2,3-difluoro-1-propoxy-4-[4-(trans-4-propylcyclohexyl)-1-cyclohexen-1-yl]-benzene

Endpoint summary

Description of key information

In an oral acute toxicity study performed in rats with the structural analogue substance no mortality, no body weight change and no signs of toxicity have been observed. The LD50 (male/female) is > 2000 mg/kg bw (reference 7.2.1 -1).

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records

Reference

Reference 1

Endpoint:

acute toxicity: oral

Type of information:

read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Justification for type of information:

For this endpoint information from structural similar compounds is available. The studies for these similar compounds were performed according to GLP and the methods applied are fully compliant with OECD TG 423. See chapter 13 report for a more detailed justification.

Reason / purpose for cross-reference:

read-across source

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Remarks on result:

not determinable due to absence of adverse toxic effects

Reference 2

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

April 22, 2003 - July 22, 2003

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

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

Version / remarks:

adopted on December 17th, 2001

Deviations:

no

Qualifier:

according to guideline

Guideline:

EU Method B.1 (Acute Toxicity (Oral))

Version / remarks:

Commission Directive of 30th. July 1996 adapting to technical progress for the 22nd time Council Directive 67/548/EEC on the approximation of the laws, regulations and administrative provisions relating to the classification, packaging and labeling of dangerous substances
(Official Journal of the European communities No. L 248, September 30, 1996)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test type:

acute toxic class method

Limit test:

yes

Specific details on test material used for the study:

TREATMENT OF TEST MATERIAL PRIOR TO TESTING
Directly before administration the test material was prepared with the vehicle using a mini shaker (Vortex Genie 2) and an Ultra-Turrax device (Janke and Kunkel).

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: F. Winkelmann, Borchen, Germany
- Age at study initiation: approx. 6 to 11 weeks
- Weight at study initiation : mean: 179 g (range from 165 to 198 g)
- Fasting period before study: 17 hours before until up to 4 hours after treatment
- Housing: separately in type III Makrolon cages
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: at least 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22°C
- Humidity (%): 49 - 68%
- Photoperiod (hrs dark / hrs light): 12 hour light - 12 hour dark

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

Route of administration:

oral: gavage

Vehicle:

methylcellulose

Remarks:

Methocel K4M Premium solution

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 200 g/L
- Amount of vehicle: 10 mL/kg
- Justification for choice of vehicle: well tolerated and established standard vehicle

Doses:

2000 mg/kg

No. of animals per sex per dose:

3 (m) / 3 (f)

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations: daily
- Frequency of weighing: day 2, 4, 6, 8, 11, 13 and 15
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, gross pathology

Statistics:

Standard statistical methods have been applied for data processing.

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Remarks on result:

not determinable due to absence of adverse toxic effects

Mortality:

All rats survived the observation period.

Clinical signs:

No signs of toxicity were detected in the 3 male and 3 female rats after treatment with 2000 mg/kg.

Body weight:

Body weight development of the treated rats was inconspicuous.

Gross pathology:

The gross pathological examination revealed no organ alterations.

Interpretation of results:

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 is higher than 2000 mg/kg after oral treatment in rats.

Executive summary:

The test material was tested for acute toxicity according to OECD TG 423 in rats after oral administration of 2000 mg/kg body weight. Directly before administration the test material was prepared with aqueous Methocel® K4M Premium solution as the vehicle. This study was performed according to the "Acute toxic class method" (ATC).

No signs of toxicity were detected in the rats (3 males and 3 females) after treatment with 2000 mg/kg. There were no deaths during the course of the study. The gross pathological examination revealed no organ alterations.Based on the result of this study, it is concluded that the substance has no acute toxic potential and that the LD50 value is higher than 2000 mg/kg after 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:

OECD TG 423, GLP, RA

Acute toxicity: via inhalation route

Endpoint conclusion

Endpoint conclusion:

no study available

Acute toxicity: via dermal route

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

Oral

There is no study for acute toxicity available for the test substance.

However, the structural analogue substance was tested for acute toxicity according to OECD TG 423 in rats after oral administration of 2000 mg/kg body weight. Directly before administration the test material was prepared with aqueous Methocel® K4M Premium solution as the vehicle. This study was performed according to the "Acute toxic class method" (ATC).

No signs of toxicity were detected in the rats (3 males and 3 females) after treatment with 2000 mg/kg bw. There were no deaths during the course of the study. The gross pathological examination revealed no organ alterations. Based on the result of this study, it is concluded that the substance has no acute toxic potential and that the LD50 value is higher than 2000 mg/kg bwafter oral treatment in rats (reference 7.2.1 -1).

Justification for classification or non-classification

Classification, Labeling, and Packaging Regulation (EC) No 1272/2008

The available data for acute oral toxicity are reliable and suitable for classification purposes under Regulation (EC) No 1272/2008. Based on this data, the substance is not classified for acute toxicity under Regulation (EC) No 1272/2008 (CLP), as amended for the twelfth time in Regulation (EU) 2019/521.