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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:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Acceptable, well-documented study report equivalent or similar to OECD guideline 404: GLP.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1993

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Exxal 13; isotridecanol
- Substance type: clear colorless liquid
- Physical state: liquid
- Storage condition of test material: room temperature

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: David Percival Ltd.
- Age at study initiation: 12 – 16 weeks
- Weight at study initiation: 2.10-2.50 kg
- Housing: Individually in suspended cages
- Diet (e.g. ad libitum): STANRAB SQC Rabbit diet, ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 5 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18-24
- Humidity (%): 54-66
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12


IN-LIFE DATES: From: 1993-10-23 To: 1993-10-27

Test system

Type of coverage:
occlusive
Preparation of test site:
shaved
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): assumed 100%
Duration of treatment / exposure:
4 hours
Observation period:
1, 24, 48 and 72 hours and 7 days post patch removal.
Number of animals:
6
Details on study design:
TEST SITE
- Area of exposure: back
- Type of wrap if used: gauze covered in an elasticated corset


REMOVAL OF TEST SUBSTANCE
- Washing (if done): gentle swabbing with cotton wool soaked in diethyl ether
- Time after start of exposure: 4 hours


SCORING SYSTEM:
- Draize method

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24 through 72 h
Score:
1.1
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24 through 72 h
Score:
0.5
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
erythema score
Basis:
animal: 75F
Time point:
24 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
erythema score
Basis:
animal: 75F
Time point:
48 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
erythema score
Basis:
animal: 75F
Time point:
72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
erythema score
Basis:
animal: 76F
Time point:
24 h
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
erythema score
Basis:
animal: 76F
Time point:
48 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
erythema score
Basis:
animal: 76F
Time point:
72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
erythema score
Basis:
animal: 79F
Time point:
24 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
erythema score
Basis:
animal: 79F
Time point:
48 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
erythema score
Basis:
animal: 79F
Time point:
72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
erythema score
Basis:
animal: 80M
Time point:
24 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
erythema score
Basis:
animal: 80M
Time point:
48 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
erythema score
Basis:
animal: 80M
Time point:
72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
erythema score
Basis:
animal: 82M
Time point:
24 h
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
erythema score
Basis:
animal: 82M
Time point:
48 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
erythema score
Basis:
animal: 82M
Time point:
72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
erythema score
Basis:
animal: 85M
Time point:
24 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
erythema score
Basis:
animal: 85M
Time point:
48 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
erythema score
Basis:
animal: 85M
Time point:
72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
edema score
Basis:
animal: 75F
Time point:
24 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
edema score
Basis:
animal: 75F
Time point:
48 h
Score:
0
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
edema score
Basis:
animal: 75F
Time point:
72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
edema score
Basis:
animal: 76F
Time point:
24 h
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
edema score
Basis:
animal: 76F
Time point:
48 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
edema score
Basis:
animal: 76F
Time point:
72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
edema score
Basis:
animal: 79F
Time point:
24 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
edema score
Basis:
animal: 79F
Time point:
48 h
Score:
0
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
edema score
Basis:
animal: 79F
Time point:
72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
edema score
Basis:
animal: 80M
Time point:
24 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
edema score
Basis:
animal: 80M
Time point:
48 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
edema score
Basis:
animal: 80M
Time point:
72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
edema score
Basis:
animal: 82M
Time point:
24 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
edema score
Basis:
animal: 82M
Time point:
48 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
edema score
Basis:
animal: 82M
Time point:
72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
edema score
Basis:
animal: 85M
Time point:
24 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
edema score
Basis:
animal: 85M
Time point:
48 h
Score:
0
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
edema score
Basis:
animal: 85M
Time point:
72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritant / corrosive response data:
Very slight to well-defined erythema was noted at all treated skin sites one and 24 hours after patch removal with very slight erythema at the 48 and 72-hour observations. The erythema extended up to 6 cm beyond all treatment sites during this time.

Very slight edema was noted at all treated skin sites one and 24 hours after patch removal. Very slight edema was noted at three treated skin sites at the 48 hours observation and persisted at one treated skin site at the 72-hour observation.

Desquamation extending up to a 6 cm beyond the treatment site was noted at two treated skin sites at the 48-hour observation, at five treated skin sites at the 72 hour observation and at all treated skin sites 7 days post exposure.

Applicant's summary and conclusion

Interpretation of results:
Category 2 (irritant) based on GHS criteria
Remarks:
Criteria used for interpretation of results: EU
Conclusions:
The skin irritation potential for isotridecanol is minimal.
Executive summary:

In this study, 6 rabbits were exposed to 0.5 ml and isotridecanol, neat, for 4 hours to evaluate the skin irritation potential.  Irritation responses were examined at 1, 24, 48, and 72 hours and 7 days post exposure.  Very slight to well-defined erythema was noted at all treated skin sites one and 24 hours after patch removal with very slight erythema at the 48 and 72-hour observations.  The erythema extended up to 6 cm beyond all treatment sites during this time.  Very slight edema was noted at all treated skin sites one and 24 hours after patch removal.  Very slight edema was noted at three treated skin sites at the 48 hours observation and persisted at one treated skin site at the 72-hour observation.  Desquamation extending up to a 6 cm beyond the treatment site was noted at two treated skin sites at the 48-hour observation, at five treated skin sites at the 72 hour observation and at all treated skin sites 7 days post exposure.   The mean skin irritation scores between 24 and 72 hours were: erythema 1.1 and edema 0.5.