Cashew, nutshell liq.

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: Results recorded at 24 and 72 hours only.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2003

Report date:

2003

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: FHSA standard 16 CFR 1500.41

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

Distilled CNSL

IUPAC Name:

Distilled CNSL

Details on test material:

- Name of test material (as cited in study report): Distilled CNSL
- Lot/batch No.: 1500-1, AF6155, 1600-1, 1650-1

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Millbrook Breeding Labs
- Age at study initiation: Young adult
- Weight at study initiation: 2.1 - 2.7 kg
- Housing: 1/cage in suspended cages
- Diet (e.g. ad libitum): Fresh PMI Rabbit Chow
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 1 w eek

ENVIRONMENTAL CONDITIONS
- Photoperiod (hrs dark / hrs light): 12 hour light/dark cycle

Test system

Type of coverage:

occlusive

Preparation of test site:

shaved

Vehicle:

unchanged (no vehicle)

Amount / concentration applied:

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

Duration of treatment / exposure:

24 hours

Observation period:

72 hours

Number of animals:

1 male/ 2 female

Details on study design:

TEST SITE
- Area of exposure: 2.5 x 2.5 cm
- Type of wrap if used: Plastic

REMOVAL OF TEST SUBSTANCE
- Washing (if done): gentle wiping
SCORING SYSTEM: Draize

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Remarks:

Sample 1500-1, animal 1

Basis:

mean

Time point:

24/48/72 h

Score:

3

Max. score:

4

Reversibility:

not fully reversible within: 72 hours

Remarks on result:

other:

Remarks:

time point only at 24h and 72 h.

Results 2

Irritation parameter:

erythema score

Remarks:

Sample 1500-1, animals 2 and 3

Basis:

mean

Time point:

24/48/72 h

Score:

3.5

Max. score:

4

Reversibility:

not fully reversible within: 72 hours

Remarks on result:

other:

Remarks:

time point only at 24h and 72 h.

Results 3

Irritation parameter:

edema score

Remarks:

Sample 1500-1, animal 1

Basis:

mean

Time point:

24/48/72 h

Score:

2.5

Max. score:

3

Reversibility:

not fully reversible within: 72 hours

Remarks on result:

other:

Remarks:

time point only at 24h and 72 h.

Results 4

Irritation parameter:

edema score

Remarks:

Sample 1500-1, animals 2 and 3

Basis:

mean

Time point:

24/48/72 h

Score:

4

Max. score:

4

Reversibility:

not fully reversible within: 72 hours

Remarks on result:

other:

Remarks:

time point only at 24h and 72 h.

Results 5

Irritation parameter:

erythema score

Remarks:

Sample AF6155, animals 1, 2 and 3

Basis:

mean

Time point:

24/48/72 h

Score:

3

Max. score:

4

Reversibility:

not fully reversible within: 72 hours

Remarks on result:

other:

Remarks:

time point only at 24h and 72 h.

Results 6

Irritation parameter:

edema score

Remarks:

Sample AF6155, animal 1

Basis:

mean

Time point:

24/48/72 h

Score:

2

Max. score:

2

Reversibility:

not fully reversible within: 72 hours

Remarks on result:

other:

Remarks:

time point only at 24h and 72 h.

Results 7

Irritation parameter:

edema score

Remarks:

Sample AF6155, animal 2

Basis:

mean

Time point:

24/48/72 h

Score:

3.5

Max. score:

4

Reversibility:

not fully reversible within: 72 hours

Remarks on result:

other:

Remarks:

time point only at 24h and 72 h.

Results 8

Irritation parameter:

edema score

Remarks:

Sample AF6155, animal 3

Basis:

mean

Time point:

24/48/72 h

Score:

3

Max. score:

3

Reversibility:

not fully reversible within: 72 hours

Remarks on result:

other:

Remarks:

time point only at 24h and 72 h.

Results 9

Irritation parameter:

erythema score

Remarks:

Sample 1600-1, animals 1, 2 and 3

Basis:

mean

Time point:

24/48/72 h

Score:

1.5

Max. score:

2

Reversibility:

not fully reversible within: 72 hours

Remarks on result:

other:

Remarks:

time point only at 24h and 72 h.

Results 10

Irritation parameter:

edema score

Remarks:

Sample 1600-1, animal 1

Basis:

mean

Time point:

24/48/72 h

Score:

0.5

Max. score:

1

Reversibility:

not fully reversible within: 72 hours

Remarks on result:

other:

Remarks:

time point only at 24h and 72 h.

Results 11

Irritation parameter:

edema score

Remarks:

Sample 1600-1, animal 2

Basis:

mean

Time point:

24/48/72 h

Score:

1

Max. score:

1

Reversibility:

not fully reversible within: 72 hours

Remarks on result:

other:

Remarks:

time point only at 24h and 72 h.

Results 12

Irritation parameter:

edema score

Remarks:

Sample 1600-1, animal 3

Basis:

mean

Time point:

24/48/72 h

Score:

1.5

Max. score:

2

Reversibility:

not fully reversible within: 72 hours

Remarks on result:

other:

Remarks:

time point only at 24h and 72 h.

Results 13

Irritation parameter:

erythema score

Remarks:

Sample 1650-1, animals 1 and 3)

Basis:

mean

Time point:

24/48/72 h

Score:

1.5

Max. score:

2

Reversibility:

not fully reversible within: 72 hours

Remarks on result:

other:

Remarks:

time point only at 24h and 72 h.

Results 14

Irritation parameter:

erythema score

Remarks:

Sample 1650-1, animal 2

Basis:

mean

Time point:

24/48/72 h

Score:

1

Max. score:

1

Reversibility:

not fully reversible within: 72 hours

Remarks on result:

other:

Remarks:

time point only at 24h and 72 h.

Results 15

Irritation parameter:

edema score

Remarks:

Sample 1650-1

Basis:

mean

Time point:

other: 24 and 72 hours

Score:

0

Max. score:

0

Remarks on result:

other:

Remarks:

time point only at 24h and 72 h.

Results 16

Irritation parameter:

edema score

Remarks:

Sample 1650-1)

Basis:

mean

Time point:

24/48/72 h

Score:

1

Max. score:

1

Reversibility:

not fully reversible within: 72 hours

Remarks on result:

other:

Remarks:

time point only at 24h and 72 h.

Results 17

Irritation parameter:

edema score

Remarks:

Sample 1650-1)

Basis:

mean

Time point:

24/48/72 h

Score:

1.5

Max. score:

2

Reversibility:

not fully reversible within: 72 hours

Remarks on result:

other:

Remarks:

time point only at 24h and 72 h.

Applicant's summary and conclusion

Interpretation of results:

irritating

Conclusions:

Samples 1500-1 and AF6155 were irritating, how ever, samples 1600-1 and 1650-1 were not irritating.

Executive summary:

In a primary dermal irritation study, 3 young adult New Zealand white rabbits were dermally exposed to CNSL Distilled for 24 hours. Animals then were observed for 72 hours. Irritation was scored by the method of Draize. In this study, CNSL, Distilled is a dermal irritant.