Registration Dossier

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
March 19th, 1991 - March 22th, 1991
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Guideline study with acceptable restrictions.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1991
Report Date:
1991

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
yes
Remarks:
: Lack of details on vehicle
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Fatty acid C16-18, ester with pentaerythriol
- Physical state: white, solid
- Analytical purity: 99%
- Lot/batch No.: 51531022
- Stability under test conditions: 18 months
- Storage condition of test material: room temperature

Test animals

Species:
rabbit
Strain:
other: Kleinrussen, Chbb:HM
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Thomae, Germany
- Age at study initiation: 19 - 20 months
- Weight at study initiation: approx.2740 g
- Housing: single holding in cage
- Diet (e.g. ad libitum): ad libitum (Altromin Haltungsdiät 2023)
- Water (e.g. ad libitum):ad libitum



ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-25
- Humidity (%): 45-70
- 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 g
- Concentration (if solution): No Data


VEHICLE
- Amount(s) applied (volume or weight with unit): No Data
Duration of treatment / exposure:
4 hours
Observation period:
72 hours
Number of animals:
3

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Remarks:
, mean of readings at
Time point:
other: 24 h, 48 h, and 72 h
Score:
0
Max. score:
4
Reversibility:
other: No effects
Irritation parameter:
edema score
Basis:
animal #1
Remarks:
, mean of readings at
Time point:
other: 24 h, 48 h, and 72 h
Score:
0
Max. score:
4
Reversibility:
other: No effects
Irritation parameter:
erythema score
Basis:
animal #2
Remarks:
, mean of readings at
Time point:
other: 24 h, 48 h, and 72 h
Score:
0
Max. score:
4
Reversibility:
other: No effects
Irritation parameter:
edema score
Basis:
animal #2
Remarks:
, mean of readings at
Time point:
other: 24 h, 48 h, and 72 h
Score:
0
Max. score:
4
Reversibility:
other: No effects
Irritation parameter:
erythema score
Basis:
animal #3
Remarks:
, mean of readings at
Time point:
other: 24 h, 48 h, and 72 h
Score:
0
Max. score:
4
Reversibility:
other: No effects
Irritation parameter:
edema score
Basis:
animal #3
Remarks:
, mean of readings at
Time point:
other: 24 h, 48 h, and 72 h
Score:
0
Max. score:
4
Reversibility:
other: No effects

Any other information on results incl. tables

Erythema score

Animal Number

1 h

24 h

48 h

72 h

1229

0

0

0

0

1230

0

0

0

0

1231

0

0

0

0

 

Edema Score

Animal Number

1 h

24 h

48 h

72 h

1229

0

0

0

0

1230

0

0

0

0

1231

0

0

0

0

Applicant's summary and conclusion

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