Cyclododecanone, reaction products with cyclized 3-chloro-2-methyl-1-propene

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP study according to current guidelines

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2014

Report date:

2014

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

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

GLP compliance:

yes (incl. QA statement)

Remarks:

Bioassay Labor für biologische Analytik GmbH

Test type:

acute toxic class method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

2-Methyl-4,5,6,7,8,9,10,11,12,13-decahydro- 1H-cyclopentacyclododecen

IUPAC Name:

2-Methyl-4,5,6,7,8,9,10,11,12,13-decahydro- 1H-cyclopentacyclododecen

Details on test material:

- Name of test material (as cited in study report): 2-Methyl-4,5,6, 7,8,9, 10, 11, 12, 13-decahydro-1 H-cyclopentacyclododecen
- Physical state: Liquid/ brown, turbid
- Analytical purity: 62.5 area-% (not corrected for the water content.)
- Lot/batch No.: Methyl-Cyclopentadien-Cyclododecan (Austrag Gasphase SVA-Fabrik 02-18.10.2012)
- Storage condition of test material: Room temperature

Test animals

Species:

rat

Strain:

Wistar

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Rat / Wistar / Crl:WI (Han) SPF, Charles River Wiga GmbH, Germany
- Age at study initiation: approx. 10 weeks
- Weight at study initiation: range of 168-188 g
- Fasting period before study: feed was withdrawn from the animals at least 16 hours before administration, but water was available ad libitum.
- Housing: Single housing
- Water: Tap water ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/-3
- Humidity (%): 30-70
- Air changes (per hr): approx 10
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

corn oil

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 15 g/ 100 ml for dose group 300 mg/kg bw; undiluted for dose group 2000 mg/kg bw
- Justification for choice of vehicle: Good homogeneity

MAXIMUM DOSE VOLUME APPLIED: 2 ml/kg bw for dose group 300 mg/kg bw; 2.15 ml/kg bw for dose group 2000 mg/kg bw

Doses:

300, 2000 mg/kg bw

No. of animals per sex per dose:

3 females (300 mg/kg bw)
6 females (2000 mg/kg bw)

Control animals:

other: not applicable

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing:
A check for any dead or moribund animals was made at least once each workday.
Clinical signs for each animal were recorded several times on the day of administration and at least once during each workday thereafter.
Body weights shortly before administration (day 0), weekly thereafter and on the last day of observation.
- Necropsy of survivors performed: yes

Results and discussion

Effect levels

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Mortality:

No mortality occurred neither in both 2000 mg/kg bw test groups nor in the 300 mg/kg bw test group.

Clinical signs:

other: Clinical signs in the first 2000 mg/kg bw test group revealed impaired general state and piloerection in two animals from hour 2 until hour 4 after administration. No clinical signs were observed during clinical examination in the second 2000 mg/kg bw tes

Gross pathology:

There were no macroscopic pathological findings in the animals sacrificed at the end of the observation period.

Applicant's summary and conclusion

Interpretation of results:

practically nontoxic

Remarks:

Migrated information

Conclusions:

The present data on acute oral toxicity do not fulfill the criteria laid down in 67/548/EEC and regulation (EU) 1272/2008, and therefore, a non-classification is warranted.