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Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
migrated information: read-across based on grouping of substances (category approach)
Adequacy of study:
key study
Study period:
May 09th, 1990 - May 12th, 1990
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: GLP guideline study with acceptable restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1990
Report date:
1990

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
yes
Remarks:
Analytical purity of test material not specified.
Qualifier:
according to guideline
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
2-ethylhexyl palmitate
EC Number:
249-862-1
EC Name:
2-ethylhexyl palmitate
Cas Number:
29806-73-3
Molecular formula:
C24H48O2
IUPAC Name:
2-ethylhexyl palmitate
Details on test material:
- Name of test material (as cited in study report): 2-ethylhexyl palmitate
- Physical state: colorless liquid
- Lot/batch No.: 950
- Storage condition of test material: RT
- Analytical purity: no data

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: David Percival Ltd., UK
- Age at study initiation: 12 - 16 weeks
- Weight at study initiation: 2.34 - 2.59 kg
- Housing: Individually in suspended metal cages
- Diet (e.g. ad libitum): ad libitum, (Rabbit diet, Preston Farmers Limited, UK)
- Water (e.g. ad libitum): ad libitum
- Acclimation period: minimum 5 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 - 21
- Humidity (%): 65 - 66
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
other: untreated sites served as controls
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 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: 2.5 cm x 2.5 cm
- Type of wrap if used: Gauze patch secured with surgical adhesive tape and wrapped with an elastic corset (TUBIGRIP)


REMOVAL OF TEST SUBSTANCE
- Washing (if done): Gentle swabbing with cottonwool soaked with diethyl ether
- Time after start of exposure: 4 h


SCORING SYSTEM: According to Draize (1959)

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal: 11, mean of readings at
Time point:
other: 24 h, 48 h and 72 h
Score:
0.7
Max. score:
4
Reversibility:
fully reversible within: 72 h
Irritation parameter:
erythema score
Basis:
animal: 24, mean of readings at
Time point:
other: 24 h, 48 h and 72 h
Score:
0.3
Max. score:
4
Reversibility:
fully reversible within: 48 h
Irritation parameter:
erythema score
Basis:
animal: 70, mean of readings at
Time point:
other: 24 h, 48 h and 72 h
Score:
0.7
Max. score:
4
Reversibility:
fully reversible within: 72 h
Irritation parameter:
edema score
Basis:
mean
Remarks:
of all three animals and of readings at
Time point:
other: 24 h, 48 h and 72 h
Score:
0.3
Max. score:
4
Reversibility:
fully reversible within: 48 h

Any other information on results incl. tables

Erythema Score

Animal Number

24 h

48 h

72 h

Total

Mean

11

1

1

0

2

0.7

24

1

0

0

1

0.3

70

1

1

0

2

0.7

 

Edema Score

Animal Number

24 h

48 h

72 h

Total

Mean

11

1

0

0

1

0.3

24

1

0

0

1

0.3

70

1

0

0

1

0.3

 

Primary Irritation Index:

Sum of 24 h and 72 h readings: 3

Primary Irritation Index: 3/6 = 0.5

Applicant's summary and conclusion

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