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Diss Factsheets

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
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
Justification for type of information:
data is from experimental reports

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1978
Report date:
1978

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: Open Epicutaneous test
Principles of method if other than guideline:
Open Epicutaneous test was carried out to evaluate the dermal sensitization potential of the test chemical
GLP compliance:
not specified
Type of study:
open epicutaneous test
Justification for non-LLNA method:
not specified

Test material

Constituent 1
Chemical structure
Reference substance name:
4-methoxybenzyl alcohol
EC Number:
203-273-6
EC Name:
4-methoxybenzyl alcohol
Cas Number:
105-13-5
Molecular formula:
C8-H10-O2
IUPAC Name:
(4-methoxyphenyl)methanol
Test material form:
liquid
Details on test material:
- Name of test material: 4-methoxybenzyl alcohol
- IUIPAC name: 4-methoxybenzyl alcohol
- Molecular Formula: C8H10O2
- Molecular Weight: 138.166 g/mol
- Substance type: Organic
- Physical state: Liquid
- Purity: 99.9%

In vivo test system

Test animals

Species:
guinea pig
Strain:
not specified
Sex:
not specified

Study design: in vivo (non-LLNA)

Induction
Route:
epicutaneous, open
Vehicle:
other: acetone
Concentration / amount:
60, 30, 10 and 3% solutions
Adequacy of induction:
not specified
Challenge
No.:
#1
Route:
epicutaneous, open
Vehicle:
other: acetone
Concentration / amount:
60, 30, 10 and 3% solutions
Adequacy of challenge:
not specified
No. of animals per dose:
6-8
Details on study design:
Induction:
Days 0-20: On day 0, 0.1ml of the test material, undiluted and, if possible or necessary of its progressively diluted solutions or emulsions or suspensions is applied to an area measuring 8cm2 on the clipped flank skin of 6-8 guinea pigs per concentration group, using 1-6 such groups for each test material.
The applications are repeated daily for 3 weeks or done 5 times weekly during 4 weeks, always using the same skin site. The application site is left uncovered and the reactions, if continuous daily applications are performed, can be read 24 hours after each application or at the end of each week. When very strong skin reactions are provoked, the application site is changed.
Challenge:
Day 21 &35: to determine whether or not contact sensitization was induced, all groups of guinea pigs previously treated for 21 days as described above, as well as 6-8 untreated or only with the vehicle pretreated controls are tested on days 21 and 35 on the contralateral flank with the test material at the minimal irritating and some lower concentrations. The minimal irritating concentration of each material is used in order to confirm the biological activity determined before starting the induction (day-1) and to exclude false results based on instability of test materials. These tests are performed by applying with a pipette 0.025ml of each concentration to skin areas measuring 2 cm2, the reactions being read after 24,48 and /or 72 hours. This procedure enables to determine the minimal sensitising concentration necessary for inducing allergic contact hypersensitivity and the minimal eliciting concentration necessary to cause a positive reaction. The test material is considered allergenic at a concentration when at least one out of the 8 animals of the concentration group concerned shows positive reactions with non-irritant concentrations used for challenge, i.e its threshold concentration causing skin reactions is shifted into the lower part of the concentration range used for challenge.
Challenge controls:
6-8 untreated or only with the vehicle pretreated controls are tested on days 21 and 35 on the contralateral flank with the test material at the minimal irritating and some lower concentrations
Positive control substance(s):
not specified

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
Key result
Reading:
1st reading
Hours after challenge:
72
Group:
test chemical
Dose level:
60 % solution
No. with + reactions:
4
Total no. in group:
8
Clinical observations:
Challenge on day 21 and 35 of the test
Remarks on result:
positive indication of skin sensitisation
Key result
Reading:
2nd reading
Hours after challenge:
72
Group:
test chemical
Dose level:
30 % solution
No. with + reactions:
4
Total no. in group:
8
Clinical observations:
Challenge on day 21 and 35 of the test
Remarks on result:
positive indication of skin sensitisation
Key result
Reading:
other: 3rd reading
Hours after challenge:
72
Group:
test chemical
Dose level:
10 % solution
No. with + reactions:
0
Total no. in group:
8
Clinical observations:
Challenge on day 21 and 35 of the test
Remarks on result:
positive indication of skin sensitisation
Key result
Reading:
other: 4th reading
Hours after challenge:
72
Group:
test chemical
Dose level:
3 % solution
No. with + reactions:
0
Total no. in group:
8
Clinical observations:
Challenge on day 21 and 35 of the test
Remarks on result:
positive indication of skin sensitisation

Any other information on results incl. tables

Capacity to induce allergic sensitisation

After daily applications over three weeks

Sensitisation rate

Number of animals (positive/ total)

Concentration %

Day 21

Day 35

60

4/8

4/8

0/8

0/8

30

10

3

Applicant's summary and conclusion

Interpretation of results:
other: weak contact sensitiser
Conclusions:
Challenge patch with the highest non irritant solution in animals pre-treated with the preparation 60% and 30% are positive in half of the animals.The test chemical can be considered to cause sensitzing reactions to guinea pigs in the OET. The test chemical was considered to be one of the weak contact sensitiser for this species.
Executive summary:

Open Epicutaneous test was carried out to evaluate the dermal sensitization potential of the test chemical

On day 0 of the induction exposure, 0.1ml of the test material, undiluted and, if possible or necessary of its progressively diluted solutions or emulsions or suspensions is applied to an area measuring 8cm2 on the clipped flank skin of 6-8 guinea pigs per concentration group, using 1-6 such groups for each test material.

The applications are repeated daily for 3 weeks or done 5 times weekly during 4 weeks, always using the same skin site. The application site is left uncovered and the reactions, if continuous daily applications are performed, can be read 24 hours after each application or at the end of each week. When very strong skin reactions are provoked, the application site is changed. To determine whether or not contact sensitization was induced, all groups of guinea pigs previously treated for 21 days as described above, as well as 6-8 untreated or only with the vehicle pretreated controls are tested on days 21 and 35 on the contralateral flank with the test material at the minimal irritating and some lower concentrations. The minimal irritating concentration of each material is used in order to confirm the biological activity determined before starting the induction (day-1) and to exclude false results based on instability of test materials. These tests are performed by applying with a pipette 0.025ml of each concentration to skin areas measuring 2 cm2, the reactions being read after 24,48 and /or 72 hours. This procedure enables to determine the minimal sensitising concentration necessary for inducing allergic contact hypersensitivity and the minimal eliciting concentration necessary to cause a positive reaction. The test material is considered allergenic at a concentration when at least one out of the 8 animals of the concentration group concerned shows positive reactions with non-irritant concentrations used for challenge, i.e its threshold concentration causing  skin reactions is shifted into the lower part of the concentration range used for challenge. 6-8 untreated or only with the vehicle pretreated controls are tested on days 21 and 35 on the contralateral flank with the test material at the minimal irritating and some lower concentrations

Challenge patch with the highest non irritant solution in animals pre-treated with the preparation 60% and 30% are positive in half of the animals.The test chemical can be considered to cause sensitzing reactions to guinea pigs in the OET. The test chemical was considered to be one of the weak contact sensitiser for this species.