Reaction mass of phenol and tetraphenylphosphonium phenolate

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1997

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline 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:

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

Version / remarks:

of 22th March 1996

Deviations:

no

Test guideline 2

Qualifier:

equivalent or similar to guideline

Guideline:

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

GLP compliance:

yes

Test type:

acute toxic class method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Tetraphenylphosphonium phenolate

EC Number:

239-480-3

EC Name:

Tetraphenylphosphonium phenolate

Cas Number:

15464-47-8

Molecular formula:

C24H20P.C6H5O

IUPAC Name:

tetraphenylphosphanium benzenolate

Constituent 2

Reference substance name:

Phenol

EC Number:

203-632-7

EC Name:

Phenol

Cas Number:

108-95-2

Molecular formula:

C6H6O

IUPAC Name:

phenol

Test material form:

solid

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Harlan Winkelmann, Borchen, Germany
- Age at study initiation: 8-10 weeks
- Weight at study initiation: 173 g (mean females) and 204 g (mean males)
- Housing: 3 animals per cage
- Diet (e.g. ad libitum): yes
- Water (e.g. ad libitum): yes
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 2 °C
- Humidity (%): 55 ± 5 °C
- Air changes (per hr): 15 - 20 per hour
- Photoperiod (hrs dark / hrs light): 12 h rhythm

IN-LIFE DATES: From: To: 10 SEPT 1997 to 08 OKT 1997

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

polyethylene glycol

Details on oral exposure:

application volume 10 mL/kg bw
The test substance was formulated in the application vehicle immediately prior to teatment. Therefore analytical investigations of the stability in the vehicle were not performed.

Doses:

2000 mg/kg bw as first dose in males; 200 mg/kg bw as second dose in male and females

No. of animals per sex per dose:

3 males and 6 females

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations: several times on the day of administration, and at least once daily during the following 14 day observation period
- body weights: weekly
- Necropsy of survivors performed: yes

Statistics:

not applicable

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 200 mg/kg bw

Based on:

test mat.

Remarks on result:

other: LD50 between 200 and 2000 mg/kg bw

Mortality:

all 3 female rats died after administration of 2000 mg/kg bw within 1 hour

Clinical signs:

other: No clinical signs

Gross pathology:

Severe red discoloration of the stomach and small intestine was observed at necropsy in the intercurrent death animals (2000 mg/kg bw group). None of the sacrificed animals showed any noticable gross pathological findings (200 mg/kg bw group).

Any other information on results incl. tables

Dose (mg/kg bw)	sex	toxicological result	mortality	onset of mortality
(1st) 2000	female	3 / 3	100 %	1h
(2nd) 200	female	3 / 0	---	---
(2nd) 200	male	3 / 0	---	---

Toxicological results:

number of dead animals / number of animals treated

Applicant's summary and conclusion

Interpretation of results:

Category 4 based on GHS criteria

Executive summary:

The acute oral LD50 in rats was determined as > 200 mg/kg bw and < 2000 mg/kg bw based on the results of a limit dose study performed according to OECD TG 423. The test dose of 2000 mg/kg led to mortality of 3/3 females with severe red discoloration of the stomach and small intestine at necropsy. The second dose of 200 mg/kg bw tested in 3 male and 3 female rats was well tolerated without clinical signs or any noticeable gross pathological findings. Since the dose of 200 mg/kg bw turned out as the NOEL for both sexes it can be considered that the LD50 is > 300 mg/kg bw (Acute Tox 4), as shown in the flow chart in Annex 3c of OECD 423 (1996) and Annex 2d of OECD 423 (2001). The test substance should thus be regarded as harmful if swallowed.