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Administrative data

Description of key information

Skin irritation (ECETOC, 1995): Guideline study (OECD 404). No GLP.
Eye irritation (Manciaux, 1999): Guideline study (OECD 405) and GLP.
Respiratory irritation : No available data. There was no need yet to carry out a study on respiratory irritation.

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records
Reference
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
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
not specified
Species:
rabbit
Strain:
not specified
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
Irritation parameter:
erythema score
Basis:
mean
Time point:
24/48/72 h
Score:
2.35
Max. score:
4
Reversibility:
other: not completely reversible
Irritation parameter:
edema score
Basis:
mean
Time point:
24/48/72 h
Score:
0.48
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
mean
Time point:
24/48/72 h
Score:
2.42
Max. score:
4
Reversibility:
other: erythema was not fully reversible

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

Interpretation of results:
Category 2 (irritant)
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.

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Eye irritation

Link to relevant study records
Reference
Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1999-03-23 till 1999-04-13
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Qualifier:
according to guideline
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
GLP compliance:
yes
Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
all males
Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
100 mg
Duration of treatment / exposure:
a single administration
Observation period (in vivo):
1h, 24h, 48h, 72 h
Number of animals or in vitro replicates:
3
Details on study design:
TOOL USED TO ASSESS SCORE: fluorescein
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
3 rabbits
Time point:
24/48/72 h
Score:
2.6
Max. score:
4
Reversibility:
fully reversible within: 8, 9 and 15 days
Irritation parameter:
conjunctivae score
Remarks:
(redness)
Basis:
mean
Remarks:
3 rabbits
Time point:
24/48/72 h
Score:
2
Max. score:
3
Reversibility:
fully reversible within: 5, 9 and 10 days
Irritation parameter:
conjunctivae score
Remarks:
(discharge)
Basis:
mean
Remarks:
3 rabbits
Time point:
24/48/72 h
Score:
1.25
Max. score:
3
Reversibility:
fully reversible within: 4 (2 rabbits) and 6 days
Irritation parameter:
iris score
Basis:
mean
Remarks:
3 rabbits
Time point:
24/48/72 h
Score:
0.7
Max. score:
2
Reversibility:
fully reversible within: 5 and 11 days
Remarks on result:
other: Effects on 2 rabbits only
Irritation parameter:
cornea opacity score
Remarks:
(intensity)
Basis:
mean
Remarks:
3 rabbits
Time point:
other: 24-48-72 hours
Score:
1.2
Max. score:
4
Reversibility:
fully reversible within: 5 (2 rabbits) and 13 days
Irritation parameter:
cornea opacity score
Remarks:
(area)
Basis:
mean
Remarks:
3 rabbits
Time point:
other: 24-48-72 hours
Score:
2.8
Max. score:
4
Reversibility:
fully reversible within: 5 (2rabbits) and 13 days

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

Cornea (opacity)

Iris

Conjunctivae (Redness)

Chemosis

Conjunctivae

(Discharge)

Max. score: 4

Max. score: 2

Max. score: 3

Max. score: 4

Max. score: 4

60 min

0/0/0

0/0/0 

0/2/2 

3/3/3 

2/2/2

24 h

 2/1/1

1/0/1 

2/2/2 

3/2/3 

S/2//2

48 h

2/1/1 

1/0/1 

 2/2/2

3/2/3 

S/1/1

72 h

1/1/1 

1/1/1 

 2/1/1

 3/2/2

0/0/1

Average 24h, 48h, 72h

 1.7/1/1

1/0.3/1 

2/1.7/1.7 

3/2/2.7 

0.7/1/1.3

Reversibility*)

c/c/c 

 c/c/c

c/c/c 

c/c/c 

c/c/c

Average time (days) for reversion

6.7 

 4.7

7.3 

9.7 

3.7

 

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

s= whitish purulent discharge

Interpretation of results:
irritating
Remarks:
Migrated information category 2 Criteria used for interpretation of results: other: REGULATION (EC) No 1272-2008
Conclusions:
According to CLP (regulation EC, No 1272-2008), the test substance Acide Undecylenique is to be classified as "Eye IrritantCategory 2 (irritating to eyes)"
Executive summary:

The potential of the test substance ACIDE UNDECYLENIQUE to induce ocular irritation was evaluated in rabbits according to OECD guideline No. 405/ and EU directive 92/69/EEC B.5. 0.1 g Acide Undecylenique was placed in the conjunctival sac of the left eye of three male New Zealand White rabbits. Animals were observed for 15 days. Eye irritation was scored and mean values for chemosis, redness of conjunktiva, iris lesions and corneal opacity were calculated. Very slight to moderate conjunctival reactions were observed in all animals from day 1; these reactions persisted up to day 14 at the latest. A slight iritis was noted in two animals at day 2, it persisted up to day 4 or 10, respectively. A very slight or slight corneal opacity was recorded in all animals on day 2; it persisted up to day 4 (two animals) or 12. Under the experimental conditions, the test substance ACIDE UNDECYLENIQUE is irritant when administered by ocular route to rabbits.

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Skin irritation :

During the in vivo skin irritation study, UNDECYLENIC ACID were applied on rabbits patch test during 4 hours. Skin irritating effects were observed, which lead to a classification as "slightly irritating" with mean erythema score equal to 2.35 and mean oedema score equal to 0.48. All erythema were not fully reversible, but oedema yes.

Eye irritation :

The 1999 study on eye irritation with a dose application of 0.1 ml (100mg) revealed that the test substance UNDECYLENIC ACID is irritant when administered by ocular route to rabbits. Acide Undecylenique (0.1g) was placed in the conjunctival sac of the left eye of three male New Zealand White rabbits. Animals were observed for 15 days. Eye irritation was scored and mean values are : chemosis (2.6/4), redness of conjunctival (2/3), iris lesions (0.7/2) and corneal opacity (1.2/4). All oculars reaction were fully reversible in 14 days.

Justification for classification or non-classification

Skin irritation:

EU regulation (EC) No 1272/2008 (CLP), acid undecylenic is classified in category 2 on skin irritation.

Justifications : mean erythema score was 2.35 (>2).

Eye irritation:

EU regulation (EC) No 1272/2008 (CLP), acid undecylenic is classified in category 2 on eye irritation.

Justifications : Cornea opacity = 1.2 (>1), conjunctivae score (redness) = 2 (= ou > 2), chemosis = 2.6 (>2). All effects were fully reversible in 15 days.