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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:
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 guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Version / remarks:
December 17, 2001
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EPA OPPTS 870.1100 (Acute Oral Toxicity)
Version / remarks:
December, 2002
Deviations:
no
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

Constituent 1
Chemical structure
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.