Registration Dossier

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
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2002
Report Date:
2002

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:
no detail information

Test animals / tissue source

Species:
rabbit
Strain:
not specified

Test system

Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
0.1 mL
Duration of treatment / exposure:
No eye wash
Observation period (in vivo):
10 days
Number of animals or in vitro replicates:
3
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing: no
- Time after start of exposure:


SCORING SYSTEM: Draize method; readings at approx. 1, 24, 48, and 72 hours, and on days 7 an d10


TOOL USED TO ASSESS SCORE: no data

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
mean score of 3 animals
Time point:
24/48/72 h
Score:
0.2
Max. score:
0.7
Reversibility:
fully reversible within: 7 days
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
mean score of 3 animals
Time point:
24/48/72 h
Score:
0.3
Max. score:
0.3
Reversibility:
fully reversible within: 7 days
Irritation parameter:
conjunctivae score
Basis:
mean
Remarks:
mean score of 3 animals
Time point:
24/48/72 h
Score:
0.8
Max. score:
1
Reversibility:
fully reversible within: 7 days

Any other information on results incl. tables

Effect

Mean scores (3 animals)

1 h

24 h

48 h

72 h

7d

10 d

Corneal opacity

0

0

0

0.7

0

0

Conjunctival chemosis

1.0

0.3

0.3

0.3

0

0

Conjunctival redness

1.0

1.0

0.7

0.7

0

0

Applicant's summary and conclusion

Conclusions:
3,5,5-trimethylhexan-1-ol was slightly irritating to the rabbit's eye below the level of the EU criteria for labelling
Executive summary:

3, 5, 5-trimethylhexan-1-ol was slightly irritating to the rabbit's eye when it was tested according to OECD TG 405 under GLP in 3 rabbits. The maximum Draize score reached was 18 out of 110. The corneal and conjunctival effects were all fully reversible within 7 days.

In conclusion, 3, 5, 5-trimethylhexan-1-ol was only slightly irritating to the rabbit's eye below the level of the EU criteria for labelling (EBSI, 2002).