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Diss Factsheets

Toxicological information

Skin sensitisation

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Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
September / October 1991
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1992
Report date:
1992

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
GLP compliance:
yes (incl. QA statement)
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
At the time the study was conducted the Guinea Pig Maximation was the accepted standard test for skin sensitisation.

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

In vivo test system

Test animals

Species:
guinea pig
Strain:
other: Pirbright White
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Fa. Winkelmann Versuchstierzucht
- Age at study initiation: -
- Weight at study initiation: male 359 - 447 g, female 334 - 425 g
- Housing: collective housing up to a maximum of 5 animals per cage
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 - 25 °C
- Humidity (%): 30 - 70 %
- Air changes (per hr): -
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: To:-

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
intradermal and epicutaneous
Vehicle:
water
Concentration / amount:
Pilot experiment:
Intradermal: 0.1 ml of 5.0 %, 1 %, 0.5 % and 0.1 % dilution in water.
Dermal: soaked patch with 100 %,50 %, 25 % , 10%, 5%, 1% and 0.5 % of the test substance in water.
Main study:
Intradermal: 0.1 ml of 1 % dilution in water.
Dermal: soaked patch with the undiluted test substance.
Challenge: soaked patch with 5 % and 1 % dilution in water.
Challengeopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
water
Concentration / amount:
Pilot experiment:
Intradermal: 0.1 ml of 5.0 %, 1 %, 0.5 % and 0.1 % dilution in water.
Dermal: soaked patch with 100 %,50 %, 25 % , 10%, 5%, 1% and 0.5 % of the test substance in water.
Main study:
Intradermal: 0.1 ml of 1 % dilution in water.
Dermal: soaked patch with the undiluted test substance.
Challenge: soaked patch with 5 % and 1 % dilution in water.
No. of animals per dose:
10 male / 10 female
Details on study design:
RANGE FINDING TESTS:

MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 2: intradermal and epicutaneous
- Exposure period:
- Test groups: 10 male / 10 female
- Control group: 10 male / 10 female
- Site: shoulders




B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Exposure period: 24 h
- Test groups: 2
- Control group: 1
- Site: flanks
- Concentrations: 5 % and 1 % dilutions in water
- Evaluation (hr after challenge): 24h and 48h after patch removal

OTHER:
Challenge controls:
2 control groups (1 % and 5 % test substance concentration)
Positive control substance(s):
yes
Remarks:
2.4 dinitrochlorobenzene and benzocaine

Results and discussion

Positive control results:
The reaction to the positive control substances 2.4 dinitrochlorobenzene (strong sensitizer) and benzocaine (moderate sensitizer) is tested periodically. The last test with an acceptable level of response to each of these substances was performed in October 1991.

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
5 % dilution
No. with + reactions:
18
Total no. in group:
20
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 5 % dilution. No with. + reactions: 18.0. Total no. in groups: 20.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
5 % dilution
No. with + reactions:
19
Total no. in group:
20
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 5 % dilution. No with. + reactions: 19.0. Total no. in groups: 20.0.
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
1 % dilution
No. with + reactions:
2
Total no. in group:
20
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 1 % dilution. No with. + reactions: 2.0. Total no. in groups: 20.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
1 % dilution
No. with + reactions:
0
Total no. in group:
20
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 1 % dilution. No with. + reactions: 0.0. Total no. in groups: 20.0.
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
5 % dilution
No. with + reactions:
17
Total no. in group:
20
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 5 % dilution. No with. + reactions: 17.0. Total no. in groups: 20.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
5 % dilution
No. with + reactions:
14
Total no. in group:
20
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 5 % dilution. No with. + reactions: 14.0. Total no. in groups: 20.0.
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
1 % dilution
No. with + reactions:
0
Total no. in group:
20
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 1 % dilution. No with. + reactions: 0.0. Total no. in groups: 20.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
1 % dilution
No. with + reactions:
0
Total no. in group:
20
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 1 % dilution. No with. + reactions: 0.0. Total no. in groups: 20.0.

Any other information on results incl. tables

The intensity and severity of responses to the test article (concentration 5 %) in the test group were compared to the responses in controls and therefore the effects refer to severity may be attributable in a value of 0.70 only to the sensitizing potential of the test article (1.25 mean value in the control group vs. 1.95 in the test group). The comparison refer to intensity was nearly indiscriminately.

Applicant's summary and conclusion

Interpretation of results:
not sensitising
Remarks:
Migrated information Criteria used for interpretation of results: expert judgment
Conclusions:
According to the grading scheme of Magnusson and Kligman, the test article “REWOTERIC QAM 50” is classified as a “mild sensitizer”. The sensitisation rate at 24 h was 10 % with the 1 % dilution. The 5 % dilution caused skin reactions in 90 % of the test group animals and in 85 % of the control group animals. From the results it is assumed that the sensitization rate is < 30 % for both concentrations and the test substance is regarded as non-sensitising.
Executive summary:

The test substance was tested regarding its skin sensitisation potential. The test was performed according to the protocol of Magnusson and Kligman, in which adjuvant is used to elicit an immunologic reaction. The test protocol is in compliance with the OECD Guideline for the Testing of Chemicals No. 406 Skin Sensitisation (1992). The maximum compatible doses for the intradermal and dermal application as well as the subirritative dose for the challenge were determined in a pilot experiment. In the main experiment two test groups of ten (10) male and ten (10) female guinea pigs of the strain "Pirbright White" were treated intradermally with 0.1 ml of a 1 % dilution of the test substance in water. Two control groups of ten (10) male and ten (10) female animals received the vehicle only. For the dermal induction the undiluted test substance or the vehicle only (control group) was used. In the challenge application 5 % or 1 % dilutions of the test substance in water were applied to the flanks of the animals. Body weight development of the animals was positive and within normal ranges.

 In the challenge visible changes of the skin ( erythema and swelling grading 1 -3 ) were observed 24 hours after patch removal in

90 % (18/20) of the 5 % test group and in 85 % (17/20) of the 5 % control group animals indicating a distinct irritating potential of the 5 % concentration of the test substance. In the 1 % test group 10 % (2/20) of the animals showed only very slight erythema at the treated skin site after 24 hours. 48 h after the challenge these skin reactions were not observed anymore. In the corresponding 1 % control group no skin reaction was observed 24 hours and 48 hours after the challenge.

According to the grading scheme of Magnusson and Kligman, the test substance is classified as a “mild sensitizer”. The sensitisation rate was 10 % at 24 h and 0 % at 48 h with the 1 % dilution. The 5 % dilution caused skin reactions both in the test group animals and in the corresponding control group. From the results it is assumed that overall the sensitization rate is < 30 % and the test substance is regarded as non-sensitising.