Fatty acids, C16-18, reaction products with triethanolamine, di-Me sulfate-quaternized

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2010-05-04 to 2010-05-25

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2010

Report date:

2010

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Version / remarks:

2002

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)

Version / remarks:

2008

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

Fatty acids, C16-18(even numbered), reaction products with triethanolamine, di-Me sulfate-quaternized

Cas Number:

91032-11-0

Molecular formula:

n.a. (UVCB)

IUPAC Name:

Fatty acids, C16-18(even numbered), reaction products with triethanolamine, di-Me sulfate-quaternized

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 g test substance.
As the test substance is a solid it was crushed with a spatula to obtain small pieces and was furthermore finely ground in a mortar. The resulting fine white powder was then applied as such.

Duration of treatment / exposure:

1 hour after treatment the treated eye was rinsed with 0.9 % saline solution to remove remaining test substance from the eye.

Observation period (in vivo):

1 hour and 24, 48, 72 hours and 7, 14 and 21 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:

REMOVAL OF TEST SUBSTANCE
- Washing (if done): with 0.9 % % saline solution
- Time after start of exposure: 1 hour after exposure

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

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

animal #1

Time point:

24/48/72 h

Score:

3

Max. score:

4

Reversibility:

fully reversible within: 21 days

Results 2

Irritation parameter:

cornea opacity score

Basis:

animal: #2, #3

Time point:

24/48/72 h

Score:

0

Max. score:

4

Results 3

Irritation parameter:

iris score

Basis:

animal #1

Time point:

24/48/72 h

Score:

1

Max. score:

2

Reversibility:

fully reversible within: 21 days

Results 4

Irritation parameter:

iris score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0.33

Max. score:

2

Reversibility:

fully reversible within: 48 hours

Results 5

Irritation parameter:

conjunctivae score

Basis:

animal #1

Time point:

24/48/72 h

Score:

2

Max. score:

3

Reversibility:

fully reversible within: 21 days

Results 6

Irritation parameter:

conjunctivae score

Basis:

animal #2

Time point:

24/48/72 h

Score:

1.67

Max. score:

3

Reversibility:

fully reversible within: 14 days

Results 7

Irritation parameter:

conjunctivae score

Basis:

animal #3

Time point:

24/48/72 h

Score:

1

Max. score:

3

Reversibility:

fully reversible within: 14 days

Results 8

Irritation parameter:

chemosis score

Basis:

animal #1

Time point:

24/48/72 h

Score:

3

Max. score:

4

Reversibility:

fully reversible within: 21 days

Results 9

Irritation parameter:

chemosis score

Basis:

animal: #2, #3

Time point:

24/48/72 h

Score:

1

Max. score:

4

Reversibility:

fully reversible within: 14 days

Irritant / corrosive response data:

All 3 animals showed moderate ocular reaction 1 h after application of the test substance. 24 h after application slight to moderate ocular reactions
were observed in two animals while the third animal showed still strong ocular irritation. Only in this animal distinct cornea damage was observed
24 h after application. The cornea damage declined with time and was not further observed on day 21 after treatment. Slight irritation of the
conjunctivae persists until day 7 or day 14 after treatment but 21 days after application all three animals were without any sign of ocular irritation.

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	2/2/2	3/2/2
24 h	3/0/0	1/1/0	2/2/1	4/1/1
48 h	3/0/0	1/0/0	2/1/1	3/1/1
72 h	3/0/0	1/0/0	2/1/1	2/1/1
7 days	3/0/0	1/0/0	2/1/1	2/1/0
14 days	1/0/0	1/0/0	2/0/0	1/0/0
21 days	0/0/0	0/0/0	0/0/0	0/0/0
Average 24h, 48h, 72h	3/0/0	1/0.33/0	2/1.67/1	3/1/1
Reversibility*)	c/c/c	c/c/c	c/c/c	c/c/c
Average time (unit) for reversion	21 days	21 days	21 days	21 days

 

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

 

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

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.
No classification for serious eye damage/eye irritation is justified for fully saturated TEA-EQ 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 g of the fully saturated TEA-EQ was instilled into the conjunctival sac of three New Zealand White rabbits. Animals then were observed for 21 days. Irritation was scored by the method stipulated by the OECD Guideline 405.

 

All 3 animals showed moderate ocular reaction 1 h after application of the test substance. 24 h after application slight to moderate ocular reactions were observed in two animals while the third animal showed still strong ocular irritation. Only in this animal distinct cornea damage was observed 24 h after application. The cornea damage declined with time and was not further observed on day 21 after treatment. Slight irritation of the conjunctivae persists until day 7 or day 14 after treatment but 21 days after application all three animals were without any sign of ocular irritation.