Registration Dossier

Administrative data

Description of key information

The oral LD50 value of 1,1’-(1,1,3-trimethylpropane-1,3-diyl)bis(cyclohexane) in Wistar rats was established to exceed 2000 mg/kg body weight.

According to the OECD 423 test guideline, the LD50 cut-off value was considered to exceed 5000 mg/kg body weight.

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records
Reference
Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
Dosing was initiated on 15 May 2018. The in-life phase of the study was completed on 31 May 2018.
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Version / remarks:
2001
Qualifier:
according to
Guideline:
EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
Version / remarks:
2008
Qualifier:
according to
Guideline:
EPA OPPTS 870.1100 (Acute Oral Toxicity)
Version / remarks:
2002
Qualifier:
according to
Guideline:
other: JMAFF Guidelines
Version / remarks:
2000, including the most recent revisions
GLP compliance:
yes
Test type:
acute toxic class method
Limit test:
yes
Specific details on test material used for the study:
Purity: 97.2%
Batch: 170918339
Species:
rat
Strain:
Wistar
Remarks:
Crl: WI(Han)
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Charles River Deutschland, Sulzfeld, Germany
- Females nulliparous and non-pregnant: Yes
- Age at study initiation: Young adult animals (approximately 9 weeks old)
- Weight at study initiation: 158 to 174 g
- Housing: Polycarbonate cages (height 18 cm.) containing sterilized sawdust as bedding material equipped with water bottles.
- Fasting: overnight (maximum of 20 hours) prior to treatment
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 to 24°C
- Humidity (%):40 to 70% ; Deviations from the maximum level of daily mean target humidity occurred on several days during the study (highest value was 75%).
This study plan deviation is considered not to have affected the integrity of the study because it did not noticeably affect the clinical condition of the animals or the outcome of the study
- Air changes (per hr): > 10 changes per hour
- Photoperiod (hrs dark / hrs light): 12 hour light/12 hour dark cycle

IN-LIFE DATES: From: 15 May 2018 To: 31 May 2018
Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Details on oral exposure:
CLASS METHOD
- Rationale for the selection of the starting dose: The dose levels were based on the OECD test guidelines and were selected from the series 5 (lowest dose level), 50, 300 and 2000 (highest dose level) mg/kg body weight. The starting dose level should be the one that is likely to produce mortality in at least some of the animals and was selected based on available toxicity data of the test item.
Doses:
2000 mg/kg bw
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 and weighing: observed 3 times on day of dosing and daily thereafter; weighed day 1 (predose), 8 and 15
- Necropsy of survivors performed: yes
Statistics:
No statistical analysis was performed.
Key result
Sex:
female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Remarks on result:
not determinable due to absence of adverse toxic effects
Key result
Sex:
female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Remarks on result:
not determinable due to absence of adverse toxic effects
Remarks:
According to the OECD 423 test guideline, the LD50 cut-off value was considered to exceed 5000 mg/kg body weight
Mortality:
No mortality occurred
Clinical signs:
Hunched posture was noted for the animals between Days 1 and 3
Body weight:
The body weight gain shown by the animals over the study period was considered to be similar to that expected for normal untreated animals of the same age and strain
Gross pathology:
No abnormalities were found at macroscopic post mortem examination of the animals
Interpretation of results:
GHS criteria not met
Conclusions:
The oral LD50 value of 1,1’-(1,1,3-trimethylpropane-1,3-diyl)bis(cyclohexane) in Wistar rats was established to exceed 2000 mg/kg body weight.
According to the OECD 423 test guideline, the LD50 cut-off value was considered to exceed 5000 mg/kg body weight.
Executive summary:

The oral LD50 value of 1,1’-(1,1,3-trimethylpropane-1,3-diyl)bis(cyclohexane) in Wistar rats was established to exceed 2000 mg/kg body weight.

According to the OECD 423 test guideline, the LD50 cut-off value was considered to exceed 5000 mg/kg body weight.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
5 000 mg/kg bw
Quality of whole database:
The database is of high quality

Additional information

Justification for classification or non-classification

According to the OECD 423 test guideline, the LD50 cut-off value was considered to exceed 5000 mg/kg body weight. Therefore, according to Regulation (EC) No 1272/2008 as amended (CLP) the test substance does not meet the criteria for Acute Oral Toxicity.