Registration Dossier

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Guideline study (GLP; QAU)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1990
Report Date:
1990

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Details on test material:
- Physical state: liquid, clear, achromatic
- Analytical purity: 99,4%
- Lot/batch No.: P. 66 A/89
- Stability under test conditions: on completion of all tests, the stability of the substance was verified by a repeated analysis
- Storage condition of test material: at room temperature
- Other: the sample appeared to be homogeneous

Test animals

Species:
rabbit
Strain:
Vienna White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: White Vienna animals from Gaukler; D-6050 Offenbach/Main, FRG
- Age at study initiation: young adult animals
- Weight at study initiation: mean bw of 2.71 kg for males (2) and 2.51 kg for female (1)
- Housing: one animal per cage in cages made of stainless steel with wire mesh walk floors (floor area : 40 cm x 51 cm)
- Diet (e.g. ad libitum): Kliba 341, 4 MM; from Klingentalmuehle AG, CH-4303 Kaiseraugst, Switzerland (about 130 g per animal per day)
- Water (e.g. ad libitum): about 250 ml tap water per animal per day
- Acclimation period: at least 8 days before the beginning of the study

ENVIRONMENTAL CONDITIONS
The animals were housed in fully air-conditioned rooms. Central air-conditioning guaranteed a temperature range and a relative humidity. There were no deviations from these ranges which influenced the results of the study.
- Temperature (°C): 20 - 24
- Humidity (%): 30 - 70
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
other: untreated skin site of the same animals
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 ml
Duration of treatment / exposure:
4 hour(s)
Observation period:
72 hours (all irritation effects were reversible within 48 hours)
Number of animals:
3
Details on study design:
TEST SITE
- Area of exposure: upper third of the back or flanks; the fur was clipped at least 15 hours before the beginning of the study
- % coverage: . application site of 2.5 x 2.5 cm was covered with the 0.5 ml (526 mg) test substance
- Type of wrap if used: semiocclusive patch

REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes, with lutrol and lutrol/water 1:1
- Time after start of exposure: at the end of exposure period (4 hours)

SCORING SYSTEM: OECD scoring system
Readings: 30 - 60 min, and 24, 48, or 72 hours after removal of test patches

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Remarks:
of all tested animals (3)
Time point:
other: 24-48-72-hour
Score:
0.3
Max. score:
4
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
edema score
Basis:
mean
Remarks:
of all tested animals (3)
Time point:
other: 24-48-72-hour
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Remarks on result:
other: no edema observed at any time point
Irritant / corrosive response data:
After 4 and 24 hours very slight (grade 1) erythema were obeserved for 2/3 animals. They were completely reversible within after 48 hours (see Table 1).
Other effects:
None observed

Any other information on results incl. tables

Table 1: Results acute skin irritation/corrosivity (OECD scores)

Test animal

After 30-60 min

After 24 hours

Âfter 48 hours

After 72 hours

Mean 24-48-72-hour

Erythema

Edema

Erythema

Edema

Erythema

Edema

Erythema

Edema

Erythema

Edema

1

1

0

1

0

0

0

0

0

0.3

0.0

2

1

0

1

0

0

0

0

0

0.3

0.0

3

0

0

0

0

0

0

0

0

0

0.0

Mean

0.67

0

0.67

0

0

0

0

0

0.2

0.0

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: other: EU GHS