Octadecanoic acid, reaction products with diethylenetriamine and urea, acetates

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2013

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2013

Report date:

2013

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Test material form:

other: Waxy solid

Details on test material:

None

Specific details on test material used for the study:

Identification: Sapamine CSN
Batch: 0024141800
Purity: not supplied
Expiry date: not supplied
Storage Conditions: room temperature in the dark

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Harlan Laboratories UK
- Age at study initiation: 12 to 20 weeks old
- Weight at study initiation: 2.30 to 2.93 kg
- Housing: Individually housed in suspended cages
- Diet (e.g. ad libitum):ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17-23 °C
- Humidity (%): 30 - 70 %
- Air changes (per hr): 15/hr
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: To: 18th June 2013 - 28th June 2013

Test system

Type of coverage:

semiocclusive

Preparation of test site:

clipped

Vehicle:

water

Controls:

other: contralateral flank

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g moistened with 0.5 mL distilled water

VEHICLE
- Amount(s) applied (volume or weight with unit): 0.5 mL

Duration of treatment / exposure:

3 minutes, 1 hour and 4 hours

Observation period:

1, 24, 48, 72 hrs

Number of animals:

3 male rabbits

Details on study design:

TEST SITE
- Area of exposure: 3 suitable sites on the back of the rabbit
- Type of wrap if used: 2.5 cm X 2.5 cm cotton gauze patch, secured with surgical adhesive tape

REMOVAL OF TEST SUBSTANCE
- Washing (if done): Residual test item was removed by gentle swabbing with cotton wool soaked in distilled water.
- Time after start of exposure: 3 minutes, 1 hour and 4 hours

SCORING SYSTEM: Draize Scheme
Dermal irritation was graded in each animal according to the following scoring scale:
- Erythema and eschar formation:
0 no erythema
1 very slight erythema (barely perceptible)
2 well-defined erythema
3 moderate to severe erythema
4 severe erythema (beet redness) to slight eschar formation (injuries in depth).

- Edema formation:
0 no edema
1 very slight edema (barely perceptible)
2 slight edema (edges of area well-defined by definite raising)
3 moderate edema (raised approximately 1 millimeter)
4 severe edema (raised more than 1 millimeter and extending beyond area of exposure).

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: all scores were zero at all time points.

Remarks on result:

no indication of irritation

Results 2

Irritation parameter:

edema score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: all scores were zero at all time points

Remarks on result:

no indication of irritation

Irritant / corrosive response data:

Primary irritation index is "0"

Other effects:

All animals showed expected gain in body weight during the study.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The test item produced a primary irritation index of 0.0 and was classified as non-irritant to rabbit skin according to the Draize classification scheme. No corrosive effects were noted.

Executive summary:

The study was performed on FAT 93580/A to assess the irritancy potential of the test item following single 3 minute, 1 and 4 hour, semi-occluded applications to the intact rabbit skin. The study was conducted according to OECD guideline 404 and in accordance with GLP.

3-minute and 1-hour semi-occluded applications of the test item to the intact skin of one rabbit produced no evidence of skin irritation. A single 4-hour, semi occluded application of the test item to the intact skin of three rabbits produced no evidence of skin irritation. All the scores at all time points tested were zero.

The test item produced a primary irritation index of 0 and was classified as non-irritant to rabbit skin according to the Draize classification scheme. No corrosive effects were noted.