Tin, dioctylbis(2,4-pentanedionato-.kappa.O2,.kappa.O4)-

Acute Toxicity: inhalation

Administrative data

Endpoint:

acute toxicity: inhalation

Type of information:

experimental study

Adequacy of study:

supporting study

Study period:

1984

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: level of 2,4-Pentadione unknown from hydrolysis, waiving to the pure substance (2,4-Pentadione)

Justification for type of information:

Tin, dioctylbis(2,4-pentanedionato-κO2,κO4)- hydrolyses with humidity into Dioctyltinoxide and 2,4-Pentadione. There is an evidence that the hydrolysis product 2,4-Pentadion cause an adverse effect in worker (US EPA)

Data source

Reference

Reference Type:

publication

Title:

The acute toxicity and pimary irrintancy of 2,4-Pentadione

Author:

Ballantyne et al.

Year:

1986

Bibliographic source:

drug and chemical toxicology, 9(2), 133-146 (1986)

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 403 (Acute Inhalation Toxicity)

Deviations:

not specified

GLP compliance:

yes

Test type:

fixed concentration procedure

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

2,4-pentadione

IUPAC Name:

2,4-pentadione

Test material form:

other: vapour

Details on test material:

99 perccent ourity

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Administration / exposure

Route of administration:

inhalation: vapour

Type of inhalation exposure:

whole body

Vehicle:

other: unchanged (no vehicle)

Analytical verification of test atmosphere concentrations:

yes

Remarks:

gas chromatography

Duration of exposure:

ca. 4 h

Concentrations:

Concentrations tested were 628, 919, 1231 and 1508 ppm (corres ponding to 2619; 3823; 5133 and 6288 mg/m³, respectively)

No. of animals per sex per dose:

5 male and female per concentration

Control animals:

not specified

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LC50

Effect level:

1 224 ppm

Based on:

test mat.

95% CL:

> 1 063 - < 1 409

Exp. duration:

4 h

Remarks on result:

other: mortality in exposure gruops of 1231 ppm upwards

Applicant's summary and conclusion

Interpretation of results:

other:

Remarks:

Criteria used for interpretation of results: expert judgment

Conclusions:

The pure 2,4-Pentadione with an LC50 of 5.1 mg/l/4h is harmful by inhalation under the conditions us

Under consideration of the vapour pressure of 6.92 Pa of Tin, dioctylbis(2,4-pentanedionato-κO2,κO4)- , 790 Pa for 2,4-Pentadione, and the hydrolysis it is to conclude, that 2,4 Pentadionwe is responsible for the vapour pressure of TIB KAT 223. The concentration of the 2,4-Pentadione as hydrolysis product is not hight enough to cause acute adverse effects. So no classification and labeling for this endpoint is requiered.

Executive summary:

Groups of 5 male and 5 female Hilltop-Wistar albino rats [HLA(WI)BR] were exposed for four hours to dynamically generated vapour of 2,4- pentanedione. Concentrations tested were 628, 919, 1231 and 1508 ppm (corres ponding to 2619; 3823; 5133 and 6288 mg/m³, respectively). Chamber concentrations concurrently analysed throughout each 4-hour exposure by GC. Postexposure period 14 d; body weight determined at 0, 7 an d 14 d postexposure. A static exposure was also performed for determination of LT50. Groups of 5 male and 5 female rats were exposed to 7732 and 6388 ppm (corresponding to 32242 and 26638 mg/m³) for 74 and 37 minutes (males) and 8374 and 7449 ppm (corresponding to 34920 and 31062 mg/m³ for 78 and 39 minutes (females).

Dynamic exposure: The results of these tests indicate that the 4 hour dynamic LC50 (95 % confidence limits) for 2,4-pentanedione (combined male and female) is 1224 (1063 to 1409) ppm (corresponding to 5.104 (4.432 - 5.876) mg/m³). LC50 determined for combined male and female rat. Deaths were observed with both male and female rats exposed to concentrations of 1508 and 1231 ppm (mortality 8/10 and 6/10, respectively). Deaths occurred mostly during exposure or within 24 hours respectively). Deaths occurred mostly during exposure or within 24 hours post-exposure (1 exception on day 3 in male rats in the 1508 ppm group). No mortalities were observed with rats exposed to dynamic concentrations of 919 or 628 ppm. Clinical signs observed in rats of the 1508 and 1231 ppm exposure groups included periocular, perinasal and perioral wetness and encrustation, forced respiration, distended abdomen, tremors, ataxia, decreased motor activity, a negative tail and toe pinch reflex and a slow righting reflex. The respiratory difficulties decreased motor activity and ataxia persisted in survivors through post-exposure day 2. No clinical signs were observed in survivors of the 1508 and 1231 ppm exposure groups on day 6 and 5, respectively. The only clinical signs in the 919 ppm group were periocular wetness and decreased motor activity in both sexes of rats during exposure. These rats appeared normal again on post-exposure day one. In the 628 ppm exposure group, no signs of toxicity were observable during or post-exposure. Body weights were observed for all exposure groups at 14 days post-exposure; necropsy of rats that died: red lungs, dark livers, gas-filled stomachs (no effects on sacrificed survivors). Static exposure: LT50 for male rats 52 min (average concentration 7060 ppm) and 55 min for female rats (average concentration 7912 ppm). All rats exposed to static saturated vapour died during exposure in approximately 76 minutes. No mortalities occurred for either sex at the exposure time of approximately 38 minutes. Clinical signs observed for all static exposure groups included periocular and perinasal wetness, forced respiration and hypoactivity during exposure. A negative toe and tail pinch reflex, and negative surface righting were observed in rats following the 38 minutes exposure. These animals appeared normal by post-exposure day one. No effects on body weight gains were observed by 14 days postexposure. No gross lesions were found in survivors at necropsy. Discoloured lungs andlivers were observed in rats dying during static exposure. The test substance with an LC50 of 5.1 mg/l/4h is harmful by inhalation under the conditions used