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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
1998-11-25 to 1998-12-3
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: OECD guideline study, GLP.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1998
Report date:
1998

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
Version / remarks:
(1992)
Deviations:
no
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Version / remarks:
(1992)
Deviations:
no
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
-
EC Number:
429-290-0
EC Name:
-
Cas Number:
3380-30-1
Molecular formula:
C12 H8 Cl2 O2
IUPAC Name:
5-chloro-2-(4-chlorophenoxy)phenol
Details on test material:
- Name of test material (as cited in study report): FAT 80'220/A
- Physical state: solid, powder
- Analytical purity: >99 %
- Lot/batch No.: GRU 98
- Expiration date of the lot/batch: 2008-10-31
- Stability under test conditions: stability of test item in bidistilled water not specified.
- Storage condition of test material: in the original container at room temperature (approx. 20°C) away from direct sunlight; the test item was stable under storage conditions.

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Elevage Scientifique des Dombes, Chatillon sur Chalaronne, France
- Age at study initiation: 15 weeks
- Weight at study initiation: 2806 g (female), 2832 g (female), 2987 g (male)
- Housing: Individually in stainless steel cages
- Diet: Pelleted standard Provimi Kliba 3410 rabbit maintenance diet ad libitum
- Water: Community tap water from Itingen, ad libitum, in water bowls
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 3°c
- Humidity (%): 40 - 70 %
- Air changes (per hr): 10 - 15 air changes/ hour
- Photoperiod (hrs dark / hrs light): 12 hours dark/ 12 hours light

Test system

Type of coverage:
semiocclusive
Preparation of test site:
other: the dorsal fur (10 × 10 cm²) was clipped with an electric clipper 3 days before treatment.
Vehicle:
water
Controls:
other: the untreated skin of each animal served for control.
Amount / concentration applied:
An amount of 0.5 g of the test item was moistened with bidistilled water and applied onto the skin.
Duration of treatment / exposure:
4 hours
Observation period:
72 hours
Number of animals:
3 animals
Details on study design:
TEST SITE
The area of exposure was about 6 cm². The wrap used consisted of a semi-occlusive dressing anchored with tape.

REMOVAL OF TEST SUBSTANCE
After 4 hours of exposure, the test patch was removed and the skin was flushed with lukewarm tap water

READING
Reading ot the skin for reaction was done at 1, 24, 48, 72 h after removal of the test patch.

SCORING SYSTEM:According to Draize scoring system.
Erythema 0-4:
0: No erythema,
1: very slight erythema (barely perceptible),
2: well-defined erythema,
3 moderate to severe erythema,
4: severe erythema (beet redness) to slight eschar formation (injuries in depth).
Edema 0-4:
0: No edema,
1: very slight edema (barely perceptible),
2: well-defined edema (edges of area well-defined by definite raising),
3: moderate to severe edema (raised approximately 1 mm),
4: severe edema (raised more than 1 mm extending beyond the area of exposure).

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Remarks:
animal 1
Time point:
other: 24, 48, 72 hours
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Remarks on result:
other: At none of the reading time points erythema was seen.
Irritation parameter:
erythema score
Basis:
mean
Remarks:
animal 2
Time point:
other: 24, 48, 72 hours
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Remarks on result:
other: At none of the reading time points erythema was seen.
Irritation parameter:
erythema score
Basis:
mean
Remarks:
animal 3
Time point:
other: 24, 48, 72 hours
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Remarks on result:
other: At none of the reading time points erythema was seen.
Irritation parameter:
edema score
Basis:
mean
Remarks:
animal 1
Time point:
other: 24, 48, 72 hours
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Remarks on result:
other: At none of the reading time points edema was seen.
Irritation parameter:
edema score
Basis:
mean
Remarks:
animal 2
Time point:
other: 24, 48, 72 hours
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Remarks on result:
other: At none of the reading time points edema was seen.
Irritation parameter:
edema score
Basis:
mean
Remarks:
animal 3
Time point:
other: 24, 48, 72 hours
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Remarks on result:
other: At none of the reading time points edema was seen.
Irritant / corrosive response data:
There were no signs of irritation on any rabbit at any of the examination time points.
Other effects:
Neither mortality nor clinical signs of toxicity were evident.
The test item did not cause staining of the treated skin.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information According to current evaluation criteria, the test item is not an irritant, and does not need to be classified, either according to the EU Directive 67/548/EC or to the CLP Regulation 1272/2008.