6,6',6''-(1,3,5-triazine-2,4,6-triyltriimino)trihexanoic acid

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

March 2, 1995 - April 4, 1995

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: GLP guideline study. No data on purity.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1995

Report date:

1995

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Version / remarks:

(adopted 1987)

Deviations:

no

GLP compliance:

yes

Remarks:

Short-term Toxicology, CIBA-GEIGY Limited, 4332 Stein / Switzerland

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

6,6',6''-(1,3,5-triazine-2,4,6-triyltriimino)trihexanoic acid

EC Number:

279-505-5

EC Name:

6,6',6''-(1,3,5-triazine-2,4,6-triyltriimino)trihexanoic acid

Cas Number:

80584-91-4

Molecular formula:

C21H36N6O6

IUPAC Name:

6,6',6''-(1,3,5-triazine-2,4,6-triyltriimino)trihexanoic acid

Details on test material:

- Physical state: solid
- Storage condition of test material: room temperature

Test animals

Species:

rat

Strain:

other: Tif: RAI f (SPF)

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Ciba-Geigy Limited, Animal Production, 4332 Stein / Switzerland
- Age at study initiation: young adult
- Weight at study initiation: 218-228 g
- Housing: individual housing in Macrolon cages, type 3
- Diet: NAFAG 890 Tox, NAFAG, Gossau/SG, Switzerland, ad libitum
- Water: ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 2
- Humidity (%): 55 ± 10
- Air changes (per hr): 15
- Photoperiod: 12 hrs dark / 12 hrs light

Administration / exposure

Type of coverage:

semiocclusive

Vehicle:

other: 0.5% (w/v) carboxymethylcellulose in 0.1% (w/v) aqueous polysorbate 80

Details on dermal exposure:

TEST SITE
- Area of exposure: an area on the back of the rat of at least 10% of the body surface was shaved with an electric clipper.
- Type of wrap if used: gauze patch

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

TEST MATERIAL
- Amount applied: 2000 mg/kg bw; 4 mL/kg bw
- Concentration: 500 mg/mL
- Constant volume or concentration used: yes

VEHICLE
- Amount(s) applied (volume or weight with unit): 4 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
- Mortality: daily; a.m. and p.m. on working days, a.m. on weekend days
- Clinical signs and symptoms: daily
- Frequency of weighing: immediately before application and on days 7 and 14
- Necropsy of survivors performed: yes

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: No mortality occurred and no clinical signs were observed.

Mortality:

No mortality occurred.

Clinical signs:

other: No signs of acute dermal toxicity were observed in this study.

Gross pathology:

At necropsy, no deviations from normal morphology were found.

Any other information on results incl. tables

Table 1: Mean body weight of male and female rats at day 0, 7, and 14.

	Mean body weight (g) ± sd
Day 0 male	222 ± 3.9
Day 0 female	225 ± 2.3
Day 7 male	265 ± 3.5
Day 7 female	234 ± 7.3
Day 14 male	309 ± 10.6
Day 14 female	243 ± 9.3

Applicant's summary and conclusion

Interpretation of results:

practically nontoxic

Remarks:

Migrated information

Conclusions:

The dermal LD50 value of the test article in rats was to determined to be greater than 2000 mg/kg body weight.

Executive summary:

The acute dermal toxicity of the test substance was assessed in a GLP-compliant study following OECD guideline 402. The test article was administered to five rats of each sex by dermal application at 2000 mg/kg body weight for 24 hours. Animals were subjected to daily observations and weekly determination of body weight. Macroscopic examination was performed after terminal sacrifice. No mortality occurred. No signs of acute dermal toxicity were observed in this study. The mean body weight gain during the observation period was within the range expected for rats used in this type of study. No abnormalities were found at macroscopic post mortem examination of the animals. The dermal LD50 value of the test substance in rats was established to exceed 2000 mg/kg body weight.