Registration Dossier

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
December 4, 1984 - December 7, 1984
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Study performed according to OECD guideline 404 (1981) and under Good Laboratory Practice.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1984
Report Date:
1984

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes
Remarks:
(Ciba-Geigy Limited, Experimental Toxicology GU 2.1, 4332 Stein/Switzerland)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Physical state: solid
- purity: commercial grade

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Kleintierfarm Haedorin AG, CH-4414 Fuellinsdorf
- Age at study initiation: 12-14 weeks
- Weight at study initiation: 2-3 kg
- Housing: individually in metal cages
- Diet: ad libitum standard rabbit pellet - Nafag No. 814, Gossau, Switzerland
- Water: ad libitum
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 3
- Humidity (%): 30-70
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: December 4, 1984 - December 7, 1984

Test system

Type of coverage:
occlusive
Preparation of test site:
shaved
Vehicle:
other: the patches were moistened with water
Controls:
other: The contralateral flank treated with a control gauze patch served as control.
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g
Duration of treatment / exposure:
4 hours
Observation period:
3 days
Number of animals:
3 males
Details on study design:
TEST SITE
- Area of exposure: flank
- Type of wrap if used: gauze patch covered with an occlusive membrane and held in place by an adhesive tape.

SCORING SYSTEM: according to the grading scheme given in OECD guideline 404

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24, 48, 72 h
Score:
0.1
Reversibility:
fully reversible within: 24 hours (2/3 animals), 48 hours (1/3 animals)
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24, 48, 72 h
Score:
0
Irritant / corrosive response data:
Minimal formation of erythema was observed in all three animals (score = 1), reversible within 48 hours the latest. All scores for edema were zero at all time points.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Under the experimental conditions employed the test substance induced erythema reactions below the regulatory threshold of significance, therefore, the test article is considered to be not irritating.