 6th day, 8th day
- Number of animals:
- 6 rabbits (3 ♂; 3 ♀)
- Details on study design:
- TEST SITE- % coverage: 2.5 X 2.5 cm- Type of wrap if used: The patch was covered with an impermeable foil of 5x5 cm, which was fixed to the body of the animals with adhesive tape.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- ca. 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Remarks on result:
- other: intact and abraded skin
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- ca. 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Remarks on result:
- other: intact and abraded skin
Applicant's summary and conclusion
- Interpretation of results:
- other: not classified
- Conclusions:
- The substance is not irritant for skin rabbit.
- Executive summary:
The substance has been tested for skin irritation according to the method inserted into the "Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics" (1959), the US Association of Food and Drug Officials (AFDO). Under the conditions of the present experiment the test preparation was found to cause none irritation when applied to intact and abraded rabbit skin.
The substance does not show signs of irritation according to The CLP Regulation (EC n. 1272/2008).
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