5-[3-(1-ethoxyethoxy)-3-methyl-4-penten-1-ynyl]-2,4,6,6-tetramethyl-5,6,7,7a-tetrahydro-1,3-benzodioxol-5-ol

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1994

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: According to OECD 404 and GLP.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1994

Report date:

1994

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

Reference substance name:

Asta-C15-acetal (C15-Acl)

IUPAC Name:

Asta-C15-acetal (C15-Acl)

Constituent 2

Reference substance name:

94/29

IUPAC Name:

94/29

Details on test material:

- NAME OF TEST SUBSTANCE: ASTA-C15-ACETAL (C15-ACL)
- SUBSTANCE NUMBER: 94/29
- LOT NUMBER: 25656/133 S
- DATE OF MANUFACTURING: 07-FEB-1994
- PHYSICAL STATE/APPEARANCE: LIQUID, OILY, YELLOW
- STORAGE CONDITIONS: ROOM TEMPERATURE, EXCLUSION OF LIGHT

Test animals

Species:

rabbit

Strain:

Vienna White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Gaukler, Offenbach a. Main, FRG
- Age at study initiation: young adult animals
- Weight at study initiation: 2.70 - 2.97 kg
- Housing: single in stainless steel wire mesh cages with grating, floor area: 3,000 cm2
- Diet (e.g. ad libitum): Kliba-Labordiaet 341, 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

Vehicle:

unchanged (no vehicle)

Controls:

other: untreated skin

Amount / concentration applied:

Application volume: 0.5 mL of the unchanged liquid test substance.

Duration of treatment / exposure:

4 h

Observation period:

72 h

Number of animals:

1 male and 2 female rabbits.

Details on study design:

TEST SITE
- Area of exposure: 2.5 x 2.5 cm
- % coverage: semiocclusive
- Type of wrap if used: Idealbinde, Pfaelzische Verbandstoff-Fabrik, Kaiserslautern) and fixomull stretch (adhesive fleece), Beiersdorf AG.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): Lutrol and Lutrol/water (1:1)
- Time after start of exposure: 4 h

SCORING SYSTEM: as decribed in OECD Guideline 404 (edema and erythema)

Results and discussion

In vivo

Results

Results 1

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

Results 2

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

other: 24 - 48 - 72 h

Score:

0.7

Max. score:

4

Reversibility:

fully reversible

Remarks on result:

other: individual scores: 1 - 1 - 0

Results 3

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

other: 24 - 48 - 72 h

Score:

0.3

Max. score:

4

Reversibility:

fully reversible

Remarks on result:

other: individual scores: 1 - 0 - 0

Results 4

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

other: 24 - 48 - 72 h

Score:

1

Max. score:

4

Reversibility:

fully reversible

Remarks on result:

other: individual scores: 2 - 1 - 0

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information

Conclusions:

Under the test conditions chosen and considering the described findings Asta-C15-acetal does not give indication of an irritatnt property to the skin. Thus, classification is not warranted according to Regulation (EC) No. 1272/2008 and EU Directive 67/548/EEC.