Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
13-17 October 1987
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1987
Report date:
1981

Materials and methods

Principles of method if other than guideline:
Not applicable
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
[2-(4-chlorobutyl)cyclopenta-2,4-dien-1-yl](cyclopenta-2,4-dien-1-yl)iron
EC Number:
604-247-0
Cas Number:
141719-29-1
Molecular formula:
C14H17ClFe
IUPAC Name:
[2-(4-chlorobutyl)cyclopenta-2,4-dien-1-yl](cyclopenta-2,4-dien-1-yl)iron
Test material form:
liquid
Details on test material:
Appearence: brown-red liquid
Specific details on test material used for the study:
SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material:
SNPE / LD 2332

- Appearence: brown-red liquid
- Name of test item: CL 1038

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material:
refrigerated under nitrogen
- Solubility and stability of the test substance in the solvent/vehicle:
soluble in common solvents (acetone, hexane, chlorinated solvents)

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Abbaye de Bellefontaine, France
- Weight at study initiation: 2.4 ± 0.2 kg
- Housing: Individually housed in polystyrene cages
- Diet (e.g. ad libitum): 112 C pelleted diet (UAR, Villemoisson-sur-Orge, France), ad libitum
- Water (e.g. ad libitum): Drinking water filtered by a FG Millipore membrane (0.22 µm), ad libitum
- Acclimation period: 7 days
- prophylactic treatment during 5 days of the acclimatation period: mucoxid at 140 mg/kg bw/day (Veda-Cogla) added to drinking water

ENVIRONMENTAL CONDITIONS
- Temperature: 20 ± 3 °C
- Humidity: 50 ± 20 %
- Photoperiod: 12 h dark / 12 h light

Test system

Type of coverage:
semiocclusive
Preparation of test site:
clipped
Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (weight with unit): 0.5 mL
Duration of treatment / exposure:
4 h
Observation period:
72 h
Number of animals:
3 males
Details on study design:
TEST SITE
- Area of exposure: right flank (6 cm²)
- Type of wrap if used: Test material was applied to the clipped skin under a gauze pad. The gauze pad was held in contact with the skin by means of an adhesive hypoallergenic aerated semi-occlusive dressing.

REMOVAL OF TEST SUBSTANCE
- After removal of the dressing, any residual test item was wiped off by means of a aguze pad with sterilised water.
- Time after start of exposure: 4 h

SCORING SYSTEM: According to OECD guideline 404

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Remarks:
mean individual score
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
animal #1
Remarks:
mean individual score
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritation parameter:
erythema score
Basis:
animal #2
Remarks:
mean individual score
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritation parameter:
edema score
Basis:
animal #2
Remarks:
mean individual score
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritation parameter:
erythema score
Basis:
animal #3
Remarks:
mean individual score
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritation parameter:
edema score
Basis:
animal #3
Remarks:
mean individual score
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritant / corrosive response data:
Slight erythema with colouration of skin by the substance was observed 1 h after exposure in all 3 animals. No reaction was recorded thereafter.
Other effects:
None

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Under the test conditions, the test item is not classified as irritating to skin according to the criteria of CLP Regulation (EC) N° (1272-2008) and GHS.
Executive summary:

In a primary dermal irritation study performed similarly to OECD Guideline 404 and in compliance with GLP, three male New Zealand White rabbits were dermally exposed to 0.5 mL of the test item under a semi-occlusive dressing. After removal of the residual test item with water, irritation was scored as outlined in the OECD guideline 404 at 1, 24, 48 and 72 h after exposure.

Slight erythema with colouration of skin by the substance was observed 1 h after exposure in all 3 animals. No reaction was recorded thereafter.

Under the test conditions, the test item is not classified as irritating to skin according to the criteria of CLP Regulation (EC) N° (1272-2008) and GHS.