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Toxicological information

Eye irritation

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Administrative data

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:
other: GLP-study according to OECD guideline and EU directive without deviations

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1999
Report Date:
1999

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Qualifier:
according to
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Physical state: Colorless solid
- Analytical purity: 99.5%
- Storage condition of test material: in dark at RT
- batch 9807016 filling 41/99

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
all males

Test system

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

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
3 rabbits
Time point:
other: 24-48-72 hours
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:
other: 24-48-72 hours
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:
other: 24-48-72 hours
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:
other: 24-48-72 hours
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

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

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

Applicant's summary and conclusion

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.