Registration Dossier
Registration Dossier
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EC number: 701-361-3 | 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:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 986
- Report date:
- 1986
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- no
Test material
- Reference substance name:
- Propylidynetrimethanol, ethoxylated, propoxylated, esters with acrylic acid (<6.5 mol EO and <6.5 mol PO)
- EC Number:
- 701-361-3
- Molecular formula:
- C6 H14 O3 . 3 (C3 H6 O . C2 H4 O)x . x C3 H4 O2
- IUPAC Name:
- Propylidynetrimethanol, ethoxylated, propoxylated, esters with acrylic acid (<6.5 mol EO and <6.5 mol PO)
Constituent 1
- Specific details on test material used for the study:
- - Lot/batch No.: Batch no. 7/85, 8.7.85
Test animals
- Species:
- rabbit
- Strain:
- Vienna White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Gaukler, Offenbach/Main
- Age at study initiation: not mentioned
- Weight at study initiation: male: 3.02 kg; females: 3.13 kg (mean of two animals)
- Housing: single housing
- Diet: Kliba 341, 4 mm, Klingentalmuehle AG, Switzerland (about 130 g per animal per day)
- Water: about 250 ml tap water per animal per day
- Acclimation period: at least 8 days before the beginning of the study
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:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied: 0.5 ml
- Concentration: undiluted
- Duration of treatment / exposure:
- 4 hrs
- Observation period:
- 72 hrs
- Number of animals:
- 3 (one male, two females)
- Details on study design:
- TEST SITE
- Area of exposure: 2.5 cm x 2.5 cm
- Type of wrap: test patches with a porous dressing (four layers of absorbent gauze + porous bandage)
REMOVAL OF TEST SUBSTANCE
- Washing: with Lutrol and Lutrol/water (1:1)
- Time after start of exposure: 4 hrs
OBSERVATION TIME POINTS
30-60 minutes after removal of the test patches and 24 hrs, 48 hrs, 72 hrs after the beginning of application.
SCORING SYSTEM: according to OECD Guideline 404
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- At the 4 hrs reading, erythema could be detected (score 1) on the skin of all three tested animals, but it was reversible within 24 hrs.
- Other effects:
- No other effects were detected.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
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