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Description of key information

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records
Reference
Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
read-across based on grouping of substances (category approach)
Adequacy of study:
key study
Study period:
1978-05-24
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Read across study
Justification for type of information:
Refer to the section 13 for details on the read across justification.
Reason / purpose:
read-across source
Qualifier:
according to
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
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
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.
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
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
test group
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 group
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
Interpretation of results:
not sensitising
Conclusions:
Under the study conditions, the test substance was therefore not considered to be sensitizing.
Executive summary:

A study was conducted to assess the sensitizing potential of the read across substance, Amides, C8-18 (even numbered) and C18-unsatd., N-(hydroxyethyl), 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).

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:

A study was conducted to assess the sensitizing potential of the read across substance, amides, C8-18 (even numbered) and C18-unsatd., N-(hydroxyethyl), 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).

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

The available in vivo study on structurally similar amides, C8-18 (even numbered) and C18-unsatd., N-(hydroxyethyl) suggests that the test substance is not a skin sensitiser. The substance is therefore not classified for this endpoint according to CLP (EC 1272/2008) criteria.