Registration Dossier

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Study period:
2009
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: The study was conducted according to an appropriate guideline and in compliance with GLP. The study was read across from1-decanol (CAS 112-30-1).

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2009
Report Date:
2009

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
EPA OPPTS 870.1200 (Acute Dermal Toxicity)
Principles of method if other than guideline:
The humidity was below the targeted lower limit of 30% during the study. A portable humidifier was used to increase the humidity levels during this time.
GLP compliance:
yes
Test type:
standard acute method
Limit test:
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: room temperature

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Ace animals Inc., Boyertown, PA
- Age at study initiation: 8-9 weeks
- Weight at study initiation: 221-236g males, 182-200g females
- Housing: singly housed in suspended stainless steel caging with mesh floors
- Diet: Purina rodent chow, ad libitum
- Water: filtered tap water, ad libitum
- Acclimation period: 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-23
- Humidity (%): 19-52
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Type of coverage:
not specified
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST SITE
- Area of exposure: trunk
- % coverage: 10
- Type of wrap if used: the gauze pad under which the test material resided was wrapped with tape to avoid dislocation of the pad and to minimize loss of the test substance.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): the test sites were gently cleansed with a 3% soap solution followed by ethanol then tap water using a clean paper towel to remove any residual test substance
- Time after start of exposure: 24 hours

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): individual doses were calculated based on the initial body weights, taking into account the specific gravity of the test substance.

Duration of exposure:
24 hours
Doses:
5000mg/kg
No. of animals per sex per dose:
5M, 5F
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days

- Frequency of observations and weighing: Individual body weights were recorded prior to test substance application (initial) and again on days 7 and 14. The animals were observed for mortality, signs of gross toxicity, and behavioural changes during the first several hours after application and at least once daily thereafter for 14 days. Observations included gross evaluation of skin and fur, eyes and mucous membranes, respiratory, circulatory, autonomic and central nervous systems, somatomotor activity and behaviour pattern. Particular attention was directed to observation of tremors, convulsions, salivation, diarrhea and coma.

- Necropsy of survivors performed: yes

- Other examinations performed: clinical signs, body weight,organ weights, histopathology, other: Tissues and organs of the thoracic and abdominal cavities were examined.

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Mortality:
There were no mortalities.
Clinical signs:
Other than the dermal irritation noted at all dose sites between days 1 and 12, there were no other clinical findings recorded for any animal over the course of the study.
Body weight:
All animals gained body weight during the study.
Gross pathology:
No gross abnormalities were noted for any of the animals when necropsied at the conclusion of the 14 day observation period.

Any other information on results incl. tables

Erythema, desquamation and hyperkeratosis were present at the dose site.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The LD50 value of >5000 mg/kg is reported in a reliable study conducted according to an appropriate guideline. The study was compliant with GLP.