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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: GLP study in accordance with relevant guideline; selected as the key study because the information provided for the hazard endpoint is sufficient for the purpose of classification and labelling and/or risk assessment.

Data source

Reference
Reference Type:
other: reference to body responsible for the test
Title:
Unnamed
Year:
1990
Report date:
1990

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
EU Method B.1 (Acute Toxicity (Oral))
Deviations:
no
Remarks:
Study was conducted according to guideline in effect at time of study.
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
4,4',4''-(ethan-1,1,1-triyl)triphenol
EC Number:
405-800-7
EC Name:
4,4',4''-(ethan-1,1,1-triyl)triphenol
Cas Number:
27955-94-8
Molecular formula:
C20H18O3
IUPAC Name:
4,4',4''-(ethan-1,1,1-triyl)triphenol
Details on test material:
- Purity: 99%
- The test substance in 1% aqueous methylcellulose

Test animals

Species:
rat
Strain:
other: Crl:CD® (SD) BR VAF plus
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Age at study initiation: 4-6 weeks
- Weight at study initiation: 98-116 g
- Fasting period before study: Not reported.
- Housing: Up to 5 rats of the same sex in groups, within metal cages with wire mesh floors
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 6 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21-23
- Humidity (%): mean value was 55%
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
other: 1 % aqueous methylcellulose
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 50%
- Amount of vehicle (if gavage): 5.0 mL/kg body weight.
- Justification for choice of vehicle: Not reported/

MAXIMUM DOSE VOLUME APPLIED: 10.0 mL/kg body weight

CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: A preliminary test was carried out using a dose of 2.5 g/kg. The rationale was not reported.
Doses:
2.5 g/kg (preliminary test)
5.0 g/kg (main study)
No. of animals per sex per dose:
- preliminary test: 2/sex/dose
- main studY: 5/sex/dose
Control animals:
no
Details on study design:
- Duration of observation period following administration: (preliminary study) 5 days; (main study) 14 days.
- Frequency of observations and weighing: observation soon after dosing, at frequent intervals for the remainder of Day 1, and twice daily for the rest of the observation period. Rats were weighed on Days 1 (day of dosing), 8, and 15 (main study).
- Necropsy of survivors performed: Yes (main study).
Statistics:
Male: 5000 mg/Kg bw; Number of animals: 5; Number of deaths: 0
Female: 5000 mg/Kg bw; Number of animals: 5; Number of deaths: 0

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Mortality:
Male: 5000 mg/Kg bw; Number of animals: 5; Number of deaths: 0
Female: 5000 mg/Kg bw; Number of animals: 5; Number of deaths: 0
Clinical signs:
Signs of toxicity related to dose levels:
The only effect seen was piloerection during the first day post-dose
Body weight:
A slight low body weight gain was recorded for 1 male rat on Day 8. All other rats achieved anticipated body weight gains throughout the study.
Gross pathology:
No treatment-related macroscopic findings were observed.

Any other information on results incl. tables

Male: 5000 mg/Kg bw; Number of animals: 5; Number of deaths: 0 Female: 5000 mg/Kg bw; Number of animals: 5; Number of deaths: 0

Applicant's summary and conclusion

Interpretation of results:
relatively harmless
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The study and the conclusions which are drawn from it fulfil the quality criteria (validity, reliability, repeatability). No specimen deaths were recorded. LD50 >5000 mg/kg.
Executive summary:

Test substance suspended in 1% aqueous methylcellulose was administed as a single 5000 mg/kg oral dose to 5 male/5 femal rats. The rats were observed for 14 days. There were no deaths during the observation period. One male rat had abnormal (lower than average) body weight gain. Gross necropsy findings were normal. The acute oral LD50 was greater than 5000 mg/kg.