Fatty acids, tall-oil, compds. with diethanolamine

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

From January 9, 1990 to February 14, 1990

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study with acceptable restrictions

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1990

Report date:

1990

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

no

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

Amides, C16-18 and C18-unsatd., N,N-bis(hydroxyethyl)

EC Number:

271-653-9

EC Name:

Amides, C16-18 and C18-unsatd., N,N-bis(hydroxyethyl)

Cas Number:

68603-38-3

Molecular formula:

The alkyl chain length of the amide ranges between 16 and 18 carbon atoms

IUPAC Name:

Amides, C16-18 (even numbered) and C18-unsatd., N, N-bis(hydroxyethyl)

Constituent 2

Reference substance name:

Glycerol

EC Number:

200-289-5

EC Name:

Glycerol

Cas Number:

56-81-5

Molecular formula:

C3H8O3

IUPAC Name:

glycerol

impurity 1

Reference substance name:

2,2'-iminodiethanol

EC Number:

203-868-0

EC Name:

2,2'-iminodiethanol

Cas Number:

111-42-2

Molecular formula:

C4H11NO2

IUPAC Name:

2,2’-iminodiethanol

Test material form:

liquid

Test animals

Species:

rabbit

Strain:

other: Small White Russian Chbb-SPF

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Dr. Karl Thomae GmbH, Biberach, Germany
- Weight at study initiation: 2.5 - 2.8 kg
- Housing: Single animals in steel cages
- Diet (e.g. ad libitum): K4 diet for rabbit, Ssniff Spezialfutter GmbH, Soest, Germany
- Water (e.g. ad libitum): yes
- Acclimation period: 14 d


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 1°C
- Humidity (%): 60 +/- 5 %
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12


IN-LIFE DATES: From: 11-01-1990 To: 05-02-1990

Test system

Type of coverage:

occlusive

Preparation of test site:

shaved

Vehicle:

unchanged (no vehicle)

Controls:

no

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 cm3 of product on a 6 cm2 skin surface
- Concentration (if solution): undiluted

Duration of treatment / exposure:

4 h

Observation period:

25 d

Number of animals:

3

Details on study design:

TEST SITE
- Area of exposure: 6 cm2
- % coverage: 100%
- Type of wrap if used: application site covered with gauze. Additional wWrapping with an elastic band.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): warm water
- Time after start of exposure: 4 h

SCORING SYSTEM: OECD 404 method

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

overall irritation score

Basis:

mean

Time point:

other: Not applicable

Score:

7

Max. score:

8

Results 2

Irritation parameter:

erythema score

Basis:

mean

Time point:

24/48/72 h

Score:

ca. 3.67

Max. score:

4

Reversibility:

other: Slow recovery occurred, under thick scabs. After 25 d, 2/3 of the animals had fully recovered. In the third animal, scabs were falling away.

Remarks on result:

positive indication of irritation

Results 3

Irritation parameter:

edema score

Basis:

mean

Time point:

24/48/72 h

Score:

ca. 4

Max. score:

4

Reversibility:

other: Slow recovery occurred, under thick scabs. After 25 d, 2/3 of the animals had fully recovered. In the third animal, scabs were falling away.

Remarks on result:

positive indication of irritation

Any other information on results incl. tables

Strong erythema and strong oedema were observed in all animals. Slow recovery occured, under thick scabs. After 25 days, 2/3 animals had fully recovered. In the third animal, scabs were falling away.

Applicant's summary and conclusion

Interpretation of results:

Category 2 (irritant) based on GHS criteria

Conclusions:

Under the conditions of the study, the undiluted test substance was considered to be highly irritating to rabbit skin.

Executive summary:

A study was conducted to determine the irritation potential of the test substance, C16-18 and C18-unsatd. DEA, to rabbit skin according to OECD Guideline 404. The substance was applied undiluted to rabbit skin under an occlusive bandage for 4 h, then washed with warm water. Animals were observed for 25 d. Strong erythema and strong oedema were recorded in all animals. Slow recovery occurred, under thick scabs. After 25 d, 2/3 of the animals had fully recovered. In the third animal, scabs were falling away. The overall irritation index was 7/8 so that the undiluted test substance was considered highly irritating to rabbit skin under the conditions of the study (Mürmann, 1990).