Registration Dossier

Toxicological information

Skin irritation / corrosion

Currently viewing:

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1981-02-02 to 1981-02-09
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1981
Report Date:
1981

Materials and methods

Test guidelineopen allclose all
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
yes
Remarks:
(no data on test material purity, test site was covered by an occlusive dressing, exposure duration was 24 h)
Qualifier:
according to
Guideline:
other: Proposed Guidelines of the United States Environmental Agency (EPA) § 163.81-5 Vol. 43, No. 163, Auguust 22, 1978
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Physical state: Solid

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Bred and raised on the premises
- Weight at study initiation: 2 - 3 kg
- Housing: Individually in metal cages
- Diet: Standard rabbit food - NAFAG, No. 814, Gossau SG, ad libitum
- Water: ad libitum
- Acclimation period: For a minimum of 4 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 2
- Humidity (%): 55 +/- 10
- Photoperiod (hrs dark / hrs light): 14/10

Test system

Type of coverage:
occlusive
Preparation of test site:
other: Shaved, one side intact, the other abraded
Vehicle:
other: polyethylene glycol (PAG 400) + saline (70 : 30 parts)
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount applied: 0.5 g
- Concentration: 50 % in vehicle
Duration of treatment / exposure:
24 h
Observation period:
7 days
Number of animals:
3 each sex
Details on study design:
TEST SITE
- Area of exposure: 2.5 x 2.5 cm
- Type of wrap if used: The patches were covered with an impermeable material and were fastened to the body of the rabbit with adhesive tape.

SCORING SYSTEM: According to Draize

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Remarks:
over all 3 animals
Time point:
other: mean over 24, 48, and 72 hours
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Remarks on result:
other: intact skin
Irritation parameter:
edema score
Basis:
mean
Remarks:
over all 3 animals
Time point:
other: mean over 24, 48, and 72 hours
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Remarks on result:
other: intact skin
Irritant / corrosive response data:
No signs of irritation during all time points.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The test substance revealed no skin irritating potential.
Executive summary:

The acute skin irritation / corrosion property of the test substance was determined in a study similar to OECD guideline 404 after single dermal administration to rabbits. 0.5 g of the test substance was prepared as 50 % suspension in polyethylene glycol and saline (70 : 30 parts) on a gauze patch (2.5 x 2.5 cm) and applied occlusively to the intact and abraded skin of 3 New Zeeland White rabbits of each sex for 24 hours. The skin reaction was appraised upon removal and during an observation period of 7 days on the basis of the Draize scoring system. Mean 24 - 48 - 72 hour scores were 0 for erythema and edema for the intact skin. In conclusion, the test substance revealed no skin irritating potential, even under more stringent conditions as required in the guideline.