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Diss Factsheets

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
Study period:
2000
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP and guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2000
Report date:
2000

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Qualifier:
according to guideline
Guideline:
EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
Qualifier:
according to guideline
Guideline:
EPA OPPTS 870.1100 (Acute Oral Toxicity)
GLP compliance:
yes
Test type:
acute toxic class method
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
4-(4-hydroxybenzoyloxy)-3-methylphenyl 4-hydroxybenzoate
EC Number:
601-643-5
Cas Number:
119959-84-1
Molecular formula:
C21H16O6
IUPAC Name:
4-(4-hydroxybenzoyloxy)-3-methylphenyl 4-hydroxybenzoate
Details on test material:
- Name of test material (as cited in study report): Bis-1,4-(p-Hydroxybenzoesaeure)-methylphenylendiester
- Physical state: solid
- Storage condition of test material: room temperature
- Analytical purity: 99.6% (HPLC)

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Boehringer Ingelheim Pharma KG
- Age at study initiation: Young adult animals.
- Weight at study initiation: 150g - 300g (+/- 20% of the mean weight)
- Fasting period before study: at least 16 hours
- Housing: Single housing in stainless steel wire mesh cages, type DK-III.
- Diet: Kliba-Labordiaet, Provimi Kliba SA, Kaiseraugst, Switzerland, ad libitum
- Water: Tap water ad libitum
- Acclimation period: at least 1 week.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 24°C
- Humidity (%): 30 - 70%
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
olive oil
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 20 g/100 ml
- Justification for choice of vehicle: Good homogeneity in olive oil.

MAXIMUM DOSE VOLUME APPLIED:
Administration volume: 10 ml/kg
Doses:
2000 mg/kg
No. of animals per sex per dose:
3
Control animals:
no
Details on study design:
Observation period: 14 days
Individual body weight determination shortly before administration (day 0), weekly thereafter and at the end of the study (before fasting period); additionally animals that died or were sacrificed moribund.
Recording of signs and symptoms several times on the day of administration, at least once each workday for the individual animals.
A check for any dead or moribund animal was made twice each workday and once on Saturdays, Sundays and on public holidays.
Necropsy at the last day of the observation period. Withdrawal of food at least 16 hours before sacrifice with CO2; then necropsy with gross-pathology examination. Necropsy of all animals that died before as early as possible.

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Mortality:
None
Clinical signs:
other: None
Gross pathology:
No abnormalities were noted at necropsy of animals sacrificed at the end of the study.

Applicant's summary and conclusion

Interpretation of results:
practically nontoxic
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Under the conditions of this study the median lethal dose of the test substance after oral application was found to be greater than 2000 mg/kg body weight for the male and female animals.
Executive summary:

The study was performed to assess the acute toxicity following oral administration of the test substance in Wistar rats. The study procedure was based on the EC, OECD and EPA/OPPTS guidelines. To a group of six fasted animals (three males and three females) a single oral dose of the test material preparation in olive oil at a dose level of 2000 mg/kg body weight was given. No signs of toxicity were noted. The expected body weight gain was observed in the course of the study. No mortality occurred. No abnormalities were noted at necropsy of animals sacrificed at the end of the study. Under the conditions of this study the median lethal dose of the test substance after oral application was found to be greater than 2000 mg/kg body weight for the male and female animals.