Diphosphoric acid, compound with 1,3,5-triazine-2,4,6-triamine

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

15 September to 9 November 2010

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP study conducted in accordance with an internationally recognised method

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2010

Report date:

2010

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))

Test guideline 3

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.1200 (Acute Dermal Toxicity)

Test guideline 4

Qualifier:

according to guideline

Guideline:

other: Japanese Ministry of Agriculture, Forestry and Fisheries, Test Data for Registration of Agricultural Chemicals, Acute dermal toxicity (2-1-2), 12 Nousan No. 8147, Agricultural Production Bureau, November 24, 2000.

GLP compliance:

yes (incl. QA statement)

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Diphosphoric acid, compound with 1,3,5-triazine-2,4,6-triamine

EC Number:

239-590-1

EC Name:

Diphosphoric acid, compound with 1,3,5-triazine-2,4,6-triamine

Cas Number:

15541-60-3

Molecular formula:

C3H6N6.xH4O7P2

IUPAC Name:

diphosphoric acid, compound with 1,3,5-triazine-2,4,6-triamine

Test material form:

solid: particulate/powder

Remarks:

migrated information: powder

Details on test material:

- Name of test material (as cited in study report): MPP
- Appearance: White powder
- Analytical purity: 97.04%
- Lot/batch No.: G10170
- Storage conditions: room temperature

Test animals

Species:

rat

Strain:

other: CD (Crl:CD ‘SD’)

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: reputable laboratory animal supplier
- Age at study initiation: 8-12 weeks
- Weight at study initiation: 228 to 370 g
- Fasting period before study:
- Housing: solid bottomed polycarbonate cages with stainless steel mesh lid. Housed individually for Day1-10 then returned to groups of five animals of the same sex.
- Diet: standard rodent diet, ad libitum
- Water: potable water taken from public supply, ad libitum
- Acclimation period: 6 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-23
- Humidity (%): 40-70
- Air changes (per hr): none, continuous supply
- Photoperiod (hrs dark / hrs light): 12 hours light/12 hours dark

IN-LIFE DATES: From: 16 September 2010 To: 6 October 2010

Administration / exposure

Type of coverage:

semiocclusive

Vehicle:

corn oil

Details on dermal exposure:

TEST SITE
- Area of exposure: dorso-lumbar region
- % coverage: 10
- Type of wrap if used: waterproof dressing

REMOVAL OF TEST SUBSTANCE
- Washing (if done): at end of exposure period the treated area of skin was washed with a mild detergent and water (30-40°C) then acetone (to remove residual test substance), followed by warm water. The treated area was then blotted dry with absorbent paper.
- Time after start of exposure: 24 hours

TEST MATERIAL
The test substance was formulated at a maximum practical concentration of 71.4% w/v in the vehicle and administered at a volume of 2.8 mL/kg bodyweight. The test substance formulation was prepared on the day of dosing

Duration of exposure:

24 hours

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

5

Control animals:

not required

Details on study design:

- Duration of observation period following administration: 14 days
- Necropsy of survivors performed: yes
- Other examinations performed:

Mortality: cages of rats were checked at least twice daily for any mortalities.

Clinical observations: animals were observed soon after dosing and at frequent intervals for the remainder of Day 1. On subsequent days, animals were observed once in the morning and again at the end of the experimental day (with the exception of Day 15 - morning only). The nature and severity, where appropriate, of the clinical signs and the time were recorded at each observation. All animals were observed for 14 days after dosing.

Dermal reactions: local dermal irritation at the treatment site was assessed daily

Bodyweight:
The weight of each rat was recorded on Days 1 (prior to dosing), 8 and 15. Individual weekly bodyweight changes and group mean bodyweights were calculated.

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

2 000 mg/kg bw

Based on:

test mat.

Mortality:

There were no deaths to treatment in any animal.

Clinical signs:

other: There was no systemic response to treatment in any animal.

Gross pathology:

No abnormalities were noted in any animal at the macroscopic examination at study termination on Day 15.

Other findings:

Very slight erythema was seen in one male on Day 2, resolving by Day 3 and in one female from Day 3, resolving by Day 10.

Applicant's summary and conclusion

Interpretation of results:

practically nontoxic

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The acute median lethal dermal dose (LD50) to rats of MPP was demonstrated to be greater than 2000 mg/kg bodyweight.