Fatty acids, C16-18, esters with pentaerythritol

Skin irritation / corrosion

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

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

yes

Remarks:

: Lack of details on vehicle

GLP compliance:

yes

Test material

Test material information

Constituent 1

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 or test system 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

Results

Results 1

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

Results 2

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

Results 3

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

Results 4

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

Results 5

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

Results 6

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