Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
From 1991-03-04 to 1991-10-28
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP Guideline study
Cross-referenceopen allclose all
Reason / purpose:
reference to same study
Reason / purpose:
reference to other study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1992
Report Date:
1992

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
other: The Guidelines for Toxicity Studies for Drugs, Japanese MOHW (1989), Single dose toxicity study, oral method.
Deviations:
not specified
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
no
Principles of method if other than guideline:
not applicable.
GLP compliance:
yes
Remarks:
GLP standards applied to industrial chemical in Japan (1984)
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): 1-(2-t-butylcyclohexyloxy)-2-butanol cited as #620

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Charles River Japan Inc.
- Age at study initiation: 6 weeks old
- Weight at study initiation: males: 183-201 kg bw; females: 142-164 kg bw.
- Fasting period before study: overnight
- Housing: 5 rats of one sex were housed in a single polycarbonate cage with hardwood chip bedding.
- Diet (e.g. ad libitum): pellet diet ad libitum
- Water (e.g. ad libitum): filtered and sterilized tap water ad libitum
- Acclimation period: 6 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 to 25 °C
- Humidity (%): 40 to 70 %
- Air changes (per hr): 12 changes per hour
- Photoperiod: 12 hrs dark / 12 hours light

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
other: 0.5% Tween 80 in 0.5% CMC-Na aqueous solution.
Details on oral exposure:
VEHICLE
- Amount of vehicle (if gavage): 1.0 mL/100 g bw
- Justification for choice of vehicle: no data
- Lot/batch no. (if required): no data
- Purity: no data
Doses:
2000 mg/kg pc
No. of animals per sex per dose:
5 animals/sex/dose
Control animals:
no
Details on study design:
- Fasting period after administration: 3 hours
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing:
Clinical signs were observed and recorded 0.5, 1 and 3 hours after administration and then at least daily for 14 days.
Body weight of all rats was measured shortly before administration, and on the 3rd, 7th and 14th days after administration.
- Necropsy of survivors performed: yes
Statistics:
mean +/- SD

Results and discussion

Preliminary study:
not applicable
Effect levelsopen allclose all
Sex:
male/female
Dose descriptor:
LD0
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
No mortality occured throughout the observation period
Clinical signs:
No abnormal clinical signs were observed in any animal during the observation period.
Body weight:
The body weight of all rats increased normally
Gross pathology:
Autopsy revealed no abnormality
Other findings:
None

Any other information on results incl. tables

No information

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Oral LD50 Combined > 2000 mg/kg bw
Executive summary:

In a limit acute oral toxicity study performed similarly to the OECD test guideline No. 401 and in compliance with GLP applied to industrial chemicals in Japan (1984), groups offasted, 6-weeks old, Sprague Dawley rats (5/sex) were administered a single oral dose of #620 (99 % pure) in 0.5% Tween 80 in 0.5% CMC-Na (1.0 mL/100 g) of 2000 mg/kg bw by gavage. The animals were observed for mortality, clinical signs and body weight for 14 days and then necropsied for macroscopic observations.

 

No mortality occurred during the study. No abnormal clinical signs were found. No abnormality was revealed at autopsy.

 

Oral LD50 Combined > 2000 mg/kg bw

 

Under the test conditions, #620 is not classified according to the criteria of the annex VI of the Regulation EC No. 1272/2008 (CLP) and of the Directive 67/548/EEC.