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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:
supporting study
Study period:
1985-05-22 to 1985-05-29
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1985
Report date:
1985

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Version / remarks:
1981
Deviations:
yes
Principles of method if other than guideline:
The deviations were:
- a shorter observation time for only 7 days
- identification and stability of the test material and stability of its preparations were not determined
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
2-benzylheptanol
EC Number:
296-229-0
EC Name:
2-benzylheptanol
Cas Number:
92368-90-6
Molecular formula:
C14H22O
IUPAC Name:
2-benzylheptan-1-ol

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Age at study initiation: 12-16 weeks
- Weight at study initiation: 2.45-2.66 kg
- Housing: individually, in suspended metal cages
- Diet: ad libitum, Rabbit Diet, A.W. Tindall Limited, Holbeach, Lincolnshire
- Water: ad libitum, tap water
- Acclimation period: min. 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19.5 ± 1.5
- Humidity (%): 50-70
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Type of coverage:
occlusive
Preparation of test site:
clipped
Vehicle:
other: petroleum jelly B.P.
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount applied: 0.5 mL
- Concentration: undiluted (100), 25, 5 and 1 %
Duration of treatment / exposure:
4 h
Observation period:
7 days.
Observations done at 1, 24, 48 and 72 h after removal and at day 7.
Number of animals:
3
Details on study design:
TEST SITE
- Area of exposure: 2.5 cm2
- Type of wrap if used: surgical gauze two layers thick secured with a cross of Sleek adhesive strapping, in addition elasticated corset (Tubigrip)

REMOVAL OF TEST SUBSTANCE
- Washing: gentle swabbing with cotton wool soaked in diethyl ether
- Time after start of exposure: immediately after 4 h treatment

SCORING SYSTEM: Draize J.H. (1959)1959), Association of Food and Drug Officials of the United States, Austin, Texas, "The Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics" Details on scouring system see "Any other information"

Interpretation of Results:
For each test material concentration the scores for erythema and oedema at the 24 and 72 hour readings were totaled for the three test rabbits (12 values). This total was divided by 6 to give the Primary Cutaneous Irritation Index of each of the four concentrations. This index was used to classify the skin irritation properties of each test material concentration according to the following scheme (after Draize J.H. (1959) Association of Food and Drug Officials of the United States, Austin, Texas, "The Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics")
Details on Primary Cutaneous Irritation Index interpretation see "Any other information"

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Remarks:
100 % test substance
Time point:
24/48/72 h
Score:
1.89
Max. score:
4
Reversibility:
not fully reversible within: 7 days
Remarks on result:
probability of mild irritation
Irritation parameter:
erythema score
Basis:
mean
Remarks:
25 % test substance
Time point:
24/48/72 h
Score:
0.22
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
mean
Remarks:
5 % test substance
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
mean
Remarks:
1 % test substance
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
mean
Remarks:
100 % test substance
Time point:
24/48/72 h
Score:
0.67
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
mean
Remarks:
25 % test substance
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
mean
Remarks:
5 % test substance
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
mean
Remarks:
1 % test substance
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
animal #1
Remarks:
100 % test substance
Time point:
24/48/72 h
Score:
2
Max. score:
4
Reversibility:
not fully reversible within: 7 days
Remarks on result:
probability of mild irritation
Irritation parameter:
edema score
Basis:
animal #1
Remarks:
100 % test substance
Time point:
24/48/72 h
Score:
0.67
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
animal #2
Remarks:
100 % test substance
Time point:
24/48/72 h
Score:
1.67
Max. score:
4
Reversibility:
not fully reversible within: 7 days
Remarks on result:
probability of mild irritation
Irritation parameter:
edema score
Basis:
animal #2
Remarks:
100 % test substance
Time point:
24/48/72 h
Score:
0.33
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
animal #3
Remarks:
100 % test substance
Time point:
24/48/72 h
Score:
2
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #3
Remarks:
100 % test substance
Time point:
24/48/72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
no indication of irritation

Any other information on results incl. tables

Mean scores

Concentration [%] Mean Erythema score (24/48/72 h) Mean Edema score (24/48/72 h)
100 1.89 0.67
25 0.22 0.00
5 0.00 0.00
1 0.00 0.00

Individual scores

Animal Concentration [%] Timepoint [h] Erythema score (of max. 4) Edema score (of max. 4)
1 100 1 1.00 0
24 2.00 1
48 2.00 1
72 2.00 0
7 days 1.00 0
mean (24/48/72h) 2.00 0.67
25 1 1.00 0
24 1.00 0
48 0.00 0
72 0.00 0
7 days 0.00 0
mean (24/48/72h) 0.33 0.00
5 1 0.00 0
24 0.00 0
48 0.00 0
72 0.00 0
7 days 0.00 0
mean (24/48/72h) 0.00 0.00
1 1 0.00 0
24 0.00 0
48 0.00 0
72 0.00 0
7 days 0.00 0
mean (24/48/72h) 0.00 0.00
2 100 1 1.00 1
24 1.00 0
48 2.00 1
72 2.00 0
7 days 1.00 0
mean (24/48/72h) 1.67 0.33
25 1 1.00 1
24 0.00 0
48 0.00 0
72 0.00 0
7 days 0.00 0
mean (24/48/72h) 0.00 0.00
5 1 0.00 0
24 0.00 0
48 0.00 0
72 0.00 0
7 days 0.00 0
mean (24/48/72h) 0.00 0.00
1 1 0.00 0
24 0.00 0
48 0.00 0
72 0.00 0
7 days 0.00 0
mean (24/48/72h) 0.00 0.00
3 100 1 1.00 0
24 2.00 1
48 2.00 1
72 2.00 1
7 days 0.00 0
mean (24/48/72h) 2.00 1.00
25 1 1.00 0
24 1.00 0
48 0.00 0
72 0.00 0
7 days 0.00 0
mean (24/48/72h) 0.33 0.00
5 1 0.00 0
24 0.00 0
48 0.00 0
72 0.00 0
7 days 0.00 0
mean (24/48/72h) 0.00 0.00
1 1 0.00 0
24 0.00 0
48 0.00 0
72 0.00 0
7 days 0.00 0
mean (24/48/72h) 0.00 0.00

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
A study to determine the skin irritation potential of the test substance in rabbits was conducted. It showed that the test substance is moderate irritant if applied undiluted, mild irritant in a concentration of 25 % and non-irritant with a concentration of 5 % or lower.
Executive summary:

A skin irritation test was performed according to OECD 404 using 3 rabbits with an exposure time of 4 h. The animals were observed for 7 days. The experiment was terminated on day 7 when most effects were not detectable anymore or in clear regression. The test substance caused erythema and edema development that was reversible. The mean Primary Cutaneous Irritation Index for 24/72h was 2.3 with the undiluted test substance. A concentration of 25 % resulted in a Primary Cutaneous Irritation Index of 0.3. A concentration of 5 % as well as 1 % resulted in an index of 0.0. The erythema score for animal 1 for 24/48/72h with the undiluted test substance was 2.0 and the edema score was 0.67. The erythema score for animal 2 for 24/48/72h with the undiluted test substance was 1.67 and the edema score was 0.33. The erythema score for animal 3 for 24/48/72h with the undiluted test substance was 2.0 and the edema score was 1.0. Due to these results the test substance was found to be moderately skin irritating but without classification.