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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:
weight of evidence
Study period:
1986-03-17 to 1986-03-24
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1986
Report date:
1986

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
yes
Remarks:
-10 mg solid dose instead of 100 mg as specfied by OECD 405 guidelines
GLP compliance:
yes

Test material

Constituent 1
Reference substance name:
Ethanaminium, 2-hydroxy-N-(2-hydroxyethyl)-N,N-dimethyl-, esters with C16-18 and C18-unsatd. fatty acids, chlorides
Cas Number:
1079184-43-2
Molecular formula:
n.a. (UVCB)
IUPAC Name:
Ethanaminium, 2-hydroxy-N-(2-hydroxyethyl)-N,N-dimethyl-, esters with C16-18 and C18-unsatd. fatty acids, chlorides
Constituent 2
Chemical structure
Reference substance name:
Propan-2-ol
EC Number:
200-661-7
EC Name:
Propan-2-ol
Cas Number:
67-63-0
Molecular formula:
C3H8O
IUPAC Name:
propan-2-ol
Test material form:
solid
Specific details on test material used for the study:
- Diethylester dimethyl ammonium chloride
- Substance type: Waxy

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Buckmasters, Henham,Hartfordshire, England
- Age at study initiation: 10-14 weeks
- Weight at study initiation: 2.3-3.2 kg
- Housing: Metal cages with perforated floors
- Diet (e.g. ad libitum): SDS standerd Rabbit Diet,ad libitum
- Water (e.g. ad libitum): Tap water,ad libitum
- Acclimation period:Not given


ENVIRONMENTAL CONDITIONS
- Temperature (°C):19 °C
- Humidity (%): 30-70%
- Air changes (per hr): 19 air charges /hour
- Photoperiod (hrs dark / hrs light): 12 hours of artificial light in each 24 hrs period.


IN-LIFE DATES: From:1986-03-17 To: 1986-03-24

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: Counter lateral eye.
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 10 mg, eye non rinsed
- Concentration (if solution): Not Applicable


VEHICLE
- Amount(s) applied (volume or weight with unit): Not Applicable
- Concentration (if solution): Not Applicable
- Lot/batch no. (if required): Not Applicable
- Purity: Not Applicable
Duration of treatment / exposure:
4 seconds in Group 2 and 7 days in Group 1
Observation period (in vivo):
24, 48, 72 hrs, 4, and 7 days after instillation for Group I and Group 2.
Number of animals or in vitro replicates:
Group 1: 6 Rabbits (10 mg undiluted test material, non-rinsed),
Group 2: 3 Rabbits (10mg undiluted test material, rinsed 4 seconds after instillation)
Details on study design:
The test substance is placed directly on the cornea of rabbit eye

REMOVAL OF TEST SUBSTANCE
- Washing (if done): Group 1 unwashed, Group 2 washing with 20 ml of lukewarm tap water.
- Time after start of exposure: 4 seconds in Group 2


SCORING SYSTEM: Draize Scoring system.


TOOL USED TO ASSESS SCORE: hand-slit lamp

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Remarks:
10 mg undiluted test material non-rinsed
Basis:
animal: #1 - #6
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Remarks:
10 mg undiluted test material non-rinsed
Basis:
animal: #1 - #6
Time point:
24/48/72 h
Score:
0
Max. score:
2
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Remarks:
10 mg undiluted test material non-rinsed
Basis:
animal: #1 - #6
Time point:
24/48/72 h
Score:
0
Max. score:
3
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Remarks:
10 mg undiluted test material non-rinsed
Basis:
animal: #1 - #6
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
cornea opacity score
Remarks:
10 mg undiluted test material rinsed group
Basis:
animal: #1, #2, #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Remarks:
10 mg undiluted test material rinsed group
Basis:
animal: #1, #2, #3
Time point:
24/48/72 h
Score:
0
Max. score:
2
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Remarks:
10 mg undiluted test material rinsed group
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
3
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Remarks:
10 mg undiluted test material rinsed group
Basis:
animal: #1, #3
Time point:
24/48/72 h
Score:
0.33
Max. score:
3
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
chemosis score
Remarks:
10 mg undiluted test material rinsed group
Basis:
animal: #1, #2, #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
The eyes of two respective group of 6 and 3 rabbits were instilled with 10 mg of undiluted test substance. The eyes of the first group of 6 rabbits were not rinsed and the second group of 3 rabbits were rinsed. No ocular irritation was observed in the non-rinsed group of 6 rabbits 24 hours after instillation. Mild conjunctival redness (overall ocular irritation score was 0.67 at 24 hours) was observed in the eyes of 2/3 rabbits in the 10 mg rinsed group that cleared by 48 hours.
Other effects:
None observed.

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 group 1 (not rinsed)

Score at time point / Reversibility

Cornea

Iris

Conjunctivae

Chemosis

Max. score: 4

Max. score: 2

Max. score: 3

Max. score: 4

60 min

-

-

-

-

24 h

0/0/0/0/0/0

0/0/0/0/0/0

0/0/0/0/0/0

0/0/0/0/0/0

48 h

0/0/0/0/0/0

0/0/0/0/0/0

0/0/0/0/0/0

0/0/0/0/0/0

72 h

0/0/0/0/0/0

0/0/0/0/0/0

0/0/0/0/0/0

0/0/0/0/0/0

Average 24h, 48h, 72h

0

0

0

0

Area effected

 

 

 

 

Maximum average score (including area affected, max 110)

 

 

 

 

Reversibility*)

C

C

C

C

Average time (unit) for reversion

 

 

 

 

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

Irritant/corrosive response data for each animal at each observation time up to removal of each animal from the test group 2 (rinsed)

Score at time point / Reversibility

Cornea

Iris

Conjunctivae

Chemosis

Max. score: 4

Max. score: 2

Max. score: 3

Max. score: 4

60 min

-

-

-

-

24 h

0/0/0

0/0/0

1/0/1

0/0/0

48 h

0/0/0

0/0/0

0/0/0

0/0/0

72 h

0/0/0

0/0/0

0/0/0

0/0/0

Average 24h, 48h, 72h

0

0

0.33/0/0.33

0

Area effected

 

 

 

 

Maximum average score (including area affected, max 110)

 

 

 

 

Reversibility*)

C

C

C

C

Average time (unit) for reversion

 

 

 

 

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

Applicant's summary and conclusion

Interpretation of results:
study cannot be used for classification
Conclusions:
No occular irritation was observed in the non-rinsed group.
A very slight irritation was observed untill the 24 hour reading with max. scores of 1 for conjunctivae. All symptomes were reversible at the 48 hour reading.
Executive summary:

In a primary eye irritation study comparable to OECD guideline 405,10 mg of MDEA-Esterquat C16-18 and C18 unsatd. was directly applied onto the cornea of one eye of six young adult New Zealand rabbits each and observed for 7 days. A subgroup of 3 additional rabbits was treated in the same matter, but eyes were rinsed 4 sec. after instillation of test substance.

Animals then were observed for 7 days.  Irritation was scored by the method of Draize.

In the main group no eye irritation was observed, all readings were zero. Mild conjunctival redness (score 1) was observed in 2/3 rabbits of subgroup (rinsed group)after 24 hours and was reversible within 48 hours.

 

No information on content of active ingredient of the test substance in this study report. However, according to producer information test substance has 80 % a.i.

 

In this study, MDEA-Esterquat C16-18 and C18 unsatd. is not an eye irritant.

 

Due to the low volume applied, the results of this study are not adequate for classification and labelling purposes.