Alkyl iodides, C8-14, γ-ω-perfluoro

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

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

Adequacy of study:

key study

Study period:

1984-07-03 to 1984-07-06

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Guideline study OECD 404, 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 404 (Acute Dermal Irritation / Corrosion)

Deviations:

no

GLP compliance:

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 06 HLAB 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 about 22°C

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: HOECHST AG, Kastengrund, coventional breeding
- Age at study initiation: n/a
- Weight at study initiation: between 3.6 and 4.2 kg
- Fasting period before study: n/a
- Housing: single, in cages
- Diet (e.g. ad libitum): yes
- Water (e.g. ad libitum): yes
- Acclimation period: n/a

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 2°C
- Humidity (%): 55 +/-10 %
- Air changes (per hr): n/a
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

unchanged (no vehicle)

Controls:

not required

Amount / concentration applied:

500 mg

Duration of treatment / exposure:

4h

Observation period:

30 min to 60 min, 24 h, 48 h and 72h after removing of patch

Number of animals:

3

Results and discussion

In vivo

Results

Irritation parameter:

overall irritation score

Basis:

animal: #1, #2, #3

Time point:

other: 24, 48 and 72h

Score:

0.22

Max. score:

1

Reversibility:

fully reversible within: 72 h after patch removal

Remarks on result:

other: none

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Under the conditions of this test the test substance is considered to "not irritant" to rabbit skin.

Executive summary:

The acute dermal irritating potential of the test item was investigated in three New Zealand White rabbits. 500 mg of the undiluted test substance was applied to the shaved skin and covered semi occlusive for a 4 hour exposure. Observation periods were approximately 1h, 24 h, 48 h and 72h after removing of the patch. The overall irritation score was determined to be 0.22. Based on the results of the test the test substance has not to be classified.