Registration Dossier

Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin 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:
1992
Report Date:
1992

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
not specified
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
no detail data

Test animals

Species:
rabbit
Strain:
not specified
Details on test animals and environmental conditions:
no data

Test system

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

Results and discussion

In vivo

Resultsopen allclose all
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.

Applicant's summary and conclusion

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).