reaction mass of cis 4-(3-methylbutyl)cyclohexanol and trans 4-(3-methylbutyl)cyclohexanol

Acute Toxicity: oral

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 guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)

Version / remarks:

, 2001

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)

Version / remarks:

, 2004

Deviations:

no

GLP compliance:

yes (incl. QA statement)

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 or test system 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.