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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 guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.3 (Acute Toxicity (Dermal))
Deviations:
no
Qualifier:
according to guideline
Guideline:
EPA OPPTS 870.1200 (Acute Dermal Toxicity)
Deviations:
no
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

Constituent 1
Chemical structure
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.