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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:
09. May 2005 - 17. May 2005
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2005
Report date:
2005

Materials and methods

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

Test material

Constituent 1
Chemical structure
Reference substance name:
-
EC Number:
480-680-7
EC Name:
-
Cas Number:
120128-90-7
Molecular formula:
Hill formula: C8H16N2O3 CAS formula: C8H16N2O3
IUPAC Name:
2-[(3-formamidopropyl)dimethylazaniumyl]acetate

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
Species: rabbit
Breed: New Zealand White, IVA: NZW
Breeder: Charles River, Extertal, Germany
Date of receipt: 2005-05-03
Sex: 1 male and 2 female
Body weights: 1805.3 g, 1905.8 g, 1949.1 g
Age: - 10 weeks
Identification: dyemarks and cage numbers
Diet: Altromin International, Lage, Germany, 2023 - 1425
Water: Drinking water for the animals consisted of normal tap water from municipal sources: Stadtische Werke Krefeld AG, Abt. 2 TGW, Krefeld, Germany. The composition of the water is regularly determined. The data are retained in the archive. The water was supplied to the animals ad libitum via drinking bottles with rubber stoppers and steel pipes.
Bedding material: Lignocel BK 10/20, Rettenmaier, Jagstzell, Germany
Husbandry: They were housed single in steel cages with a plastic bottom mould and a habitat of 5445 cm2 at the bottom and an overall height of 600 mm. A non-barrier system with air conditioning was used. The air conditioning had the following nominal values: Temperature: 20 ± 3 °C, Humidity: 30 -70 %. Climate control was run automatically. The lightening was in a 12-hour light/dark-cycle. Temperature and humidity were recorded continuously using a thermohygrometer, Lambrecht GmbH, Gottingen, Germany. The data were archived. There have been no deviations from nominal temperature and humidity values during the experiment.

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
0.5 ml of the test substance was applied to the left flank
Duration of treatment / exposure:
4 hours
Observation period:
Examination of the treated skin sites was done 1 hour, and approximately 24, 48, 72 hours as well as 7 days after removal of the test Substance.
Number of animals:
3
Details on study design:
Before the experiment was started, the animals had an acclimatization period of at least 5 days. The animals were clearly marked with dye and weighed. Food and drinking water was left for the animals ad libitum. 24 hours before dosing a part of the fur on both sides of the dorso-Iumbal region of each animal was removed by shearing with an electrical shaving machine exposing an area of skin approximately 10 x 15 cm. Care was taken to avoid abrading the skin and only animals with healthy intact skin were used in the experiment. Body weight was recorded immediately before test substance application and on the day of the final observation. As neither corrosive nor strong irritating effects to the skin have been expected the test substance was applied to all three animals for four hours at the same time. 0.5 ml of the test substance was applied to the left flank covered with a gauze pad (3 x 2 cm) which was held in place by strips of Blenderm (3M company, St. Paul, USA). The right flank
served as control region. Semi-occlusive dressings were bandaged with Acrylastic (Beiersdorf AG, Hamburg, Germany) and fixed with Leukoplast (Beiersdorf AG, Hamburg, Germany). Thus access by the animal to the patch and resultant ingestion of the test substance was prevented.
The test substance was removed by washing with tap water after 4 hours exposure time and the application areas were examined.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
mean
Time point:
other: 24 - 72 h
Score:
0
Max. score:
1
Reversibility:
fully reversible within: 24 h
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
edema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
edema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible

Any other information on results incl. tables

Skin Reactions: Only very slight erythema but no oedema was observed in one animal 1 h after removal of the test substance Formamidopropyldimethylbetain 50%ig. The numerical scores to the erythema and oedema formations are presented in the following table:

 

Rabbit 504male

Rabbit 505 RV female

Rabbit 507 female

 

1h

24h

48h

72h

7d

1h

24h

48h

72h

7d

1h

24h

48h

72h

7d

Erythema

0

0

0

0

0

0

0

0

0

0

1

0

0

0

0

Oedema

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

Mean (24h-72h)

 

0 (E)

0 (Oe)

 

 

0 (E)

0 (Oe)

 

 

0 (E)

0 (Oe)

 

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: other: CLP, EU GHS (Regulation (EC) No 1272/2008)
Conclusions:
Formamidopropyldimethylbetain 50%ig is not 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 the Directive 67/548/EEC as well as GHS Regulation EC No 1272/2008.
Executive summary:

For labelling and classification purposes the test substance Formamidopropyldimethylbetain 50%ig, a yellowish clear liquid, was tested regarding its skin irritation potential. The potential to cause inflammatory or corrosive changes upon first contact with skin was

assessed by semi-occluded application of the test substance for four hours to the shorn skin of two female and one male rabbit, strain New Zealand White according to the DECO Guideline for the Testing of Chemicals, 404 "Acute Dermal Irritation/Corrosion". As neither corrosive nor strong irritating effects to the skin have been expected Formamidopropyldimethylbetain 50%ig was applied to all three animals for four hours at the same time. Dermal reactions at the treated skin sites were assessed 1 hour after removal of the test substance and approximately 24, 48, and 72 hours as well as 7 days later.

Systemic toxic symptoms after application were not observed at any time during the study. Body weight development of the animals was positive and within normal ranges. Only very slight erythema but no oedema was observed in one animal 1 h after removal of the

test substance. Especially between 24 and 72 hours no erythema and oedema were observed. The mean scores for erythema and oedema formation for the time period 24 h - 72 h were 0. The Primary Skin Irritation Index was calculated to be 0. Under the conditions of this study the test substance Formamidopropyldimethylbetain 50%ig is non irritating and does not have to be classified for skin irritation.