4,4'-Isopropylidenediphenol, ethoxylated

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

From 30 NOV 2011 to 31 MAY 2012

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2012

Report date:

2012

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)

Version / remarks:

December 17, 2001

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)

Deviations:

no

Test guideline 3

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.1100 (Acute Oral Toxicity)

Version / remarks:

December, 2002

Deviations:

no

Test guideline 4

Qualifier:

according to guideline

Guideline:

other: Japan MAFF Testing Guideline of 12 Nosan No. 8147

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test type:

acute toxic class method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

4,4'-Isopropylidenediphenol, ethoxylated

EC Number:

500-082-2

EC Name:

4,4'-Isopropylidenediphenol, ethoxylated

Cas Number:

32492-61-8

Molecular formula:

C15H16O2.(C2H5O)n.(C2H5O)m sum of n+m: >1 - <4.5 moles EO

IUPAC Name:

2-[4-[2-[4-(2-hydroxyethoxy)phenyl]propan-2-yl]phenoxy]ethanol

Test material form:

liquid: viscous

Test animals

Species:

rat

Strain:

Wistar

Sex:

female

Details on test animals or test system and environmental conditions:

Test species/strain/quality: Rat/Wistar/Crl:WI (Han)
Reason for selection of the test species: Rats were selected since this rodent species is recommended in the respective test guidelines. Wistar rats were selected since there is extensive experience available in the laboratory with this strain of rats.
Age on day 0: Young adult animals (female animals approx. 10 weeks)
Sex: As suggested by the OECD guideline nulliparous and non-pregnant female animals were used for the test, because there is no indication that male animals are likely to be more sensitive to the acute effects of the test item.
Supplier: Charles River Wiga GmbH, Sandhofer Weg 7, 97633 Sulzfed, Germany.
Arrival in the testing facility: Acclimatization period of at least 5 days before the beginning of the experimental phase: during the acclimatization period, the animals were accustomed to the environmental conditions of the study and to the diet.
Identification: Individual identification by cage cards and tail marking.
Body weight on day 0: Animals of comparable weight (+/- 20% of the mean weight)
Room temperature/relative humidity: The animals were housed in fully air-conditioned rooms. Central air-conditioning guaranteed a range of 22°C ± 3°C for temperature and of 30-70% for relative humidity. There were no deviations from these ranges, which influenced the results of the study.

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

Route of administration: Single oral administration by gavage
Fasting period: Feed was withdrawn from the animals at least 16 hours before administration, but water was available ad libitum.
Time of day of administration: In the morning
Observation period: 14 days

Doses:

2000 mg/kg/bw

No. of animals per sex per dose:

6

Control animals:

no

Details on study design:

By request of the sponsor a starting dose of 2000 mg/kg/bw was chosen in the first step with 3 female animals. Because no mortality occurred in the first step, 2000 mg/kg/bw were administered to another group of 3 females animals in the second step.

Results and discussion

Effect levels

Key result

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Mortality:

No mortality occurred.

Clinical signs:

other: No clinical signs were observed during clinical examination.

Gross pathology:

There were no macroscopic pathological findings in the animals sacrificed at the end of the observation period.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Under the conditions of this study, the acute oral median lethal dose (LD50) of the test material was found to be > 2000 mg/kg bodyweight. The classification of test substance for acute oral toxicity is not warranted in accordance with CLP Regulation 1272/2008.

Executive summary:

In an acute oral toxicity study (acute toxic class method, according to OECD Test Guideline 423), groups of approx. 10 weeks old female rats (n= 3 rats/step) were given a single oral dose of the undiluted test material (purity: 99.2%). In the first step, three females received 2000 mg/kg bw, and all animals treated with this dose survived until the end of the study without showing any test item-related signs of toxicity. Based on these results and according to the acute toxic class method regime, a second step was performed at a dose of 2000 mg/kg bw. All animals survived; throughout the 14-day observation period, they did not show any test item related signs of toxicity. Necropsy of the surviving rats did not reveal any findings. Based on the results from this study, the oral LD50 is considered to be > 2000 mg/kg bw. Therefore, the classification of test substance for acute oral toxicity is not warranted in accordance with CLP Regulation 1272/2008.