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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:
1992-06-30 to 1992-07-05
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1993
Report date:
1993

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)
Remarks:
The study was conducted in compliance with the following GLP Regulations: GLP in Switzerland, Procedures and Principles, March 1986; OECD Principles of GLP, Paris, France, adopted May 12, 1981 and EPA, GLP Standards, Final Rule, U.S.A., Federal Register,

Test material

Constituent 1
Reference substance name:
Ethanaminium, 2-hydroxy-N-(2-hydroxyethyl)-N,N-dimethyl-, esters with C16-18 and C18-unsatd. fatty acids, chlorides
Cas Number:
1079184-43-2
Molecular formula:
n.a. (UVCB)
IUPAC Name:
Ethanaminium, 2-hydroxy-N-(2-hydroxyethyl)-N,N-dimethyl-, esters with C16-18 and C18-unsatd. fatty acids, chlorides
Test material form:
solid: particulate/powder
Specific details on test material used for the study:
- Name of test material (as cited in study report): Diethyl ester dimethyl ammonium chloride (DEEDMAC, E-4429.01)
- Physical state: Solid

Test animals

Species:
rabbit
Strain:
other: Chbb: NZW (SPF)
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Dr. Karl Thomae GmbH
- Age at study initiation: 19 weeks
- Weight at study initiation: Male: 3.2 kg and Females: 3.1 - 3.3 kg
- Housing: Individually housed in stainless steel cages (size: 86 X 54 X 33 cm) equipped with feed hoppers and drinking water bottles
- Diet (e.g. ad libitum): Pelleted standard Kliba 341, Batch 70/92 rabbit maintenance diet, ad libitum
- Water (e.g. ad libitum): Community tap water from Fullinsdorf, ad libitum
- Acclimation period: 5 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/-3
- Humidity (%): 40-70 %
- Air changes (per hr): 10-15
- Photoperiod (hrs dark / hrs light): 12 hours artificial fluorescent light (approx. 100 lux)/ 12 hours dark, music during the light period


IN-LIFE DATES: From: 1992-06-30 To: 1992-07-05

Test system

Type of coverage:
semiocclusive
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 gm
- Concentration (if solution): Not applicable


VEHICLE
- Amount(s) applied (volume or weight with unit): Not applicable
- Concentration (if solution): Not applicable
- Lot/batch no. (if required): Not applicable
- Purity: Not applicable
Duration of treatment / exposure:
Three Chbb: NZW (SPF) rabbits were dosed with 0.5 gm of Diethyl ester dimethyl ammonium chloride (DEEDMAC, E-4429.01). The test article was applied moistened with tap water to approximately 6 cm2 of the intact skin of the clipped area. It was covered with a 3.0 cm X 3.0 cm patch of surgical gauze. The gauze was covered with a semi-occlusive dressing. The duration of treatment was 4 hours. Then the dressing was removed and the skin was flushed with lukewarm-tap water. The skin reaction was assessed at 1, 24, 48 and 72 hours after removal of the dressing, gauze patch and test article.
Observation period:
1, 24, 48 and 72 hours after removal of the dressing, gauze patch and test article.
Number of animals:
3 animals (one male and two females)
Details on study design:
TEST SITE
- Area of exposure: Approximately 6 cm2
- % coverage: Covered with a 3.0 cm X 3.0 cm patch of surgical gauze
- Type of wrap if used: The gauze was covered with a semi-occlusive dressing. The dressing was wrapped around the abdomen and anchored with an elastic bandage


REMOVAL OF TEST SUBSTANCE
- Washing (if done): Skin was flushed with lukewarm-tap water
- Time after start of exposure: 4 hours


SCORING SYSTEM: Erythema and escher scoring from0-4 with 0 = no erythema, 1= very slight erythema, 2 = well defined erythema, 3 = moderate to severe erythema, 4 = severe erythema to slight eschar formation.
Oedema scoring from0-4 with 0 = no oedema, 1= very slight oedema, 2 = slight oedema, 3 = moderate oedema, 4 = severe oedema.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Remarks:
Intact skin site
Basis:
animal: #1, #3
Time point:
24/48/72 h
Score:
0.33
Max. score:
4
Reversibility:
fully reversible within: 48 hours
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Remarks:
intact skin site
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Remarks:
Intact skin site
Basis:
animal: #1, #2, #3,
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
PDII 0.33 at 1 hour for intact skin site
PDII 0.67 at 24 hours for intact skin site
PDII 0 at 48 and 72 hours for intact skin site
Other effects:
No corrosive effect occurred on the treated skin of any animal at each measuring interval

Any other information on results incl. tables

GHS Classification Evaluation

 Animal # Degree of erythema after...[observation time]              Degree of oedema after...[observation time]        GHS ClassificationØ 24/48/72 h>/= 2.3?  
   1h  24h  48h  72h  1h  24h  48h  72h  Erythema  Oedema
 40 (M)  1  1  0  0  0  0  0  0  No  No
         Ø 24/48/72 h =  0.33           Ø 24/48/72 h =  0      
 41 (F)  0  0  0  0  0  0  0  0  No  No
         Ø 24/48/72 h =  0           Ø 24/48/72 h =  0    
 42 (F)  0  1  0  0  0  0  0  0  No  No
          Ø 24/48/72 h =  0.33            Ø 24/48/72 h =  0    

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
MDEA-Esterquat C16-18 and C18 unsatd. is slightly irritating to the skin of rabbits. The mean grades of skin reactions at 24, 48 and 72 h reading correspond to values classified as not irritant by theDirective 67/548/EEC as well as GHS Regulation EC No 1272/2008.
Executive summary:

In a primary dermal irritation study comparable to OECD guideline 404, 12 May 1981, three White New Zealand rabbits were dermaly exposed to 0,5 g  of MDEA-Esterquat C16-18 and C18 unsatd. undiluted for 4 hours to an intact area of approximately 6 cm² covered by a semi-occlusive dressing. Animals then were observed for 3 days.  Irritation was scored by the method of Draize 1;  24; 48 and 72 hours after exposure.

Very slight erythema was observed 1 h after exposure in one animal and in 2/3 animals at the 24 hour reading and was reversible within 48 hours after exposure. No oedema was observed.

The mean grades of skin reactions at 24, 48 and 72 h reading correspond to values classified as not irritant by the Directive 67/548/EEC as well as GHS Regulation EC No 1272/2008.

When applied to the skin, the test article MDEA-Esterquat C16-18 and C18 unsatd. is classified as "not irritant" in this study.

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