1,6-Octadien-3-ol, 3,7-dimethyl-, acid-isomerized

Endpoint summary

Description of key information

Concentrations higher than 10% induced weak to strong concentration dependant skin irritation. Therefore the maximum concentration considered for skin irritation unaffected by skin irritation was 10%.

At 10% of Lime Oxide in ethanol, no allergic potential was observed under the test conditions and Lime Oxide was well tolerated on the skin of guinea pigs.

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records

Reference

Reference 1

Endpoint:

skin sensitisation: in vivo (non-LLNA)

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1982

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

study well documented, meets generally accepted scientific principles, acceptable for assessment

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 406 (Skin Sensitisation)

Deviations:

not specified

GLP compliance:

no

Type of study:

open epicutaneous test

Justification for non-LLNA method:

A valid in vivo test is available which follows accepted guidance for skin sensitisation.
In addition, this means no further unnecessary animal work is required.

Species:

guinea pig

Strain:

not specified

Sex:

male

Details on test animals and environmental conditions:

One to six experimental groups and one control group of six to eight animals.

Route:

epicutaneous, open

Vehicle:

unchanged (no vehicle)

Concentration / amount:

3, 10, 30 and 100 %

Day(s)/duration:

21 days

Adequacy of induction:

highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically

No.:

#1

Route:

epicutaneous, open

Vehicle:

not specified

Concentration / amount:

30%

Day(s)/duration:

Day 21

Adequacy of challenge:

highest non-irritant concentration

No. of animals per dose:

6-8

Details on study design:

On day "0" application of 0.1 mL of the test material on the flank skin of 6 to 8 guinea pigs.
Applied repeatedly for 3 weeks or 5 times weekly during 4 weeks.
The application site was left uncovered.

Challenge controls:

The minimumirritating concentration was used in order to confirm biological activity determined before starting the induction (day -1).
0.025 mL of each concentration was applied to the skin.

Key result

Reading:

1st reading

Hours after challenge:

24

Group:

test chemical

Dose level:

100%

No. with + reactions:

0

Total no. in group:

6

Clinical observations:

None

Remarks on result:

no indication of skin sensitisation

Interpretation of results:

GHS criteria not met

Conclusions:

Concentrations higher than 10% induced weak to strong concentration dependant skin irritation. Therefore the maximum concentration considered for skin irritation unaffected by skin irritation was 10%.
At 10% of Lime Oxide in ethanol, no allergic potential was observed under the test conditions and Lime Oxide was well tolerated on the skin of guinea pigs

Executive summary:

No allergic reactions were observed. Therefore no classification is required.

Reference 2

Endpoint:

skin sensitisation: in vitro

Data waiving:

study scientifically not necessary / other information available

Justification for data waiving:

other:

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not sensitising)