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Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
From 06 December 2012 to 04 February 2013
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: OECD guideline and EU method. GLP study.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2013
Report date:
2013

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 (incl. QA statement)

Test material

Constituent 1
Chemical structure
Reference substance name:
[(±)-(4-amino-2-hydroxy-4-oxobutyl)trimethylammonium] chloride
EC Number:
226-073-0
EC Name:
[(±)-(4-amino-2-hydroxy-4-oxobutyl)trimethylammonium] chloride
Cas Number:
5261-99-4
Molecular formula:
C7H17N2O2.Cl
IUPAC Name:
4-amino-2-hydroxy-N,N,N-trimethyl-4-oxobutan-1-aminium chloride
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder
Details on test material:
- Physical state: white powder
- Analytical purity: 99,4%
- Lot/batch No.: WI 2274
- Storage condition of test material: at room temperature not exceeding 40°C.

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Institute of Occupational Medicine, Łódź
- Age at study initiation: The experiment was conducted on one 5-month-old female and two females which were 5.5 months old.
- Weight at study initiation: 3.2-4.4 kg
- Housing: The animals were kept individually in metal cages with the following dimensions: 60 x 35 x 40 cm (length x width x height).
- Diet (e.g. ad libitum): LSK standard granulated laboratory fodder, ad libitum
- Water (e.g. ad libitum): drinking tap water, ad libitum
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 - 21°C
- Humidity (%): 35 – 68%
- Air changes (per hr): about 16 times/hour
- Photoperiod (hrs dark / hrs light): 12 hours light – 12 hours dark

IN-LIFE DATES: From: 7 December 2012 To: 15 December 2012

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
other: drenched with a few drops of water
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g
Duration of treatment / exposure:
4 hours
Observation period:
1, 24, 48 and 72 hours after the end of the treatment.
Number of animals:
Three females
Details on study design:
TEST SITE
- Area of exposure: The area of skin treated with the test item was about 6 cm2.
- Type of wrap if used: The test item was applied to a multilayer gauze patch (2.5 x 2.5 cm) and drenched with a few drops of water. The gauze patch was laid on the prepared skin. The gauze patch was covered with PVC foil and protected using a non-irritating sticking plaster. The rabbit’s trunk was covered with lignin, and an elastic bandage was used to make a circular protecting band.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): The band and the gauze patch were taken off and the residual test item was removed using water.
- Time after start of exposure: 4 hours

SCORING SYSTEM:
Erythema and Eschar Formation
No erythema 0
Very slight erythema (barely perceptible) 1
Well defined erythema 2
Moderate to severe erythema 3
Severe erythema (beefy redness) to eschar formation preventing grading of erythema 4

Edema Formation
No edema 0
Very slight edema (barely perceptible) 1
Slight edema (edges of area well defined by definite raising) 2
Moderate edema (raised approximately 1 mm) 3
Severe edema (raised more than 1 mm and extending beyond area of exposure) 4

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
other: 24-72 h
Score:
0
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
other: 24-72 h
Score:
0
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
other: 24-72 h
Score:
0
Irritation parameter:
edema score
Basis:
animal #1
Time point:
other: 24-72 h
Score:
0
Irritation parameter:
edema score
Basis:
animal #2
Time point:
other: 24-72 h
Score:
0
Irritation parameter:
edema score
Basis:
animal #3
Time point:
other: 24-72 h
Score:
0
Irritant / corrosive response data:
During the reading which took place 1 hour after the end of the exposure, very slight erythema (barely perceptible) was stated on the skin in the site of the test item application in rabbit no. 1. During the readings which took place 24, 48 and 72 hours after the end of the exposure, no pathological changes were observed on the treated skin of the three rabbits.

Any other information on results incl. tables

 

 

Table 1: Dermal irritation scores

 

Erythema

Oedema

Animal No

1

2

3

1

2

3

after 24 h

0

0

0

0

0

0

after 48 h

0

0

0

0

0

0

after 72 h

0

0

0

0

0

0

Mean score 24 – 72 h

 

0

0

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Based on the available results, the test substance is not classified as skin irritating.
Executive summary:

The acute skin irritation/corrosion study, according to the OECD Guideline No. 404 / EU Method B.4., was performed in order to obtain information on health hazards likely to arise from skin contact with the test item. The study commenced with a sighting study on one animal. The test item (grounded to a powder) in the amount of 0.5 g was applied only once to the shaved skin of one animal and covered with a protecting band. The exposure lasted 4 hours. After the evaluation of the treated skin, the test item was applied to the skin of the next two rabbits for 4 hours. General clinical observations of all animals for morbidity and mortality were performed daily during the entire experiment. Detailed clinical observations of the treated skin were performed 1, 24, 48 and 72 hours after the end of the exposure. The animals’ body weight was determined on the administration day (day 0) and on the last day of the experiment. During the reading which took place 1 hour after the end of the exposure, very slight erythema (barely perceptible) was stated on the skin in the site of the test item application in rabbit no. 1. During the readings which took place 24, 48 and 72 hours after the end of the exposure, no pathological changes were observed on the treated skin of the three rabbits.