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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: OECD Guideline study (404)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1988
Report date:
1988

Materials and methods

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

Test material

Constituent 1
Reference substance name:
Oxirane, 2-methyl-, oligomeric reaction products with oxirane, ether with 2-ethyl-2-(hydroxymethyl)-1,3-propanediol (3:1)
EC Number:
610-877-7
Cas Number:
52624-57-4
Molecular formula:
C6 H14 O3 . 3 (C3 H6 O . C2 H4 O)x
IUPAC Name:
Oxirane, 2-methyl-, oligomeric reaction products with oxirane, ether with 2-ethyl-2-(hydroxymethyl)-1,3-propanediol (3:1)
Details on test material:
- Name of test material (as cited in study report): Lupranol VP 9053
- Lot/batch No.: Batch 9
- Analytical purity: technical grade

Test animals

Species:
guinea pig
Strain:
Vienna White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Gaukler; Offenbach/Main, Germany
- Weight at study initiation: mean body weight of the three animals: 2.59 kg
- Housing: Cage made of stainless steel with wire mesh walk floors, floor area 40 cm x 51 cm
- Diet (e.g. ad libitum): Kliba 341, Kaiseraugust, Switzerland; about 130g / animal / day
- Water (e.g. ad libitum): tap water; about 250 ml / animal / day
- Acclimation period: at least 8 days before beginning of the study

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-24°C
- Humidity (%): 30-70%
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Type of coverage:
semiocclusive
Preparation of test site:
other: clipping
Vehicle:
unchanged (no vehicle)
Controls:
other: untreated skin sites of the same animal
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 ml of the undiluted test substance to the test patch (2.5 cm x 2.5 cm)
Duration of treatment / exposure:
4h
Observation period:
72h
Number of animals:
3
Details on study design:
TEST SITE
- Area of exposure: 2.5 x 2.5 cm
- Type of wrap if used: Test patches were secured in position with a porous dressing (four layers of absorbent gauze + porous bandage)


REMOVAL OF TEST SUBSTANCE
- Washing (if done): with lutrol and litrol/water (1:1)
- Time after start of exposure: at the end of the exposure period of 4h


SCORING SYSTEM: see OECD Guideline 404

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24 / 48 / 72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24 / 48 / 72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritant / corrosive response data:
no irritation effects detected

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: OECD GHS