Registration Dossier

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Guideline study.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1989
Report Date:
1989

Materials and methods

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

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): C13 - C15 - Alkohol
- Physical state: colorless liquid
- Analytical purity: 99.3% alcohols (0.5% low boiling substances, 0.2% high boiling substances)
- Composition of test material, percentage of components: 29.5% i-C13-alcohol, 33% n-C13-alcohol, 19% i-C15-alcohol, 17.8% n-C15-alcohol
- Lot/batch No.: from continuous production
- Sustance number: 88/577

Test animals

Species:
rabbit
Strain:
Vienna White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Gaukler, Offenbach/Main, Germany
- Weight at study initiation: mean(males): 3.13 kg, female: 2.82 kg
- Housing: single
- Diet: Kliba 341, 4 mm, Klingentalmuehle, Kaiseraugst, Switzerland (about 130 g per animal per day)
- Water: about 250 ml tap water per animal per day
- Acclimation period: at least 8 days before the beginning of the study (same housing conditions as during the study)


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


Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 ml
Duration of treatment / exposure:
4 h
Observation period:
15 days
Number of animals:
3 (2 males, 1 female)
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 lutrol/water (1:1) at the end of the exposure period


SCORING SYSTEM: according to OECD 404 / Draize

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Remarks:
(animal 1 - 3)
Time point:
other: 24 - 48 - 72 h
Score:
2.6
Max. score:
4
Reversibility:
fully reversible within: 15 days
Remarks on result:
other: erythema score >/= 2 in 3 animals; see table below for details
Irritation parameter:
edema score
Basis:
mean
Remarks:
(animal 1 - 3)
Time point:
other: 24 - 48 - 72 h
Score:
0.4
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
other: see table below for details
Other effects:
(Severe) scale formation at 8 and 15 days after application of test substance in 3 animals.

Any other information on results incl. tables

Animal number

Evaluation Interval

Erythema

Oedema

1

2

3

4 hour

2

2

2

1

1

1

1

2

3

24 hours

3

3

2

1

0

1

1

2

3

48 hours

3

2

3

0

0

1

1

2

3

72 hours

3

1

3

0

0

1

1

2

3

8 days

1

1

2

0

0

0

1

2

3

15 days

0

0

0

0

0

0

1

2

3

ME

3.0

2.0

2.7

0.3

0.0

1.0

ME

2.6

0.4

Calculation of the mean according to 83/467/EEC criteria of July 29 th, 1983

Applicant's summary and conclusion

Interpretation of results:
irritating
Remarks:
Migrated information