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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:
weight of evidence
Study period:
1986-07-03 to 1986-08-01
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Guideline study with acceptable restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1986
Report date:
1986

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Deviations:
yes
Remarks:
Concentration of test substance used for induction was not the highest to cause mild irritation.
GLP compliance:
yes
Type of study:
Buehler test
Justification for non-LLNA method:
A sensitisation test using a non-LLNA method was carried out prior to the obligation to use the LLNA method.

Test material

Constituent 1
Reference substance name:
1-Propanaminium, 2-hydroxy-N-(2-hydroxypropyl)-N,N-dimethyl-, esters with fatty acids, C16-18 (even numbered) and C18 unsatd., Me sulfates (salts)
Cas Number:
1079184-43-2
Molecular formula:
n.a. (UVCB)
IUPAC Name:
1-Propanaminium, 2-hydroxy-N-(2-hydroxypropyl)-N,N-dimethyl-, esters with fatty acids, C16-18 (even numbered) and C18 unsatd., Me sulfates (salts)
Details on test material:
- Name of test material (as cited in study report): FV-base E2819.03
- (Diethyl ester dimethyl ammonium chloride) (FV-Base)
- Molecular formula (if other than submission substance): C42H84NO4Cl
- Molecular weight (if other than submission substance): 702.573
- Substance type: Pure active substance
- Physical state: solid
-Analytical purity: Not available
- Impurities (identity and concentrations): Not available
- Composition of test material, percentage of components: Not available
- Isomers composition: Not available
- Purity test date: Not available
- Lot/batch No.: Not available
- Expiration date of the lot/batch: Not available
- Stability under test conditions: Not available
- Storage condition of test material: Room temperature

In vivo test system

Test animals

Species:
guinea pig
Strain:
Pirbright-Hartley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Lippische Versuchstierzucht Hagemann GmbH & Co.
- Age at study initiation: Not available
- Weight at study initiation: 327 - 387 grams
- Housing: 5 aniamls in one cage, Macrolon Plastic cages IV
- Diet (e.g. ad libitum): ad libitum, Ssniff-G
- Water (e.g. ad libitum):ad libitum, aqua fontana
- Acclimation period: 4 days instead of 5 days recommended by the OECD guideline 406


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 +/- 2
- Humidity (%): 50 - 85 % instead of 30 – 70 % recommended by the OECD guideline 406
- Air changes (per hr): Not available
- Photoperiod (hrs dark / hrs light): Fluorescent light 120 lux.


IN-LIFE DATES: From: 1986-07-03 To: 1986-08-01

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
other: Induction: ethanol 96 % was used instead of 80 % recommended by the OECD guideline 406, Challenge : Acetone
Concentration / amount:
Induction 15 % test substance in ethanol 96 %
Challenge 7.5 % test substance in acetone
One group of 20 test animals were treated with 0.3ml of 15% test substance in ethanol for a period of 6 hours weekly for 3 induction exposures.
Test group and 10 control animals were challenged with 7.5% test substance in acetone.
Challengeopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
other: Induction: ethanol 96 % was used instead of 80 % recommended by the OECD guideline 406, Challenge : Acetone
Concentration / amount:
Induction 15 % test substance in ethanol 96 %
Challenge 7.5 % test substance in acetone
One group of 20 test animals were treated with 0.3ml of 15% test substance in ethanol for a period of 6 hours weekly for 3 induction exposures.
Test group and 10 control animals were challenged with 7.5% test substance in acetone.
No. of animals per dose:
20 animals in the test substance group and 10 animals in the vehicle control group
Details on study design:
RANGE FINDING TESTS:
The entire back and both sides were clipped one day prior to application.
Four animals were exposed to various concentrations of the test substance
Concentration: 15% and 7.5% test substance in acetone
Grading: at 24 hours and 48 hours



MAIN STUDY
A. INDUCTION EXPOSURE
Prior to treatment the left shoulder of each animal was clipped with a small animal clipper. 0,3 ml of the freshly prepared test substance were applied to the Hill Top Chambers and placed on the clipped surface of each animal in the test group and secured with rubber dental dam. Animals were immobilized in metal restrainers for 6 hours. After that time patches were taken off and the test substance was removed with a gentle rinse of warm water before returning the animals to their cages. The procedure was repeated at the same site once a week for the next two weeks.
- No. of exposures: 3 induction exposures
- Exposure period: 6 hours
- Test groups: 20 animals were exposed to 0.3 ml of 15 % test substance in ethanol 96 %
- Control group: 10 animals, procedure not described
- Site: upper left quadrant of the back of the test animal
- Frequency of applications: once a week for 3 weeks.
- Duration: 6 hours under occlusion
- Concentrations: 15 % test substance in ethanol 96 %



B. CHALLENGE EXPOSURE
The animals from the test group as well as from the control group were treated following the same patching procedure as described for induction.
- No. of exposures: one 6 hour exposure
- Day(s) of challenge: two weeks after third induction
- Exposure period: 6 hours under occlusion
- Test groups: 0.3 ml of 7.5 % test substance in acetone
- Control group: 0.3 ml of 7.5 % test substance in acetone
- Site: Patches were applied to a naive skin site
- Concentrations: 7.5 % test substance in acetone
- Evaluation (hr after challenge): 24 and 48 hours after challenge exposure.


OTHER:
Grading of all animals was done by positioning them under a four tube fluorescent type light. The control animals were graded before the test animals according to the Scoring system below.

Scores:
No reaction 0
slight patchy erythema ± (0,5)
Slight, but confluent or moderate
Patchy erythema 1
Moderate erythema 2
Severe erythema with or without edema 3
Challenge controls:
10 control animals were challenged with 7.5 % test substance in acetone
Positive control substance(s):
no

Results and discussion

Positive control results:
None

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
7.5 % in acetone
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
no animals with positive responses
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 7.5 % in acetone. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: no animals with positive responses.
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
7.5 % in acetone
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
no animals with positive responses
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 7.5 % in acetone. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: no animals with positive responses.
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
7.5 % in acetone
No. with + reactions:
3
Total no. in group:
20
Clinical observations:
slight patchy erythema, socre 0.5 was observed in 3 animals
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 7.5 % in acetone. No with. + reactions: 3.0. Total no. in groups: 20.0. Clinical observations: slight patchy erythema, socre 0.5 was observed in 3 animals.
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
7.5 % in acetone
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
no animals with positive responses
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 7.5 % in acetone. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: no animals with positive responses.

Any other information on results incl. tables

No skin alterations were observed during the induction period with 15 % test substance in ethanol 96 %. After challenge with 7,5 % test article, partly slight, patchy erythema (score 0,5) was observed in the test group in 3/20 animals at the 48 hour reading. The control group showed no skin reactions. Normal weight gains were obseved during the study.

Applicant's summary and conclusion

Interpretation of results:
not sensitising
Remarks:
Migrated information Criteria used for interpretation of results: other: GHS Regulation EC No 1272/2008
Conclusions:
MDEA-esterquat C16-18 and C18 unsatd. did not induce sensitization in the guinea pig model.
Executive summary:

In a dermal sensitization study according to OECD guideline 406, 12 May, 1981 with MDEA-Esterquat C16-18 and C18 unsatd.  (80 % a.i) in IPA, Pirbright-Hartley guinea pig (10 male and 10 female) were tested using the method of Bühler.

No skin alterations were observed during the induction period with 15 % test substance in ethanol 96%. After challenge with 7.5 % test article no skin reaction was observed in the test group at the 24 hour reading, partly slight, patchy erythema (score 0.5) was observed in 3/20 animals at the 48 hour reading. No skin reactions were observed in the control animals. There was a very slight intergroup difference in skin alteration between test- and control group.

In this study, MDEA-Esterquat C16-18 and C18 unsatd.  is not a dermal sensitizer.