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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

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Diss Factsheets

Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
other: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Study period:
September 1985
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study
Remarks:
The test was conducted on a similar substance, the complete justification for the Read Across approach is reported at section 13. The original Reliability of the test is 2

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1985
Report date:
1985

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
no

Test material

Constituent 1
Reference substance name:
Similar substance 3
IUPAC Name:
Similar substance 3

Test animals

Species:
rabbit
Strain:
Vienna White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: GAUKLER: 0-6050 OFFENBACH/MAIN, FRG
- Weight at study initiation: 2.63 kg
- Housing: single housed in a cage made of stainless steel with wire mesh walk floors, floor area: 40 cm x 51 cm
- Diet: kliba 341, 4 mm, firma klingentalmuehle ag ch-4303 kaiseraugst. switzerland (about 130 g per animal per day)
- Water: 250 ml, tap water
- Acclimation period: 8 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 24 °C
- Humidity (%): 30 - 70 %
- Air changes (per hr): fully air-conditioned room
- Photoperiod (hrs dark / hrs light): 12 hours cycle dark/light from 6:00 AM to 6:00 PM

Test system

Type of coverage:
occlusive
Preparation of test site:
shaved
Vehicle:
water
Controls:
yes, concurrent no treatment
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit):
- Concentration (if solution): 50 % aqueous formulation w/w

VEHICLE
- Amount(s) applied (volume or weight with unit): 0.5 g of the suspension
Duration of treatment / exposure:
1 hour
Observation period:
30 — 60 minutes after removal of the test patches and 24 h. 48 h, 72 h, after the beginning of application
Number of animals:
3 male rabbits
Details on study design:
TEST SITE
- Area of exposure: 2.5 cm X 2.5 cm
- Type of wrap if used: 0.5 mm layer, test patches are secured in position with a porous dressing (four layers of absorbent gauze + porous bandage).

Results and discussion

In vivo

Results
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 1h, 24, 48, 72 h
Score:
ca. 0
Max. score:
4
Reversibility:
fully reversible

Applicant's summary and conclusion

Interpretation of results:
other: Not classified according to the CLP Regulation
Conclusions:
The test substance is not irritating for rabbit skin.
Executive summary:

The substance has been tested for skin irritation according to the OECD guideline 404. The substance was applied to the shaved skin of 3 males rabbits. The test item was removed after 1 hour and the effects were observed for subsequently 72 hours. During the observation period no effects were seen into the shaved area of the rabbits.