Registration Dossier

Administrative data

Description of key information

3,5,5-trimethylhexan-1-ol was irritating in an OECD TG 404 test conducted under GLP and using rabbits. 
3,5,5-trimethylhexan-1-ol was slightly irritating to the rabbit's eye in an OECD TG 405, GLP study using rabbits, below the EU classification criteria.

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records
Reference
Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
not specified
GLP compliance:
yes
Species:
rabbit
Strain:
not specified
Details on test animals and environmental conditions:
no data
Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied: 0.5 mL per animal
- Concentration (if solution): undiluted

VEHICLE
- Amount(s) applied (volume or weight with unit): n.a.
Duration of treatment / exposure:
4 hours
Observation period:
min. 7 days
Number of animals:
6
Details on study design:
TEST SITE
- Area of exposure: no data
- % coverage: no data
- Type of wrap if used: semiocclusive


REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes
- Time after start of exposure: 4 hours

SCORING SYSTEM: Draize method
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
mean
Time point:
other: 24-72 hours
Score:
2.08
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24, 48, 72 hours
Score:
1.83
Reversibility:
not fully reversible within: 7 days
Remarks on result:
other: desquamation on day 7 in all 6 animals
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24, 48, 72 hours
Score:
0.22
Reversibility:
not fully reversible within: 7 days
Irritant / corrosive response data:
The test substance caused well-defined erythema in two of the six animals and mild erythema in the remaining animals at the 45 minute interval.
At 24, 48, and 72 hours, 5 animals had well-defined erythema and 1 animal had mild erythema. By Day 7, only one animal had slight erythema.
One animal at the 48 hour interval and 3 animals at the 72 hour interval had slight edema.
By Day 7, desquamation was observed in all 6 animals.
Interpretation of results:
irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
3, 5, 5-trimethylhexan-1-ol was irritating to the rabbit's skin, as desquamation was seen in all animals on day 7, i.e. possibly at the end of the observation period
Executive summary:

3, 5, 5-trimethylhexan-1-ol was moderately irritating in an OECD TG 404 test conducted under GLP and using 6 female rabbits. Following a 4 hour contact of the neat test material to the intact skin under semiocclusive dressing, the mean erythema score for 24, 48, and 72 hours after patch removal was 1.83 (mean edema score: 0.22). Erythema was reversible, but desquamation was seen in all 6 animals on day 7 after patch removal (EBSI, 1992; only secondary source available).

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Eye irritation

Link to relevant study records
Reference
Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes
Species:
rabbit
Strain:
not specified
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
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

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

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).

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Additional information

Skin: 3, 5, 5-trimethylhexan-1-ol was moderately irritating in an OECD TG 404 test conducted under GLP and using 6 female rabbits. Following a 4 hour contact of the neat test material to the intact skin under semiocculsive dressing, the mean erythema score for 24, 48, and 72 hours after patch removal was 1.83 (mean edema score: 0.22). Erythema was reversible, but desquamation was seen in all 6 animals on day 7 after patch removal (EBSI, 1992; only secondary source available).

Eye: 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 slightly irritating to the rabbit's eye below the level of the EU criteria for classification and labeling (EBSI, 2002; only secondary source available).


Effects on skin irritation/corrosion: irritating

Justification for classification or non-classification

Skin:

the mean erythema score was 1.83 on three consecutive days; desquamation persisted until the end of the observation period.

Regulation 67/548/EEC: classification criteria not met

Regulation 1272/2007/EC: irritating; Cat 2; H315

Eye:

Regulation 67/548/EEC: classification criteria not met

Regulation 1272/2007/EC: irritating, cat.2; H319