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Diss Factsheets

Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation / corrosion, other
Remarks:
The skin irritation potential was assessed by rthe results obtained in a dermal toxicity study.
Type of information:
experimental study
Adequacy of study:
key study
Study period:
8 June 2015 - 23 June 2015
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2015

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
no
GLP compliance:
yes (incl. QA statement)

Test material

Constituent 1
Reference substance name:
(2-carboxyethyl)({2-[(2-carboxyethyl)(2-hydroxyethyl)amino]ethyl})azanium; [({2-[(2-carboxyethyl)(2-hydroxyethyl)amino]ethyl}carbamoyl)methyl](dodecyl)dimethylazanium; ethanol
IUPAC Name:
(2-carboxyethyl)({2-[(2-carboxyethyl)(2-hydroxyethyl)amino]ethyl})azanium; [({2-[(2-carboxyethyl)(2-hydroxyethyl)amino]ethyl}carbamoyl)methyl](dodecyl)dimethylazanium; ethanol

Test animals

Species:
rat
Strain:
other: CD / Crl: CD(SD)
Details on test animals or test system and environmental conditions:
Strain / Stock CD / Crl: CD(SD)
Supplier: Charles River Laboratories, Research Models and Services, Germany GmbH, Sandhofer Weg 7, 97633 Sulzfeld, Germany
Body weight (at dosing):Males: 213 - 223 g; Females: 206 - 234 g
Age (at dosing): Males: approx. 8 weeks; Females: approx. 9 weeks
Identification of animals: By coloured marks and cage label

Commercial diet, ssniff® R/M-H V1534 (ssniff Spezialdiäten GmbH, 59494 Soest, Germany) served as food. Feeding was discontinued approx. 16 hours before administration; only tap water was then available ad libitum.
Periodic analysis of the food for contaminants based on EPA/USA is conducted at least twice a year by LUFA-ITL. Certificates of analysis of the composition and for contaminants were provided by the manufacturer and are included in the raw data.
Housing
Granulated textured wood (Granulat A2, J. Brandenburg, 49424 Goldenstedt, Germany) was used as bedding material for the cages. The cages were changed and cleaned twice a week.
Periodic analysis of the bedding material for contaminants based on EPA/USA is conducted at least once a year by LUFA-ITL (see Appendix 2 'Limitation for Contaminants in the Bedding Material').
During the 14-day observation period the animals were kept singly in MAKROLON cages (type III plus) at a room temperature of 22°C ± 3°C (maximum range) and a relative humidity of 55% ± 15% (maximum range). Deviations from the maximum range caused for example during cleaning procedures are dealt with in SOPs.
The rooms were lit (150 lux at approx. 1.50 m room height) and darkened for periods of 12 hours each.

Drinking water
Drinking water in bottles was offered ad libitum.
Drinking water is examined according to the 'Deutsche Trinkwasserverordnung 2011 [German Regulations on drinking water 2011] by the Hamburger Wasserwerke, 20539 Hamburg, Germany, at least four times a year (see Appendix 2 'Limitation for Contaminants in the Drinking Water').
In addition, drinking water samples taken at LPT are analysed by LUFA-ITL once a year for means of bacteriological investigations according to the 'Deutsche Trinkwasserverordnung 2011, Anlage 1' [German Regulations on drinking water 2011, Addendum 1].

Test system

Type of coverage:
occlusive
Preparation of test site:
shaved
Vehicle:
water
Controls:
no
Amount / concentration applied:
The test substance was used as supplied. The application volume was 3.73 mL/kg b.w. as the density of the test item was 1.0731 g/mL.
The test item was an approx. 50% aqueous solution. A correction factor of 2 was employed. The concentration refers to the solid content (active ingredient).
Duration of treatment / exposure:
24 hours
Observation period:
2 weeks
Number of animals:
5 animals/sex
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: 5, 15, 30 min after administration, as well as 3, 6 and 24 hours after administration
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight,organ weights, histopathology: changes of skin and fur, eyes and mucous membranes, respiratory and circulatory function, autonomic and central nervous system and somatomotor activity as well as behaviour pattern, were observed at least once a day until all symptoms subsided, thereafter each working day. Attention was also paid to possible tremors, convulsions, salivation, diarrhoea, lethargy, sleep and coma.
Observations on mortality were made at least once daily to minimize loss of animals during the study. Individual body weights were recorded before administration of the test item and thereafter in weekly intervals up to the end of the study. Changes in weight were calculated and recorded.
The skin was observed for the development of erythema and oedema.

Results and discussion

In vivo

Results
Irritation parameter:
other: visual inspection
Basis:
other: all animals in test
Time point:
other: daily until end of test
Remarks on result:
no indication of irritation

Any other information on results incl. tables

Summarized results

Symptoms/Criteria

Test substance

2000mg/kg b.w.

(n = 5)

 

males

females

Clinical signs

none

none

Skin reactions

none

none

Mortality

within 6 h

within 27 h

within 7 d

within 14 d

 

0

0

0

0

 

0

0

0

0

Mean body weight (in g)

start

 

217.6

 

218.2

After 7 days

275.8

(+ 26.7)

238.6

(+ 9.3)

After 14 days

331.8

(+ 52.5)

263.8

(+ 20.9)

Inhibition of body weight gain

none

None

Necropsy findings

none

none

 

In brackets: body weight gain in %, compared to the start value

The dose level refers to the active ingredient

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: expert judgment
Conclusions:
No skin reactions were observed at the application site 24 hours after application until end of observation period (2 weeks).
Executive summary:

There is no evidence for a skin irritating potential of Amines, C12-16 alkyl dimethyl, reaction products with ethyl chloroacetate, 2-(2-aminoethylamino)ethanol and 2-propenoic acid from an acute dermal toxicity study (OECD guideline 402). Groups of 5 male and female young adult rats (Rattus norvegicus) were dermally exposed to the test substance for 24 hours under an occlusive dressing. The applied dose of 2000 mg/kg bw (related to a.i.) is equivalent to an average concentration of 29.1 mg/cm² and 29.4 mg/cm² for males and females, respectively. Calculation is based on mean applied volume males: 0.81 mL, females: 0.82 mL; densitiy 1.0731 g/mL and area of exposue 5 x 6 cm.

No signs of irritation were recorded during the 14 day observation period.