Registration Dossier

Diss Factsheets

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

Constituent 1
Reference substance name:
Automatically generated during migration to IUCLID 6, no data available
IUPAC Name:
Automatically generated during migration to IUCLID 6, no data available
Details on test material:
- Name of test material (as cited in study report): 2-(2-Methylallyl)-cyclododecanon-Rein
- Physical state: Liquid/ colorless, clear
- Analytical purity: 99.3 area-% (not corrected with the water content), Capillary GC-analysis
- Lot/batch No.: 2-(2-Meth-allyl)cyclododecanon (MACD Probe aus B410.16 vom 04.10.2012)
- 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 176-187 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- Fasting period before study: feed was withdrawn from the animals at least 16 hours before administration, but water was available ad libitum.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:
No clinical signs were observed during clinical examination in both 2000 mg/kg bw test groups.
One animal in the 300 mg/kg bw test group revealed impaired general state and piloerection at hour 5 after administration only.
Body weight:
The mean body weight of the animals increased within the normal range throughout the study period with exception of three females in both 2000 mg/kg bw test groups. One of these animals marginally lost weight, while two animals revealed a stagnation of body weight in the second week.
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.