Registration Dossier
Registration Dossier
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EC number: 701-017-2 | 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: GLP guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 010
- Report date:
- 2010
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:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Reaction product of 2,4/ 2,6 TDI (m-tolylidene diisocyanate, CAS 26471-62-5) in excess and m-TDA (diaminotoluene, CAS 25376-45-8) forming Biuret structures via non-isolated polyurea intermediates
- IUPAC Name:
- Reaction product of 2,4/ 2,6 TDI (m-tolylidene diisocyanate, CAS 26471-62-5) in excess and m-TDA (diaminotoluene, CAS 25376-45-8) forming Biuret structures via non-isolated polyurea intermediates
- Details on test material:
- - Name of test material (as cited in study report): Desmodur VP.PU 60WF14
- Physical state: liquid
- Purity: 100 % (as indicated by the sponsor)
- Lot/batch No.: P1DE000345
- Storage condition of test material: room temperature
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Strain: Crl:KBL(NZW)BR
- Sex: female
- Source: Charles River, Kißlegg, Germany
- Age at study initiation: adult
- Weight at study initiation: 2.8-2.9 kg
- Housing: individual
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 3
- Humidity (%): 50 +/- 25
- Photoperiod (hrs dark / hrs light): 12 / 12
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: the surrounding untreated skin area of test animals served as control
- Amount / concentration applied:
- Amount: 0.5 ml
- Duration of treatment / exposure:
- 4 hours
- Observation period:
- 1, 24, 48, 72 hours, 7 and 14 days after patch removal
- Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: approx. 2.5 x 2.5 cm
- Type of wrap if used: gauze patch
REMOVAL OF TEST SUBSTANCE
- Washing: treated skin area carefully washed with water
- Time after start of exposure: 4 hours
SCORING SYSTEM: according to Draize
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- other: 24, 48, 72 hours
- Score:
- 1 - 3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 14 days
- Remarks on result:
- other: mean score after 72 hours: 2.0
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- other: 24, 48, 72 hours
- Score:
- 0 - 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 14 days
- Remarks on result:
- other: mean score after 72 hours: 1.3
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- other: 24, 48, 72 hours
- Score:
- 1 - 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 14 days
- Remarks on result:
- other: mean score after 72 hours: 1.7
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- other: 24, 48, 72 hours
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Remarks on result:
- other: mean score after 72 hours: 0.0
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- other: 24, 48, 72 hours
- Score:
- 1 - 4
- Max. score:
- 4
- Reversibility:
- fully reversible within: 14 days
- Remarks on result:
- other: mean score after 72 hours: 2.7
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- other: 24, 48, 72 hours
- Score:
- 0 - 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 14 days
- Remarks on result:
- other: mean score after 72 hours: 1.3
- Other effects:
- No systemic intolerance reactions were observed.
Any other information on results incl. tables
Table 1: Summary of irritant effects on the skin (Exposure: 4 hours):
Observation time 1h 24h 48h 72h day7 day14
(after patch removal)
Animal 1
Erythema (redness)
and eschar formation 0 1 2 3 3 0
Oedema formation 0 0 2 2 2 0
Animal 2
Erythema (redness)
and eschar formation 0 1 2 2 2 0
Oedema formation 0 0 0 0 0 0
Animal 3
Erythema (redness)
and eschar formation 0 1 3 4 4 0
Oedema formation 0 0 2 2 2 0
Animal 1 and 2, day 7: desquamation at the treated skin area
Animal 3, day 14: desquamation at the treated skin area
The observed desquamation is expected as a healing process of the
occurred inflammation of the skin. At the end of the observation time
this healing process was not finished in animal 3.
Applicant's summary and conclusion
- Conclusions:
Classification: not irritating- Executive summary:
In a dermal irritation/corrosion study according to OECD TG 404 Desmodur VP.PU 60WF14 was applied under semiocclusive dressings for 4 hours to the shaved skin of 3 female rabbits. Skin irritation was assessed after 1, 24, 48, 72 hours and 7 and 14 days using the Draize scale. The mean irritation index for erythema was 2.1 of max. 4 (1.7 -2.7), the mean irritation index for edema was 0.9 of max. 4 (0.0 -1.3). Signs were fully reversible in all animals within two weeks. No relevant systemic intolerance reactions were observed.
According to classification criteria Desmodur VP.PU 60WF14 is an irritant to the skin.
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