Registration Dossier

Toxicological information

Skin irritation / corrosion

Currently viewing:

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
weight of evidence
Study period:
1979-03-21 to 1979-03-23
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Well documented and scientifically accepted study.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1979
Report Date:
1979

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: 49 CFR 172.240
Deviations:
not specified
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
liquid
Details on test material:
Details described in study specific records
Specific details on test material used for the study:
- Name of test material (as cited in study report): none used
- Sample label: 4236-21-35
- Substance type: Clear liquid
- Physical state: Liquid

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Perfection Breeders, Box 75, Douglasville, Pa.
- Weight at study initiation: 2 - 3 kg
- Housing: The animals were housed 2/cage (30" x 18" x 18") in a room reserved exclusively for rabbits on acute tests. The cages were identified by test material, starting date, animal number and sex. In addition, odd numbered animals in each cage were identified with an indelible ear mark.
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: one week

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 21°C

Test system

Type of coverage:
occlusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL/test site
Duration of treatment / exposure:
4 hours
Observation period:
Dermal reactions were scored at 4 and 48 hours. Signs of systemic effects were recorded at dermal observation time.
Number of animals:
6 (4 males and 2 females)
Details on study design:
TEST SITE
0.5 mL of the test material as received was applied once dermally to one site per animal under 2.5 cm square gauze patches. The trunk of the rabbits was wrapped with impervious material.

REMOVAL OF TEST SUBSTANCE
The test material was kept in contact with the skin for 4 hours, at which time the wrappings were removed

SCORING SYSTEM:
Corrosivity, defined as destruction or irreversible alteration of the tissue, is considered to have occurred if at any of the readings there is ulceration or necrosis. Tissue destruction does not include merely sloughing of the epidermis, or erythema, edema or fissuring.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 4h - 48h
Score:
1 - 3
Max. score:
4
Reversibility:
no data
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 4h - 48h
Score:
0 - 2
Max. score:
4
Reversibility:
no data
Irritation parameter:
erythema score
Basis:
mean
Time point:
24/48/72 h
Remarks on result:
other: other time points used (4h-48h)
Irritation parameter:
edema score
Basis:
mean
Time point:
24/48/72 h
Remarks on result:
other: other time points used (4h-48h)
Irritant / corrosive response data:
Slight to moderate erythema and no or slight edema was noted in all animals at 4 hours or 48 hours.

Applicant's summary and conclusion

Interpretation of results:
study cannot be used for classification
Conclusions:
The substance was observed to be non-corrosive.