4'-trans-propyl-1,1'-bicyclohexyl-4-trans-carboxaldehyde

Endpoint summary

Description of key information

Key, rat, OECD 423, GLP, limit test: LD50 > 2000 mg/kg bw/d

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records

Reference

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

23 MAR 2007 - 18 OCT 2007

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP study performed according to OECD TG 423.

Qualifier:

according to guideline

Guideline:

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

Version / remarks:

17 December 2001

Deviations:

no

GLP compliance:

yes

Test type:

acute toxic class method

Limit test:

yes

Species:

rat

Strain:

Wistar

Remarks:

HsdCpb: WU,

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: F. Winkelmann, 33178 Borchen
- Age at study initiation: 7 to 8 weeks
- Weight at study initiation: 163 g (151 - 173 g)
- Fasting period before study: yes (17 hours before treatment)
- Housing: separately in type III Makrolon cages
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 - 23
- Humidity (%): 42 - 65
- Air changes (per hr): about 10
- Photoperiod (hrs dark / hrs light): 12 / 12

IN-LIFE DATES: From: day 1 To: day 15

Route of administration:

oral: gavage

Vehicle:

other: Methocel® K4M Premium solution

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 200 g/L
- Amount of vehicle (if gavage): 10 mL/kg
- Justification for choice of vehicle: low toxicity and long term historical data
- Lot/batch no. (if required): ZDP 12/07, 14/07 and 15/07

MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg

DOSAGE PREPARATION (if unusual):
Directly before the administration the test material was prepared with the vehicle using a mini shaker (Vortex-Genie 2®) and an Ultra-Turrax ®device.

CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: --

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

3 males and 3 females

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: The behavior and general condition of all rats were monitored for at least 6 hours after administration and checked then daily. All animals were weighed before treatment and on days 2, 4, 6, 8, 11, 13, and 15 of the experimental part.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, gross pathology

Statistics:

The body weight data were entered into the validated PC-program "AKUDAT". The statistical evaluations of the body weight were carried out with the validated PC-program "TOX 511 A", developed by the Institute of Toxicology of Merck KGaA, Darmstadt. The body weight development of each rat and group was determined. The group mean value was calculated for each measurement and printed on spread sheets

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

There were no deaths during the course of the study.

Clinical signs:

No signs of toxicity were detected in the 3 male and 3 female rats after treatment.

Body weight:

The body weight development of the rats was inconspicuous.

Gross pathology:

At necropsy, no organ alterations were seen.

Interpretation of results:

other: EU GHS criteria not met

Conclusions:

Based on the result of this study, it is concluded that the test material has no acute toxic potential and that the LD50 value for males and females is >2000 mg/kg bw after single oral treament in rats. 

Executive summary:

Study design

The test material was tested for acute toxicity in rats after single oral administration of 2000 mg/kg bw. The test material was suspended with aqueous Methocel® K4M Premium solution as vehicle. The GLP study was performed according to the OECD Guideline for Testing of Chemicals, No. 423.

Results

No signs of toxicity were seen in the rats (3 males and 3 females) after treatment with 2000 mglkg bw. There were no deaths during the course of the study.
The gross pathological examination revealed no organ alterations.

Conclusion

Based on the result of this study, it is concluded that the test material has no acute toxic potential and that the LD50 value for males and females is >2000 mg/kg bw after single oral treatment in rats. 

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

discriminating dose

Value:

2 000 mg/kg bw

Quality of whole database:

A GLP-compliant key study according to OECD guideline is available. Therefore, the quality of the database is considered to be high.

Acute toxicity: via inhalation route

Endpoint conclusion

Endpoint conclusion:

no study available

Acute toxicity: via dermal route

Endpoint conclusion

Endpoint conclusion:

no study available

Justification for classification or non-classification

Based on the result of the available study, the registered substance is not subject to classification in accordance with Regulation (EC) No 1272/2008.