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Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Study period:
2008
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: The study was conducted according to an appropriate protocol and in compliance with GLP. The study is read across from 1-decanol (CAS 112-30-1).

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2008
Report Date:
2008

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
EPA OPPTS 870.2500 (Acute Dermal Irritation)
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Alfol 10

- Physical state: colourless liquid, sweet pungent odour

- Storage condition of test material: at room temperature

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Robinson Services Inc., Clemmons, NC
- Age at study initiation: young adults
- Housing: individually suspended stainless steel caging with mesh floors
- Diet: Purina rabbit chow, ad libitum
- Water: filtered tap water, ad libitum
- Acclimation period: 13 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-21
- Humidity (%): 55-83
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.2ml
- Concentration (if solution): undiluted

Duration of treatment / exposure:
4 hours
Observation period:
The individual dose sites were scored at ca. 30-60 minutes, 24,48 and 72 hours and at 7 and 10 days after patch removal.
Number of animals:
3F
Details on study design:
TEST SITE
- Area of exposure: the back

- Type of wrap if used: The pad and the entire trunk of each animal were wrapped with semi-occlusive tape.

REMOVAL OF TEST SUBSTANCE
- Washing (if done):the test sites were gently cleansed with acetone, ethanol and a 3% soap solution followed by tap water using a clean paper towel to remove any residual test substance
- Time after start of exposure: 4 hours

SCORING SYSTEM: Draize

Results and discussion

In vivo

Results
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
other:
Time point:
other: PDI for 30-60 minutes,24,48 and 72 hours/4
Score:
2.8
Irritant / corrosive response data:
For the first 24 hours after patch removal, all three treated sites exhibited well-defined erythema and very slight edema. The overall incidence and severity of irritation decreased gradually with time. All animals were free of dermal irritation by day 10 (study termination).
Other effects:
All animals appeared active and healthy during the study. Apart from the dermal irritation noted, there were no signs of gross toxicity, adverse pharmacologic effects or abnormal behaviour.

Applicant's summary and conclusion

Interpretation of results:
moderately irritating
Remarks:
Migrated information Criteria used for interpretation of results: other: EPA US
Conclusions:
Under the conditions of this study, Alfol 10 is classified as moderately irritating to the skin.