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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
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: The study was conducted according to the O.E.C.D. test guideline 404 with GLP compliance.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2012
Report Date:
2012

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
other: Liquid at room temperature.
Details on test material:
As per IUCLID5 Sections 1.1. 1.2. 1.3. and 4.1.

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
The rabbits were acquired from Rich-Glo II, Inc. Wills Point, Texas and weighted 2.72-4.0 kg at study initiation. The study animals were housed in suspended, wire bottom, stainless steel cages, 1 per cage. The animals were keept in an animal room that maintained a temperature of 18-22°C and a relative humidity 46-98%. The animal room had a 12-hour light/dark cycle and 10-12 air changes/hour The rabbits were allowed PMI Feeds, Inc.TM Lab Rabbit Diet #532 1 ~ 8 oz. daily and Municipal water supply analyzed by TCEQ Water Utilities Division; available ad libitum from automatic water system.







Test system

Type of coverage:
semiocclusive
Preparation of test site:
clipped
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
0.5 mL undiluted.
Duration of treatment / exposure:
4 hours
Observation period:
14 days.
Number of animals:
4
Details on study design:
Each animal was prepared on the day prior to treatment by clipping the dorsal area of the trunk free of hair to expose an area at least 8 x 8 cm. On Day 0, 0.5 mL of the undiluted test substance was applied to each test site and covered with a 4 ply, 2.5 x 2.5 cm surgical gauze patch. Each patch was secured in place with a strip of non-irritating adhesive tape. The entire trunk of each animal was loosely wrapped with a semi-permeable dressing (orthopedic stockinette) which was secured on both edges with strips of tape to retard evaporation of volatile substances and to prevent possible ingestion of the test substance.

After four hours, the patches and wrappings were removed. The test sites were gently washed with room temperature tap water and a clean cloth to remove as much residual test substance as possible. The test sites were observed for erythema and edema formation, and any other dermal defects or irritation at 1, 24, 48 and 72 hours, and on Days 7, 10 and 14 after unwrap (day of treatment is Day 0).

Results and discussion

In vivo

Results
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
mean
Time point:
other: 72 hours
Score:
ca. 3.4
Reversibility:
not reversible
Remarks on result:
other: Evidence of skin corrosion was observed in 2/4 of the animals and was not reversible by day 14.
Irritant / corrosive response data:
Very slight to severe erythema and very slight to moderate edema were present for each animal at each observation through Day 14. Other signs of irritation included coriaceousness, desquamation, eschar, discoloration and necrosis.

Applicant's summary and conclusion

Interpretation of results:
corrosive
Remarks:
Migrated information Criteria used for interpretation of results: expert judgment
Conclusions:
The test substance is considered to be corrosive to rabbit skin under the conditions of the study. 2/4 animals placed on study exhibited eschar and necrosis at the site of treatment that was not reversible by 14 days.
Executive summary:

The test substance, Formaldehyde, polymer with 1,3 -benzenedimethanamine and phenol was accessed for skin irritation/corrosion potential in an O.E.C.D. test guideline 404 study. The test substance is considered to be corrosive to rabbit skin under the conditions of the study. 2/4 animals placed on study exhibited eschar and necrosis at the site of treatment that was not reversible by 14 days.