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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:
other: Study conducted according to OECD Guideline 404 in compliance with GLP.
Justification for data waiving:
other:
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:
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
Principles of method if other than guideline:
Not applicable
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Comperlan KD
- Purity: > 95%

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

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.
Other effects:
None

Any other information on results incl. tables

None

Applicant's summary and conclusion

Interpretation of results:
irritating
Remarks:
Migrated information Criteria used for interpretation of results: other: Draize scoring system
Conclusions:
Under the test conditions, amides, C12-18 and C18-unsatd., N,N-bis(hydroxyethyl) was considered to be irritating to rabbit skin.
Executive summary:

A OECD guideline study was conducted to assess the skin irritation potential of amides, C12-18 (even numbered) and C18-unsatd., N,N-bis(hydroxyethyl) in rabbits.

The 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 (scoring according to the Draize system) for 21 d after patch removal. Exposure to undiluted amides, C12-18(even-numbered) and C18(unsatd.), N,N-bis(hydroxyethyl) 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, amides, C12-18 (even numbered) and C18 -unsatd., N,N-bis(hydroxyethyl) was considered to be irritating to rabbit skin.