12-hydroxy-N-(2-hydroxyethyl)octadecan-1-amide

Skin sensitisation

Administrative data

Endpoint:

skin sensitisation: in vivo (non-LLNA)

Type of information:

experimental study

Adequacy of study:

key study

Study period:

July 13, 1978

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

comparable to guideline study

Remarks:

(study well documented, followed method comparable to OECD Guideline 406, non-GLP.)

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:

no

Type of study:

Buehler test

Justification for non-LLNA method:

Test performed prior to LLNA guideline

Test material

Test material information

Constituent 1

Reference substance name:

Amides, coco, N-(hydroxyethyl)

EC Number:

268-770-2

EC Name:

Amides, coco, N-(hydroxyethyl)

Cas Number:

68140-00-1

IUPAC Name:

Amides, coco, N-(hydroxyethyl)

Test material form:

solid: flakes

Details on test material:

- Name of test material: Coconut monoethanolamide (Cocamide MEA)
- TSIN: T-0358.01
- CAS#: 68140-00-1
- Substance type: Pure active substance
- Physical state: solid flakes
- Appearance: Off-white
- Analytical purity: 96.1% (measured)
- Storage condition of test material: Cool and dry conditions

In vivo test system

Test animals

Species:

guinea pig

Strain:

Hartley

Remarks:

(albino strain)

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: Purina Guinea Pig Chow; ad libitum
- Water: 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 before the study

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

Study design: in vivo (non-LLNA)

Induction

Route:

epicutaneous, occlusive

Vehicle:

water

Concentration / amount:

Test animals: 0.4 mL of 30% w/v solution of test substance in distilled water was applied by dermal patches using Parke-Davis bandage
Control animals: no treatment

Day(s)/duration:

Once a week for three weeks

Adequacy of induction:

not specified

Challenge

No.:

#1

Route:

epicutaneous, occlusive

Vehicle:

water

Concentration / amount:

0.4 mL of 30% w/v solution of test substance in distilled water was applied to all animals (including test and control) by dermal patches using Parke-Davis bandage.

Day(s)/duration:

After two weeks of induction phase, animals were once exposed to primary challenge.

Adequacy of challenge:

not specified

No. of animals per dose:

Treatment group: 20 animals
Control group: 10 animals

Details on study design:

RANGE FINDING TESTS: 4 additional guinea pigs were treated on their backs with each of the four different concentration (30, 15, 8 and 4% w/v solutions) in distilled water to determine the highest non-irritating concentration that can be applied for primary challenge phase.

MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 3
- Exposure period: 6 hours
- Test groups: 1
- 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
- Concentrations: 30% w/v solution in distilled water

B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: 2 weeks after the 3rd induction exposure
- Exposure period: 6 hours under occlusion
- Test groups: 1
- Control group: 1
- Site: Lower left quadrant of the backs of test and control animals
- Concentrations: Coconut monoethanolamide (Cocamide MEA) as a 30% w/v solution in distilled water
- Evaluation: 24 and 48 hours after challenge exposure

Challenge controls:

10 animals (previously unexposed) treated with Coconut monoethanolamide (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)

Results

Results 1

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

Remarks on result:

no indication of skin sensitisation

Remarks:

(Reactions included 7 grades of ± and 13 grades of 0)

Results 2

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

Remarks on result:

no indication of skin sensitisation

Remarks:

(Reactions included 1 grades of ± and 9 grades of 0)

Results 3

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

Remarks on result:

no indication of skin sensitisation

Remarks:

(Reactions included 2 grades of ± and 18 grades of 0)

Results 4

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

Remarks on result:

no indication of skin sensitisation

Remarks:

(Reactions included 10 grades of 0)

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Under the conditions of this Buehler assay, Coconut monoethanolamide (Cocamide MEA) did not induced any positive responses in the test substance treated as well as control animals at primary challenge, hence cocamide MEA is not skin sensitizer in the guinea pig model.

Executive summary:

The study was performed to assess the skin sensitization potential of Coconut monoethanolamide (Cocamide MEA) by following method comparable to the OECD guideline 406 (Skin Sensitisation).

 

Male and female Hartley guinea pigs were obtained from Murphy breeding laboratories were used in this study. Animals were singly in wire mesh cages suspended above the droppings and maintained under standard laboratory conditions (12 hours light (artificial)/12 hours dark cycle). Prior to the treatment, animals were acclimatized under laboratory conditions for a minimum period of 4 days. The animals received Purina Guinea Pig Chow and non-medicated water ad libitum.

 

The test substance was tested at a concentrations of 0% w/v solution in distilled water. Animals were divided into two groups: test substance treatment group (20 animals) and control group (10 animals).

 

In induction phase, one group of 20 test animals was treated with 0.4 mL of Coconut monoethanolamide (Cocamide MEA) as a 30% w/v solution in distilled water by dermal patches using Parke-Davis bandage. Exposure period was 6 hours and it was repeated weekly for 3 induction exposures. The patch sites were scored for irritation 4-5 hour later. After 2 weeks of last induction exposure, all animals (both test and control) were challenged with 30% w/v solution of Coconut monoethanolamide (Cocamide MEA) in distilled water. The sites were scored after 24 and 48 hours of challenge.

 

At primary challenge, no positive responses were observed in the test substance treated and control animals. Therefore, it was concluded that Cocamide monoethanolamide (Cocamide MEA) is not a skin sensitizer.

 

This Buehler assay study is classified as acceptable, and satisfies the guideline requirements of OECD 406 (Skin Sensitization).