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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:
2001
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2001
Report Date:
2001

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Test material form:
liquid

Test animals

Species:
rabbit
Strain:
New Zealand White

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
A dose of 0.5 ml liquid test substance was applied to small area (approximately 6 cm2) of non abraded skin of 3 rabbits. Each application area was covered with a gauze patch, held in place by a non irritating tape, for an exposure period of 4 hours.
Duration of treatment / exposure:
4 hour(s)
Number of animals:
3 (1 male and 2 female)
Details on study design:
Erythema and edema scores were determined for each of three rabbits at 60 min, 24, 48 and 72 hours after patch removal (at minimum).

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 24, 48, 72 hrs
Score:
0
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 60 minutes
Score:
1
Max. score:
1
Reversibility:
fully reversible within: 24 hours
Irritant / corrosive response data:
Very slight erythema was observed in all rabbits following the 4-hour exposure. By the 24-hour observation point, the irritation was reversed, with no sign of erythema present at the 24-, 48- and 72-hour observations for all three rabbits. No edema was observed at any of the observation points. Based upon the Draize scale for scoring skin reaction, the test substance is considered a very slight irritant.

Any other information on results incl. tables

All of the animals exhibited a gain in body weight during the study.

No overt sign of toxicity was evident in any of the animals during the course of the study.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated informationCriteria used for interpretation of results: EU
Conclusions:
Classification: not irritating.
Executive summary:

Very slight erythema was observed in all rabbits following the 4-hour exposure. By the 24-hour observation point, the irritation was reversed, with no sign of erythema present at the 24-, 48- and 72-hour observations for all three rabbits. No edema was observed at any of the observation points. Based upon the Draize scale for scoring skin reaction, the test substance is considered a very slight irritant.