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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
Study period:
1996
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: No GLP, no guideline was followed (published literature)

Data source

Reference
Reference Type:
publication
Title:
Unnamed
Year:
1996
Report Date:
1996

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
yes
Remarks:
, see below in "Principles of method"
Principles of method if other than guideline:
Male rabbits generally five per group were examined . Fur was carefully removed from the ventral skin, using an electric clipper . The rabbit was immobilized while 0.01 mL of sample was applied to the ventral skin. The dose site was not occluded during the contact period, which lasted 30 min or, if earlier, until the test material appeared to be completely absorbed or evaporated . At the end of the contact period, any remaining sample residue was removed with moist gauze and the rabbit was returned to its cage. After 18-24 h, the rabbits were again immobilized and the application site was swabbed with cottonwool moistened with lukewarm water (to enhance the visibility of any reaction), and the site was inspected for signs of local injury and inflammation . Additional sets of rabbits were tested using diluted sample, as required, to establish a dose response. The undiluted test material was also tested on occluded rabbit skin . For this procedure 0.5 mL (or 0 .5 g) of test material was applied to the shaven dorsal trunk skin and covered with a 1-in square gauze patch. Polyethylene sheeting was loosely wrapped around the animal's trunk and secured . During a 4-h contact period, the animal was restrained to avoid disturbing the dose site . Excess test material was carefully removed with cleansing tissue . Reactions were recorded at the end of the contact period and at 24 and 48 h following contact.
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rabbit
Strain:
not specified

Test system

Type of coverage:
other: In the first part of the experiment with the undiluted tets substance the dose site was not occluded. In the second part (new set of animals) using a diluted test substance the dose site was occluded.
Preparation of test site:
shaved
Vehicle:
other: In the first part of the experiment the undiluted test substance was applied. In the second part the test substance diluted in water was applied
Controls:
not required
Amount / concentration applied:
In the first part of the experiment 0.01 mL of the undiluted test substance was applied.
in the second part bof teh experiment 0.5 mL of the diluted (10 %) test substance was applied.
Duration of treatment / exposure:
In the first part (undiluted test substance) exposure duration of 30 minutes or until the test substance was absorbed,
In the second part (diluted test substance) 4 hours exposure duration.
Observation period:
In the first part (undiluted test substance) - 18 - 24 hours.
In the second part (diluted test substance) - 24 and 48 hours.
Number of animals:
5 animals
Details on study design:
TEST SITE
- Type of wrap if used: In the second part of the experiment polyethylene sheeting was loosely wrapped around the animal's trunk and secured.

REMOVAL OF TEST SUBSTANCE
- Washing: yes, at the end of the contact/ exposure period, any remaining sample residue was removed with moist gauze.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
other: necrosis
Basis:
mean
Time point:
other: 24 hours
Remarks on result:
other: Necrosis was observed in all animals applied with the undiluted tets substance
Irritation parameter:
other: irritaion, necrosis
Basis:
mean
Time point:
other: 24, 48 hours
Remarks on result:
other: No indications were observed when animals were treated with the diluted (10 %) test substance.

Applicant's summary and conclusion

Interpretation of results:
corrosive
Remarks:
Migrated information Criteria used for interpretation of results: EU