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Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
16 Apr - 24 Apr 2009
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Cross-reference
Reason / purpose for cross-reference:
reference to other study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2009
Report date:
2009

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Remarks:
Ministerium für Arbeit, Gesundheit und Soziales des Landes Nordrhein-Westfalen, Düsseldorf, Germany

Test material

Constituent 1
Chemical structure
Reference substance name:
Ethane- 1,2-diol, propoxylated
EC Number:
500-078-0
EC Name:
Ethane- 1,2-diol, propoxylated
Cas Number:
31923-84-9
Molecular formula:
HO(C3H6O)nC2H4(C3H6)nOH sum of n: >1 - <4.5 mol PO
IUPAC Name:
Ethane-1,2-diol, propoxylated
Details on test material:
- Physical state: liquid
- Content: 100%
- molecular weight: approx. 235

Test animals

Species:
rabbit
Strain:
New Zealand White
Remarks:
Crl:KBL(NZW)BR

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
other: contralateral untreated skin area of test animals served as control
Amount / concentration applied:
Amount: 0.5 mL
Duration of treatment / exposure:
4 h
Observation period:
1, 24, 48, 72 h, 7 and 14 days after application
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 h

SCORING SYSTEM: Draize

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Remarks:
of all animals
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritation parameter:
edema score
Basis:
mean
Remarks:
of all animals
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Other effects:
There were no systemic intolerance reactions.

Any other information on results incl. tables

Table 1: Iritant Effects on the Skin - (Exposure 3 min / 1 h)

Animal 1 (first animal)              

Observation (immediately after patch removal)       3 min       1 h

Erythema (redness) and eschar formation               0             0

Oedema formation                                                 0             0

Table 2: Irritant Effects on the Skin (Exposure: 4 h)

Animal 1, Body Weight 3.5 kg                                          

Observation (after patch removal)              1 h       24 h       48 h       72 h       7 days       14 days

Erythema (redness) and eschar formation    0         0         0        0         --        --

Oedema fomation                                    0         0         0         0        --        --

Animal 2, Body Weight 3.3 kg                                          

Observation (after patch removal)        1 h       24 h       48 h       72 h       7 days       14 days

Erythema (redness) and eschar formation    0        0        0     0        --         --

Oedema formation                                   0       0         0         0         --        --

Animal 3, Body Weight 3.2 kg                                          

Observation (after patch removal)        1 h       24 h       48 h       72 h       7 days       14 days

Erythema (redness) and eschar formation   0       0         0         0        --         --

Oedema formation                                     0         0        0         0        --        --

Applicant's summary and conclusion

Interpretation of results:
other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No. 1272/2008.
Conclusions:
Ethane-1,2 -diol, propoxylated is not an irritant to the rabbit skin.