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Diss Factsheets

Toxicological information

Skin sensitisation

Currently viewing:

Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1978-05-24
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline 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.
GLP compliance:
yes
Type of study:
Buehler test
Justification for non-LLNA method:
The study was conducted before the requirement for LLNA testing came into force

Test material

Constituent 1
Reference substance name:
Amides, C8-18 and C18-unsatd., N-(hydroxyethyl)
EC Number:
931-330-1
Molecular formula:
The alkyl chain length of the amide ranges between 8 and 18 carbon atoms
IUPAC Name:
Amides, C8-18 and C18-unsatd., N-(hydroxyethyl)
Test material form:
solid
Details on test material:
- Name of test material (as cited in study report): Marchan coconut monoethanolamide
- Substance type: Pure active substance
- Physical state: Solid
- Composition of test material, percentage of components: Amide 96.1%

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.
- Age at study initiation: Not Available
- Weight at study initiation: Not Available
- 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 days


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


IN-LIFE DATES: 1978-05-24

Study design: in vivo (non-LLNA)

Induction
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 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.
Challenge
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 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 weeks
- 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 days 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 hours after challenge exposure


OTHER: None
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

In vivo (non-LLNA)

Resultsopen allclose all
Key result
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
Key result
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
Key result
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
Key result
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
Key result
Group:
positive control
Remarks on result:
not measured/tested

Applicant's summary and conclusion

Interpretation of results:
not sensitising
Conclusions:
Under the study conditions, the test substance was not considered to be sensitizing.
Executive summary:

A study was conducted to assess the sensitizing potential of the test substance according to OECD Guideline 406 (Buehler test), in compliance with GLP. One group of 20 Guinea pigs was treated with 0.4 mL of the test substance 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 the test substance as a 30% w/v solution in distilled water. At primary challenge, no positive responses were observed in any of the groups. Under the study conditions, the test substance was therefore not considered to be sensitizing (Vinegar, 1978).