Registration Dossier
Registration Dossier
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EC number: 947-623-2 | CAS number: -
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- February - April 1997
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP OECD 401 guideline-compliant study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 997
- Report date:
- 1997
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 (Acute Toxicity (Oral))
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- no
Test material
- Reference substance name:
- Reaction mass of 2,4,6-tris(1-phenylethyl)phenol and 2,6-bis(1-phenylethyl) phenol
- EC Number:
- 915-333-5
- IUPAC Name:
- Reaction mass of 2,4,6-tris(1-phenylethyl)phenol and 2,6-bis(1-phenylethyl) phenol
Constituent 1
- Specific details on test material used for the study:
- Of note, in the absence of specific data on the registered Reaction mass of o-(1-phenylethyl) phenol and bis(1-phenylethyl) phenol and 2,4,6-tris(1-phenylethyl)phenol and the obligation to generate some data for intermediates, data from the Reaction mass of 2,4,6-tris(1-phenylethyl)phenol and 2,6-bis(1-phenylethyl) phenol have been included in the dossier by default as comparable hazard profile could be expected between both substances.
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 Italia
- Age at study initiation: < 3 months
- Weight at study initiation: 270 - 293 g (males) / 186 - 245 g (females)
- Fasting period before study: About 16 hours before dosing
- Housing: Grill cages 40.5x38.5x18 cm with stainless steel feeder
- Diet: GLP 4RF21 pelleted diet ad libitum
- Water: Filtered tap water ad libitum
- Acclimation period: > 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 2
- Humidity (%): 55 +/- 10
- Air changes (per hr): about 20
- Photoperiod (hrs dark / hrs light): 12 / 12 (7 a.m. - 7 p.m.)
IN-LIFE DATES: From: February 1997 To: April 1997
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Details on oral exposure:
-
MAXIMUM DOSE VOLUME APPLIED: 18.52 mL/kg (administered twice at 3-hour interval at highest dose level)
VEHICLE
No vehicle used - Doses:
- 5, 10, 20 or 40 g/kg
- No. of animals per sex per dose:
- 5 females/dose at 5, 10, 20 or 40 g/kg
5 males at 40 g/kg - Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing:
Clinical signs and mortality: 30 min, 2, 4 and 6 h on administration day and twice daily afterwards
Body weight: twice before dosing, and on days 3, 8 and 14
- Necropsy of survivors performed: yes
- Other examinations performed: No - Statistics:
- No statistical analysis performed
Results and discussion
- Preliminary study:
- Not applicable
Effect levelsopen allclose all
- Sex:
- male/female
- Dose descriptor:
- LD0
- Effect level:
- 40 other: g/kg
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 40 other: g/kg
- Mortality:
- No death occurred at any dose up to 40 g/kg inclusive
- Clinical signs:
- other: - At 20 and 40 g/kg: hypoactivity, piloerection and hunched posture (2-4 h after dosing), diarrhea and urine-stained perineum (after a few days) - At 10 g/kg: piloerection (from day 4) and urine-stained perineum (one animal between days 4 and 6) - Recover
- Gross pathology:
- No abnormality detected
- Other findings:
- No abnormality detected
Any other information on results incl. tables
- Maximum daily frequency of clinical signs:
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Applicant's summary and conclusion
- Interpretation of results:
- practically nontoxic
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- No mortality occurred in Sprague-Dawley rats given a single oral dose up to 40 g/kg inclusive, during a 14-day observation period.
TSP/DSP is not classified for oral toxicity according to the criteria of Annex VI Directive 67/748/EEC or UN/EU GHS. - Executive summary:
In an acute oral toxicity study (RBM study No. 970071), groups of fasted Sprague-Dawley rats (5/sex), aged less than 3-month old, received a single oral dose of Tristyrenated phenol/Distyrenated phenol (75/25 molar %) at doses of 5, 10 or 20 g/kg bw (females only) or 40 g/kg bw (males and females), and were observed for 14 days.
No oral LD50 could be determined because no mortality occurred up to the dose of 40 g/kg inclusive.
At 20 and 40 g/kg, hypoactivity, piloerection and hunched posture were observed 2 to 4 h after dosing, and diarrhea and urine-stained perineum within a few days after dosing. At 10 g/kg, piloerection was observed from day 4 and urine-stained perineum occurred in one animal between days 4 and 6. Recovery was noted on day 8 at 10 and 20 g/kg. Slight decreases in body weight (down to -10% versus pre-dose based on individual data) were observed on day 3 at 20 and 40 g/kg. No abnormality was seen at necropsy.
TSP/DSP is not classified for oral toxicity according to the criteria of Annex VI Directive 67/748/EECor UN/EU GHS
This acute oral study is classified as acceptable. It satisfies the OECD 401 guideline requirements for an acute oral study in the rat.
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