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Toxicological information

Skin irritation / corrosion

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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:
other: FHSA standard 16 CFR 1500.41
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
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 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

Resultsopen allclose all
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.