1,2-Propanedione, 1-(2,5,5-trimethyl-1,3-dioxan-2-yl)-, 1-(O-methyloxime), (1E)-

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1999

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: According to OECD guideline and GLP.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1999

Report date:

1999

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

GLP compliance:

yes

Test material

Test material information

Constituent 1

Details on test material:

- Name of the test substance: Neopentylglykol-Ketal (Stufe 3 der BAS 520 F-Synthese)
- Substance number: 98/417-1
- Batch number: 29003-138
- Degree pf purity/content: 96.2 g/100 g (H-NMR spectroscopy)
- Date of manufacturing: 1998-09-14
- Physical state/appearance: viscous, colourless-clear
- Storage conditions: room temperature, exclusion of light

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Boehringer Ingelheim Pharma KG
- Age at study initiation: young adult animals
- Weight at study initiation: 3.6 - 3.89 kg
- Housing: single housing in stainless steel wire mesh cages with grating, floor area: 3000 cm2
- Diet (e.g. ad libitum): Kliba-Labordiaet, Klingentalmuehle AG, Kaiseraugst, Switzerland (about 130 g per animal per day)
- Water (e.g. ad libitum): about 250 mL tap water per animal per day
- Acclimation period: at least 1 week

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

Test system

Type of coverage:

semiocclusive

Preparation of test site:

other: clipping of fur

Vehicle:

unchanged (no vehicle)

Controls:

other: Untreated skin sites of the same animal.

Amount / concentration applied:

0.5 mL

Duration of treatment / exposure:

4 h

Observation period:

72 h

Number of animals:

3

Details on study design:

TEST SITE
- Area of exposure: Upper third of the back of flanks.
- Coverage: 2.5 cm x 2.5 cm
- Type of wrap if used: test patch (Idealbinde, Pfaelzische Verbandstoff-Fabrik, Kaiserslautern) and Fixomull(R) stretch (adhesive fleece), Beiersdorf AG

REMOVAL OF TEST SUBSTANCE
- Washing: The test substance was removed at the end of the exposure period with Lutrol(R) (=Polyethylenglykol DAE, BASF AG) and Lutrol(R)/water <1:1).
- Time after start of exposure: 4 h

SCORING SYSTEM:
TEST SITE
- Area of exposure:
- % coverage:
- Type of wrap if used:

REMOVAL OF TEST SUBSTANCE
- Washing (if done):
- Time after start of exposure:

SCORING SYSTEM: for information on scoring system, see below "Attached background material".

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

other: animal 1, 2 and 3

Time point:

other: 24 - 48 - 72 h

Score:

0

Max. score:

4

Reversibility:

other: not applicable

Remarks on result:

other: individual scores: 0 - 0 - 0

Results 2

Irritation parameter:

edema score

Basis:

other: animal 1, 2 and 3

Time point:

other: 24 - 48 - 72 h

Score:

0

Max. score:

4

Reversibility:

other: not applicable

Remarks on result:

other: individual scores: 0 - 0 - 0

Any other information on results incl. tables

For information on the individual scores see below: "Attached background material".

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: OECD GHS

Executive summary:

Under the test conditions chosen and considering the described findings Neopentylglykol-Ketal (Stufe 3 der BAS 520 F.-Synthese) does not give indication of an irritant property to the skin.