TETRASODIUM ETHYLENE 1,1-DIPHOSPHONATE

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2002-07-09 - 2002-07-23

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2002

Report date:

2002

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Test guideline 2

Qualifier:

according to guideline

Guideline:

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

GLP compliance:

yes (incl. QA statement)

Remarks:

2000-04-26

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

-

EC Number:

443-520-7

EC Name:

-

Cas Number:

33016-77-2

Molecular formula:

C2H4Na4O6P2

IUPAC Name:

tetrasodium (1-phosphonatoethenyl)phosphonate

Test material form:

solid

Specific details on test material used for the study:

- Synonyms: ITC 908, vinylidenephosphonic acid tetrasodium salt (VDPA tetrasodium salt)
- Lot/batch No.of test material: 562CH/646
- Purity: 87.33%
- Storage condition of test material: Room temperature, in the dark

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 (UK) Ltd, Margate, Kent, UK
- Females nulliparous and non-pregnant: yes
- Age at study initiation: 8-12 weeks
- Weight at study initiation: at least 220g
- Fasting period before study: No
- Housing: Suspended solid-floor polypropylene cages furnished with woodflakes. Housed individually during the 24-hour exposure period and in groups of five, by sex, for the remainder of the study
- Diet: Certified Rat and Mouse Diet supplied by IPS Product Suppliers Limited, Wellingborough, Northants, UK, ad libitum
- Water: ad libitum
- Acclimation period: At least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-25
- Humidity (%): 30-70
- Air changes (per hr): at least 15
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Type of coverage:

semiocclusive

Vehicle:

water

Remarks:

The test material was weighed out according to each animal's indvidual bodyweight and moistened with distilled water prior to application.

Details on dermal exposure:

TEST SITE
- Area of exposure: back and flanks
- % coverage: 10
- Type of wrap if used: self-adhesive bandage

REMOVAL OF TEST SUBSTANCE
- Washing: Wiped with cotton wool moistened with distilled water
- Time after start of exposure: 24h

TEST MATERIAL
- For solids, paste formed: yes

Duration of exposure:

24h

Doses:

2000 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
- Frequency of observations and weighing:
* The animals were observed for deaths or overt signs of toxicity 30min, 1, 2 and 4 hours after dosing and subsequently once daily for fourteen days.
*After removal of the dressings and subsewuently once daily for fourteen days, the test sites were examined for evidence of primary irritation and scored according to Draize
*Individual bodyweights were recorded prior to application of test material on Day 0 ad on Days 7 and 14.
- Necropsy of survivors performed: yes

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortality was observed.

Clinical signs:

other: There were no signs of systemic toxicity. There were no signs of dermal irritation (all scores for females and males for Edema and Erythema were all 0).

Gross pathology:

No abnormalities were noted.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The acute dermal median lethal dose (LD50) of the test material was found to be greater than 2000 mg/kg bw.

Executive summary:

The acute dermal median lethal dose (LD50) of the test material was found to be greater than 2000 mg/kg bw. The test material does not meet the criteria for classification and will not require labelling for dermal toxicity.