Registration Dossier

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Guideline study with acceptable restrictions. Lack of data on test substance. Lack of data on test material. Occlusive conditions.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1988
Report Date:
1988

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
yes
Remarks:
Lack of data on test material. Occlusive conditions.
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Triglycerindiisostearat
- Physical state: liquid
- Appearance: yellow liquid
- Analytical purity: no data

Test animals

Species:
rabbit
Strain:
other: Kleinrusse, Chbb:HM
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Thomae, Biberach, Germany
- Age at study initiation: adult
- Weight at study initiation: 2.3 kg
- Housing: The animals were single housed in rabbit cages.
- Diet: 20 ZH 5, Nohrlin GmbH
- Water: tap water, ad libitum
- Acclimation period: at least 7 d

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 21
- Humidity (%): 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: Not required, untreated sites of the same animal served as 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 d
Reading time points: 1, 24, 48 and 72 h and 7 d
Number of animals:
4 males
Details on study design:
TEST SITE
- Area of exposure: 6.25 cm² on the dorsal area of the trunk
- Type of wrap if used: The treated skin was covered with a plastic film, held in place with adhesive plasters and acrylastic tape.

SCORING SYSTEM: Draize scoring system

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
other: mean out of all 4 animals
Time point:
other: mean over 24, 48 and 72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 7 d
Irritation parameter:
edema score
Basis:
other: mean out of all 4 animals
Time point:
other: mean over 24, 48 and 72 h
Score:
0
Max. score:
4
Reversibility:
other: reversibility: not applicable
Irritant / corrosive response data:
The dermal application of the test substance did not result in edema in any of the animals tested at any observation time point. Very slight to slight erythema formation was observed in 3/4 animals at the 24 and 48 h reading time points. At the 72 h reading time point, slight and moderate erythema formation was observed in 2/4 animals. The effects were reversible in all animals within 7 d after the application of the test substance.

Any other information on results incl. tables

Table 1. Results of skin irritation study

Observation time

Rabbit no.

1

2

3

4

Erythema

Edema

Erythema

Edema

Erythema

Edema

Erythema

Edema

1 h

0

0

1

0

0

0

1

0

24 h

0

0

1

0

1

0

2

0

48 h

0

0

1

0

1

0

2

0

72 h

0

0

0

0

1

0

3

0

7 d

0

0

0

0

0

0

0

0

Mean value 24 + 48 + 72 h

0.00

0.00

0.67

0.00

1.00

0.00

2.33

0.00

Mean value 24 + 48 + 72 h all animals

1.00

0.00

 

 

 

 

 

 

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