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Toxicological information

Skin sensitisation

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Administrative data

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

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1982
Report date:
1982

Materials and methods

Test guideline
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.

Test material

Constituent 1
Reference substance name:
Lime Oxide
IUPAC Name:
Lime Oxide
Constituent 2
Reference substance name:
1,6-Octadien-3-ol, 3,7-dimethyl-, acid-isomerized
EC Number:
277-225-8
EC Name:
1,6-Octadien-3-ol, 3,7-dimethyl-, acid-isomerized
Cas Number:
73018-51-6
IUPAC Name:
1,6-Octadien-3-ol, 3,7-dimethyl-, acid-isomerized
Constituent 3
Reference substance name:
Reaction mass of (E)-5-(but-2-en-2-yl)-2,2-dimethyltetrahydrofuran and 1-isopropyl-4-methylcyclohexa-1,3-diene and 1-isopropyl-4-methylcyclohexa-1,4-diene and 1-methyl-4-(propan-2-ylidene)cyclohex-1-ene
IUPAC Name:
Reaction mass of (E)-5-(but-2-en-2-yl)-2,2-dimethyltetrahydrofuran and 1-isopropyl-4-methylcyclohexa-1,3-diene and 1-isopropyl-4-methylcyclohexa-1,4-diene and 1-methyl-4-(propan-2-ylidene)cyclohex-1-ene
Test material form:
other: liquid
Details on test material:
- Name of test material (as cited in study report): Lime Oxide
- Molecular formula: predominantly a mixture of monoterpenes C10H16 and cyclic monoterpene ethers C10H18O
- Molecular weight: monoterpenes C10H16 molecular weight 136.2, cyclic monoterpene ethers C10H18O molecular weight 154.2
- Physical state: clear colorless liquid
- Analytical purity: 61.8%, sum of 4 major peaks
- Impurities: Known impurities are similar in nature to the major components and have empirical formulae of either C10H16 or C10H18O
- Lot/batch No.: SC00009577
- Expiration date of the lot/batch: 13 October 2015
- Storage condition of test material: room temperature, in the dark

In vivo test system

Test animals

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.

Study design: in vivo (non-LLNA)

Induction
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
Challenge
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.

Results and discussion

In vivo (non-LLNA)

Results
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

Applicant's summary and conclusion

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.