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Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
July 01st, 1986 - July 15th, 1986
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1986
Report date:
1986

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Isopropyl palmitate
EC Number:
205-571-1
EC Name:
Isopropyl palmitate
Cas Number:
142-91-6
Molecular formula:
C19H38O2
IUPAC Name:
propan-2-yl hexadecanoate
Details on test material:
- Name of test material (as cited in study report): isopropyl palmitate
- Physical state: colourless liquid
- Analytical purity: approx. 100% ester
- Storage condition of test material: RT in the dark

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Sex: Female
- Source: Broekman Institute, Someren, The Netherlands
- Age at study initiation: approx. 12 weeks
- Weight at study initiation: Mean 3446 g
- Diet: Standart laboratory animal diet LK-01
- Water: ad libitum
- Acclimation period: 1 week


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 23
- Humidity (%): 65 - 85
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL
Duration of treatment / exposure:
4 h
Observation period:
14 d
Number of animals:
3
Details on study design:
TEST SITE
- Area of exposure: 6 cm²
- Type of wrap if used: The test substance was applied to a gauze patch which was attached with a drop of petrolatum to aluminium foil and mounted on a permeable tape (Micropore, 3M, St. Paul, USA).


REMOVAL OF TEST SUBSTANCE
- Washing (if done): Yes, using a tissue moistened with tap-water


SCORING SYSTEM: According to the criteria for irritancy and corrosiveness on the skin, Off. J. Europ. Commun., L 180/56 (91/325/EEC)

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal: 480
Time point:
other: average 24, 48 and 72h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 7d
Irritation parameter:
erythema score
Basis:
animal: 483
Time point:
other: average 24, 48 and 72h
Score:
1.66
Max. score:
4
Reversibility:
fully reversible within: 14d
Irritation parameter:
erythema score
Basis:
animal: 484
Time point:
other: average 24, 48 and 72h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 7d
Irritation parameter:
edema score
Basis:
animal: 480
Time point:
other: average 24, 48 and 72h
Score:
0
Max. score:
4
Reversibility:
other: no effects
Irritation parameter:
edema score
Basis:
animal: 483
Time point:
other: average 24, 48 and 72h
Score:
0.66
Max. score:
4
Reversibility:
fully reversible within: 7d
Irritation parameter:
edema score
Basis:
animal: 484
Time point:
other: average 24, 48 and 72h
Score:
0
Max. score:
4
Reversibility:
other: no effects

Any other information on results incl. tables

Erythema Score

Animal Number

24 h

48 h

72 h

7 days

14 days

Mean

(24-72 h)

480

1

1

1

0

0

1.0

483

1

2

2

1

0

1.7

484

1

1

1

0

0

0.0

 

Edema Score

Animal Number

24 h

48 h

72 h

7 days

14 days

Mean

(24-72 h)

480

0

0

0

0

0

0.0

483

0

1

1

0

0

0.7

484

0

0

0

0

0

0.0

The dermal application of the test substance to rabbits caused very slight to well-defined erythema dissappearing completely within 7 to 14 d. According to DSD and CLP the test substance has not to be classified.

Applicant's summary and conclusion

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