Reaction mass of 2,6-bis(1-phenylethyl)phenol and 2,4,6-tris(1-phenylethyl)phenol

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

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 402 guideline-compliant study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1997

Report date:

1997

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

EU Method B.3 (Acute Toxicity (Dermal))

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Deviations:

no

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

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

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: 225 - 258 g (males) / 200 - 244 g (females)
- Fasting period before study: No
- 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: March 1997

Administration / exposure

Type of coverage:

semiocclusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

TEST SITE
- Area of exposure: About 6x5 cm on the body dorsal surface
- % coverage: Approximately 10% of body surface
- Type of wrap if used: No data


REMOVAL OF TEST SUBSTANCE
- Washing: With water
- Time after start of exposure: 24 hours following application


TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 4.63 mL/kg
- Concentration (if solution): Not applicable
- Constant volume or concentration used: yes


VEHICLE
No vehicle used

Duration of exposure:

24 hours

Doses:

5000 mg/kg

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days (following the 24-hour exposure period)
- Frequency of observations and weighing:
Clinical signs and mortality: 30 min, 2, 4 and 6 h on the day following application, twice daily afterwards
Body weight: twice before dosing, and on days 8 and 15
- Necropsy of survivors performed: yes
- Other examinations performed: No

Statistics:

No statistical analysis performed

Results and discussion

Preliminary study:

Not applicable

Effect levels

Effect levels 1

Sex:

male/female

Dose descriptor:

LD0

Effect level:

5 000 mg/kg bw

Effect levels 2

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Mortality:

No death occurred at the dose level tested

Clinical signs:

other: No systemic or local change was observed at the dose tested

Gross pathology:

No abnormality detected

Other findings:

No abnormality detected

Applicant's summary and conclusion

Interpretation of results:

practically nontoxic

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

No mortality, clinical signs or body weight changes occurred in Sprague-Dawley rats applied a single dermal dose of 5000 mg/kg, during a 14-day observation period.
TSP/DSP is not classified for dermal toxicity according to the criteria of Annex VI Directive 67/748/EEC or UN/EU GHS.

Executive summary:

In an acute dermal toxicity study (RBM study No. 970072), groups of fasted Sprague-Dawley rats (5/sex), aged less than 3-month old, were applied a single dermal dose of Tristyrylphenol/Distyrylphenol (75/25 molar %) at 5000 mg/kg bw, and observed for 14 days.

No dermal LD50 could be determined because no mortality occurred at the dose of 5000 mg/kg.

No systemic or local clinical signs and no significant changes in body weight were observed at 5000 mg/kg. No abnormality was seen at necropsy.

TSP/DSP is not classified for dermal toxicity according to the criteria of Annex VI Directive 67/748/EECor UN/EU GHS.

This acute dermal study is classified as acceptable. It satisfies the OECD 402 guideline requirements for an acute dermal study in the rat.