Reaction mass of sodium hydrogen N,N-dibutyl-10-(sulphonatooxy)octadecanamidate and sodium sulphooctadecanoate

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1985-12-11 to 1985-12-18

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1985

Report date:

1986

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

N,N-dibutyloleamide and oleic acid, sulphated, sodium salts

EC Number:

915-926-9

Molecular formula:

C18H34Na2O6S + C26H52NNaO5S

IUPAC Name:

N,N-dibutyloleamide and oleic acid, sulphated, sodium salts

Test material form:

liquid

Details on test material:

The water content of the actual test item was 57.6% (w/w); the water content of the REACH registration substance was analytically determined to be 3.8% (w/w).

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Nottingham University, School of Agriculture, Sutton Bonington, Leicestershire, U.K
- Age at study initiation: 12 to 16 weeks old
- Weight at study initiation: 2.30 - 2.59 kg
- Housing: individually housed in suspended metal cages
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: ≥ 5 days

ENVIRONMENTAL CONDITIONS

- Temperature (°C): 18 – 21 °C
- Humidity: (%): 45 - 70
- Photoperiod: 12 hours light and 12 hours darkness

Test system

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

unchanged (no vehicle)

Controls:

not required

Amount / concentration applied:

0.5 mL

Duration of treatment / exposure:

4 h

Observation period:

72 h

Number of animals:

3

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

2.3

Max. score:

4

Reversibility:

fully reversible within: 7 d

Results 2

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

3

Max. score:

4

Reversibility:

fully reversible within: 7 d

Results 3

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

4

Max. score:

4

Reversibility:

fully reversible within: 7 d

Results 4

Irritation parameter:

edema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

1

Max. score:

4

Reversibility:

fully reversible within: 48 h

Results 5

Irritation parameter:

edema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

1.7

Max. score:

4

Reversibility:

fully reversible within: 7 d

Results 6

Irritation parameter:

edema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

2.3

Max. score:

4

Reversibility:

fully reversible within: 7 d

Irritant / corrosive response data:

The test material was found to be irritant to rabbit skin

Applicant's summary and conclusion

Interpretation of results:

Category 2 (irritant) based on GHS criteria

Conclusions:

The test material was found to be irritant to rabbit skin

Executive summary:

The study was performed according to OECD Guidelines for Testing of Chemicals (1981) No. 404 "Acute Dermal Irritation/Corrosion" and was carried out in order to assess the irritancy potential of the test item following a single 4-hour, semi-occluded application to the intact rabbit skin. The test system was chosen because the rabbit has been shown to be a suitable model for this type of study and is recommended by the test method. For this purpose, a suitable test site was selected on the back of each of 3 rabbits. A quantity of 0.5 mL of the test material was introduced under a 2.5 cm x 2.5 cm gauze patch and placed in position on the shorn skin. The patch was secured in position over the test material with two lengths of adhesive strapping (SLEEK) in the form of a cross. To prevent the animals from interfering with the patches the trunk of each rabbit was wrapped in an elasticated corset (TUBIGRI P) and the animals were returned to their cages for the duration of the exposure period. Four hours after application the corset and patches were removed from each animal and any residual test material removed by gentle swabbing with cotton wool soaked in distilled water. Approximately one hour following removal of the patches, and 24, 48 and 72 hours later, the test sites were examined for evidence of primary irritation and scored according to the scale of Draize J.H. (1959). Well-defined erythema with moderate edema was noted at 3/3 treated skin sites one hour after removal of the patches. 0ne test site showed slight dermal haemorrhage over the test site. The irritation increased at the 24 -hour observation. One treated skin site showed light brown eschar at this time; the remaining treated skin sites showed moderate to severe erythema. The edema at all treated skin sites remained moderate. The dermal irritation gradually regressed and only one treated skin site showed very slight erythema on day 7: all skin sites showed desquamation. The test item was found to be irritant to rabbit skin.