Reaction mass of 1,1,2,2,3,3,4,4-octafluoro-1,4-diiodobutane and 1,6-diiodoperfluorohexane

Acute Toxicity: inhalation

Administrative data

Endpoint:

acute toxicity: inhalation

Type of information:

experimental study

Remarks:

read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study

Justification for type of information:

The toxicity observed in this study is most likely caused by the relatively high reactivity of the diiodofluoroalkane. The PDA-3 is smaller than the primary components of the PDA-4,6 mixture, and the dediiodination reaction most likely occurs at somewhat faster rate than the PDA-4,6, but the reaction occurs in both. Because of this, the data for PDA-3 is a conservative estimation of the toxicity resulting from PDA-4,6 and so it is reasonable to read across to it.

Cross-reference

Reason / purpose for cross-reference:

read-across source

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2015

Report date:

2015

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 403 (Acute Inhalation Toxicity)

Deviations:

yes

Remarks:

Initials were on the first page of each chromatogram but were not on every page. This deviation does not adversely impact the study as the operator(s) was clearly identified on the first page of the chromatograms generated for the day.

GLP compliance:

yes

Test type:

traditional method

Test material

Test material information

Constituent 1

Reference substance name:

Reference substance 001

Cas Number:

422-91-3

Test material form:

liquid

Details on test material:

- Purity: Not reported
- CAS: 422-91-3

Test animals

Species:

rat

Strain:

other: Crl:CD (SD)

Sex:

male/female

Administration / exposure

Route of administration:

inhalation: mixture of vapour and aerosol / mist

Type of inhalation exposure:

nose only

Vehicle:

air

Remark on MMAD/GSD:

1.22 µm for the 0.92 mg/L exposure/4.74 µm
2.45 µm for the 2.9 mg/L exposure/4.02
2.17 µm for the 4.8 mg/L exposure/3.84
2.40 µm for the 5.3 mg/L exposure/3.71
2.18 µm for the 16 mg/L exposure/3.79

Duration of exposure:

4 h

Concentrations:

0.93 mg/L (0.92 mg/L vapor and 0.0074 mg/L aerosol)
2.9 mg/L (2.9 mg/L vapor and 0.013 mg/L aerosol)
4.8 mg/L (4.8 mg/L vapor and 0.023 mg/L aerosol)
5.3 mg/L (5.3 mg/L vapor and 0.022 mg/L aerosol
16 mg/L (16 mg/L vapor and 0.057 mg/L aerosol

No. of animals per sex per dose:

5 males and 5 females

Control animals:

no

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LC50

Effect level:

4.5 mg/L air

Based on:

test mat.

95% CL:

> 3.5 - < 5.3

Exp. duration:

4 h

Applicant's summary and conclusion

Interpretation of results:

Category 3 based on GHS criteria

Conclusions:

4-hour LC50 = 4.5 mg/L

Executive summary:

An acute inhalation toxicity study was conducted in accordance with OECD Guideline 403. Under the conditions of this study, the 4-hour inhalation median lethal concentration (LC50) for the test substance in male and female rats was 4.5 mg/L total atmospheric concentration with 95% confidence limits at 3.5-5.3 mg/L.