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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
Study period:
June 2, 1995 - July 27, 1995
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Well conducted study performed according to established methodology

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1995
Report date:
1995

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
other: EPA Guideline No. 81-5
Deviations:
not specified
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Decan-1-ol, ethoxylated
Cas Number:
26183-52-8
Molecular formula:
not applicable
IUPAC Name:
Decan-1-ol, ethoxylated
Test material form:
liquid

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Ray Nichols Rabbitry; Lumberton, Texas
- Age at study initiation: Young adult
- Weight at study initiation: Males (2.050-2.900 kg); Females (2.625-3.200 kg)
- Housing: 1 per cage (Suspended, wire bottom, stainless steel)
- Diet (e.g. ad libitum): Purina Rabbit Chow; presented in measured amounts
- Water (e.g. ad libitum): Municipal water supply, available ad libitum from automatic
water system
- Acclimation period: At least five days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 72° ± 5°F
- Humidity (%): 30 - 80 %
- Air changes (per hr): 10-12
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Type of coverage:
semiocclusive
Preparation of test site:
clipped
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
0.5 mL of the undiluted test material
Duration of treatment / exposure:
4 hours
Observation period:
72 h
Number of animals:
6 (3 m / 3 f)
Details on study design:
The study was conducted on six New Zealand White rabbits, 3 male and 3 female, to determine the skin irritation potential of the test material. The animals were individually housed, equilibrated in the laboratory, and released from quarantine prior to testing. Normal growth, appearance, and behavior during the equilibration period were factors used to select healthy animals for testing.

Each animal was prepared on the day prior to treatment by clipping the dorsal area of the trunk free of hair to expose an area at least 8 x 8 cm. Only those animals with exposure areas free of pre-existing skin irritation or defects were selected for testing. A single intact exposure site was selected as the test site while the contralateral intact site served as a control site.

On Day 0, 0.5 mL of the undiluted test material was applied to each test site and covered with a surgical gauze patch measuring 2.5 x 2.5 cm and two single layers thick. Each patch was secured in place with a strip of non-irritating adhesive tape. The entire trunk of each animal was loosely wrapped with a semi-permeable dressing (orthopedic stockinette) and secured on both edges with . strips of tape to retard evaporation of volatile substances and to prevent possible ingestion of the test material..

After four hours, the patches and wrappings were removed. The test sites were gently washed with room temperature tap water and a clean wet cloth to remove as much residual test material as possible.

The test sites were observed for erythema and edema formation, and any other dermal defects or irritation at 1/2, 24, 48 and 72 hours after washing.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
24/48/72 h
Score:
0.17
Max. score:
1
Reversibility:
fully reversible within: 72 h
Remarks on result:
probability of weak irritation
Irritation parameter:
edema score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
other: not applicable
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
Very slight erythema was present at each observation through 24 hours in three animals. Edema was not observed at any time throughout the study. No other signs of irritation were observed during the study.
Other effects:
none

Any other information on results incl. tables

                                                Erythema                            Edema                     

   Animal number    1/2 h        24 h       48 h       72 h       1/2 h        24 h       48 h       72 h

1 (m)                1              1            0            0            0            0              0        0

2 (m)                1              0            0            0            0            0              0        0

3 (m)                1              1            0            0            0            0              0        0

4 (f)                  1              0            0            0            0            0              0        0

5 (f)                  1              1            0            0            0            0              0        0

6 (f)                  1              0            0            0            0            0              0        0

m = male; f = female

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Reported skin irritation results for the test animals do not meet the criteria for irritant or mild irritant under GHS.
Executive summary:

The study was conducted on six New Zealand White rabbits, 3 male and 3 female, to determine the skin irritation potential of the test material. The animals were individually housed, equilibrated in the laboratory, and released from quarantine prior to testing. Normal growth, appearance, and behavior during the equilibration period were factors used to select healthy animals for testing.

Each animal was prepared on the day prior to treatment by clipping the dorsal area of the trunk free of hair to expose an area at least 8 x 8 cm. Only those animals with exposure areas free of pre-existing skin irritation or defects were selected for testing. A single intact exposure site was selected as the test site while the contralateral intact site served as a control site.

On Day 0, 0.5 mL of the undiluted test material was applied to each test site and covered with a surgical gauze patch measuring 2.5 x 2.5 cm and two single layers thick. Each patch was secured in place with a strip of non-irritating adhesive tape. The entire trunk of each animal was loosely wrapped with a semi-permeable dressing (orthopedic stockinette) and secured on both edges with . strips of tape to retard evaporation of volatile substances and to prevent possible ingestion of the test material..

After four hours, the patches and wrappings were removed. The test sites were gently washed with room temperature tap water and a clean wet cloth to remove as much residual test material as possible.

The test sites were observed for erythema and edema formation, and any other dermal defects or irritation at 1/2, 24, 48 and 72 hours after washing.

Very slight erythema was present at each observation through 24 hours in three animals. Edema was not observed at any time throughout the study.

Reported skin irritation results for the test animals do not meet the criteria for irritant or mild irritant under GHS.