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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:
key study
Study period:
1978
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Study was conducted according to OECD Guideline 406
Cross-referenceopen allclose all
Reason / purpose for cross-reference:
reference to same study
Reason / purpose for cross-reference:
reference to other study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1978
Report date:
1978

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Deviations:
yes
Remarks:
(Pre and post study body weights of the animals are not given)
Principles of method if other than guideline:
Not applicable
GLP compliance:
no
Type of study:
Buehler test
Justification for non-LLNA method:
A reliable Buehler test already existed. The LLNA Guideline was not available at the time of test performance.

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Marchan coconut monoethanolamide
- Substance type: Pure active substance
- Physical state: Solid
- Analytical purity: Not available
- Impurities (identity and concentrations): Not readable
- Composition of test material, percentage of components: See below
- Lot/batch No.: Not readable
- Expiration date of the lot/batch: See below
- Storage condition of test material: Cool, dry

In vivo test system

Test animals

Species:
guinea pig
Strain:
Hartley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Murphy breeding laboratories, Inc.
- Housing: Singly in wire mesh cages suspended above the droppings
- Diet (e.g. ad libitum): Purina Guinea Pig Chow, ad libitum
- Water (e.g. ad libitum): Animals were maintained on medicated water containing 4 % of sulfaethoxypyridazine ( 6.25 % S.E.Z., American Cyanamid ) for 4 days. Then they were furnished with non-medicated water ad libitum.
- Acclimation period: At least 4 d


ENVIRONMENTAL CONDITIONS
- Temperature (°C): Not Available
- Humidity (%): Not Available
- Air changes (per hr): Not Available
- Photoperiod (hrs dark / hrs light): 12-h light/ 12-h dark cycle


IN-LIFE DATES: 1978-05-24

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
water
Concentration / amount:
One group of 20 test animals was treated with 0.4 mL of Cocamide MEA as a 30 % w/v solution in distilled water for an exposure period of 6 h
weekly for 3 induction exposures.
Both test (20) and control (10) animals were challenged with Cocamide MEA as a 30 % w/v solution in distilled water.

One group of 20 test animals was treated with 0.4 ml of Cocamide MEA as a 30 % w/v solution in distilled water for an exposure period of 6 hours
weekly for 3 induction exposures.
Both test (20) and control (10) animals were challenged with Cocamide MEA as a 30 % w/v solution in distilled water.


Challengeopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
water
Concentration / amount:
One group of 20 test animals was treated with 0.4 mL of Cocamide MEA as a 30 % w/v solution in distilled water for an exposure period of 6 h
weekly for 3 induction exposures.
Both test (20) and control (10) animals were challenged with Cocamide MEA as a 30 % w/v solution in distilled water.

One group of 20 test animals was treated with 0.4 ml of Cocamide MEA as a 30 % w/v solution in distilled water for an exposure period of 6 hours
weekly for 3 induction exposures.
Both test (20) and control (10) animals were challenged with Cocamide MEA as a 30 % w/v solution in distilled water.


No. of animals per dose:
Induction: group of 20 test animal treated with 0.4 mL of Cocamide MEA as a 30 % w/v solution in distilled water.
Range Finding test: 4 test animals treated with each of the following concentration- Cocamide as 30, 15, 8 and 4% w/v solutions in distilled water.
Primary challenge: 20 test animals and 10 control animals treated with Cocamide MEA as a 30 % w/v solution in distilled water.
Details on study design:
RANGE FINDING TESTS: 4 test animals treated with each of the following concentration- Cocamide as 30, 15, 8 and 4 % w/v solutions in distilled
water


MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 3
- Exposure period: 6 hours
- Test groups: 0.4 ml of Cocamide MEA as a 30 % w/v solution in distilled water
- Control group: None
- Site: Upper left quadrant of the backs of test animals
- Frequency of applications: Once a week for 3 wk
- Duration: 6 hours Webril swatch under occlusion
- Concentrations: Cocamide MEA as a 30 % w/v solution in distilled water


B. CHALLENGE EXPOSURE
- No. of exposures: One 6 hour exposure
- Day(s) of challenge: not specified- 12 to 16 d after the 3rd induction exposure
- Exposure period: 6 hours under occlusion
- Test groups: Cocamide MEA as a 30 % w/v solution in distilled water
- Control group: Cocamide MEA as a 30 % w/v solution in distilled water
- Site: Lower left quadrant of the backs of test and control animals
- Concentrations: Cocamide MEA as a 30 % w/v solution in distilled water
- Evaluation (hr after challenge): 24 and 48 h after challenge exposure
Challenge controls:
10 animals (previously unexposed) treated with Cocamide MEA as a 30 % w/v solution in distilled water

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:
30 % w/v in distilled water
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
no animals with positive response
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 30 % w/v in distilled water . No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: no animals with positive response .
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
30 % w/v in distilled water
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
no animals with positive response
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 30 % w/v in distilled water . No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: no animals with positive response .
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
30 % w/v in distilled water
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
no animals with positive response
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 30 % w/v in distilled water . No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: no animals with positive response .
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
30 % w/v in distilled water
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
no animals with positive response
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 30 % w/v in distilled water . No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: no animals with positive response .

Any other information on results incl. tables

None

Applicant's summary and conclusion

Interpretation of results:
not sensitising
Remarks:
Migrated information
Conclusions:
Under the test conditions, amides, C8-18 (even numbered) and C18-unsatd., N-(hydroxyethyl) did not induce sensitization in the guinea pig model
Executive summary:

A group of 20 test animals was treated with 0.4 mL of amides, C8-18 (even numbered) and C18-unsatd., N-(hydroxyethyl) as a 30 % w/v solution in distilled water for an exposure period of 6 hours weekly for 3 induction exposures according toOECD guideline 406. Test (20) and control (10) animals were challenged with the test substance as a 30% w/v solution in distilled water. At primary challenge, no positive responses were observed in the test and control animals. Under the test conditions,amides, C8-18 (even numbered) and C18-unsatd., N-(hydroxyethyl) is not a sensitizer.