trans-1,4-bis(iodomethyl)cyclohexane

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2004

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: The study has been conducted in compliance with GLP and according to the OECD guideline 423.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2004

Report date:

2004

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

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

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test type:

acute toxic class method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

trans-1,4-bis(iodomethyl)cyclohexane

Cas Number:

83447-96-5

Molecular formula:

C8H14I2

IUPAC Name:

trans-1,4-bis(iodomethyl)cyclohexane

Test animals

Species:

rat

Strain:

Wistar

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Age at study initiation: approximately 7 weeks (at start of acclimatisation)
- Weight at study initiation: 197.5 g +/- 7.4 g (3.7%) n=6
- Fasting period before study: the night before administration and 3 hours after administration
- Housing: up to 3 animals/cage
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 6 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20.5 - 21.5°C
- Humidity (%): 30-45%
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

other: 0.5% (m/v) solution of Tylose MH 1000 in deionised water

Details on oral exposure:

3 g test item filled up to 15 ml using 0.5 % (m/v) solution of Tylose MH 1000 in deionised water.
1 ml / 100 g body weight. Individual doses were adjusted according to the recorded body weight.

Doses:

2000 mg/kg b.w.

No. of animals per sex per dose:

6

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations: at 1.5, 2.5, 3, 6 and 8 h after dosing and once daily thereafter
- Frequency of weighing: day 0 (prior to dosing), day 7 and day 14
- Necropsy of survivors performed: yes
- Other examinations performed: the cranial, thoracic and abdominal cavities were then opened and examined macroscopically.

Results and discussion

Effect levels

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

None of the animals died during the course of investigation

Clinical signs:

Not any alteration of the general state of well-being was observed during the course of the study.

Body weight:

The body weight gain of the animals was not affected by the administration of the test item.

Gross pathology:

Not any pathological finding was observed.

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

In accordance with the criteria of Annex 6 to Directive 2001/59/EU of August 06, 2001 P2 is neither a toxic nor a harmful substance according to
this acute oral toxicity study.

Executive summary:

At the tested dose level of 2000 mg/kg body weight no mortality was observed within the 14 day observation period after single dosing. During the course of this study no relevant clinical signs and changes in body weight gain and resulting body weights was noted. At necropsy also no histopathological changes were noted. Concluding the LD50 of the substance is higher than 2000 mg/kg and therefore no classification is necessary.