Tris(2-hydroxyethyl)-1,3,5-triazinetrione

Acute Toxicity: inhalation

Administrative data

Endpoint:

acute toxicity: inhalation

Type of information:

experimental study

Adequacy of study:

disregarded due to major methodological deficiencies

Reliability:

3 (not reliable)

Rationale for reliability incl. deficiencies:

other: see 'Remark'

Remarks:

The present study is similar to the inhalation hazard test described in the Annex of OECD Guideline 403 of 1981. However, the test substance used is a non-sublimating powder, whereas the Annex of OECD 403 is foreseen for volatile liquids or sublimable solids. In the present study, documentation is restricted mainly in that the particle size of the generated test atmosphere (a dust aerosol) was not measured. In addition, the test atmosphere concentration is only presented as a nominal concentration usually being a considerable overestimate of the concentration to which the animals were exposed. The study was not conducted according to GLP.

Data source

Reference

Reference 1

Reference Type:

study report

Title:

Unnamed

Year:

1976

Report date:

1976

Reference 2

Reference Type:

publication

Title:

Unnamed

Year:

2002

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

other: Annex of OECD 403 (of 1981): Inhalation hazard test

Deviations:

yes

Remarks:

1) The test substance used is a non-sublimating powder, whereas the Annex of OECD 403 is foreseen for volatile test material. 2) Determination of the test concentration is restricted to nominal concentration. 3) The chamber volume is not clearly defined.

GLP compliance:

no

Test type:

other: Inhalation hazard test similar to the annex of OECD 403 of 1981, but using a non-volatile powder for test atmosphere generation.

Test material

Test material information

Constituent 1

Reference substance name:

Tris(2-hydroxyethyl)-1,3,5-triazinetrione

EC Number:

212-660-9

EC Name:

Tris(2-hydroxyethyl)-1,3,5-triazinetrione

Cas Number:

839-90-7

Molecular formula:

C9H15N3O6

IUPAC Name:

tris(2-hydroxyethyl)-1,3,5-triazinane-2,4,6-trione

Details on test material:

- Name of test material (as cited in study report): THEIC
- Physical state: solid
- Analytical purity: ca. 99%

Test animals

Species:

rat

Strain:

not specified

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: breeder (not specified)
- Mean weight at study initiation (treatment day): males 212 g, females 187 g, mean males and females at study initiation: 199 g

ENVIRONMENTAL CONDITIONS
not reported

Administration / exposure

Route of administration:

inhalation: dust

Type of inhalation exposure:

whole body

Vehicle:

other: unchanged (no vehicle)

Details on inhalation exposure:

Rats were exposed for 8 h, to a dust enriched atmosphere.

Dust was generated by bubbling dry air at a rate of 200 L/h through a fritted glass followed by a layer of test substance of 5 cm height inside a glass cylinder of approximately 50 mL volume. The study was conducted at room temperature. Dust formation, very marked in degree, was observed.

Analytical verification of test atmosphere concentrations:

no

Duration of exposure:

8 h

Concentrations:

9.33 mg/L air (mean of two trials). Each trial comprised 3 male and 3 female rats

No. of animals per sex per dose:

Treated animals: 6.
Air control animals: 3.

Control animals:

yes

Details on study design:

- Duration of observation period following administration: 7 days
- Frequency of observations and weighing: Weighing was done on the day of treatment (Day 1) and 7 days afterwards (Day 8).
Observation was presumably several times on the day of exposure and daily therafter with the exception of weekends and holidays.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs

Statistics:

Not applicable, because no mortality and only one dose group.

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

other: IHT (inhalation hazard test)

Effect level:

9.33 mg/L air (nominal)

Based on:

test mat.

Exp. duration:

8 h

Remarks on result:

other: No mortality. Contrary to the claims of the cited OECD SIDS the nominal test atmosphere concentration documented in the raw data is only 9.33 mg/L air (mean of two replicate trials).

Mortality:

0/12 animals died

Clinical signs:

other: Nothing abnormal found.

Body weight:

Body weight gain was normal during the observation period:
- mean weight on the exposure day (Day 1): 212 g for males; 187 g for females; 199 g overall mean weight for both sexes on this day.
- mean weight at study termination (Day 8): 249 g for males; 198 g for females; 223 g overall mean weight for both sexes on this day.

Gross pathology:

Nothing abnormal found.

Other findings:

Strong dust formation in the inhalation chamber is circumstantial evidence for some exposure of the animals to the test substance. However, the degree of inhalability of the generated aerosol cannot be assessed, because the particle size distribution of the generated aerosol was not determined.

Applicant's summary and conclusion

Conclusions:

There were no deaths and no indication of any adverse effects induced by 8 hours of whole body exposure to a nominal mean aerosol concentration of 9.33 mg/L air in rats. Strong dust formation in the inhalation chamber is circumstantial evidence for some exposure of the animals to the test substance. However, the degree of inhalability of the generated aerosol cannot be assessed, because the particle size distribution of the generated aerosol was not determined. In addition, the test atmosphere concentration was only determined as a nominal concentration usually being a considerable overestimate of the concentration to which the animals were exposed.