Registration Dossier
Registration Dossier
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EC number: 700-457-2 | CAS number: -
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: According to GLP; OECD-guideline 404; 2004/73/EC, B.4.; US EPA OPPTS 870.2500; Japan/MAFF.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 009
- Report date:
- 2009
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:
- Reaction mass of N-butylphosphorothioic triamide and N-propylphosphorothioic triamide
- EC Number:
- 700-457-2
- Molecular formula:
- Unspecified
- IUPAC Name:
- Reaction mass of N-butylphosphorothioic triamide and N-propylphosphorothioic triamide
- Details on test material:
- - Name of test material (as cited in study report): LIMUS-Sambaydestillation
- Test-substance No.: 07/0684-1
- Physical state: solid/yellowish
- Analytical purity: 87%
- Lot/batch No.: 8712 / 062
- Storage condition of test material: < -18°C
- pH-value: ca. 9 (undiluted test substance)
- Stability: stable over 5 days
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- other: New Zealand White A 1077 INRA (SPF)
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Centre Lago S. A., 01540 Vonnas, France
- Age at study initiation: ca. 6 months
- Weight at study initiation: 3.78 - 4.11 kg
- Housing: single housing; Stainless steel wire mesh cages with grating, floor area: 3000 cm²
- Diet (e.g. ad libitum): Kliba-Labordiät (Kaninchen & Meerschweinchenhaltung “GLP”), Provimi Kliba SA, Kaiseraugst, Basel, Switzerland (about 130 g/a nimal per day)
- Water (e.g. ad libitum): tap water
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 24
- Humidity (%): 30 - 70
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- other: fur was clipped
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: untreated skin of the animals
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g of the undiluted pasty test substance - Duration of treatment / exposure:
- 4 h
- Observation period:
- 14 days
- Number of animals:
- 3 (2 females, 1 male)
- Details on study design:
- TEST SITE
- Area of exposure: 2.5 x 2.5 cm on the dorsolateral part of the trunk
- Type of wrap if used: semiocclusive dressing
REMOVAL OF TEST SUBSTANCE
- Washing (if done): Lutrol and Lutrol/water (1:1)
- Time after start of exposure: 4 h
SCORING SYSTEM:
Erythema and eschar formation
Grading
0 No erythema
1 Very slight erythema (barely perceptible)
2 Well defined erythema
3 Moderate to severe erythema
4 Severe erythema (beet redness) to eschar formation preventing grading of erythema
Edema formation
Grading
0 No edema
1 Very slight edema (barely perceptible)
2 Slight edema (edges of area well defined by definite raising)
3 Moderate edema (raised approx. 1 mm)
4 Severe edema (raised more than 1 mm and extending beyond area of exposure)
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- other: animals #1 and 3
- Time point:
- other: 24 - 48 - 72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: individual scores: 0 - 0 - 0
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- other: 24 - 48 - 72 h
- Score:
- 0.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 h
- Remarks on result:
- other: individual scores: 1 - 0 - 0
- Irritation parameter:
- edema score
- Basis:
- other: animals #1, 2 and 3
- Time point:
- other: 24 - 48 - 72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: individual scores: 0 - 0 - 0
- Other effects:
- Moderate erythema (grade 2), observed in all animals immediately and 1 hour after removal of the patch, decreased to slight (grade 1) in one animal at the 24-hour reading.
The cutaneous reactions were reversible in two animals within 24 hours and in one animal within 48 hours after removal of the patch.
Mean scores over 24, 48 and 72 hours for each animal were 0.0, 0.3 and 0.0 for erythema and 0.0 for edema.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information
- Conclusions:
- Considering the described cutaneous reactions as well as the average score for irritation, LIMUS-Sambaydestillation does not show a skin irritation potential under the test conditions chosen. A classification according to Directive 67/548/EEC or GHS (UN) is not needed.
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