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:
1982-08-30 to 1982-09-02
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study without detailed documentation
Remarks:
Limited details were provided on the test substance (e.g., purity was lacking) and environmental conditions of animals. Details on measurement of the area of test application site was missing, but it can be assumed that it was smaller than the recommended 6cm^2 based on the patch that covered it was only 1 in^2. Observations were only made at 4 and 44 hours after test substance administration.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1982
Report Date:
1982

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
yes
Remarks:
Limited details were provided on the test substance (e.g., purity was lacking) and environmental conditions of animals. Details on area of test application site was missing. Observations were only made at 4 and 44 hours.
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
liquid
Details on test material:
- Physical state: liquid
- Storage condition of test material: Room temperature
Specific details on test material used for the study:
- Name as cited in study report: poly[oxy(methyl-1,2-ethanediyl)], alpha-(2-aminomethylethyl)-omega-(2-aminomethylethoxy)
- Substance type: Active
- Color: clear
- Storage: no change in physical state of test substance during administration
-Lot: 5601-9-1, order#J-154

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Perfection Breeders, Douglassville, Pennsylvania
- Weight at study initiation: 2-3 kg
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: 1982-08-30To: 1982-09-01

Test system

Type of coverage:
occlusive
Preparation of test site:
clipped
Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 ml was applied once directly on the intact skin site (one non-abraded skin site per animal).


Duration of treatment / exposure:
4 hours
Observation period:
Animals were observed at 4 and 44 hours after treatment.
Number of animals:
3 males and 3 females
Details on study design:
TEST SITE
- Area of exposure: All application sites were clipped free of fur and non-abraded. No further information was provided on the area of exposure.
- Type of wrap if used: Following the application of the test substance, one-inch square gauze patches were applied to the test site. The trunk of the animal was then wrapped with a rubber dam and an Ace bandage to retard evaporation.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): At the end of the four hour exposure period, the wrappings were removed and the skin was wiped to remove any remaining test substance.
- Time after start of exposure: 4 hours

SCORING SYSTEM: Corrosion was considered to have resulted if the test substance in contact with the rabbit skin had caused destruction or irreversible alteration of the tissue on at least two out of each six rabbits tested. Tissue destruction was considered to have occurred if at any of the readings there was ulceration or necrosis.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 4h
Remarks on result:
other: visible
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 44h
Remarks on result:
other: visible
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 4h
Remarks on result:
other: visible
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 44h
Remarks on result:
other: visible
Irritation parameter:
other: necrosis
Basis:
mean
Time point:
other: 4h
Remarks on result:
other: visible in 2 out of 6 rabbits
Irritation parameter:
other: necrosis
Basis:
mean
Time point:
other: 44h
Remarks on result:
other: visible in 5 out of 6 rabbits
Irritant / corrosive response data:
Erythema and edema were visible at 4 and 44 hours after treatment. Signs of necrosis were visible in two of six rabbits at the 4 hour reading and in five of six rabbits at the 44 hour observation period. Based upon the results, the test substance was considered to be corrosive.

Applicant's summary and conclusion

Interpretation of results:
corrosive
Conclusions:
The test substance was evaluated for primary dermal corrosivity in rabbits. Based on the results of the study, the test substance was determined to be corrosive and considered to be classified as category 1C according to CLP Regulation.