Registration Dossier

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1986
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Guideline study without no GLP - test substance was diluted before application (50 % end concentration).

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1986
Report Date:
1986

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Version / remarks:
(adopted may 1981).
Deviations:
yes
Remarks:
(test substance tested as 50% aqueous solution).
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rabbit
Strain:
Vienna White
Details on test animals and environmental conditions:
TEST ANIMALS- Source: Gaukler; D-6050 Offenbach/ Main, Frg.- Age at study initiation: no data.- Average weight at study initiation: 2.93 kg (male), 2.53 (female).- Housing: Individual caging in stainless steel cages with wire mesh walk floors; floor area = 40 cm x 51 cm.- Diet: Kliba 341, 4 mm; Klingenthalmuehle AG, CH-4303 Kaiseraugst, Switzerland; ad libitum (ca. 130 g/animal/day).- Water: ad libitum (ca. 250 mL tap water/animal/day).- Acclimation period: at least 8 days.ENVIRONMENTAL CONDITIONS- Temperature (°C): 20-24.- Humidity (%): 30-70.- Air changes (per hr): no data- Photoperiod (hrs dark / hrs light): 12/12.

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
water
Controls:
other: untreated skin of the same animal.
Amount / concentration applied:
TEST MATERIAL- Amount(s) applied: ca. 0.5 g- Concentration (if solution): 50%
Duration of treatment / exposure:
4 hours
Observation period:
72 hours- readings were performed 30-60 min after removal of the test patches, as well as 24, 48 and 72 hours after the start of exposure.
Number of animals:
3 (2 males and 1 female)
Details on study design:
TEST SITE- Shaving of fur: at least 15 hours before treatment.- Area of exposure: 2.5 cm x 2.5 cm.- % coverage: at least 10% of entire body surface.- Type of wrap if used: four layers of absorbent gauze and pourous bandage.REMOVAL OF TEST SUBSTANCE- Washing (if done): yes (with lutrol and lutrol:water (1:1)).- Time after start of exposure: 4 hours.SCORING SYSTEM: OECD scoring system.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Remarks:
(3 animals)
Time point:
other: 1, 24, 48 and 72 hours)
Score:
0
Max. score:
4
Reversibility:
other: not applicable.
Irritation parameter:
edema score
Basis:
mean
Remarks:
(3 animals)
Time point:
other: 1, 24, 48 and 72 hours).
Score:
0
Max. score:
4
Reversibility:
other: not applicable.

Applicant's summary and conclusion

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