Benzenesulfonic acid, 2-[(2Z)-2-(2,6-diamino-4-oxo-5(4H)-pyrimidinylidene)hydrazinyl]-3-methyl-

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2009-03-11, 209-03-25

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Performed according to OECD guideline and under GLP

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2009

Report date:

2009

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

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

Deviations:

no

Test guideline 3

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.1200 (Acute Dermal Toxicity)

Deviations:

no

Test guideline 4

Qualifier:

according to guideline

Guideline:

other: JMAFF Guidelines (2000), including the most recent revisions

Deviations:

no

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

2-[(1E)-2-(2,4-diamino-6-hydroxypyrimidin-5-yl)diazen-1-yl]-5-methylbenzene-1-sulfonic acid

EC Number:

700-002-8

Cas Number:

1333483-07-0

Molecular formula:

C11H12N6SO4

IUPAC Name:

2-[(1E)-2-(2,4-diamino-6-hydroxypyrimidin-5-yl)diazen-1-yl]-5-methylbenzene-1-sulfonic acid

Test material form:

solid: particulate/powder

Details on test material:

- Substance type: orange solid
- Physical state: solid powder
- Analytical purity: 95.6 % w/w
- Expiration date of the lot/batch:
- Stability under test conditions: stable
- Storage condition of test material: room temperature

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River Deutschland, Sulzfeld, Germany
- Age at study initiation: approx. 8 weeks
- Weight at study initiation: did not exceed +/- 20% of the sex mean
- Housing: Individually in labeled Macrolon cages (MIII type, height 18 cm.) containing sterilized sawdust as bedding material (Litalabo, S.P.P.S., Argenteuil, France) and paper as cage-enrichment (Enviro-dri, Wm. Lillico & Son (Wonham Mill Ltd), Surrey, United Kingdom).
- Diet: ad libitum, pelleted rodent diet (SM R/M-Z from SSNIFF® Spezialdiäten GmbH, Soest, Germany).
- Water: ad libitum, tap water
- Acclimation period: at least 5 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19.5 – 20.7
- Humidity (%): 41 - 65
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12 / 12

Administration / exposure

Type of coverage:

occlusive

Vehicle:

CMC (carboxymethyl cellulose)

Details on dermal exposure:

TEST SITE
- Area of exposure: back
- % coverage: approx. 10 %
- Type of wrap if used: the test substance formulation was held in contact with the skin with a dressing, consisting of a surgical gauze patch (Surgy 1D), successively covered with aluminum foil and Coban elastic bandage. A piece of Micropore tape was additionally used for fixation of the bandages in females only.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): with tap water
- Time after start of exposure: 24 hours

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2000 mg/kg (10 mL/kg) body weight
- Constant volume or concentration used: yes

VEHICLE
- Amount(s) applied (volume or weight with unit): 1 % aqueous carboxymethyl cellulose

Duration of exposure:

24 hours

Doses:

1

No. of animals per sex per dose:

5

Control animals:

not required

Details on study design:

- Duration of observation period following administration: 15 days
- Frequency of observations and weighing: twice daily (mortality/viability); days 1 (pre-administration), 8 and 15 (body weights)
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs

Statistics:

Observations/measurements in the study were recorded electronically using the following programme(s):
REES Centron Environmental Monitoring system version SQL 2.0 (REES scientific, Trenton, NJ, USA);
TOXDATA version 8.0 (NOTOX B.V., ‘s-Hertogenbosch, The Netherlands): Clinical signs, Body weights

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Mortality:

No mortality occurred

Clinical signs:

other: Hunched posture, piloerection, chromodacryorrhoea and/or hypothermia were noted among animals on Days 1 and/or 2. Scales were observed in the treated skin-area of one animal during the observation period. Yellow staining of the treated skin-area was noted

Gross pathology:

No abnormalities were found at macroscopic post mortem examination of the animals.

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The dermal LD50 value in Wistar rats was established to exceed 2000 mg/kg body weight.