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Diss Factsheets

Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
From October 31, 2007 to November 22, 2007
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2010
Report date:
2010

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Version / remarks:
2002
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
Version / remarks:
2004
Deviations:
no
GLP compliance:
yes

Test material

Constituent 1
Reference substance name:
Fatty acids, C16-18 (even numbered) and C18 unsatd., reaction products with diethylene triamine, di-Me sulfate quaternized
Molecular formula:
UVCB
IUPAC Name:
Fatty acids, C16-18 (even numbered) and C18 unsatd., reaction products with diethylene triamine, di-Me sulfate quaternized
Test material form:
solid
Remarks:
Paste

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Age at study initiation: 12 weeks
- Housing: Individually in stainless steel cages equipped with feed hoppers and drinking water bowls. Wood blocks (Harlan Laboratories Ltd., Füllinsdorf) and haysticks 4642 (batch no. 08/07, Provimi Kliba AG / Switzerland) were provided for gnawing.
- Diet: ad libitum, pelleted standard Provimi Kliba 3418 rabbit maintenance diet (batch no. 52/07) provided by Provimi Kliba AG, 4303 Kaiseraugst /Switzerland.
- Water: ad libitum, municipal water
- Acclimation period: 4-6 d

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17-23°C
- Humidity (%): 30-70%
- Air changes (per hr): 10-15
- Photoperiod: 12 h light/dark cycle

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
water
Controls:
not specified
Amount / concentration applied:
TEST MATERIAL
- Amount applied: 0.5 mL test substance was weighed as delivered by the Sponsor and then moistened with approximately 0.5 mL of purified water before application.
- pH: 6.44 (1% solution)
Duration of treatment / exposure:
4 h
Observation period:
14 d
Number of animals:
3 animals (1 male and 2 females)
Details on study design:
PRE-EXPERIMENTAL PROCEDURE:
4 d before treatment, the left flank was clipped with an electric clipper, exposing an area of approximately 100 cm2 (10 cm x 10 cm). The skin of the animals was examined one day before treatment, and regrown fur of all animals was clipped again.

ADMINISTRATION OF THE TEST SUBSTANCE:
On the day of treatment, 0.5 mL of test substance was placed on a surgical gauze patch (ca. 2.5 cm x 2.5 cm). This gauze patch was applied to the intact skin of the clipped area. The patch was covered with a semi-occlusive dressing. The dressing was wrapped around the abdomen and anchored with tape. The application sites were observed for erythema, edema and other dermal findings approximately 1, 24, 48 and 72 hours after patch removal and on study days 7, 10 and 14.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes
- Time after start of exposure: 4 hours
Then the dressing was removed and the skin was flushed with lukewarm tap water to clean the application site so that any reactions (erythema) were clearly visible at that time.

SCORING SYSTEM: The skin reaction was assessed according to the numerical scoring system listed in the Commission Directive 2004/73/EC, April 29, 2004.

Grading of skin reaction

Erythema and Eschar formation
No erythema 0
Very slight erythema (barely perceptible) 1
Well-defined erythema 2
Moderate to severe erythema 3
Severe erythema (beef redness) or eschar formation
(injuries in depth preventing erythema reading) 4

Oedema formation
No oedema 0
Vera slight oedema (barely perceptible) 1
Slight oedema (edges of area well-defined by definite raising) 2
Moderate oedema (edges raised approximately 1mm) 3
Severe oedema (raised more then 1mm and
extending beyond the are of exposure) 4

Mortality / Viability: the rabbits were observed daily from acclimatization of the animals to the termination of test.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
3
Max. score:
4
Reversibility:
not fully reversible within: 14 d
Remarks on result:
other: Scaling present
Irritation parameter:
erythema score
Basis:
animal: #2, #3
Time point:
24/48/72 h
Score:
3
Max. score:
4
Reversibility:
fully reversible within: 14 d
Remarks on result:
other: Scaling present
Irritation parameter:
edema score
Basis:
animal: #1, #2
Time point:
24/48/72 h
Score:
2.33
Max. score:
4
Reversibility:
fully reversible within: 14 d
Remarks on result:
other: Scaling present
Irritation parameter:
edema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 14 d
Remarks on result:
other: Scaling present
Irritant / corrosive response data:
CLINICAL SKIN OBSERVATIONS:
1 h after removal of the dressing a well-defined erythema was observed in all animals which progressed into moderate to severe and persisted as very slight up to 10 or 14 d after treatment. A very slight to moderate oedema was recorded in all animals from the 1 h up to the 72 h reading or up to 10 d after treatment. Scaling was present in all animals 7 to 14 d after removal of the application patch. No alterations and no corrosive effects were observed on the treated skin.

REVERSIBILITY
With the exception of scaling in all three animals and a very slight erythema in the male, these effects were reversible and were no longer evident 14 days after treatment.
Other effects:
TOXIC EFFECTS OTHER THAN SKIN IRRITATION
- No clinical signs of systemic toxicity were observed in the animals during the study and no mortality occurred.
- Body weights: the body weights of all rabbits were considered to be within the normal range of variability.
- No necropsy was performed on the animals sacrificed at termination of observation.

Any other information on results incl. tables

Irritant/corrosive response data for each animal at each observation time

Score at time point

Erythema

Edema

Max. score: 4

Max. score: 4

1 h

2/2/2

3/2/2

24 h

3/3/3

3/3/2

48 h

3/3/3

2/2/2

72 h

3/3/3

2/2/2

7 d

1/1/1

1/0/1 *

10 d

1/1/1

1/0/1 *

14 d

1/0/0

0/0/0 *

* = scaling present

Applicant's summary and conclusion

Interpretation of results:
other: Category 2 (irritant) based on CLP criteria
Conclusions:
Under the study conditions, the test substance was considered to be irritating to rabbit skin.
Executive summary:

A study was conducted to determine the in vivo skin irritation potential of the test substance, 'di-C16-18 and C18-unsatd. AAEMIM-MS', according to OECD Guideline 404, in compliance with GLP. Three young adult New Zealand White rabbits (1 male and 2 females) were dermally exposed to 0.5 mL test substance moistened with 0.5 mL purified water for 4 h under semi-occlusive conditions, followed by observation for 14 d. The skin reactions were scored according to the guideline. 1 h after removal of the dressing, well-defined erythema was observed in all animals which progressed into moderate to severe reaction and persisted as very slight up to 10 or 14 d after treatment. A very slight to moderate oedema was recorded in all animals after 1 h and up to 72 h reading as well up to 10 d following treatment. Scaling was present in all animals 7 to 14 d after removal of the application patch. No alterations and no corrosive effects were observed on the treated skin. Under the study conditions, the test substance was considered to be irritating to rabbit skin (Evonik XXXXX, 2010).