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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:
1988
Report date:
1988

Materials and methods

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

Test material

Constituent 1
Chemical structure
Reference substance name:
Isoundecan-1-ol
EC Number:
257-376-6
EC Name:
Isoundecan-1-ol
Cas Number:
51750-47-1
Molecular formula:
C11H24O
IUPAC Name:
3,5 dimethyl nonanol-1

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Hazelton Research Products, Inc.
- Age at study initiation: Approximately 13 weeks
- Weight at study initiation: Males ( 2.17 - 2.69 kg), Females (2.38 - 2.48 kg)
- Housing: Individual
- Diet (e.g. ad libitum): Purina certified rabbit chow HF, ad libitum
- Water (e.g. ad libitum): Automatic watering system ad libitum
- Acclimation period: 15 d


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18-21
- Humidity (%): 40-60%
- Photoperiod (hrs dark / hrs light): 12/12


IN-LIFE DATES: From: 1987-7-21 To: 1987-8-4

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
- Undiluted
Duration of treatment / exposure:
4h exposure
Observation period:
-45 min; 24, 48 and 72 hours; and Day 7
Number of animals:
Male (4), Female (2)
Details on study design:
TEST SITE
- Area of exposure: Dorsal surface from the shoulder to the lumbar region
- Type of wrap if used: Occlusive; gauze patch covered by a plastic sleeve

REMOVAL OF TEST SUBSTANCE
- Washing (if done): Distilled water and paper towels
- Time after start of exposure: 4 hours


SCORING SYSTEM:
- Draize method: Primary Irritation Index (>0-<2 = mild irritant, >2<6 = moderate irritant, >6 severe irritant)

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24h through 72h
Score:
ca. 1.83
Reversibility:
not fully reversible within: 7 days
Remarks on result:
other: few animals with slight erythema
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24h through 72h
Score:
ca. 1.5
Reversibility:
not fully reversible within: 7 days
Remarks on result:
other: few animals with slight edema
Irritation parameter:
erythema score
Basis:
animal: JEF418F
Time point:
24 h
Score:
2
Max. score:
4
Irritation parameter:
erythema score
Basis:
animal: JEF418F
Time point:
48 h
Score:
2
Max. score:
4
Irritation parameter:
erythema score
Basis:
animal: JEF418F
Time point:
72 h
Score:
2
Max. score:
4
Irritation parameter:
edema score
Basis:
animal: JEF418F
Time point:
24 h
Score:
2
Max. score:
4
Irritation parameter:
edema score
Basis:
animal: JEF418F
Time point:
48 h
Score:
2
Max. score:
4
Irritation parameter:
edema score
Basis:
animal: JEF418F
Time point:
72 h
Score:
2
Max. score:
4
Irritation parameter:
erythema score
Basis:
animal: JEF404F
Time point:
24 h
Score:
1
Max. score:
4
Irritation parameter:
erythema score
Basis:
animal: JEF404F
Time point:
48 h
Score:
1
Max. score:
4
Irritation parameter:
erythema score
Basis:
animal: JEF404F
Time point:
72 h
Score:
1
Max. score:
4
Irritation parameter:
edema score
Basis:
animal: JEF404F
Time point:
24 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
animal: JEF404F
Time point:
48 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
animal: JEF404F
Time point:
72 h
Score:
0
Max. score:
4
Irritation parameter:
erythema score
Basis:
animal: JEF407M
Time point:
24 h
Score:
2
Max. score:
4
Irritation parameter:
erythema score
Basis:
animal: JEF407M
Time point:
48 h
Score:
2
Max. score:
4
Irritation parameter:
erythema score
Basis:
animal: JEF407M
Time point:
72 h
Score:
3
Max. score:
4
Irritation parameter:
edema score
Basis:
animal: JEF407M
Time point:
24 h
Score:
2
Max. score:
4
Irritation parameter:
edema score
Basis:
animal: JEF407M
Time point:
48 h
Score:
2
Max. score:
4
Irritation parameter:
edema score
Basis:
animal: JEF407M
Time point:
72 h
Score:
2
Max. score:
4
Irritation parameter:
erythema score
Basis:
animal: JEF411M
Time point:
24 h
Score:
1
Max. score:
4
Irritation parameter:
erythema score
Basis:
animal: JEF411M
Time point:
48 h
Score:
2
Max. score:
4
Irritation parameter:
erythema score
Basis:
animal: JEF411M
Time point:
72 h
Score:
2
Max. score:
4
Irritation parameter:
edema score
Basis:
animal: JEF411M
Time point:
24 h
Score:
1
Max. score:
4
Irritation parameter:
edema score
Basis:
animal: JEF411M
Time point:
48 h
Score:
1
Max. score:
4
Irritation parameter:
edema score
Basis:
animal: JEF411M
Time point:
72 h
Score:
1
Max. score:
4
Irritation parameter:
erythema score
Basis:
animal: JEF405M
Time point:
24 h
Score:
2
Max. score:
4
Irritation parameter:
erythema score
Basis:
animal: JEF405M
Time point:
48 h
Score:
2
Max. score:
4
Irritation parameter:
erythema score
Basis:
animal: JEF405M
Time point:
72 h
Score:
2
Max. score:
4
Irritation parameter:
edema score
Basis:
animal: JEF405M
Time point:
24 h
Score:
2
Max. score:
4
Irritation parameter:
edema score
Basis:
animal: JEF405M
Time point:
48 h
Score:
2
Max. score:
4
Irritation parameter:
edema score
Basis:
animal: JEF405M
Time point:
72 h
Score:
2
Max. score:
4
Irritation parameter:
erythema score
Basis:
animal: JEF419M
Time point:
24 h
Score:
2
Max. score:
4
Irritation parameter:
erythema score
Basis:
animal: JEF419M
Time point:
48 h
Score:
2
Max. score:
4
Irritation parameter:
erythema score
Basis:
animal: JEF419M
Time point:
72 h
Score:
2
Max. score:
4
Irritation parameter:
edema score
Basis:
animal: JEF419M
Time point:
24 h
Score:
2
Max. score:
4
Irritation parameter:
edema score
Basis:
animal: JEF419M
Time point:
48 h
Score:
2
Max. score:
4
Irritation parameter:
edema score
Basis:
animal: JEF419M
Time point:
72 h
Score:
2
Max. score:
4
Irritant / corrosive response data:
ERYTHEMA
- Slight erythema was noted in all animals 45min after patch removal
- Erythema scores increased for 4 animals at 24h when 4 animals displayed well defined erythema and 2 animals displayed very slight erythema.
- Erythema scores increased at 72h; 1 animal exhibited very slight erythema, 4 animals exhibited well-defined erythema, 1 animal exhibited moderate/severe erythema.

EDEMA
- At 45min, very slight edema was noted for 3 animals and slight edema was noted for 2 animals.
- Edema scores increased after 45min and at 24, 48, and 72h 4 animals showed slight edema and 1 animal showed very slight edema.
- Edema decreased after 72h and on Day 7, three animals were clear of edema and 3 animals showed very slight edema.

OTHER
- Desquamation was noted for 2 animals at 24, 48, and 72h and on Day 7
- Atonia was noted for 1 animal at 48h, for 4 animals at 72h, and for 3 animals on Day 7
Other effects:
- Soft stool and mucoidal stool were noted for 2 animals during the study

Applicant's summary and conclusion

Interpretation of results:
slightly irritating
Remarks:
Does not require classification. Criteria used for interpretation of results: EU
Conclusions:
The skin irritation potential for isoundecanol is minimal.
Executive summary:

Isoundecanol was administered via an occluded dermal patch to 6 rabbits at a dose of 0.5 ml neat solution for 4 hours to assess the skin irritation potential.   Dermal evaluations occurred at 45 minutes, 24h, 48h, 72h, and 7 days post patch removal. Application sites were graded for erythema, edema, and other signs of dermal irritation according to the Draize method of scoring.  Signs of erythema were noticed in all animals at 45 minutes post patch removal; ranging from very slight to slight. At the 72h observation point, erythema had increased in severity in all animals; ranging from very slight to moderate/severe with signs of edema. Irritation decreased after 72h and by Day 7, 3 animals were clear of erythema and edema while the remaining 3 animals exhibited very slight erythema and very slight edema.  The mean skin irritation scores between 24 and 72 hours were: erythema 1.83 and edema 1.5.