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Diss Factsheets

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:
1996-05-13 to 1996-06-04
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1996
Report date:
1996

Materials and methods

Test guidelineopen allclose all
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

Test material

Constituent 1
Reference substance name:
9-Octadecenoic acid (Z)-, reaction products with triethanolamine, di-Me sulfate-quaternized
EC Number:
302-242-5
EC Name:
9-Octadecenoic acid (Z)-, reaction products with triethanolamine, di-Me sulfate-quaternized
Cas Number:
94095-35-9
Molecular formula:
n.a. (UVCB)
IUPAC Name:
Fatty acids, C18 unsatd., reaction products with triethanolamine, di-Me sulfate-quaternized

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White

Test system

Vehicle:
not specified
Remarks:
most probably water
Controls:
other: untreated eye served as control
Amount / concentration applied:
0.1 mL of 28 % a.i. dilution of test substance
Duration of treatment / exposure:
no washing
Observation period (in vivo):
1, 24, 48 and 72 hours. Additional observations were carried out after 7 days to check the reversiblitlity of the observed reactions.
Number of animals or in vitro replicates:
3
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): not done

SCORING SYSTEM: as outlined in the OECD guideline 405, 1987

TOOL USED TO ASSESS SCORE: hand-slit lamp / biomicroscope / fluorescein

In the readings at 24 and 48 hours after treatment cornea was observed, by applying a 2 % aqueous sodium fluorescein solution to test the area and
then washing the area with a 0.9 % physiological saline solution. Once surplus fluorescein had been removed, the corneal alterations were observed
with the 'lid of a transilluminator with a cobalt blue filter.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal: #1, #2, #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
iris score
Basis:
animal: #1, #2, #3
Time point:
24/48/72 h
Score:
0
Max. score:
2
Irritation parameter:
conjunctivae score
Basis:
animal: #1, #2, #3
Time point:
24/48/72 h
Score:
1.33
Max. score:
3
Reversibility:
fully reversible within: 7 days
Irritation parameter:
chemosis score
Basis:
animal: #1, #2, #3
Time point:
24/48/72 h
Score:
0.33
Max. score:
4
Reversibility:
fully reversible within: 48 hours
Irritant / corrosive response data:
At the 60 minute and 24 hour reading moderate conjunctival redness (score 2) and mild to moderate chemosis (score 1 and 2) was observed.
Symptoms decrease with time, scores were 0 at the 48 hour reading for chemosis and after 7 days for conjuncitva. Cornea damage and iritis was not observed at any time during the study.
Other effects:
The behaviour and physical condition of the rabbits were normal throughout the 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

2/2/1

24 h

0/0/0

0/0/0

2/2/2

1/1/1

48 h

0/0/0

0/0/0

1/1/1

0/0/0

72 h

0/0/0

0/0/0

1/1/1

0/0/0

7days

0/0/0

0/0/0

0/0/0

0/0/0

Average 24h, 48h, 72h

0/0/0

0/0/0

1.33/1.33/1.33

0.33/0.33/0.33

Reversibility*)

c/c/c

c/c/c

c/c/c

c/c/c

Average time (unit) for reversion

 

7 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
Remarks:
28 % dilution of test substance
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 the oleic acid-based TEA-Esterquat (28 % a.i. dilution) according to CLP, EU GHS
(Regulation (EC) No 1272/2008).
Executive summary:

In a primary eye irritation study according to OECD Guideline 405, 1987 0.1 mL of the oleic acid-base TEA-Estequat was instilled into the conjunctival sac of three New Zealand White rabbits. Animals then were observed for 7 days. Irritation was scored by the method stipulated by the OECD Guideline 405.

At the 60 minute and 24 hour reading moderate conjunctival redness (score 2) and mild to moderate chemosis (score 1 and 2) was observed in all animals. Symptoms decrease with time. Scores were zero at the 48 hour reading for chemosis and after 7 days for conjuncitva. Cornea damage and iritis was not observed at any time during the study.