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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:
1985
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP and guideline followede, all data available
Cross-referenceopen allclose all
Reason / purpose:
reference to same study
Reason / purpose:
reference to other study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1985
Report Date:
1985

Materials and methods

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

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Details on test material:
TEPIC-C, sample C,

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
rabbits were 12 - 16 weeks old, with a weight of 2.24 - 2.60 kg, and kept in individual cages.
The animals rooms had 15 cycles of air per hour, a temperature of 18-23 °C, and a relative humidity of 45 - 55 %.
A 12hour dark/light cycle was applied.

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
water
Controls:
not required
Amount / concentration applied:
0.4 gm in 1 ml of water
Duration of treatment / exposure:
4 hours
Observation period:
72 hours
Number of animals:
3
Details on study design:
animals were shave on the back, and TGIC suspension was applied on an area of 2 x 2 cm, and covered with a semi-occlusive bandage for 4 hours. Reading was at 4, 24, 48, and 72 hours.
Body weight was measured daily

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
24/48/72 h
Score:
ca. 0
Max. score:
4
Reversibility:
other: no irritation observed
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
mean
Time point:
24/48/72 h
Score:
ca. 0
Max. score:
4
Reversibility:
other: No irritation observed
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
same responsed observed at 24, 48, and 72 hours (0.0)
Other effects:
Body weight development was similar to concurrent control animals of different study.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
TEPIC-C, sample C, was not irritant to skin in the assay with rabbits when treatment was 4 hours
Executive summary:

TEPIC-C, sample C, was not irritant to skin in the assay with rabbits when treatment was 4 hours