Registration Dossier
Registration Dossier
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EC number: 200-184-4 | CAS number: 53-84-9
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- July 2011
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 011
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- GLP compliance:
- yes
Test material
- Reference substance name:
- Nadide
- EC Number:
- 200-184-4
- EC Name:
- Nadide
- Cas Number:
- 53-84-9
- Molecular formula:
- C21H27N7O14P2
- IUPAC Name:
- nadide
- Details on test material:
- - Substance type: organic
- Physical state: off-white crystalline powder
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River France, L'Arbresle Cedex, France
- Age at study initiation: 6 weeks
- Weight at study initiation: 1.0 kg
- Housing: individually housed in labeled cages with perforated floors and shelters.
- Diet: pelleted diet approx 100 g per day
- Water: ad libitum
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21.0
- Humidity (%): 40-70
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- other: clipped with electric clippers
- Vehicle:
- water
- Controls:
- no
- Amount / concentration applied:
- 0.5 g of test substance moistened with 0.2 mL of the vehicle and applied to the skin
- Duration of treatment / exposure:
- 4 hours
- Observation period:
- 72 hours
- Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure:150 square centimeters (10x15 cm)
- Type of wrap if used: Micropore Tape
REMOVAL OF TEST SUBSTANCE
- Washing: tap water
- Time after start of exposure: 4 hours
SCORING SYSTEM:
Erythema and eschar formation:
No erythema 0
Very slight erythema (barely perceptible) 1
Well-defined erythema 2
Moderate to severe erythema 3
Severe erythema (beet redness) * 4
*. Where signs of necrosis or corrosion (injuries in depth) prevent erythema scoring, the
maximum grade for erythema (= 4) is given.
Oedema formation:
No oedema 0
Very slight oedema (barely perceptible) 1
Slight oedema (edges of area well-defined by definite raising) 2
Moderate oedema (raised approximately 1 millimeter) 3
Severe oedema (raised more than 1 millimeter and extending beyond the area of exposure) 4
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- other: 1,24,48 and 72 hours
- Score:
- 0
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritant / corrosive response data:
- none
- Other effects:
- none
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Based on these results Nadide does not have to be classified and has no obligatory labelling requirements for skin irritation acc to the : GHS and EU CLP regulations
- Executive summary:
Primary skin irritation/corrosion study with nadide in the rabbit (4-hour semi-occlusive application).
The study was carried out based on the guidelines described in:
OECD No.404, "Acute Dermal Irritation/Corrosion" (2002)
Three rabbits were exposed to 0.5 grams of nadide, moistened with water by application onto clipped skin for 4 hours using a semi-occlusive dressing. Skin reactions were assessed 1, 24, 48 and 72 hours after exposure.
No skin irritation was caused by 4 hours exposure to nadide.
Based on these results nadide does not have to be classified and has no obligatory labelling requirement for skin irritation according to the EU CLP
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