Reaction product of Aminoguanidine bicarbonate and Tall Oil fatty acid

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Well-documented, GLP study, performed in accordance with the OECD Guideline 404 (1992; Acute dermal irritation/corrosion)

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2001

Report date:

2001

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

GLP compliance:

yes

Remarks:

purity and stability of the substance not reported

Test material

Test material information

Constituent 1

Reference substance name:

-

EC Number:

442-600-9

EC Name:

-

Molecular formula:

The substance is a UVCB for which it is not possible to provide a molecular formula

IUPAC Name:

(9E)-N-[(N'-hexadecanoyloctadecanehydrazido)methanimidoyl]octadec-9-enamide

Details on test material:

Description: Complex reaction product of an aminate base-carbonate and fatty acids
Chemical name: HiTEC 7134 Performance additive
- Physical state: viscous liquid
- Storage condition of test material: ambient temperature in the dark
- Physical state: viscous liquid

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River UK Limited, Margate, Kent, UK
- Age at study initiation: young adults
- Weight at study initiation: 3730-4450 g
- Housing: individually in cages
- Diet: ad libitum, STANRAB SQC, Special Diet Services Limited, Stepfield, Witham, Essex, UK
- Water: ad libitum
- Acclimation period: at least 5 d

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18±3
- Humidity (%): 30-70
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Type of coverage:

occlusive

Preparation of test site:

other: removal of hair with veterinary clippers

Vehicle:

unchanged (no vehicle)

Controls:

not required

Amount / concentration applied:

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

Duration of treatment / exposure:

4 h

Observation period:

28 days

Number of animals:

2 male and one female

Details on study design:

TEST SITE
- Area of exposure: 2.5*2.5 cm
- % coverage: 100
- Type of wrap if used: 4-ply surgical gauze, secured by surgical tape; impermeable rubber sheeting was wrapped around the trunk of the animals

REMOVAL OF TEST SUBSTANCE
- Washing (if done): the substance was removed with swabs of absorbent cotton wool soaked in warm water
- Time after start of exposure: 4 h

SCORING SYSTEM: The Draize scale (1959) was used to assess the degree of erythrema and oedema at the application sites approximately 1 h and 1, 2 and 3 days after removal of the cover and then at intervals for up to 28 days.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

animal #1

Remarks:

male

Time point:

other: mean of 1, 2 and 3 days after decontamination

Score:

2

Max. score:

4

Reversibility:

fully reversible within: 24 days

Results 2

Irritation parameter:

erythema score

Basis:

animal #2

Remarks:

male

Time point:

other: mean of 1, 2 and 3 days after decontamination

Score:

2.3

Max. score:

4

Reversibility:

fully reversible within: 10 days

Results 3

Irritation parameter:

erythema score

Basis:

animal #3

Remarks:

female

Time point:

other: mean of 1, 2 and 3 days after decontamination

Score:

1.7

Max. score:

4

Reversibility:

fully reversible within: 10 days

Results 4

Irritation parameter:

edema score

Basis:

animal #1

Remarks:

male

Time point:

other: mean of 1, 2 and 3 days after decontamination

Score:

1.3

Max. score:

4

Reversibility:

fully reversible within: 7 days

Results 5

Irritation parameter:

edema score

Basis:

animal #2

Remarks:

male

Time point:

other: mean of 1, 2 and 3 days after decontamination

Score:

2.3

Max. score:

4

Reversibility:

fully reversible within: 7 days

Results 6

Irritation parameter:

edema score

Basis:

animal #3

Remarks:

female

Time point:

other: mean of 1, 2 and 3 days after decontamination

Score:

0

Max. score:

4

Irritant / corrosive response data:

Very slight, well-defined or moderate to severe erythrema was seen in two of the animals for 7 days and in one for 21 days after the application of the substance. Very slight, slight or moderate edema was observed in two animals for 4 days after application. Other signs of skin irritation included desquamation, thickening, wrinkling, scabbing, bruising and areas with newly formed skin. Most of the symptoms persisted till the end of the 14 days (in at least 2 of the three animals tested) but disappeared 28 days post-exposure.

Other effects:

No other sings of toxicity were detected in the animals during the study.

Applicant's summary and conclusion

Interpretation of results:

Category II

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

H7134 was tested for its skin irritation potential New Zeland rabbits. Under these test conditions the test material was a moderate skin irritant.

Executive summary:

Three New Zeland white albino rabbits were tested for skin irritation with HiTEC 7134, after a single 4h application of 0.5 ml. The animals were observed for up to 28 days for any sings of skin irritation. Very slight, well-defined or moderate to severe erythrema was seen in two out of the three animals for 7 days and one animal for 21 days post-application. Very slight, slight or moderate edema was observed in two animals up to 4 days after application. Additional signs of irritation such as desquamation, thickening, wrinkling, scabbing, bruising and areas of new skin were recorded during the conduction of this experiment. Based on these results the test substance may be considered as a moderate skin irritant to the rabbit.

Despite the fact that , the mean scores obtained for erythrema and edema for two out opf the three animals, are below 2.3 (limit for classification according to Regulation 1272/2008), the substance shall be classified as a skin irritant, due to persistence of inflammatory symptoms (like desquamation) over the 14 day initial obsevation period.