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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:
supporting study
Study period:
1976
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1976
Report date:
1976

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
yes
Remarks:
; purity not reported, 50% dilution of test substance
GLP compliance:
no

Test material

Constituent 1
Reference substance name:
3234-85-3 (50% dilution)
IUPAC Name:
3234-85-3 (50% dilution)
Details on test material:
- Name of test material (as cited in study report): [only trade name given]
- Analytical purity: no data

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Weight at study initiation: 1.8-2.4 kg

Test system

Vehicle:
other: corn oil
Controls:
other: the left eye served as the control
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL
- Concentration (if solution): 50% (w/w)

VEHICLE
- Concentration (if solution): 50% (w/w)
Duration of treatment / exposure:
Single application without washing
Observation period (in vivo):
7 days
Reading time points: 24, 48 and 72 h, and 7 days
Number of animals or in vitro replicates:
6
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): the treated eye was not washed after instillation.

SCORING SYSTEM: Draize scoring system

TOOL USED TO ASSESS SCORE: hand-held lens

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
of all 6 animals
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: reversibility not applicable
Irritation parameter:
iris score
Basis:
mean
Remarks:
of all 6 animals
Time point:
24/48/72 h
Score:
0
Max. score:
2
Reversibility:
other: reversibility not applicable
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0.66
Max. score:
3
Reversibility:
fully reversible within: 72 h
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0.33
Max. score:
3
Reversibility:
fully reversible within: 48 h
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
3
Reversibility:
other: reversibility not applicable
Irritation parameter:
conjunctivae score
Basis:
animal #4
Time point:
24/48/72 h
Score:
0.33
Max. score:
3
Reversibility:
fully reversible within: 48 h
Irritation parameter:
conjunctivae score
Basis:
animal #5
Time point:
24/48/72 h
Score:
0.33
Max. score:
3
Reversibility:
fully reversible within: 48 h
Irritation parameter:
conjunctivae score
Basis:
animal #6
Time point:
24/48/72 h
Score:
0
Max. score:
3
Reversibility:
other: reversibility not applicable
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
out of all 6 animals
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: reversibility not applicable
Irritant / corrosive response data:
Slight redness was observed in 4/6 animals at the 24-hour reading time point, which had cleared completely within 72 hours (see Table 1). No other eye irritation effects were observed in any of the animals.

Any other information on results incl. tables

Table 1: Individual eye irritation scores

 

Rabbit #

 

Time [h]

 

conjunctivae

 

iris

 

cornea

 

 

conjunctivae

 

iris

 

cornea

 

redness

swelling

redness

swelling

1

 

 

 

 

 

 

 

 

 

 

24

1

0

0

0

48

1

0

0

0

72

0

0

0

0

average

0.67

0.0

0.0

0.0

Time to reversion

72.0

0.0

0.0

0.0

2

 

 

 

 

 

 

 

 

 

 

 

24

1

0

0

0

48

0

0

0

0

72

0

0

0

0

average

0.33

0.0

0.0

0.0

Time to reversion

48.0

0.0

0.0

0.0

3

 

 

 

 

 

 

 

 

 

 

 

24

0

0

0

0

48

0

0

0

0

72

0

0

0

0

average

0.0

0.0

0.0

0.0

Time to reversion

0.0

0.0

0.0

0.0

4

 

 

 

 

 

 

 

 

 

 

 

24

1

0

0

0

48

0

0

0

0

72

0

0

0

0

average

0.33

0.0

0.0

0.0

Time to reversion

48.0

0.0

0.0

0.0

5

 

 

 

 

 

 

 

 

 

 

 

24

1

0

0

0

48

0

0

0

0

72

0

0

0

0

average

0.33

0.0

0.0

0.0

Time to reversion

48.0

 0.0

 0.0

0.0 

6

 

 

 

 

 

 

 

 

 

 

 

24

0

0

0

0

48

0

0

0

0

72

0

0

0

0

average

0.0

0.0

0.0

0.0

Time to reversion

0.0

0.0 

0.0 

0.0 

 

 

 

Time [h]

conjunctivae

 

iris

cornea

 

redness

swelling

 

 

avg. time to reversion

36.0

0.0

0.0

0.0

average

score

 

 

 

 

 

 

24

0.67

0.00

0.00

0.00

48

0.17

0.00

0.00

0.00

72

0.00

0.00

0.00

0.00

24+48+72

0.28

0.00

0.00

0.00

 

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
not irritating to the eyes
Executive summary:

An in vivo eye irritation study in rabbits was perfromed with tetradecyl myristate (CAS No. 3234 -85 -3), a constituent of the registration substance. Mean scores for cornea, iris, conjunctiva redness and chemosis for all 6 animals after 24, 48, and 72 hours were 0, 0 and in the range of 0.33 to 0.66. All effects were fully reversible within 72 h. Thus, the substance does not have to be classified according to the criteria laid down in the EU Classification Labelling and Packaging Regulation (1272/2008/EC).

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