Registration Dossier

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:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
Guideline study OECD 404, OECD 1981. Due to ECHA practical guide No.6 "How to report read-across and categories" section 4, paragraph 4.1 and although this study report is a Klim 1 report it has to be validated as reliability 2 because being used for read across.

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

Constituent 1
Chemical structure
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:
- 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
- Purity test date: n/a
- 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.