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:
1989-07-04 to 1989-10-23
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1989
Report Date:
1989

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Version / remarks:
adopted 12th May 1981
Deviations:
no
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder
Details on test material:
Reactive Orange 12

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: breeder Interfauna U.K. Ltd., Wyton, Huntingdon, England
- Age at study initiation: adult
- Females were nulliparous and not pregnant
- Weight at study initiation: Females: 2.3 – 3.8 kg
- Housing: standardized conventional conditions in individual stainless steel cages. Excrement trays beneath the cages contained low-dust wood shavings (type S 8/18, Ssniff Spezialdiäten GmbH, Soest, Germany)
- Identification of animals: The rabbits were identified by individual ear marks (tattoos) and cage marks.
- Diet (e.g. ad libitum): Diet “Ssniff K4” (Ssniff Spezialdiäten GmbH, Soest, Germany); approx. 100 -120 g per animal and day; feeding once per day in the morning.
- Water (e.g. ad libitum): Tap water, ad libitum
- Acclimation period: The animals were kept for at least 14 days in the quarantine station of the Department of Laboratory Animal Services before treatment and monitored for diseases (clinical). Shortly after arrival collective faeces specimens were examined for Coccidia oocysts .

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 3
- Humidity (%): 50
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12 / 12

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
water
Remarks:
test item moistened with water
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 500 mg
Duration of treatment / exposure:
4 hours
Observation period:
7 days, irritation scores were obtained 1, 24, 48, 72 hours and 7 days after treatment
Number of animals:
3
Details on study design:
TEST SITE
- Area of exposure: 6 cm²
- Type of wrap if used: Hansamed band-aid ´hypoallergene´ (Beiersdorf No. 2342), Fixomull-Strech Klebevlies (Beiersdorf No. 2039)

REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes, washed with water
- Time after start of exposure: 4 h

OBSERVATION TIME POINTS
(indicate if minutes, hours or days) : 1, 24, 48, 72 h and 7 days

SCORING SYSTEM:
- Method of calculation: Draize (see Table 1 in box "Any other information on material and methods incl. tables")

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Remarks:
of 3 animals
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
mean
Remarks:
of 3 animals
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
No signs of irritation were observed. For individual results see Table 2 in box "Any other information on results incl. tables".

Any other information on results incl. tables

Table 2: Individual Skin Irritation Scores

24 hours 48 hours 72 hours Mean 24/48/72 hours
Animal No. Erythema Edema Erythema Edema Erythema Edema Erythema Edema
1 0 0 0 0 0 0 0 0
2 0 0 0 0 0 0 0 0
3 0 0 0 0 0 0 0

0

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Based on the results from an acute dermal irritation/corrosion study, conducted according to OECD 404, the test item can be considered as non-irritating to the skin.
Executive summary:

In a primary dermal irritation study (OECD 404), three (2 males, 1 female) New Zealand White rabbits were dermally exposed to 0.5 g of the test item for 4 hours to an area of exposure of 6 cm² under semi-occlusive conditions. Animals then were observed for 7 days. Irritation was scored by the method of Draize. No signs of irritation were recorded at any of the observation points. Based on the results, the test item can be considered as not dermal irritating.