Reaction Mass of Didodecyl nonylphenyl phosphite and Dodecyl bis(4-nonylphenyl) phosphite and 4-nonylphenyl ditridecyl phosphite and Bis(4-nonylphenyl) tridecyl

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1992

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1992

Report date:

1992

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Version / remarks:

February 24, 1987

Deviations:

not specified

GLP compliance:

yes (incl. QA statement)

Test type:

fixed dose procedure

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Didodecyl nonylphenyl phosphite

EC Number:

252-457-2

EC Name:

Didodecyl nonylphenyl phosphite

Cas Number:

35239-35-1

Molecular formula:

C39-H73-O3-P

IUPAC Name:

Phosphorous acid, didodecyl nonylphenyl ester

Constituent 2

Reference substance name:

Dodecyl bis(4-nonylphenyl) phosphite

EC Number:

284-117-4

EC Name:

Dodecyl bis(4-nonylphenyl) phosphite

Cas Number:

84787-76-8

Molecular formula:

C42-H71-O3-P

IUPAC Name:

Phosphorous acid, dodecyl bis(4-nonylphenyl) ester

Constituent 3

Reference substance name:

4-nonylphenyl ditridecyl phosphite

EC Number:

284-119-5

EC Name:

4-nonylphenyl ditridecyl phosphite

Cas Number:

84787-77-9

Molecular formula:

C41-H77-O3-P

IUPAC Name:

Phosphorous acid, 4-nonylphenyl ditridecyl ester

Constituent 4

Reference substance name:

Bis(4-nonylphenyl) tridecyl phosphite

EC Number:

284-120-0

EC Name:

Bis(4-nonylphenyl) tridecyl phosphite

Cas Number:

84787-78-0

Molecular formula:

C43-H73-O3-P

IUPAC Name:

Phosphorous acid, bis(4-nonylphenyl) tridecyl ester

impurity 1

Reference substance name:

Tris(nonylphenyl) phosphite

EC Number:

247-759-6

EC Name:

Tris(nonylphenyl) phosphite

Cas Number:

26523-78-4

IUPAC Name:

tris(2-nonylphenyl) phosphite

impurity 2

Reference substance name:

Didodecyl phosphonate

EC Number:

244-325-8

EC Name:

Didodecyl phosphonate

Cas Number:

21302-09-0

Molecular formula:

C24H51O3P

IUPAC Name:

Di(n-dodecyl)hydrogen phosphate

impurity 3

Reference substance name:

Phenol, 4-nonyl-, branched

EC Number:

284-325-5

EC Name:

Phenol, 4-nonyl-, branched

Cas Number:

84852-15-3

Molecular formula:

C15H24O

IUPAC Name:

4-Nonylphenol, branched

Test material form:

liquid

Specific details on test material used for the study:

TEST MATERIAL NAME (as stated in study report): TK 12437 (Trade Name: Irgastab CH 302)

SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: Sponsor; Batch No. 08520495
- Expiration date of the lot/batch: July, 1996
- Purity: within the product specifications

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: room temperature

Test animals

Species:

rat

Strain:

other: Tif: RAI f (SPF)

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: in house
- Age at study initiation: young adult
- Weight at study initiation: 209 to 247 g
- Housing: individually in Macrolon cages type 3, with standardized soft wood bedding
- Diet (e.g. ad libitum): Rat diet (NAFAG 890 Tox, NAFAG, Gossau/SG, Switzerland); ad libitum
- Water (e.g. ad libitum): ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 2 °C
- Humidity (%): 55 + 10 %
- Air changes (per hr): approximately 15
- Photoperiod (hrs dark / hrs light): 12 / 12

Administration / exposure

Type of coverage:

semiocclusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

Approximately 24 hours before treatment an area on the back of the rat of at least 10% of the body surface was shaved with an electric clipper.

The test article was evenly dispersed on the skin. It was covered with a gauze-lined semiocclusive dressing fastened around the trunk with an adhesive elastic bandage. After 24 hours the dressing was removed and the skin was cleaned with lukewarm water. Thereafter the skin reaction was appraised repeatedly,

Duration of exposure:

24 hours

Doses:

2000 mg/kg

No. of animals per sex per dose:

5 males and 5 females

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Observed for mortality daily, a.m. and p.m. on working days, a.m. on weekend days. Observed for signs and symptoms daily.
- Body weights: immediately before application and on days 7 and 14.
- Necropsy of survivors performed: yes

Statistics:

Not needed

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortalities occurred in this study.

Clinical signs:

other: Piloerection was observed in males and females on the day of application. At the application site, erythema was observed in the females followed by slight necrosis. Females recovered within 14 days.

Gross pathology:

No deviations from normal morphology were found.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Remarks:

Not classified by CLP criteria

Conclusions:

In a guideline (OECD 402) rat study, the acute dermal LD50 of Irgastab CH 302 was > 2,000 mg/kg. No mortality occurred during the study.