Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

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:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2021
Report date:
2021

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
GLP compliance:
yes
Test type:
acute toxic class method
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Tricyclo[8.2.2.24,7]hexadeca-4,6,10,12,13,15-hexaene, 5,11,13,15-tetramethyl-
Cas Number:
205825-52-1
Molecular formula:
C20H24
IUPAC Name:
Tricyclo[8.2.2.24,7]hexadeca-4,6,10,12,13,15-hexaene, 5,11,13,15-tetramethyl-
Test material form:
solid: particulate/powder
Specific details on test material used for the study:
Batch no. 350321

Test animals

Species:
rat
Strain:
Wistar
Sex:
female
Details on test animals or test system and environmental conditions:
Source: Charles River, 97633 Sulzfeld, Germany
Sex: Female (non-pregnant and nulliparous)
Number of animals: 3 per step
Age at the beginning of the study:
Step 1: 8 – 9 weeks
Step 2: 9 – 10 weeks
Body weight on the day of administration:
Step 1: 157 – 165 g;
Step 2: 160 – 181 g

Housing and Feeding Conditions
- Full barrier in an air-conditioned room
- Temperature: 22  3 °C
- Relative humidity: 55  10%
- Artificial light, sequence being 12 hours light, 12 hours dark
- Air change: 10 x / hour
- Free access to Altromin 1324 maintenance diet for rats and mice
- Free access to tap water, sulphur acidified to a pH value of approximately 2.8 (drinking water,
municipal residue control, microbiological controls at regular intervals)
- The animals were kept in groups in IVC cages, type III H, polysulphone cages on Altromin saw
fibre bedding
- Adequate acclimatisation period (at least five days) under laboratory conditions

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
corn oil
Doses:
The test item was suspended with the vehicle corn oil at a concentration of 0.2 g/mL and administered at a dose volume of 10 mL/kg.
The starting dose was selected to be 2000 mg/kg body weight.
No. of animals per sex per dose:
3
Details on study design:
All animals were examined for clinical signs several times on the day of dosing and once daily until the end of the observation period. Their body weights were recorded on day 1 (prior to the administration) and on days 8 and 15. All animals were necropsied and examined macroscopically.

Results and discussion

Effect levels
Key result
Sex:
female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
No mortality.
Clinical signs:
other:
Body weight:
lower than 10% body weight loss
Gross pathology:
No macroscopic findings were observed in any animal of any step.

Applicant's summary and conclusion

Interpretation of results:
Category 5 based on GHS criteria
Conclusions:
Under the conditions of the present study, a single oral application of the test item PARYFREE®
DIMER to rats at a dose of 2000 mg/kg body weight was associated with slight signs of toxicity but no mortality.
The median lethal dose of PARYFREE® DIMER after a single oral administration to female rats,
observed over a period of 14 days is:
LD50 cut-off (rat): 5000 mg/ kg bw