Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
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 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:
2008
Report Date:
2008

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
EPA OPPTS 870.1100 (Acute Oral Toxicity)
GLP compliance:
yes
Test type:
up-and-down procedure
Limit test:
no

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:
rat
Strain:
Sprague-Dawley
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Ace Animals Inc., Boyertown, PA
- Age at study initiation: Young adult (10-12 weeks)
- Weight at study initiation: 183-210 g


ENVIRONMENTAL CONDITIONS
- Temperature (°C):19-21C
- Humidity (%): 63-87

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Doses:
175mg/kg, 550 mg/kg, 1750mg/kg, 5000mg/kg
No. of animals per sex per dose:
175mg/kg (1 animal), 550 mg/kg (1 animal), 1750mg/kg (1 animal), 5000mg/kg (3 animals)
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days

- Frequency of observations and weighing: the animals were observed for mortality, signs of gross toxicity and behavioural changes during the first several hours post-dosing and at least once daily thereafter for 14 days after dosing. 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.
Statistics:
The acute oral toxicity (Guideline 425) Statistical Program (Westat, version 1.0 May 2001) was used for all data analyses including dose progression selections, stopping criteria determinations and/or LD50 and confidence limit calculations.

Results and discussion

Effect levels
Sex:
female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Mortality:
There were no mortalities.
Clinical signs:
All animals appeared active and healthy during the study. There were no signs of gross toxicity, adverse pharmacologic effects or abnormal behaviour at the lower doses, however at the 5000mg/kg following administration all females exhibited ano-genital staining and one female also exhibited
soft faeces. All animals recovered by day 2 and appeared active and healthy for the remainder 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.
Other findings:
None reported.

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 >5000mg/kg is reported in a reliable study conducted according to an appropriate guideline. The study was also compliant with GLP.