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Toxicological information

Acute Toxicity: oral

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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:
1990
Report date:
1990

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
EU Method B.1 (Acute Toxicity (Oral))
Deviations:
no
Remarks:
The study was conducted according to guideline in effect at time of study conduct.
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-[1,1-bis(4-hydroxyphenyl)ethyl]phenol
Details on test material:
- Purity: 99%

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: groups of up to 5 rats of the same sex in 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% w/v 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:
2/sex/dose (preliminary test)
5/sex/dose (main study)
Control animals:
no
Details on study design:
- Duration of observation period following administration: 5 days (preliminary study); 14 days (main study)
- 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:
No statistical analyses were reported.

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Mortality:
There were no deaths.
Clinical signs:
Piloerection was observed in all rats within 5 minutes of dosing and throughout the remainder of Day 1. There were no other clinical signs, and recovery was complete, as judged by external appearance and behaviour, by Day 2.
Body weight:
A slightly 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:
Gross pathology findings were normal.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
LD50 >5000 mg/kg
Executive summary:

The test substance was then suspended in 1% aqueous methylcellulose and given as a single 5000 mg/kg oral dose by gavage to 5 male and 5 female rats. The rats were then observed for 14 days for mortality and clinical signs, and body weights were recorded on Days 1, 8, and 15. There were no deaths during the observation period. The only clinical sign was piloerection on Day 1. All but one male rat had normal body weight gain. Gross necropsy findings were normal. The acute oral LD50was greater than 5000 mg/kg.