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Diss Factsheets

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

Constituent 1
Chemical structure
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.