Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2004-10-04 to 2004-11-12
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2004
Report Date:
2004

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Version / remarks:
, 2001
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
Version / remarks:
, 2004
Deviations:
no
GLP compliance:
yes (incl. certificate)
Remarks:
signed 2000-08-02
Test type:
acute toxic class method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): PI-23513, 4-(3-methylbutyl)cyclohexanol
- Substance type: liquid, colourless
- Physical state: technical product
- Storage condition of test material: ambient temperature, dry, dark

- no further significant details stated

Test animals

Species:
rat
Strain:
Crj: CD(SD)
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Charles River Deutschland GmbH
- Age at study initiation: males: 40 days, females: 44 days
- Weight at study initiation: males: 197-205 g, females: 164-171 g
- Fasting period before study: 16 hours before administration
- Housing: bedding material for cages: granulated textured wood, cages changed and cleaned twice weekly; during 14-days observation period the animals were kept in groups of 3 in MAKROLON cages
- Diet : sniff R/M-H V1534
- Water: tap water, ad libitum
- Acclimation period: 5 adaptation days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): RT of 22 °C +/- 3 °C
- Humidity (%): 55 % +/- 15 %
- Photoperiod (hrs dark / hrs light): 12/12

- no further details stated

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Details on oral exposure:
MAXIMUM DOSE VOLUME APPLIED: 2.2 mL/kg bw
Rationale for the selection of the starting dose: limit test
Doses:
2.2 ml/kg bw
No. of animals per sex per dose:
3 animals of each sex
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations: 0, 5, 15, 30, 60 min and 3, 6, and 24 hours after administration
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, organ weights, histopathology:
- once a day until symptoms subsided, thereafter each working day: changes of skin, eyes and mucous membranes, respiratory and the circulatory, autonomic and central nervous system and somatomotor activity as well as behaviour pattern
- attention on possible tremor, convulsion, salivation, diarrhoea, lethargy, sleep and coma
- once daily: observation of mortality
- before administration and thereafter weekly: recording of body weight
- post-mortem macroscopic examination (as no changes were found, no microscopic examination was performed)

no further significant details stated

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Mortality:
no mortality
Clinical signs:
no clinical signs
Body weight:
all animals gained the expected body weight
Gross pathology:
no findings
Other findings:
no further details stated

Any other information on results incl. tables

Table 1: Summerised results

Symptoms/Criteria

Dose of PI-23513

2000 mg/kg bw

males (n=3)

females (n=3)

Clinical signs

none

none

mortality

none

none

Mean body weight [g]

201.3

167.3

Start

after 7 days

247.3

(22.9)

190.7

(13.9)

after 14 days

299.3

(48.7)

211.0

(26.0)

Inhibition of body weight gain

none

none

Necropsy findings

none

none

In brackets: body weight gain in %, compared to the start value

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
According to the EC-Commission directive 67/548/EEC and the results obtained under the present test conditions, PI-23513 requires no classification.