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Acute Toxicity: dermal

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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

Constituent 1
Chemical structure
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:
No signs of acute dermal toxicity were observed in this study.
Body weight:
Body weight was not affected by treatment (see details in table 1 "Any other information on results").
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.

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