Registration Dossier

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1987-04-27 to 1987-06-30
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Guideline study (OECD), non-GLP but internally audited.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1987
Report Date:
1987

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
yes
Principles of method if other than guideline:
Test item application: soaked test patch instead of exactly 0.5 mL
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, Offenbach/Main, Germany
- Age at study initiation: not specified
- Weight at study initiation: 221 and 2.53 (two males); 2.21 (one female)
- Housing: Stainless steel cage with wire mesh walk floor (floor area: 40 x 51 cm)
- Diet: about 130 g /animal / day
- Water: about 250 mL tap water / animal / day
- Acclimation period: at least 8 days

ENVIRONMENTAL CONDITIONS
- Temperature: 20 - 24°C
- Humidity: 30 - 70 %
- Air changes: not specified ("fully air conditioned")
- Photoperiod: 12 hrs dark / 12 hrs light

IN-LIFE DATES: From 1987-04-27 up to 1987-06-07

Test system

Type of coverage:
semiocclusive
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount applied: wetted test patch (estimation in report: "0.5 mL of liquid was absorbed")
- Concentration: 30% ("ber. 100%")
Duration of treatment / exposure:
4h
Observation period:
72h (and subsequently from 17 to 40 days, depending on animal)
Animal #1 (female, 0769): 25 days
Animal #2 (male, 0762): approximately 40 days. Found dead, cause of death: accidental ( 360° torsion of hepatic lobe)
Animal #3 (male, 0745): 17 days
Number of animals:
2 males, 1 female
Details on study design:
TEST SITE
- Area of exposure: one site per rabbit on the upper third of the back or flanks
- % coverage: approximately 2.5 x 2.5 each


REMOVAL OF TEST SUBSTANCE
- Washing: yes, at the end of exposure with Lutrol and Lutrol / water (1:1)


SCORING SYSTEM: Draize score

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
other: 24, 48 and 72h (mean)
Score:
0
Max. score:
4
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
other: 24, 48 and 72h (mean)
Score:
0
Max. score:
4
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
other: 24, 48 and 72h (mean)
Score:
0.66
Max. score:
4
Reversibility:
fully reversible within: 72h
Irritation parameter:
edema score
Basis:
animal #1
Time point:
other: 24, 48 and 72h (mean)
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
animal #2
Time point:
other: 24, 48 and 72h (mean)
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
animal #3
Time point:
other: 24, 48 and 72h (mean)
Score:
0
Max. score:
4

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information
Conclusions:
Classification: not irritating