2,2',2''-(hexahydro-1,3,5-triazine-1,3,5-triyl)triethanol

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:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1997

Report date:

1997

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Deviations:

no

Principles of method if other than guideline:

A single dermal dose of the undiluted test substance was applied to one group of 10 Wistar rats (5 males and 5 females) at a dose level of 4000 mg/kg bw (3.43 mL/kg). The test material was applied to the clipped epidermis (dorsal and dorsolateral parts of the trunk) of each animal and was covered by a semiocclusive dressing for 24 hours. Post-observation period: 14 days.

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

2,2',2''-(hexahydro-1,3,5-triazine-1,3,5-triyl)triethanol

EC Number:

225-208-0

EC Name:

2,2',2''-(hexahydro-1,3,5-triazine-1,3,5-triyl)triethanol

Cas Number:

4719-04-4

Molecular formula:

C9H21N3O3

IUPAC Name:

2,2',2''-(1,3,5-triazinane-1,3,5-triyl)triethanol

Specific details on test material used for the study:

SOURCE OF TEST MATERIAL
- Lot/batch No.of test material: PK 95/222

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: refridgerated

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Dr. K. Thomae GmbH, Biberach
- Age at study initiation: Young adult animals
- Weight at study initiation: 200-300 g
- Fasting period before study: > 15 h
- Housing: Single housing in fully air-conditioned rooms.
- Diet (ad libitum): Kliba-Labordiaet 343 (Klingentakmuehle AG, Kaiseraugst, Switzerland)
- Water (ad libitum): tap water
- Acclimation period: for at least 1 week


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-24
- Humidity (%): 30-70
- Photoperiod (hrs dark / hrs light): 12 h/12 h

Administration / exposure

Type of coverage:

semiocclusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

TEST SITE
- Area of exposure: about 50 cm²
- Type of wrap: The bandage consisted of four layers absorbent Gauze and fixomull stretch (adhesive fleece).


REMOVAL OF TEST SUBSTANCE
- Washing: with warm water
- Time after start of exposure: 24 h


TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 3.43 mL/kg
- Concentration: undiluted

Duration of exposure:

24 h

Doses:

4000 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: Individual readings 30 - 60 min. after removal of the semiocclusive dressing (day 1), at least once each workday.
- Necropsy of survivors performed: yes.
- Other examinations performed: clinical signs, body weight, scoring of skin findings.

Statistics:

Statistical analysis: Binomial test (Snedecor and Cochran, 1989).

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 4 000 mg/kg bw

Mortality:

No mortality observed.

Clinical signs:

other: Systemic signs of toxicity were not noted.

Gross pathology:

No pathologic findings noted. No abnormalities were noted at necropsy of animals sacrified at the end of the study.

Other findings:

The following local effects were observed 1 day or 7 days after application: very slight, well-defined or moderate erythema, very slight to slight edema, scaling and superficial scabbing.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met