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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
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Study performed according to OECD guideline under GLP. Assessment supported with ToxRTool (Schneider, K. et al. "ToxRTool", a new tool to assess the reliability of toxicological data. Toxicol Lett. 2009 Sep 10:189(2):138-44)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1996
Report Date:
1996

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
Details on test material:
- Name of test material (as cited in study report): Lix 860N-NEAT (C-9-Aldoxime)
- Physical state: viscous, amber-cloured liquid
- Lot/batch No.: 070596
- Expiration date of the lot/batch: 09/1997
- Storage condition of test material: room temperture, dark

Test animals

Species:
rabbit
Strain:
other: Mol:Russian

Test system

Type of coverage:
occlusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
0.5 ml
Duration of treatment / exposure:
4h
Observation period:
21 days
Number of animals:
3

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: mean of 24, 48 and 72 h
Score:
ca. 1.6
Max. score:
2
Reversibility:
fully reversible within: 21 days
Irritation parameter:
edema score
Basis:
mean
Time point:
other: mean of 24, 48 and 72h
Score:
ca. 1.9
Max. score:
3
Reversibility:
fully reversible within: 21 days

Applicant's summary and conclusion

Interpretation of results:
Category 2 (irritant)
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Based on the results of a study according to OECD Test Guideline 404 under GLP, the test substance is considered as skin irritating (applying the evaluation system of the EU regulation 1272/2008).
Executive summary:

The skin irritation potential of the test substance was evaluated in a study according to OECD Test Guideline 404 under GLP.

The amount of 0.5 ml of the substance was applied unchanged under occlusive conditions for 4 hours to the shaved skin of three Mol:Russian rabbits, which were observed for 21 days post application. Over the first three days, clear erythema and oedema were observed in all rabbits, which reversed fully within 21 days.

Interpreting these results by applying the evaluation system of the EU regulation 1272/2008, the test substance is considered irritating to the skin.