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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:
01.10.2001 - 15.10.2001
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2001
Report Date:
2001

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Lot#18197-D-5
2,4,7,9-Tetramethyl-4,7-decanediol
CAS# 17913-76-7

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White

Test system

Vehicle:
unchanged (no vehicle)
Controls:
no
Duration of treatment / exposure:
0,1 ml initial instillation
Observation period (in vivo):
1, 24, 48, 72 hours and on days 7 and 14
Number of animals or in vitro replicates:
3
Details on study design:
SCORING SYSTEM: Draize

TOOL USED TO ASSESS SCORE: mini-Maglite

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
iris score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0.3
Max. score:
2
Reversibility:
fully reversible
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
24/48/72 h
Score:
2
Max. score:
3
Reversibility:
fully reversible
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24/48/72 h
Score:
2
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
24/48/72 h
Score:
1.3
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
iris score
Basis:
animal #2
Time point:
24/48/72 h
Score:
1
Max. score:
2
Reversibility:
fully reversible
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
24/48/72 h
Score:
2
Max. score:
3
Reversibility:
fully reversible
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
24/48/72 h
Score:
2.7
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
iris score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0.3
Max. score:
2
Reversibility:
fully reversible
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
24/48/72 h
Score:
1.7
Max. score:
3
Reversibility:
fully reversible
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
24/48/72 h
Score:
1.7
Max. score:
4
Reversibility:
fully reversible

Any other information on results incl. tables

Score at time point / Reversibility

Cornea

Iris

Conjunctivae

Chemosis

Discharge

 

Max. score: 4

Max. score: 2

Max. score: 3

Max. score: 4

Max. score: 3

60 min

0h/0/0

0/0/0

1/2/2

2/3/3

2/2/2

24 h

0h/0h/0h

1/1/1

2/2/2

2/3/2

2/2/2

48 h

0h/2/0h

0/1/0

2/2/2

2/3/2

1/2/2

72 h

0/2/0

0/1/0

2/2/1

2/2/1

1/2/1

7 d

0/0/0

0/0/0

1/1/1

0/1/0

0/1/0

14 d

0/0/0

0/0/0

0/0/0

0/0/0

0/0/0

Average 24h, 48h, 72h

0/1.3/0

0.3/1/0.3 

2/2/1.7 

2/2.7/1.7

1.3/2/1.7

 

h = lack of normal luster

Applicant's summary and conclusion

Interpretation of results:
Category 2 (irritating to eyes) based on GHS criteria
Conclusions:
2,4,7,9-tetramethyldecane-4,7-diol is an ocular irritant, but not corrosive.
Executive summary:

Ocular findings:

Corneal opacity was noted in 1/3 eyes, although fluorescein stain retention was noted in all the eyes.

The opacity cleared by day 7.

Iritis, noted in 3/3 eyes, cleared by day 7. Conjunctival irritation, noted in 3/3 eyes, cleared by day 14.