Registration Dossier

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 compliant, OECD guideline study performed without deviation.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2001
Report date:
2001

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EPA OPPTS 870.1100 (Acute Oral Toxicity)
Deviations:
no
GLP compliance:
yes
Remarks:
US EPA (40 CFR, Part 792) and OECD GLP
Test type:
acute toxic class method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Type:
Constituent
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder
Details on test material:
- Name of test material (as cited in study report): Dimethyl cyclohexyl bisphenol (DMBPC; CAS No. 2362-14-3)
- Synonyms: Dimethyl bisphenolcyclohexane; 4,4’-cyclohexylidene di-o-cresol; 1,1-Bis(4-hydroxy-3-ethyl)cyclohexane; Bis-OC-Z
- Appearance: fine white powder

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals or test system and environmental conditions:
Six outbred albino rats per sex were received from the supplier. Female rats were nulliparous and non-pregnant. They weighed 216.5-247.8 g and were at least 8 weeks old at the start of the study. They were single housed upon arrival in polycarbonate cages with hardwood chip bedding. The animals were acclimated for at least 5 days prior to dosing. Tap water was provided ad libitum throughout the study and feed was provided ad libitum, with the exception of overnight prior to dosing. The temperature and humidity were maintained at 68 ± 5 °F and 30 - 70 %, respectively. Room lights were on a 12-hour light/dark cycle.

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
other: methanol
Details on oral exposure:
DMBPC was dissolved in methanol prior to dosing. The dosing volume did not exceed 1 mL/100 g body weight.
Doses:
2000 mg/kg
No. of animals per sex per dose:
6
Control animals:
no
Details on study design:
Food was withheld from the animals the night prior to dosing. Animals were administered a single dose of DMBPC by oral gavage. After dosing, the animals were returned to their cages and supplied with feed and water ad libitum.

Careful clinical observations were made at least twice on the day of dosing. Animals were observed daily for 14 days for clinical manifestations. Animals were weighed on Day 0 (prior to dose administration), Day 7 and Day 14.

On Day 14 animals were sacrificed by CO2 inhalation and a gross necropsy was performed.

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
All animals survived the duration of the study.
Clinical signs:
No clinical signs of toxicity were observed in any animals over the course of the study.
Body weight:
All animals gained weight over the course of the study.
Gross pathology:
No unusual findings were found during necropsy for the animals euthanised at study termination.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Under the conditions of this study, DMBPC was determined to have an acute oral LD50 of greater than 2000 mg/kg.
Executive summary:

The acute toxicity potential of the test material was investigated in a study conducted in accordance with the standardised guidelines OECD 423 and EPA OPPTS 870.1100 under GLP conditions using the acute toxic class method.

Six Sprague-Dawley rats were exposed to the test material at a limit dose of 2000 mg/kg bw in methanol by oral gavage.

Careful clinical observations were made at least twice on the day of dosing. Animals were observed daily for 14 days for clinical manifestations. Animals were weighed on Day 0 (prior to dose administration), Day 7 and Day 14. On Day 14, animals were sacrificed by CO₂ inhalation and a gross necropsy was performed.

All animals survived the duration of the study. No clinical signs of toxicity were observed in any animals over the course of the study and all animals gained weight over the course of the study. No unusual findings were found during necropsy for the animals euthanised at study termination.

Under the conditions of this study, DMBPC was determined to have an acute oral LD50 of greater than 2000 mg/kg.