Pyrimido[5,4-g]pteridine-2,4,6,8-tetramine, 4-methylbenzenesulfonate, base-hydrolyzed

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2001

Report date:

2001

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

GLP compliance:

yes (incl. QA statement)

Test type:

fixed dose procedure

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

-

EC Number:

440-560-7

EC Name:

-

Cas Number:

346709-25-9

Molecular formula:

Unspecified

IUPAC Name:

2,6,8-triamino-4H,10H-pyrimido[5,4-g]pteridin-4-one; pyrimido[5,4-g]pteridine-2,4,6,8-tetramine

Details on test material:

- Description: Yellow solid
- Batch: MAF 382/053
- Purity: 94.8 %
- Test substance storage: At room temperature in the dark
- Stability under storage conditions: Stable
- Expiry date: 06 November 2005
- Stability in vehicle water: at least 4 h

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. 9 weeks old
- Weight at study initiation: males (mean): 312 g ; females (mean): 220 g
- Housing: Individually housed
- Diet (e.g. ad libitum): Free access to standard pelleted laboratory animal diet (from Altromin (code VRF 1), Lage, Germany)
- Water (e.g. ad libitum): Free access to tap-water
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 ± 3
- Humidity (%): 30-70
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Type of coverage:

occlusive

Vehicle:

water

Details on dermal exposure:

TEST SITE
- Area of exposure: i.e. approx. 25 cm2 for males and 18 cm2 for females.
- % coverage: approx. 10 % of the total body surface
- Type of wrap if used: surgical gauze patch (Surgy 1D), successively covered with aluminium foil and Coban flexible bandage

REMOVAL OF TEST SUBSTANCE
- Washing: with water
- Time after start of exposure: 24 hours after application

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 10 ml/kg bw

Duration of exposure:

24 hours

Doses:

2000 mg/kg bw

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: mortality = twice daily; weighing: days 1, 8 and 15
- Necropsy of survivors performed: yes, at the end of the observation period
- Other examinations performed: clinical signs = once daily

Statistics:

No statistical analysis was performed.

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Remarks on result:

other: 0/10 animals died; clinical signs were reversible within 7 to 15 days

Mortality:

No mortality occurred.

Clinical signs:

other: Two males showed ptosis, hunched posture and/or piloerection on days 1 and/or 2. Most animals also showed chromodacryorrhoea. Yellow staining of the treated skin and/or head, noted among all animals, was considered to be related to staining properties of

Gross pathology:

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

Applicant's summary and conclusion

Interpretation of results:

practically nontoxic

Remarks:

Migrated information Criteria used for interpretation of results: EU