Registration Dossier

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
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 guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes (incl. QA statement)

Test material

Constituent 1
Chemical structure
Reference substance name:
2,2'-Iminodiethanol, propoxylated
EC Number:
500-085-9
EC Name:
2,2'-Iminodiethanol, propoxylated
Cas Number:
35176-06-8
Molecular formula:
C4H11O2N(C3H6O)n; n = 1 – 6.5
IUPAC Name:
2,2'-Iminodiethanol, propoxylated
Details on test material:
- Physical state: Liqiud
- content: > 99%

Test animals

Species:
rabbit
Strain:
other: Crl: KBL(NZW)BR
Details on test animals or test system and environmental conditions:
according to guideline
sex of the test animals: female

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
other: The surrounding untreated skin served as control
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 ml
Duration of treatment / exposure:
4 hours
Observation period:
1, 24, 48 and 72 hours after patch removal. If dermal irritation was observed, additional monitoring on day 7 and 14 after patch removal was done.
Number of animals:
3
Details on study design:
TEST SITE
- Area of exposure: 2.5 x 2.5 cm

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal: #1-#3
Time point:
other: 24, 48, 72 hours
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
animal: #1-#3
Time point:
other: 24, 48, 72 hours
Score:
0
Max. score:
4
Other effects:
There were no systemic intolerance reactions.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
An acute dermal irritation/corrosion test (OECD 404) was performed with Diethethanolamine, propoxylated. No signs of dermal irritation were observed.
Executive summary:

An acute dermal irritation/corrosion test (OECD 404) was performed with Diethethanolamine, propoxylated. No signs of dermal irritation were observed.

According to classification criteria (CLP and DSD) Diethanolamine, propoxylated is not an irritant to the skin.

There were also no systemic intolerance reactions.