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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:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Guideline study (OECD 404). No data on GLP requirements. Restriction : Only little information is given on the testing laboratory and the individual tests, no data of control

Data source

Reference
Reference Type:
review article or handbook
Title:
Skin and corrosion: reference chemical data bank
Author:
ECETOC
Year:
1995
Bibliographic source:
ECETOC Technical report n°66

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Purity: 98.8%

Test animals

Species:
rabbit
Strain:
not specified

Test system

Type of coverage:
not specified
Vehicle:
unchanged (no vehicle)
Duration of treatment / exposure:
4 h
Observation period:
7 days
Number of animals:
4
Details on study design:
- Applied volume : 0.5 ml
- Administration frequency: once
-Examination: 1 h, 24 h, 48 h, 72 h, 7 days
SCORING SYSTEM: Draize`s score

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
mean
Time point:
other: 24,48,72
Score:
2.42
Max. score:
4
Reversibility:
other: erythema was not fully reversible
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24-48-72h
Score:
2.35
Max. score:
4
Reversibility:
other: not completely reversible
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 14-48-72h
Score:
0.48
Max. score:
4
Reversibility:
fully reversible

Any other information on results incl. tables

Table 1: Irritant/corrosive response data for each animal at each observation time up to removal of each animal from the test

Score at time point / Reversibility

Erythema

Edema

Max. score: 4

Max. score: 4

60 min

0.5/0.5/1/0.5

0.5/0.5/0.5/0.5 

24 h

1.5/2/2/2 

0.5/1/0.5/0.5 

48 h

2/2/2/1.5 

0.5/0.5/0.5/0 

72 h

 1.5/2/2/1.5

 0.5/1/0.5/0

Average 24h, 48h, 72h

1.7/2/2/1.7

0.5/0.7/0.5/0.2

Reversibility*)

c/n.c./n.c./n.c. 

c/c/c/c

 

*) Reversibility: c. = completely reversible; n.c. = not completely reversible; n. = not reversible

Applicant's summary and conclusion

Interpretation of results:
Category 2 (irritant)
Remarks:
Migrated information Criteria used for interpretation of results: other: REGULATION (EC) No 1272-2008
Conclusions:
According to CLP criteria, the test substance undecylenic acid requires classification as "Irritant" (category 2).
Executive summary:

The potential of the test substance undecylenic acid to induce irritation or corrosion in rabbit skin was evaluated according to OECD guideline 404 in rabbits and was determined as irritant (category 2) according to regulation (EC) No. 1272 -2008.