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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2002-08-20 to 2002-09-11
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP and guideline compliant

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2002
Report date:
2002

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Version / remarks:
(1996)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.1 (Acute Toxicity (Oral))
Version / remarks:
(1996)
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Test type:
acute toxic class method
Limit test:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
-
EC Number:
449-400-0
EC Name:
-
Cas Number:
25822-43-9
Molecular formula:
C24H34
IUPAC Name:
1,1'-(2,3-dimethylbutane-2,3-diyl)bis[4-(propan-2-yl)benzene]
Test material form:
other: solid, fine scales

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Charles River Deutschland GmbH, D-97633 Sulzfeld
- Age at study initiation: About 8 weeks
- Weight at study initiation: 6 Female about 116 g, 6 male about 132 g
- Housing: Single caging in Makrolon cages type III (39 cm x 23 cm x 18 cm). Wire mesh lids. Sanitation of the cages once a week.
- Diet: Altromin 1324 forte, gamma irradiated with 25 kGy 60Co, ad libitum (Producer: Altromin GmbH, D-32791 Lage). Exception: The feed was withdrawn the evening before the administration of the test substance and was offered again about three hours afterwards.
- Water: Tap water
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature: 22 °C
- Humidity: 67.7 %
- Air changes: 12 per hour
- Photoperiod: Artificial light from 6 a.m. to 6 p.m.

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
other: 0.1 % Na-carboxymethylcellulose plus 0.1 % Tween 80
Details on oral exposure:
MAXIMUM DOSE VOLUME APPLIED: 10 mL/ kg bw

DOSAGE PREPARATION: The test substance was ground in a mortar and suspended in 0.1 % CMC (carboxymethyl cellulose) plus 0.1 % Tween 80 in deionised water. The suspensions were prepared freshly before administration and were administered within 5 minutes after the preparation.

CLASS METHOD:
- Rationale for the selection of the starting dose: As no prior information on the toxicity of the test substance was available, a starting dose of 200 mg of the test item per kg body weight was chosen. The further proceeding was in accordance with the guideline/directive.
Doses:
male: 200 and 2000 mg/kg bw
female: 200 and 2000 mg/kg bw
No. of animals per sex per dose:
3/sex/dose
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing:
daily observation for clinical signs 0 - 0.5, 0.5 - 1, 1 -2, 2 - 4 and 4 - 6 hours after administration and at least once a day for a total of 2 weeks. Body weight measurements were done before administration and at day 7 and 14. Body weight gain was calculated for each week of the study.
- Necropsy of survivors performed: Yes. The animals were killed by 80 % CO2 + 20 % air 14 days post application and subjected to a necropsy including a gross pathological examination.
- Other examinations performed: clinical signs, body weight, organ weights, histopathology, feed consumption, haematology, clinical biochemistry.

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
There was no mortality observed in either male or female rats in any dose.
Clinical signs:
other: No relevant signs of toxicity, only signs of discomfort, were observed up to 6 h post application in the high dosed group.
Gross pathology:
No relevant toxic effects on organs were observed
Other findings:
Slight reduction of plasma urea concentration in the high dosed females was observed.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
No mortality and no toxic effects of the test item were observed during the study period. The test item is therefore not classified as "acute toxic" according to the Directive 67/548/EEC (DSD) and the Regulation (EC) No 1272/2008 (CLP).
Executive summary:

The aim of the study was to investigate acute toxic effects of the test item after a single peroral administration to Sprague-Dawley rats according to the OECD 423. Administration of 200 and 2000 mg/kg bw were performed once per gavage to 3 males and 3 females, respectively. No clinical signs of toxicity and no mortality were observed within the observation period of 14 days. The LD50 was estimated to be > 2000 mg/kg bw.