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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
13 - 23 May 2014
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP compliant Guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2014
Report date:
2014

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Version / remarks:
(2002)
Deviations:
no
GLP compliance:
yes

Test material

Constituent 1
Reference substance name:
109884-54-0
Cas Number:
109884-54-0
IUPAC Name:
109884-54-0
Test material form:
other: liquid
Details on test material:
- Name of test material (as cited in study report): only trade name given
- Physical state: clear colourless liquid
- Analytical purity: 100%
- Batch No.: OE31003999
- Expiration date of the batch: 03 October 2017
- Storage condition of test material: at room temperature in the dark
- pH (1% in water, indicative range): 6.5 - 5.7

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Charles River France, L’Arbresle Cedex, France
- Age at study initiation: 12 - 24 weeks
- Weight at study initiation: at least 1.5 kg
- Housing: individually housed
- Diet: Pelleted diet for rabbits appr. 100 g/day, hay and wooden sticks
- Water: tap water, ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 - 24
- Humidity (%): 40 - 70
- Air changes (per hr): at least 10
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Type of coverage:
semiocclusive
Preparation of test site:
clipped
Vehicle:
unchanged (no vehicle)
Controls:
other: not required (adjacent areas of the untreated skin of each animal served as controls)
Amount / concentration applied:
TEST MATERIAL
- Amount applied: 0.5 mL
Duration of treatment / exposure:
4 h
Observation period:
72 h
Reading time points: 1, 24, 48 and 72 h
Number of animals:
3 males
Details on study design:
TEST SITE
- Area of exposure: 2x3 cm
- Type of wrap if used: The test substance was applied to the skin of one flank using a patch. The patch was mounted on a tape, which was wrapped around the abdomen and secured with elastic bandage.

REMOVAL OF TEST SUBSTANCE
- Washing: The skin was cleaned of residual test substance using tap water.
- Time after start of exposure: 4 h

SCORING SYSTEM:
Draize scoring system

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Remarks:
of 3 animals
Time point:
other: mean after 24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritation parameter:
edema score
Basis:
mean
Remarks:
of 3 animals
Time point:
other: mean after 24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritant / corrosive response data:
The dermal application of the test substance did not result in erythema or edema in any of the animals tested at any observation time point.
Other effects:
No staining of the treated skin by the test substance was observed and no test substance remnants were seen. No symptoms of systemic toxicity were observed in the animals during the test period and no mortality occurred.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
CLP: not classified