Alkyl iodides, C8-14, γ-ω-perfluoro

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

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

Adequacy of study:

key study

Study period:

1984-07-09 to 1984-07-24

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Guideline study OECD 401, acute oral toxicity, OECD 1981

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1984

Report date:

1984

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Version / remarks:

OECD 1981

Deviations:

no

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Alkyl iodides, C8-14, γ-ω-perfluoro

EC Number:

289-100-5

EC Name:

Alkyl iodides, C8-14, γ-ω-perfluoro

Cas Number:

85995-91-1

Molecular formula:

CnF2(n-2)+1H4I

Details on test material:

- Name of test material (as cited in study report): Fluowet EI, code 06HLAB 005
- Molecular formula (if other than submission substance): n/a
- Molecular weight (if other than submission substance): about 560
- Chemical name: 2-Perfluoralkylethyljodid
- Physical state: light yellow, compact compound
- Analytical purity: 99% Rf-CH2-CH2-J, 1 % inert ingredients and catalyser surpluses
- Impurities (identity and concentrations): n/a
- Composition of test material, percentage of components: n/a
- Purity test date: n/a
- Lot/batch No.: E06 400 406
- Expiration date of the lot/batch: n/a
- Stability under test conditions: n/a
- Storage condition of test material: in the dark at 22°C

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: HOECHST AG, Kastengrund, SPF breeding
- Age at study initiation: n/a
- Weight at study initiation: males between 187 and 194g, females between 182 and 194g
- Fasting period before study: yes, 16 hours prior and 2 hours after treatment
- Housing: in groups of 5 animals
- Diet (e.g. ad libitum): yes
- Water (e.g. ad libitum): yes
- Acclimation period: at least 5 days

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

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

other: sesame oil

Doses:

5000 mg/kg bw

No. of animals per sex per dose:

5

Control animals:

no

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Mortality:

none

Clinical signs:

other: Males did not show any clinical signs during the whole 14-day study period. After treatment in females crouch, calm behaviour and contracted flancs were observed, thereafter increased startle response. During the second day after application all females

Gross pathology:

The adrenals of two males out of five were coloured dark. There were no other makroscopical findings in males.
In females no makroskopical findings were observed.

Applicant's summary and conclusion

Interpretation of results:

practically nontoxic

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The acute oral median lethal dose (LD50) of the test material, was found to be greater than than 5000 mg/kg bw.

Executive summary:

The acute oral toxicity of the test item was tested in Wistar rats (5/ sex) by a single oral gavage application of 5000 mg/kg bw in sesame oil. The acute oral median lethal dose (LD50) of the test material, was found to be greater than than 5000 mg/kg bw (males and females). No mortality occurred.