Tetrakis(hydroxymethyl)phosphonium chloride, oligomeric reaction products with urea

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

04 July 2006 - 18 July 2006

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Guideline study with GLP

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2006

Report date:

2006

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Version / remarks:

24 February 1987

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test type:

fixed dose procedure

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Tetrakis(hydroxymethyl)phosphonium chloride, oligomeric reaction products with urea

EC Number:

500-057-6

EC Name:

Tetrakis(hydroxymethyl)phosphonium chloride, oligomeric reaction products with urea

Cas Number:

27104-30-9

Molecular formula:

C5H16ClN2O5P

IUPAC Name:

Phosphonium, tetrakis(hydroxymethyl)-, chloride (1:1), polymer with urea

Details on test material:

technical product

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

Young healthy adult rats, age not reported, 13 days of acclimatisation; weight range: male 249-258 g, female 201-220 g; husbandry: individual caging at 12 h light and 12 h dark, 19-25°C, 30-70% relative humidity.

Administration / exposure

Type of coverage:

semiocclusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

A limit test was carried out involving a dose of 2000 mg/kg bw with five malev and female animals each.
A single dermal dermal administration followed by a 14-d observation period was performed.
One day before the start of the test the trunk of the animals was shaved. The test item was applied in pure form in a single dose on about 10% of the total body surface for 24 h. Sterile gauze pads were placed on the skin of the rats and kept in contact with the skin by hypoallergenic plaster. Then the entire trunk of the animal was wrapped with semiocclusive plastic wrap for 24 hours. At the end of the exposure period, resuidual test item was removed by using water with body temperature.

Duration of exposure:

24 hours single exposure

Doses:

On single dosis: 2000 mg/kg bw

No. of animals per sex per dose:

5 animals per sex per dose

Control animals:

no

Details on study design:

Clinical observations were done for 14 days: 1 h and 5 h after the end of exposure and once a day on the following days.
Individual observations were done on the skin, fur, eyes, mucous membranes, respiration, circulation, autonomic and central nervous system, somatomotoric activity and behaviour.
Body weight was determined at the start (day 0) and on days 7 and 14.
Gross necropsy was performed on all animals after 14 days. External appearance and abnormalities of the organs in the cranial, thoracic and abdominal cavities were recorded.

Results and discussion

Effect levels

Effect levels 1

Sex:

male

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Effect levels 2

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortality was observed in this test.

Clinical signs:

other: No dermal changes in male rats. Female rats: erythema (5/5), epithelisation (5/5), necrosis (1/5). After 9-11 days, the skin in 4 of 5 animals returned to normal.

Gross pathology:

Pinprick-sized haemorrhages in the lungs (male 3/5, female 3/5) were observed.
One female had scar on the site of administration due to test item.

Other findings:

Behaviour and general state of male and female animals were normal during the whole observation period.

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

AFLAMMIT SAP does not fulfill the criteria for classification and labelling according to the Commission Directive 2001/59/EC.
AFLAMMIT SAP was ranked into the WHO toxic class II-III (moderately/slightly hazardous).
AFLAMMIT SAP was ranked into the EPA toxci class III ("Caution").
Because of the skin effects (one animal showed necrosis and scar at the end of the recovery period) classification with "corrosive, R34" is considered to be necessary.

Executive summary:

A acute dermal toxity test was performed on the test item AFLAMMIT SAP using Wistar rats.The test item was applied in one dose (2000 mg/kg bw) for 24 hours followed by a 14 day observation period.

No mortalities occured in male and female rats (five male and five female): LD50 > 2000 mg/kg bw.

Symptoms in the skin were observed only in female rats and were reversible after 11 day with the exeption of one female rat, which showed necrosis and scar on the treated skin at necropsy.

Pinprick-size haemorrhages were observed in 3 of male and 3 of 5 female rats by necropsy after 14 days.

AFLAMMIT SAP does not fulfill the criteria for classification adn labelling according to the Commission Directive 2001/59/EC.

AFLAMMIT SAP was ranked into the classes WHO II-III (moderately/slightly hazardous) and EPA III ("Caution").