Registration Dossier
Registration Dossier
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EC number: 500-105-6 | CAS number: 39423-51-3 1 - 6.5 moles propoxylated
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2012-02-28 to 2012-03-09
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 012
- Report date:
- 2012
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2500 (Acute Dermal Irritation)
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Test material form:
- liquid
- Details on test material:
- Name of test material: Trimethylolpropanepoly(oxypropylene)triamine
EC no.: 500-105-6
CAS no.: 39423-51-3
Physical state: clear colourless liquid
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: 1L708
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: room temp (21-26°C)
OTHER SPECIFICS:
- Analytical purity: Certificate of Analysis was provided by the Sponsor. No additional analysis was performed.
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Millbrook Breeding Labs
- Age at study initiation: 19 weeks
- Weight at study initiation: 3.3 - 3.5 kg
- Housing: individually
- Diet (e.g. ad libitum): access to PMI certified Hi Fiber Rabbit diet
- Water (e.g. ad libitum): ad libitum via an automatic watering device
- Acclimation period: minimum of 5 days prior dosing
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 - 22 °C
- Humidity (%): 36 - 63 %
- Photoperiod (hrs dark / hrs light): 12h light / 12h dark
IN-LIFE DATES: From: 28 Feb 2012 To: 9 Mar 2012
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL - Duration of treatment / exposure:
- 3 minutes, 1 hour, 4 hours
- Observation period:
- 10 days
- Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: 5 cm x 5 cm
- Type of wrap if used: gauze patch
REMOVAL OF TEST SUBSTANCE
- Washing (if done): residual test article was removed using water and gauze
SCORING SYSTEM: Draize
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- primary dermal irritation index (PDII)
- Basis:
- mean
- Time point:
- other: 30-60 min, 24h, 48h, 72h after exposure
- Score:
- 1.7
- Max. score:
- 8
- Reversibility:
- fully reversible within: 10 days
- Remarks on result:
- other: after 4h exposure
- Irritation parameter:
- erythema score
- Basis:
- animal: 646M
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 10 days
- Remarks on result:
- other: after 4 h treatment
- Irritation parameter:
- erythema score
- Basis:
- animal: 647M
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 9 days
- Remarks on result:
- other: after 4h treatment
- Irritation parameter:
- erythema score
- Basis:
- animal: 648M
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 9 days
- Remarks on result:
- other: after 4h treatment
- Irritation parameter:
- edema score
- Basis:
- animal: 646M
- Time point:
- 24/48/72 h
- Score:
- 0.67
- Max. score:
- 4
- Reversibility:
- fully reversible within: 10 days
- Remarks on result:
- other: after 4h treatment
- Irritation parameter:
- edema score
- Basis:
- animal: 647M
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: after 4h treatment
- Irritation parameter:
- edema score
- Basis:
- animal: 648M
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: after 4h treatment
- Irritant / corrosive response data:
- After 3 min exposure, the following is observed: very slight erythema without edema observed starting on day 3. Flaking of the skin observed on day 7. After 60 min exposure, the following is observed: well-defined erythema without edema observed starting on day 3. Flaking of the skin observed starting on day 8. After 60 min exposure, the following is observed: well-defined erythema and/or very slight edema observed starting at 24h post unwrap. Flaking of the skin observed starting on day 6.
- Other effects:
- No mortality is observed.
No clinical signs were recorded.
Applicant's summary and conclusion
- Interpretation of results:
- Category 3 (mild irritant) based on GHS criteria
- Conclusions:
- The substance is found to be a mild irritant (cat 3). The primary irritation index was 1.7.
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