Amidinourea phosphate

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

20-03-2017 to 29-06-2017

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2017

Report date:

2017

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Version / remarks:

OECD Guidelines for Testing of Chemicals, Section 4, No. 402, “Acute Dermal Toxicity” adopted 24 Feb, 1987

Deviations:

yes

Remarks:

For technical reasons all raw data were recorded on paper.

GLP compliance:

yes (incl. QA statement)

Test type:

fixed dose procedure

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Amidinourea phosphate

EC Number:

241-659-6

EC Name:

Amidinourea phosphate

Cas Number:

17675-60-4

Molecular formula:

C2H6N4O.xH3O4P

IUPAC Name:

diaminomethylideneurea;phosphoric acid

Test material form:

solid: particulate/powder

Specific details on test material used for the study:

Batch No.: 16VL8189
Expiry Date: 03 August 2017
Storage Conditions: room temperature, protected from light

Test animals

Species:

rat

Strain:

Wistar

Remarks:

WISTAR Crl: WI(Han) rats

Sex:

male/female

Details on test animals or test system and environmental conditions:

Age at the beginning of the study: males: 9-10 weeks old; females: 9-10 weeks old
Body weight on the day of administration: males: 265 – 289 g females: 200 – 215 g

Housing and Feeding Conditions:

Full barrier in an air-conditioned room
Temperature: 22 3 °C
Relative humidity: 55 10%
Artificial light, sequence being 12 hours light, 12 hours dark
Air change: 10 x / hour
Free access to Altromin 1324 maintenance diet for rats and mice
Free access to tap water, sulphur acidified to a pH value of approximately 2.8 (drinking water,
municipal residue control, microbiological controls at regular intervals)
The animals were kept individually in IVC cages, type III H, polysulphone cages on Altromin saw
fibre bedding
Adequate acclimatisation period (at least five days) under laboratory conditions

Preparation of the Animals:

The animals were marked for individual identification by tail painting.
Approximately 25 (for males) and 24 (for females) hours before the test, the fur was removed from
the dorsal area of the trunk using an electric clipper. Care was taken to avoid abrading the skin, and
only animals with healthy intact skin were used.
No less than 10% of the body surface was cleared for the application.
Prior to the application a detailed clinical observation was made of all animals. Only healthy animals
were used.

Administration / exposure

Type of coverage:

occlusive

Vehicle:

water

Details on dermal exposure:

Approximately 25 (for males) and 24 (for females) hours before the test, the fur was removed from the dorsal area of the trunk using an electric clipper. Care was taken to avoid abrading the skin, and only animals with healthy intact skin were used.

No less than 10% of the body surface was cleared for the application.

Prior to the application a detailed clinical observation was made of all animals. Only healthy animals were used.

Duration of exposure:

24 hours

Doses:

Single dose of 2000 mg/kg body weight

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

OECD 402: All animals were observed for 14 days after dosing.

Statistics:

Signs of erythema and oedema were assessed using the scoring system (Table 2) laid down in OECD Guideline 404

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No test substance related deaths

Clinical signs:

other: No signs of toxicity for both sexes. No skin irritation for both sexes.

Gross pathology:

No significant findings.

Any other information on results incl. tables

Absolute Body Weights in g and Body Weight Change in %

Dose: 2000 mg/kg body weight
Animal No. / Sex	^g Day 1	g Day 8	^g Day 15	% Day 1-15
21 / male	265	281	304	15
22 / male	273	291	317	16
23 / male	273	299	326	19
24 / male	289	307	350	21
25 / male	271	289	322	19
26 / female	206	211	217	5
27 / female	201	205	210	4
28 / female	205	203	224	9
29 / female	215	219	233	8
30 / female	200	210	214	7

Applicant's summary and conclusion

Conclusions:

The dermal LD50was determined to be > 2000 mg GUANYLUREA PHOSPHATE / kg body weight.

Executive summary:

Under the conditions of the present study, single dermal application of the test item GUANYLUREA PHOSPHATE to rats at a dose of 2000 mg/kg body weight was associated with no mortality and neither signs of toxicity nor signs of irritation. The dermal LD50 was determined to be > 2000 mg GUANYLUREA PHOSPHATE / kg body weight.