trans-4-aminocyclohexan-1-ol

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1999-04-27 - 1999-05-12

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1999

Report date:

1999

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

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

Test guideline 2

Qualifier:

according to guideline

Guideline:

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

Version / remarks:

EC Commission Directive 96/54/EC

GLP compliance:

yes

Test type:

acute toxic class method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

trans-4-aminocyclohexan-1-ol

EC Number:

248-492-8

EC Name:

trans-4-aminocyclohexan-1-ol

Cas Number:

27489-62-9

Molecular formula:

C6H13NO

IUPAC Name:

4-aminocyclohexanol

Specific details on test material used for the study:

Identification: Trans-4-Aminocyclohexanol Description : White PowderBatch: 722Purity: Not indicated by sponsor: treated as 100% pureTest substance storage: At room temperature in the dark Expiry date: 2000-04-08 (allocated by NOTOX, 1 year after receipt of the test substance)

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

Conditions: Air-conditioned room with approximately 15 air changes per hour and the environment controlled with optimal conditions considered as being at temperature of 21°C and a relative humidiy of 50%. Fluctuations from these optimal conditions were noted, but were considered not to have affected study integrity. Lighting was 12h artificial fluorescent light and 12h dark per day. Accommodation: Group housing of 3 animals per sex per cage in labelled polycarbonate cages containing purified sawdust as bedding material (Woody SPF, supplied by B.M.I. Helmond, The Netherlands, from 3 May onwards,: SAWI, Jelu Werk, Rosenberg, germany). Certificates of analysis were examined and then retained in the NOTOX archives. Acclimatiisation period was at least 5 days before start of treatmentunder laboratory conditions. Diet: Free access to standard pelleted laboratory animal diet (from Cafil Quality BVBA, Oud-Turnhout, Belgium). Certificates of analysis were examined and then retained in the NOTOX archives.Water: Free access to tap-water. Certificates of quarterly analysis were examined and the retained in the NOTOX archives.

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

water

Remarks:

Milli-U

Details on oral exposure:

Fasting: Food was withheld overnight (for a maximum of 20hours prior to dosing until approximately 3-4 hours after administration of the test substance. Frequency: Single dosage, on day 1

Doses:

2000mg/kg

No. of animals per sex per dose:

3 female rats3 male rats

Control animals:

no

Details on study design:

The Toxicity of the test substance was assessed by stepwise treatment of groups of 3 animals. The first group was treated at a dose level of 2000mg/kg body weight. the absence or presence of mortality of animals dosed at one step determined the next step, based on the test procedure defined in the guidelines. The onset, duration and severity of the signs of toxicity were to be taken into account for determination of the time interval between the dose groups.

Statistics:

No statistical analysis was performed (The method used is not intended to allow the calculation of a precise LD50 value)

Results and discussion

Effect levels

Effect levels 1

Key result

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Effect levels 2

Key result

Sex:

male

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

The incidence of mortality was as follows, presented in chronological order of treatment: DoseMortaitySexDate of treatment 2000mg/kg0/3females1999-04-272000mg/kg1/3males1999-04-28The decedent was found on day 2

Clinical signs:

Uncoordinated movements were noted in one female on day 1. No further clinical signs of systemic toxicity were noted in any of the animals.

Body weight:

The body weight gain shown by the surviving animals over the study period was onsidered to be similar to thhat expected of normal untreated animals of the same age and strain.

Other findings:

Mascroscopic FindingsMocroscopic post mortem examination of the animal that was found dead during the study revealed abnormalities in the stomach (thickening of the limiting ridge and glandular mucosa). No abnormalities were found at macroscopic post mortem examination of the surviving animals.

Applicant's summary and conclusion

Interpretation of results:

other: "not classified" according CLP

Conclusions:

The oral LD50 value of Trans-4-Aminocyclohexanol in Wistar rats was established to exceed 2000mg/kg body weight. Based on these results and according to the EC criteria for classification and labelling requirements for dangerous substances and preparations (Guidelines in Commission Directive 93/21/EEC), trans-4-Aminocyclohexanol does not have to be classified and has no obligatory labelling requirement for oral toxicity.