Registration Dossier

Toxicological information

Skin irritation / corrosion

Currently viewing:

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
23 Jun - 30 Jun 1987
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Guideline study with acceptable restrictions. The exposure was done under occlusive conditions, few details on the test substance were given.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1987
Report date:
1987

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Version / remarks:
adopted 1981
Deviations:
yes
Remarks:
occlusive exposure, lack of details on test substance
Qualifier:
according to guideline
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
Deviations:
yes
Remarks:
occlusive exposure, lack of details on test substance
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Fatty acids, C16-18, isotridecyl esters
EC Number:
306-084-8
EC Name:
Fatty acids, C16-18, isotridecyl esters
Cas Number:
95912-88-2
Molecular formula:
C29H58O2 and C31H62O2
IUPAC Name:
Fatty acids, C16-18, isotridecyl esters
Details on test material:
- Name of test material (as cited in study report): isotridecylstearate
- Physical state: colourless liquid
- Analytical purity: no data

Test animals

Species:
rabbit
Strain:
other: Kleinrusse, Chbb:HM
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Fa. Thomae, Biberach, Germany
- Weight at study initiation: 2442 g (average)
- Housing: single housing in rabbit cages, (Fa. Heinkel, Kuchen, Germany)
- Diet: feed 20 ZH 5 (Fa. Nohrlin GmbH, Bad Salzuflen, Germany)
- Water: tap water, ad libitum
- Acclimation period: at least 1 week

ENVIRONMENTAL CONDITIONS
- Temperature (°C): approximately 20-21
- Humidity (%): approximately 45-50
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Type of coverage:
occlusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
other: the untreated skin served as the control
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL
Duration of treatment / exposure:
4 h
Observation period:
7 days
Reading time points: 1, 24, 48 and 72 h, and 7 days
Number of animals:
5 males
Details on study design:
TEST SITE
- Area of exposure: dorsal skin, an approximately 2.5 cm x 2.5 cm area
- Type of wrap if used: a 2.5 cm x 2.5 cm gauze patch with the test substance was applied to the skin of the rabbit. The gauze patch was covered by a plastic film, which was fixed with adhesive tapes; then finally an acrylastic band (occlusive) was applied. During the 4-hour exposure the animals were kept in special boxes to ensure the wrapping did not move.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): not reported

SCORING SYSTEM: Draize scoring system

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
other: mean over 24, 48 and 72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
other: mean over 24, 48 and 72 h
Score:
0.33
Max. score:
4
Reversibility:
fully reversible within: 72 h
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
other: mean over 24, 48 and 72 h
Score:
1.33
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
erythema score
Basis:
animal #4
Time point:
other: mean over 24, 48 and 72 h
Score:
1.67
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
erythema score
Basis:
animal #5
Time point:
other: mean over 24, 48 and 72 h
Score:
0
Max. score:
4
Reversibility:
other: reversibility not applicable
Irritation parameter:
edema score
Basis:
animal #1
Time point:
other: mean over 24, 48 and 72 h
Score:
0.33
Max. score:
4
Reversibility:
fully reversible within: 48 h
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
other: mean over 24, 48 and 72 h
Score:
0
Max. score:
4
Reversibility:
other: reversibility not applicable
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
other: mean over 24, 48 and 72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
erythema score
Basis:
animal #4
Time point:
other: mean over 24, 48 and 72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritant / corrosive response data:
No irritation effects were observed 1 hour after exposure ended. At the 24-hour reading time point, 3/5 animals had very slight erythema and edema. By the 48-hour reading time point, the severity had increased to well-defined erythema in 2/5 animals, while 2/5 had very slight erythema. 2 of these rabbits also had very slight edema, which was still present at the 72-hour reading time point. Very slight to well-defined erythema persisted in 3/5 rabbits until 72 hours after exposure. All the irritation effects had cleared completely within 7 days.

Any other information on results incl. tables

Table 1: Individual skin irritation scores

 

Observation time

Rabbit no.

1

2

3

4

5

 

Erythema

Edema

Erythema

Edema

Erythema

Edema

Erythema

Edema

Erythema

Edema

 

 

1 h

0

0

0

0

0

0

0

0

0

0

 

 

24 h

1

1

0

0

1

1

1

1

0

0

 

 

48 h

1

0

1

0

2

1

2

1

0

0

 

 

72 h

1

0

0

0

1

1

2

1

0

0

 

 

7 days

0

0

0

0

0

0

0

0

0

0

 

 

Mean value 24 + 48 + 72 h

1.00

0.33

0.33

0

1.33

1.00

1.67

1.00

0

0

 

 

Mean value 24 + 48 + 72 h all animals

0.87

0.47

 

 

 

 

 

 

 

 

 

 

 

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
CLP: not classified
DSD: not classified