Registration Dossier

Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
24-03-1980 to 27-03-1980
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
Remarks:
The restrictions was feeding conditions and analytical purity of the test substance was not provided in the study report.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1980
Report Date:
1980

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
yes
Remarks:
feeding condition and analytical purity was not stated in the study report.
Qualifier:
according to
Guideline:
other: Federal Hazardous Substances Act as stated in the Code of Federal Regulations, 16 CFR 1500.42.
Deviations:
yes
Remarks:
feeding condition and analytical purity was not stated in the study report.
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Dutchland Laboratory Animals, Inc., Denver, Pennsylvania.
- Age at study initiation: Not stated.
- Weight at study initiation: Not stated.
- Housing: Individually in elevated metal cages.
- Diet : Commerical rabbit ration (Purina Lab Rabbit Chow©).
- Water : Water (via automated watering system) were available ad libitum.
- Acclimation period: Approximately for one-week period.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): Not stated.
- Humidity (%): Not stated.
- Air changes (per hr):Not stated.
- Photoperiod (hrs dark / hrs light):Not stated.

Test system

Type of coverage:
semiocclusive
Preparation of test site:
other: Abraded and shaved
Vehicle:
unchanged (no vehicle)
Controls:
other: Untreated sites of the same animal served as control
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 ml
Duration of treatment / exposure:
24 h
Observation period:
Reading time points: 24 and 48 h. No further observation required.
Number of animals:
3 males and 3 females
Details on study design:
TEST SITE
- Area of exposure: Trunk. The skin at one site was abraded with minor incision and the skin of the other site remained intact.
- % coverage: Not stated
- Type of wrap if used: One-half-inch square gauze patch (two layers thick) which was secured with a non-absorbent binder composed of polyethylene tubing and Coban elastic bandage (Minnesota Minning and Manufacturing Company, St. Paul, Minnoesota).

REMOVAL OF TEST SUBSTANCE
- Washing (if done): The exposure sites were wiped with gauze.
.
- Time after start of exposure: 24 h

SCORING SYSTEM: Draize scoring system

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Remarks:
out of all 3 animals
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: reversibility: not applicable.
Irritation parameter:
edema score
Basis:
mean
Remarks:
out of all 3 animals
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: reversibility: not applicable.
Irritant / corrosive response data:
No erythema, oedema, ot other dermal effects were noted at any exposure site. The primary irritation score was zero.

Applicant's summary and conclusion

Interpretation of results:
other: CLP/EU GHS criteria are not met, no classification required according to Regulations (EC) No 1272/2008
Conclusions:
In a reliable skin irritation study conducted according to OECD TG 404 but not in compliance with GLP, showed the test material was not a skin irritant.