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Diss Factsheets

Toxicological information

Skin irritation / corrosion

Currently viewing:

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:
2010
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

Constituent 1
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

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.