1-bromo-4-(trans-4-ethylcyclohexyl)benzene

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

Jan 27 - 31, 2006

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2006

Report date:

2006

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Version / remarks:

The study report was performed according to the OECD Guideline for testing of Chemicals, No. 402, and according to Commission Directive 92/69/EEC.

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

1-bromo-4-(trans-4-ethylcyclohexyl)benzene

EC Number:

422-030-7

EC Name:

1-bromo-4-(trans-4-ethylcyclohexyl)benzene

Cas Number:

91538-82-8

Molecular formula:

Hill formula: C14H19Br CAS formula: C14H19Br

IUPAC Name:

1-bromo-4-(trans-4-ethylcyclohexyl)benzene

Test material form:

liquid: viscous

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: F. Winkelmann, 33178 Borchen
- Age at study initiation: 10 - 12 weeks
- Weight at study initiation: 237 g (range from 214 to 272 g).
- Fasting period before study: no
- Housing: separately in type III Makrolon cages with a shelter, placed on mobile racks
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 to 23 °C
- Humidity (%): 46 to 72 %.
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12 / 12 h

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

Administration / exposure

Type of coverage:

semiocclusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

TEST SITE
- Area of exposure: 6 x 6 cm
- % coverage: 100
- Type of wrap if used: self-adhesive fabric (Fixomull stretch, Beiersdorf).

REMOVAL OF TEST SUBSTANCE
- Washing (if done): Yes
- Time after start of exposure: 24 h

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 1.64 ml/kg
- Concentration (if solution): 1220 g/L
- Constant volume or concentration used: no

Duration of exposure:

24 h

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

5 (m) / 5 (f)

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: 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

Statistics:

Standard statistical methods have been applied for data processing.

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

Male: 2000 mg/kg bw; Number of animals: 5; Number of deaths: 0
Female: 2000 mg/kg bw; Number of animals: 5; Number of deaths: 0

Clinical signs:

The body weight development was inconspicuous. There were no deaths during the course of the study.

Body weight:

The body weight development was inconspicuous.

Gross pathology:

The gross pathological examination revealed no organ alterations.

Other findings:

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

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The test material can be considered to have no acute toxic potential and to have a LD50 value higher than 2000 mg/kg after dermal application to rats.

Executive summary:

Study design

The test material was tested for acute toxicity in rats after single dermal administration of 2000 mg/kg body weight. The study was performed according to the OECD Guideline for Testing of Chemicals, No. 402, and according to Commission Directive 92/69EEC.

Results

No signs of toxicity were seen in the rats (5 males, 5 females) after treatment with 2000 mg/kg of the test item.
The body weight development of the rats was inconspicuous during the study.
There were no deaths during the course of the study.
The gross pathological examination revealed no organ alterations.

Conclusion

The test material can be considered to have no acute toxic potential and to have a LD₅₀ value higher than 2000 mg/kg after dermal application to rats.