Registration Dossier

Toxicological information

Acute Toxicity: dermal

Currently viewing:

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: The study was performed and documented in a robust manner (adopted from OECD SIDS)

Data source

Referenceopen allclose all

Reference Type:
secondary source
Title:
Unnamed
Year:
1987
Report Date:
1987
Reference Type:
publication
Title:
No information
Author:
PPG Ind. Inc.
Year:
1987
Bibliographic source:
TSCATS, OTS 0513463, Doc. I.D. 89-878000001

Materials and methods

Principles of method if other than guideline:
US EPA guidelines
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Purity of test material was not analytically confirmed. It was used as received from PPG Industries. Purity of that material is listed as > 98% on the MSDS.

Test animals

Species:
rabbit
Strain:
New Zealand White
Sex:
male/female
Details on test animals and environmental conditions:
The animals (5 per sex) were acclimated for at least one week before use. The animals weighed 2.1 to 3.6 kg when tested. Food and water were available ad libitum for the duration of the study. The animals did not have any evidence of pre-existing skin irritation or defects.

Administration / exposure

Type of coverage:
semiocclusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
The hair on the dorsal surface of the trunk of each animal was clipped on the day prior to treatment. On the day of treatment, surgical gauze (2 layers thick) was applied to the site and taped with non-irritating adhesive tape. The entire trunk of each animal was wrapped with a semi-permeable material and secured with the tape. The test material (2010 mg/kg; 2.12 ml/kg) was introduced under the gauze. The dressings were removed 24 hours after treatment, and the exposure area was not washed.
Duration of exposure:
24 h
Doses:
2010 mg/kg bw
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
Animals were observed for toxicity at 1/2, 3, and 6 hour after treatment and at least once daily thereafter for 14 days. They were observed for erythema (and eschar formation) and edema 24 hours after treatment and on Days 2, 3, 4, 7, 10 and 14. The maximum possible scores on each day were 4 for both endpoints. At each time, all erythema and edema scores were added and the sum was divided by the number of animals to determine an irritation score. Body weights were recorded just prior to treatment and on Days 7 and 14. A gross necropsy was performed on each animal upon euthanization on day 14.

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 010 mg/kg bw
Mortality:
No animals died during the study.
Clinical signs:
Toxicological effects observed in 1-4 animals during the study included activity decrease, ataxia, decreased defecation and urination, hemorrhaging (at exposure area), and small feces.
Body weight:
All males and 2 females gained weight.
Gross pathology:
Gross necropsy findings in each animal were unremarkable.
Other findings:
The maximum irritation score was 6.8 (Days 2, 3 and 14). This corresponds to a rating of "severe irritant". Erythema and edema averaged 2.8 (well-defined to moderate) and 4.0 (severe) on Day 14, respectively.

Any other information on results incl. tables

Since necrosis and ulceration occurred in all animals, the test material was given a descriptive rating of corrosive.

Applicant's summary and conclusion