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Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
migrated information: read-across based on grouping of substances (category approach)
Adequacy of study:
key study
Study period:
From 08 APR 1980 to 11 APR 1980
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: FDA guideline (minor deviations from OECD guideline)
Cross-reference
Reason / purpose:
reference to same study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1980
Report Date:
1980

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: FDA guideline (Federal register 38, No. 187, 27.9.1973, p.27019)
Deviations:
no
GLP compliance:
no
Remarks:
study was performed previous to GLP implementation

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rabbit
Strain:
Himalayan
Details on test animals and environmental conditions:
TEST ANIMAin-house breed colony
- Weight at study initiation: 1.8 -2.4 kg
- Housing: single
- Diet: ERKA 8300 (Futtermittelwerke Robert Koch oHG, Hamm, Germany), ad libitum
- Water: ad libitum

Test system

Type of coverage:
occlusive
Preparation of test site:
other: clipped intact and clipped scarified
Vehicle:
physiological saline
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 500 mg pasted in 1.5 ml 0.9 % physiol. saline
Duration of treatment / exposure:
24 h
Observation period:
48 h after removal of patch with observation time points immediately after removal 24 and 48 h later.
Number of animals:
6
Details on study design:
TEST SITE
- Area of exposure: 2.5 x 2.5 cm
- Type of wrap if used: gauze patch

REMOVAL OF TEST SUBSTANCE
- Washing (if done): no

SCORING SYSTEM: erythema and edema scores (0-4)

Skin was evaluated immediately, 24 h and 48 h after after removal of the patch. Mean values of the readings 24 and 48 h after removal are reported in the results table.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal: #1, #2, #4, #6 each
Time point:
other: mean of 24 and 48 h
Score:
0
Max. score:
4
Reversibility:
other: not relevant since no effect
Remarks on result:
other: clipped intact
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
other: mean of 24 and 48 h
Score:
1
Max. score:
4
Reversibility:
not fully reversible within: the shortened observation period of 48 h
Remarks on result:
other: clipped intact / Expected to be reversible in the course of a prolonged observation period
Irritation parameter:
erythema score
Basis:
animal #5
Time point:
other: mean of 24 and 48 h
Score:
0.5
Max. score:
4
Reversibility:
fully reversible within: 48 h
Remarks on result:
other: clipped intact
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24 and 48 h
Score:
0
Max. score:
4
Reversibility:
other: not relevant since no effect
Remarks on result:
other: clipped intact
Irritant / corrosive response data:
individual animal data immediately / 24 h / 48 h after removal of patch for animal #1-#6 :

erythema: 0/0/0, 0/0/0, 1/1/1,
1/0/0, 0/1/0, 0/0/0

edema: 1/0/0, 0/0/0, 1/0/0,
0/0/0, 0/0/0, 1/0/0

Effects from scarified skin were a little stronger, but in the same range.

Applicant's summary and conclusion

Conclusions:
The test material did not reveal any remarkable irritation potential onto the skin of rabbits under these test conditions (FDA guidelines (Fed. Reg. Vol. 38, No. 187, p. 27019, 1973)). 500 mg of substance were applied to the skin of six animals and skin reactions were noted for 48 h after end of exposure (exposure lasted for 24 h).Only slight effects could be observed (erythema score 1, edema score 1), 1/6 animals had still an erythema score of 1 at the end of the observation time. It can be concluded that a longer observation period would have resulted in a complete reversibility.