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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:
From January 01, 1986 to February 18, 1986
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1986
Report Date:
1986

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
Qualifier:
according to
Guideline:
other: EU Method B.6 (Skin Sensitization)
Deviations:
no
GLP compliance:
no

Test material

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

Test animals

Species:
rabbit
Strain:
other: Kleinrusse Chbb
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: HM/Fa. Thomae, Germany
- Average weight at study initiation: 2,192 g


Test system

Type of coverage:
occlusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
Undiluted
Duration of treatment / exposure:
4 h
Observation period:
21 d
Number of animals:
5
Details on study design:
24 h before test start, the right flank of the rabbits was shaved and the skin inspected for intactness. Only rabbits with intact skin were used for the study. 0.5 mL of the undiluted test substance were applied to a 2.5 x 2.5 cm patch and placed onto the shaved skin, then securely fastened with a larger plastic sheet to provide an occlusive dressing. After 4 h, the dressing was removed and the skin was scored for reddening (erythema) and swelling (oedema) after 1, 24, 48 and 72 h, then 7, 10, 14, 17 and 21 d according to the Draize system.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
24/48/72 h
Score:
3.96
Max. score:
4
Reversibility:
fully reversible within: 14 d
Remarks on result:
positive indication of irritation
Irritation parameter:
edema score
Basis:
mean
Time point:
24/48/72 h
Score:
3.12
Max. score:
4
Reversibility:
fully reversible within: 14 d
Remarks on result:
positive indication of irritation
Irritant / corrosive response data:
Light to moderate erythema and light oedema were observed on the treated skin after removal of the patch. The reactions intensified until the 72 h observation time point when strong erythema and moderate to strong oedema, as well as eschar formation were seen. No or only traces of the eschar were left in 1/5 and 4/5 animals, respectively, after 21 d. The acute reactions were no longer visible after 14 d.

Any other information on results incl. tables

Results table:

Product Animal number Hours after the plaster removal Days after the plaster removal
immediate 1 24 48 72 7 10 14 17 21
E O E O E O E O E O E O E O E O E O E O N S
ke 421 left side 339 3 2 4 2 4 4 4 4 4 4 4 2 4 2 4 0 4 0 4 0 N S Na
342 4 2 4 2 4 4 4 4 4 4 4 2 4 2 4 0 4 0 4 0 N S
352 4 2 4 2 4 4 4 4 4 4 4 2 4 2 4 2 4 2 4 0 N S
355 4 2 4 2 4 4 4 4 4 4 4 2 4 3 4 2 4 1 4 0 N S
369 4 2 4 2 4 4 4 3 4 3 4 2 4 2 1 0 0 0 0 0 S Na
X 5.8 6 8 7.8 7.8 6 6.2 4.2 3.8 3.2
X% 72.5 75 100 97.5 97.5 75 77.5 52.5 47.5 40
Right side 339 1 0 2 0 3 2 4 3 4 3 3 2 3 2 1 0 0 0 0 0
342 1 1 2 1 3 2 3 3 4 3 4 2 3 2 1 0 0 0 0 0 Sx
352 1 1 1 1 3 1 4 3 4 3 2 2 2 2 0 0 0 0 0 0 Sx
355 2 1 2 1 3 2 3 3 4 3 2 1 1 0 0 0 0 0 0 0 Sx
369 2 1 1 1 3 2 4 3 4 4 1 0 1 0 0 0 0 0 0 0 Sx
X 2.2 2.4 4.8 6.6 7.2 3.8 3.2 0.4 0 0
X% 27.5 30 60 82.5 90 47.5 40 5 0 0

E = Erythema

O = Odema

N = Necrotic skin change

S = Scab

Sx = Punctiform scraps

Na = Scar

Applicant's summary and conclusion

Interpretation of results:
other: Category 2 (irritant) based on CLP criteria
Conclusions:
Under the test conditions, test substance was considered to be irritating to rabbit skin.
Executive summary:

A study was conducted to assess the skin irritation potential of test substance, C12-18 and C18 -unsatd. DEA, to rabbit skin according to OECD Guideline 404. In this study, shaved skin of 5 rabbits was exposed to the undiluted test substance using occlusive patches for 4 h. The skin was then observed for effects for 21 d after patch removal and scored according to the Draize system. Exposure to undiluted test substance caused light to moderate erythema and light oedema immediately after removal of the patch. The reactions intensified until the 72 h observation time point when strong erythema and moderate to strong oedema, as well as eschar formation were seen. No or only traces of the eschar were left in 1/5 and 4/5 animals, respectively, after 21 d. The acute reactions were no longer visible after 14 d. Under the test conditions, test substance was considered to be irritating to rabbit skin (Kästner, 1986).