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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:
2010-04-07 to 2010-05-10
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2010
Report Date:
2010

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Version / remarks:
2002
Qualifier:
according to
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
Version / remarks:
2008
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: The left eye remained untreated and served as a control.
Amount / concentration applied:
0.1 ml of the test substance was applied by means of a syringe to the eye of the animals.
Duration of treatment / exposure:
eyes were not rinsed
Observation period (in vivo):
1 hour and 24, 48, 72 hours and 7, 14, 21 and 28 days after application of the test substance.
Number of animals or in vitro replicates:
3 animals, 1 male and 2 females
Details on study design:

SCORING SYSTEM: as outlined in the OECD guideline 405, 2002

TOOL USED TO ASSESS SCORE: hand-slit lamp / biomicroscope / fluorescein
Examinations of ocular reactions were facilitated without any device. After recording the observations at 24 hours, the eyes of all rabbits were further examined with the aid of fluorescein to look for damage of the cornea.
One drop of a 0.5 % (w/v) fluorescein solution in saline was poured into both eyes and washed off with saline solution 30 seconds later. Afterwards
scoring was executed by use of an UV-light lamp. This procedure was repeated at all observation time points until cornea damage was no longer
observed.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal: #1, #2, #3
Time point:
other: mean 24, 48, 72 hours
Score:
0.33
Max. score:
4
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
iris score
Basis:
other: #1, #2, #3
Time point:
other: mean 24, 48, 72 hours
Score:
1
Max. score:
2
Reversibility:
fully reversible within: 21 days
Irritation parameter:
conjunctivae score
Basis:
other: #1, #2, #3
Time point:
other: mean 24, 48, 72 hours
Score:
1.67
Max. score:
3
Reversibility:
fully reversible within: 21 days
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
other: mean 24, 48, 72 hours
Score:
1.67
Max. score:
4
Reversibility:
fully reversible within: 28 days
Irritation parameter:
chemosis score
Basis:
animal #2
Remarks:
#2, #3
Time point:
other: mean 24, 48, 72 hours
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 21 days
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
other: mean 24, 48, 72 hours
Score:
2.3
Max. score:
4
Reversibility:
fully reversible within: 21 days
Irritant / corrosive response data:
All 3 animals showed moderate to strong ocular reaction 1 h after application of the test substance. 24 h after application slight to moderate ocular
reactions were observed in all three animals. Slight cornea opacity was observed in all animals 24 h after application. The cornea damage was not
further observed 48 h after treatment. Slight irritation of the conjunctivae and the iris persists within 14 days. At day 21 effects were fully reversible
with exception of chemosis (socre 1) in one animal, which was fully reversible after 28 days.

Other effects:
No symptoms of systemic toxicity were observed during the whole study.

Any other information on results incl. tables

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

Iris

Conjunctivae

Chemosis

Max. score: 4

Max. score: 2

Max. score: 3

Max. score: 4

60 min

0/0/0

0/0/0

1/2/1

2/4/3

24 h

1/1/1

1/1/1

2/2/2

2/2/4

48 h

0/0/0

1/1/1

2/2/2

2/2/2

72 h

0/0/0

1/1/1

1/1/1

1/2/1

7 days

0/0/0

1/1/0

1/1/1

1/1/1

14 days

0/0/0

1/0/0

1/1/1

1/1/1

21 days

0/0/0

0/0/0

0/0/0

1/0/0

28 days

0/0/0

0/0/0

0/0/0

0/0/0

Average 24h, 48h, 72h

0.33/0.33/0.33

1/1/1

1.67/1.67/1.67

1.67/2/2.3

Reversibility*)

c/c/c

c/c/c

c/c/c

c/c/c

Average time (unit) for reversion

48 hours

21 days

21 days

28 days

 

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

Applicant's summary and conclusion

Interpretation of results:
Category 2A (irritating to eyes)
Remarks:
Migrated information Criteria used for interpretation of results: other: CLP, EU GHS (Regulation (EC) No 1272/2008)
Conclusions:
Classification is based on effects on the cornea, iris and conjunctiva calculated as mean scores following grading at 24, 48 and 72 hours after instillation of the test material, in consideration of reversibility.
Classification Cat.2 for eye irritation is justified for the oleic acid-base TEA-Esterquat according to CLP, EU GHS (Regulation (EC) No 1272/2008).

Executive summary:

In a primary eye irritation study according to OECD Guideline 405, 2002 0.1 mL of the oleic acid-based TEA-Esterquat was instilled into the conjunctival sac of three New Zealand White rabbits. Animals then were observed for 28 days. Irritation was scored by the method stipulated by the OECD Guideline 405.

 

All 3 animals showed moderate to strong ocular reaction 1 h after application of the test substance. 24 h after application slight to moderate ocular reactions were still observed in all three animals. Slight cornea opacity was observed in all animals 24 h after application. The cornea damage was not further observed 48 h after treatment. Slight irritation of the conjunctivae and the iris persisted until day 14 in two animals and chemosis only until day 21 in one animal.. At day 21 effects were fully reversible with exception of a chemosis score 1 in one animal, which was fully reversible within 28 days.