Fatty acids, C18-unsatd., reaction products with ammonia-ethanolamine reaction by-products

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Berolamine AA15. pre-GLP, and not according to standard testing method.

Cross-reference

Reason / purpose for cross-reference:

reference to same study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1979

Report date:

1979

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

other: FDA - Fed.Reg. 37(244),27635, 1972

Principles of method if other than guideline:

FDA
Six rabbits, exposed with 0.5 ml of test susbstance and control (10% aqueous SLS) on intact clipped skin, and abraded skin. Under 1 inch square patched, left under occlusion for 24 hours. Scoring immediately after exposure and 48 hours later (72 hour reading). Scoring according FDA scoring system.

GLP compliance:

no

Remarks:

Pre-GLP; signed authentication form present

Test material

Test material information

Constituent 1

Reference substance name:

Fatty acids, C18 unsaturated, reaction product with ammonia-ethanolamine reaction by-products

EC Number:

629-757-0

Cas Number:

1224966-15-7

Molecular formula:

UVCB, no structural formula can be set

IUPAC Name:

Fatty acids, C18 unsaturated, reaction product with ammonia-ethanolamine reaction by-products

Details on test material:

Name: BEROLAMINE AA15, a amide/imidazoline of Berolamine 20 and a fatty acid.
Described: dark brown highly viscous liquid.

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Leslie Moore Ltd
- Age at study initiation: not indicated
- Weight at study initiation: Between 2 and 3 kg
- Housing: 1 animal/cage
- Diet (e.g. ad libitum): Spratts Rabbit Diet (Spillers) - ad lib.
- Water (e.g. ad libitum): ad lib.
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS: Not indicated

Test system

Type of coverage:

occlusive

Preparation of test site:

other: clipped, partially abraded

Vehicle:

unchanged (no vehicle)

Controls:

no

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 ml
- Concentration (if solution): applied unchanged

CONTROL: Aqueous sodium lauryl sulphate (SLS)
- Amount(s) applied (volume or weight with unit): 0.5 ml
- Concentration (if solution): applied unchanged: 10%

Duration of treatment / exposure:

24 hours

Observation period:

72 hours from start of exposure

Number of animals:

6 animals, 4 sites per animal:
- Test substance and control
- Clipped and abraded

Details on study design:

TEST SITE
- Area of exposure: Under seperate 1" square patches of chromatography paper
- % coverage: not indicated
- Type of wrap if used: overlapping patch of impermeable plastic adheasive tape (Blenderm). The whole area was bound by Sleek occlusive tape wrapped round the entire trunk of the animal.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): The site was 'gently cleaned'
- Time after start of exposure: After 24 hours

SCORING SYSTEM: FAD scoring system

Results and discussion

In vivo

Results

Irritation parameter:

overall irritation score

Basis:

mean

Time point:

other: 24 and 72 hour

Score:

2.6

Max. score:

8

Reversibility:

no data

Remarks on result:

other: PII 10% SLS = 3.6

Any other information on results incl. tables

Primary Skin Irritation in Rabbits: Mean scores and primary irritation scores

	Reading time (h)	Reaction score
		A	B
Erythema & Eschar Formation
Intact skin	24	1,17	1,83
Intact skin	72	0,92	1,00
Abraded skin	24	1,83	2,33
Abraded skin	27	1,33	1,83
Sub total		5,25	6,99
Oedema formation
Intact skin	24	1,00	1,83
Intact skin	72	0,92	1,17
Abraded skin	24	2,00	2,33
Abraded skin	27	1,33	2,17
Sub total		5,25	7,50
Total		10,50	14,49
Primary Irritation Score		2,6	3,6

A = Berolamine AA15

B = 10% SLS

The reaction score is the average value of results from the 6 test animals. The primary irritation score calculation: Values for erythema and eschar formation at 24 h and 72 h (4 values) are added to the values for oedema at 24 h and 72 h ( 4 values) and the resulting figure is divided by 4.

The primary irritation score of Berolamine AA15 calculated for intact skin and abraded skin seperately:

Intact skin:       2.0

Abraded skin:  3.2

Same for SLS:

Intact skin:       2.9

Abraded skin:  4.3

Scoring:

Value - Erythema and Eschar Formation

0 - No erythema

1 - Very slight erythema (barely perceptible, edges of area not well defined)

2 - Slight erythema (pale red in color and edges definable)

3 - Moderate to severe erythema (definite red in color and area well defined)

4 - Severe erythema (beet or crimson red) to slight eschar formation (injuries in depth)

Edema Formation:

0 - No edema

1 - Very slight edema (barely perceptible, edges of area not well defined)

2 - Slight edema (edges of area well defined by definite raising)

3 - Severe edema (raised more than 1 mrn and extending beyond area of exposure)

4 - Moderate edema (raised approximately 1 mm)

Applicant's summary and conclusion

Conclusions:

Not corrosive, but possibly itrritating. Not suitable for EU classification.

Executive summary:

Berolamine AA15 was tested for primary irritation according to FDA - Fed.Reg. 37(244),27635, 1972. The substance was applied to the intact and abraded skin of 6 rabbits following 24 hour exposure from 0.5 ml on 1 square inch chromatography paper under occlusion. Scoring for erythema and eschar formation and oedema formation were performed on 24 and 72 hours after the start of the exposure. The primary irritation index resulted to 2.0 for the intact skin following FDA scoring system.

Based on the calculated primary irritation index, the susbstance would be classified as moderate skin irritant.

The iritation and oedema scoring for the intact skin was on average about 1 for each at 24 hour observation period as well as at 72 hour observation periode. As such, the level of rritation was less than following exposure to 10% aqueous sodium lauryl sulphate.

Although no evaluation according OECD/EU guideline, the exposure of 0.5 mL under occlusion for 24 hours, is expected to result to more severe dermal reactions compared to OECD guideline exposures of 0.5 ml for 4 hours under semi-occlusive conditions.

Results from this study indicate that the substance is not corrosive, but possibly irritating.